Performance Work Statement updated 2.27.2026.docx

PERFORMANCE WORK STATEMENT (PWS)

Hematology Analyzer 27 February 2026

PART 1

GENERAL INFORMATION

1.0. General: This is a non-personal service(s) contract under which the personnel rendering the service(s) are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

1.1. Description of Services/Introduction: This is a non-personal service(s) contract to provide Fox Army Health Center, Redstone Arsenal, AL, a Hematology Analyzer with capability to interface with digital cell morphology platform, to allow remote pathologist review of blood smear, reagents, and consumables.

1.2. Background: The Pathology department at FAHC, Redstone Arsenal, Alabama serves soldiers, retirees, and family members and has done so for over 30 years. The laboratory intent is to upgrade from the analyzer to sustain the medical needs of the patients and committed to providing the highest quality healthcare in a friendly and professional environment. The equipment will be located in the hematology section of the laboratory under the management of the Department of Pathology. Funding will be allocated annually subject to the availability of funds.

1.3. Scope: The Contractor shall provide non-personal service(s). The successful offeror shall furnish all equipment, reagents, consumables, controls, and any services i.e., maintenance of furnished equipment to the Department of Pathology, under a Cost-Per-Reportable basis. Under the Cost-Per-Reportable Results arrangement, the Contractor is responsible for providing all equipment, reagents, controls, consumables, and any other parts or services to ensure the laboratory is able to execute the required testing. Contractor shall include delivery, installation, all calibrators/standards, reagents, and quality control materials. This requirement is for a base year beginning 1 January 2026 or date of award through 31 December 2026, and four option years if exercised.

1.4. Objectives:

· Contractor shall ensure analyzer can perform the following tests: Complete Blood Count (CBC), and automated differentials with capability to interface with digital cell morphology platform, to allow remote pathologist review of blood smear.

The system must have a Five Part Differential that includes neutrophils, lymphocytes, monocytes, eosinophils and basophils, cell-by-cell analyses; with WBC Analytical Measuring Range (level that the analyzer can directly measure without dilution) that is within the clinically significant range of 0.2 – 100 x 103 with integrity check flags for abnormalities in RBC, WBC and PLT.”

· Contractor shall ensure analyzer installation requirements conform to existing space limitations and power availability; 115V dedicated power, maximum width 30 inches, maximum depth 30 inches.

· Contractor shall ensure 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)).

1.5. General Information:

1.5.1. Quality Control (QC) and Quality Assurance (QA): The Contractor shall develop and maintain a QC and QA to ensure services are performed in accordance with 1.5.1.2. (IAW) this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor's QCP is the means by which it assures that the work provided complies with the requirements of the contract.

1.5.1.2. The QC Plan shall include: 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.

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

1.5.1.4. 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.

1.5.2. Quality Assurance: 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.

1.5.3. Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g. deliverables, submittals, etc.) deadlines fall on a holiday, the closest workday prior to the holiday will apply as the deadline for submittal.

1.5.3.1. U.S. Holidays: Work shall not be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer. When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

· New Year’s Day - January 1st

· M. L. King Birthday Day - 3rd Monday in January

· Presidents’ Day - 3rd Monday in February

· Memorial Day - Last Monday in May

· Juneteenth - June 19th

· Independence Day - July 4th

· Labor Day - 1st Monday in September

· Columbus Day - 2nd Monday in October

· Veteran’s Day - November 11th

· Thanksgiving Day - 4th Thursday in November

· Christmas Day - December 25th

1.5.4. Operating Hours: Operation Hours are 7:30 am to 4:00 pm CST, Monday through Friday.

1.5.4.1. Government Facility Office Hours/Operating Orders: The Government facility office hours are 7:30 am to 4:00 pm CST, Monday through Friday except U.S. Holidays identified in paragraph 1.5.3.1 above or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.5.4.2. Contractor Support Hours: 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. The Contractor shall maintain an adequate workforce at all times, for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential.

1.5.5. Training Holidays: The Army has historically granted military personnel training holidays as compensation for time that they spent in field training. These are typically combined with regular holiday leave schedules (for example, Christmas half days or days on day off schedules). Training holidays may affect access to military operated facilities. If scheduled work or access to facilities is required, coordination with occupants will be necessary or the work in affected facilities shall be rescheduled after the training holiday. However, announced training holidays or exodus of military personnel may provide the Contractor with an opportunity for unrestricted access to facilities and areas. The Contractor shall take full advantage of such opportunities by planning maintenance or actions that are better accomplished when such areas are vacant.

1.5.6. Place of Performance: The work to be performed under this contract will be performed:

Fox Army Health Center Department of Pathology 4100 Goss Rd SW Redstone Arsenal, AL 35809

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

Department of Pathology FAHC Laboratory Tel: (256) 955-8888 ext. 1039

1.6. Security Requirements: The following information is provided on security related matters.

1.6.1. Security Program: N/A

1.6.2. Installation Access: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

The Contractor shall be aware of and comply with the requirements associated with Installation Access Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements.

The Contractor shall return installation passes to the issuing IACS office when the contract is completed or when a Contractor employee no longer requires access.

1.6.2.1. Installation Pass: The contractor shall ensure each employee obtains the required identification items as applicable for access of contractor personnel, privately owned vehicles and contractor owned/leased vehicles. The contractor personnel and any of their approved subcontractors entering any military installation shall abide by all security regulations and shall be subject to security checks enacted by the Department of Defense. The log must at a minimum contain the following information Name, Company, and vehicle information. The log shall be updated as employees are added or removed.

1.6.3. Individual Termination or Expiration of Employment: The contractor shall notify the FM and COR by the end of the business day in which the release or termination occurs. The contractor shall obtain from employees upon the ending of their employment all base identification and access badging, keys and associated materials by the end of the next business day.

1.6.4. Contract Termination or Cancellation: Upon termination or cancellation of this contract, the Contractor shall collect all outstanding installation access passes and return them to the issuing office within five (5) business days.

1.6.5. Common Access Cards (CAC) and CAC Log: Contract personnel will be issued a common access card (CAC) only if duties involve one of the following: (1) both physical access to a DoD facility and access to DoD information systems or networks; (2) remote access to a DoD information system or network using DoD-approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. Before CAC issuance, contract personnel must have, at a minimum, a favorably adjudicated Tier 1 investigation or an equivalent or higher investigation in accordance with applicable Army regulations and Homeland Security Presidential Directive-12 (HSPD-12). At the discretion of the RA, an initial CAC may be issued based on a favorable review of a fingerprint check and a successfully scheduled Tier 1 investigation with the National Background Investigations Bureau. The RA provides contract personnel with additional information and forms to initiate the CAC issuance process, and/or to initiate background investigations, when required. Contract personnel shall complete these processes within established timelines to avoid delays.

1.6.6. Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use Personnel or any representative of the contractor entering Redstone Arsenal shall abide by all security regulations and shall be subject to security checks. Contractor and all associated sub-contractor employees shall comply with applicable installation / facility access and local security policies and procedures (provided by Government representative as needed). The contractor shall also provide all information required to meet installation access requirements if required including background checks to be accomplished by installation Provost Marshall Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9 (Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes.

1.6.6.1. Ensure personnel report to the Administrative Officer of the Day (AOD) or Plans, Training, Mobilization and Security (PTMS) located within the health center sign in and obtain a temporary vendor security badge PRIOR to commencing all on-site visits, preventive maintenance service, or repairs to equipment in the laboratory under this contract if necessary.

1.6.6.2. Ensure that any requirement to remove, exchange, or add contractor’s equipment during the ordering period of this contract is coordinated through the Contract Officer’s Representative (COR) and must also include the site OIC/NCOIC, Chief, Equipment Management Branch (EMB) and the Property Book Officer (PBO).

1.7. Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the Contracting Officer will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

1.7.1. The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the Government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

1.8. Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. The designation letter states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including Government drawings, designs, specifications, monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.9. Key Personnel: The Contractor shall provide a Program/Contract Manager who shall be responsible for the performance of the work. The name of this person and an Alternate Program/Contract Manager, who shall act for the Contractor when the Program/Contract Manager is absent, along with a Curriculum Vitae (CV) for each of these individuals, shall be provided in writing to the Contracting Officer no later than five (5) days after contract award. The Contract Manager and Alternate Contract Manager shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The Contract Manager or Alternate Contract Manager shall be available between Monday thru Friday 0730 to 1600 CST. Qualifications for all key personnel are listed below:

a. Contract Manager and Alternate Contract Manager: Must speak English and have a full comprehensive understanding of Clinical Laboratory operations and understanding of the analyzer. Must be fully trained to operate the analyzer by vendor.

b. Quality Control Manager: Must speak English and have a full comprehensive understanding of Clinical Laboratory operations and understanding of the analyzer. Must be fully trained to operate the analyzer by vendor.

c. Systems Administrator: Must speak English and have a full comprehensive understanding of Clinical Laboratory operations and understanding of the analyzer. Must be fully trained to operate the analyzer by vendor.

d. Special Qualifications: Must speak English and have a full comprehensive understanding of Clinical Laboratory operations and understanding of the analyzer. Must be fully trained to operate the analyzer by vendor.

1.9.1. Contractor Identification Badges: Contractor personnel shall be easily identifiable through the display of badges IAW Contractor Identification (AE Reg. 27-715). (For services at Child, Youth, and School Services where children are present, recommend personnel wear identification when children are present

1.10. Data Rights: The Government has unlimited rights to all documents and materials produced under this contract. All documents and materials, to include the source codes of software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the Contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.11. Non-Disclosure Requirements: Performance under this contract may require the Contractor to access data and information proprietary to a government agency, another Government Contractor, or of such nature that its dissemination or use other than as specified in this work statement would be adverse to the interests of the Government or others. The Contractor and Contractor personnel shall not divulge, or release data or information developed, or obtained under performance of this PWS, except to authorized Government personnel or upon written approval of the Contracting Officer. The Contractor shall not use, disclose, or reproduce proprietary data, which bears a restrictive legend, other than as specified in this PWS. All documentation showing individual names or other personal information shall be controlled and protected under the provisions of the Privacy Act of 1974, Public Law 93-579, 5 United States Code (U.S.C.) Section 552a.

1.12. Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at www.dimoc.mil/resources/limitations/ , the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.13. Organizational Conflict of Interest (OCI): Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent OCI as defined in FAR Subpart 9.5. The Contractor’s OCI Mitigation Plan will be determined to be acceptable solely at the discretion of the Contracting Officer. In the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.14. Required Training: The following provides information on training requirements.

1.14.1. Anti-Terrorism (AT) Level I Training: AT Level 1 Training. All contractor employees, to include subcontractor employees, requiring access Army installations, facilities, and controlled access areas shall complete AT Level 1 training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR, or to the Contracting Officer, if a COR is not assigned, within 10 days after completion of training by all employees and subcontractor personnel. AT Level 1 Awareness Training is available at the following website: https://atlevel1.dtic.mil/at.

1.14.2. OPSEC Training: AT Level I Training.

This provision/contract text is for contractor employees with an area of performance within an Army controlled installation, facility or area. All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I awareness training annually IAW current contractor personnel training requirements. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website:

https://jkodirect.jten.mil/Atlas2/faces/page/login/Login.seam.

1.14.3. iWATCH Training: This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

PART 2

DEFINITIONS & ACRONYMS

2.0. Definitions and Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer – means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local terminology can be COR, Contracting Officer’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line-item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the Contracting Officer as alternate CORs.”

Contractor – means a supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

Contractor-acquired Property - means property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the Government has title.

Day – means, unless otherwise specified, a calendar day.

Defective Service – means a service output that does not meet the standard of performance associated with the Performance Work Statement.

Deliverable – means anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, Government-furnished Property “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract

Government Property - means all property owned or leased by the Government. Government property includes both Government-furnished and Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

Property Administrator - means an authorized representative of the Contracting Officer appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

High Level Objective (HLO) – means a key overarching result-based objective for a project necessary to achieve the project’s vision. HLOs are similar to Level 2 in a Work Breakdown Structure. Each HLO may contain several statements to flesh out the areas necessary to meet the objective.

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance – (or Government contract quality assurance) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – means the key Government-developed surveillance process document and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the Performance Work Statement (PWS). It provides specific details on how the Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished; however, they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas necessary to meet the objective. Statements are similar to Level 3 in a Work Breakdown Structure.

Subcontractor – means one that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Workday - The number of hours per day the Contractor provides services in accordance with the contract.

Work Week - Monday through Friday, unless otherwise specified.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

USAG United States Army Garrison WAWF Wide Area Workflow

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3.0. Government Property and Services: N/A

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4.0. Contractor Furnished Property and Services

4.1 General: The Contractor shall furnish and deliver one new automated hematology analyzer; including auxiliary equipment including the following:

4.2. Materials: The contractor shall furnish all materials required to perform maintenance, repairs, or service. Any costs associated with travel, lodging or meals to conduct services or preventive maintenance will be at the cost of the contractor.

4.2.1. Completion of Service. Upon completion of services, a written service report will be provided to the Biomedical Maintenance / Clinical Engineering Manager and lab supervisor. The service report shall be completely filled out, provide detailed information regarding the cause of equipment malfunction and corrective action taken, to include the time required to complete the work, price of labor (hourly rate), and a list of parts replaced with a price for each part. In the event all information is not available to contractor’s representative when services are performed, the initial service report shall include all information stated above except for price. Contractor shall provide the balance of the required information in writing to the Department of Pathology as soon as possible.

4.2.2. Contractor shall provide new and/or refurbished parts that are certified and documented to meet Original Equipment Manufacturers (OEM) specifications on all manufacturers’ mandatory modifications and apply recalls by FDA.

4.2.3. Contractor shall provide new or updated user manuals when changes are made at no additional cost.

4.2.4. Contractor shall furnish all applicable MSDS for reagents, equipment and supplies utilized under this contract at no additional cost.

4.2.5. Contractor shall deliver one Automated Complete Blood Count System and Components with the following test capabilities:

(MCH)

Concentration (MCHC)

4.3. Vehicles and Equipment: N/A

PART 5

SPECIFIC TASKS

5.1. Basic Services: The Contractor shall provide Fox Army Health Clinic laboratory with new FDA approved Hematology analyzers on a cost per reportable result (CPRR) basis with reagents, supplies, maintenance, parts as required in order to maintain the system in optimal operating condition, consumables and installation and removal. The equipment use, equipment service, calibrators, and reagents are to be included in the cost and proposal. This contract will include telephonic technical support available 24/7, and in-house service (8 x 5) as needed for all analyzers on contract. The systems must be compatible with the current laboratory information system (LIS) which is Cerner Millenium/Military Health System-Genesis (MHS-G) and must include all normal ranges, reference intervals and units of measurement for each assay. The Contractor must provide a type-one reagent grade water system that the Contractor installs and maintains, if applicable/required. Service contract covering the term of the agreement is the requirement of the contractor, if required.

5.2. Tasks: Tasks consist of the following:

a) To perform maintenance, repairs, or service to maintain contractor owned equipment. Any costs associated with travel, lodging or meals to conduct services or preventive maintenance shall be at the cost of the contractor.

b) Upon completion of maintenance services provide a written service report.

c) Contractor shall provide new and/or refurbished parts that are certified and documented to meet Original Equipment Manufacturers (OEM) specifications on all manufacturers’ mandatory modifications and apply recalls by FDA.

d) Contractor shall furnish all applicable MSDS for reagents, equipment and supplies utilized under this contract at no additional cost.

e) Contractor shall perform installation validation prior to contract initiation including:

· Precision studies

· Accuracy studies

· Method comparison

f) The Contractor shall provide with its quotation, a transitioning plan for the complete transition to including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all comparisons and validations. This transition shall be completed no later than 60 days after date of award. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe.

g) Contractor shall provide training in the operation of the analyzer including:

· Up to 10 operator level training during installation

· Two (2) key operator training including travel and lodging, available for scheduling within six (6) months of installation.

h) Contractor shall provide routine testing should require minimal technician intervention; examples include minimal pre-treatment requirements, bar coded reading of primary sample tubes and reagents.

i) Contractor shall provide on-site technical support for analyzer installation and maintain a fully operational status.

j) Contractor shall ensure proper packaging and shipping of reagents, supplies, and equipment according to manufacturer specifications.

k) Contractor shall provide reagent updates for any reagents in writing within 5 business days and ensure continuity of services and availability of reagents during reagent revision when required.

l) Contractor shall ensure reagents meet quality control guidelines set forth by manufacturer.

m) Contractor shall provide all software upgrades at no additional cost.

n) Contractor shall notify the laboratory within 24 hours of manufacturer’s recalls for all reagents or equipment.

o) Contractor shall perform all on-site scheduled service as specified by the manufacturer’s published maintenance manual as necessary to keep analyzer in good condition including lubrications, cleaning (other than those performed at the operator’s level), calibrations, and diagnostics, during the lease period at no additional cost.

p) A technical assistance or support center shall be available by telephone hotline 24/7 days/week with a maximum call back response time of 1 hour with on-site service provided, not to exceed 24 hours following determination that site service is required. The technical assistance center shall be staffed with personnel who are fluent in English without the use of an interpreter.

q) Contractor shall ensure analyzer can perform the following tests: Complete Blood Count (CBC), and automated differentials.

r) Contractor shall ensure analyzer installation requirements conform to existing space limitations and power availability; 115V dedicated power, maximum width 30 inches, maximum depth 30 inches.

s) Contractor shall ensure analyzer has capability to interface with digital cell morphology platform, to allow remote pathologist review of blood smear

t) Contractor shall ensure 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)).

u) The system will come equipped to perform continuous, random and statistical analysis; capable of real time or (on-line) Quality Control. Provide QC assessment with comparison to a peer group on a daily, weekly, and monthly basis, to include QC Lot’s, means, ranges, SD, and CVs%. Changing or modifying existing QC parameters can be performed during instrument operation (e.g. “on-the-fly”).

v) The system must have positive patient identification via on-board barcode scanner.

w) The system must have a Five Part Differential that includes neutrophils, lymphocytes, monocytes, eosinophils and basophils, cell-by-cell analyses; reportable range from 0.2 – 100 x 103 with integrity check flags for abnormalities in RBC, WBC and PLT.” The accuracy of the automated differential as compared to manual differentials will be no less than the accuracy of the current system.

5.3. Service Contract Reporting

5.3.1. System for Award Management (SAM) Service Contract Report (SCR): Reserved

PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions): The following publications, manuals, regulations, etc. are mentioned in this PWS and are listed below.

6.1. Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard (AUTO01-A)

Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard (AUTO02-A2) Laboratory Automation: Communications With Automated Clinical

Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition (AUTO03-A2)

Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard (AUTO04-A)

Laboratory Automation: Data Content for Specimen Identification; Approved Standard (AUTO07-A) Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard (AUTO09-A) Autoverification of Clinical Laboratory Test Results; Approved Guideline (AUTO10-A)

IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard (AUTO11-A)

Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline— Third Edition (C28-A3)

Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition (EP05-A2)

Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (EP06-A)

Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition (EP07-A2)

Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Second Edition (EP09-A2) Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline-Third Edition (EP10-A3)

Laboratory Statistics — Standard Deviation; A Report (EP13-R)

Evaluation of Matrix Effects; Approved Guideline—Second Edition (EP14-A2)

User Verification of Performance for Precision and Trueness; Approved Guideline-Second Edition (EP15-A2) Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline (EP17-A) Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition (EP18-A2)

Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline (EP21-A) Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard (H17-A)

Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved Standard—Second Edition (LIS01-A2) Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard—Second Edition (LIS02-A2)

Standard Guide for Selection of a Clinical Laboratory Information Management System (LIS03-A) Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems (LIS06-A) Standard Specification for Use of Bar Codes on Specimen Tube in the Clinical Laboratory (LIS07-A)

Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems (LIS08-A) Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architecture (LIS09-A)

PART 7

PERSONALLY IDENTIFIABLE INFORMATION, PROTECTED HEALTH INFORMATION AND

FEDERAL INFORMATION REQUIREMENTS

7.1. General Requirements Overview ‐ Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Laws. This Section addresses the Contractor’s requirements under The Privacy Act of 1974 (Privacy Act), The Freedom of Information Act (FOIA), and The Health Insurance Portability and Accountability Act (HIPAA) as set forth in applicable statutes, implementing regulations and Department of Defense (DoD) issuances. In general, the Contractor shall comply with the specific requirements set forth in this Section and elsewhere in this Contract. The Contractor shall also comply with requirements relating to records management as described herein.

7.1.1. This Contract incorporates by reference the federal regulations and DoD issuances referred to in this Section. If any authority is amended or replaced, the changed requirement is effective when it is incorporated under contract change procedures. Where a federal regulation and any DoD issuance govern the same subject matter, the Contractor shall first follow the more specific DoD implementation unless the DoD issuance does not address or is unclear on that matter. DoD issuances are available at http://www.dtic.mil/whs/directives.

7.1.2. For purposes of this Section, the following definitions apply.

· DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDI 5400.11, DoD Privacy and Civil Liberties Programs, January 29, 2019, and DoDI 5400.11‐ R, Department of Defense Privacy Program, May 14, 2007.

7.1.3. HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 Code of Federal Regulations (CFR) Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C‐E (Enforcement), as amended. Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this Section and are not included in the term HIPAA Rules.

7.1.4. DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoDM 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs,” March 13, 2019, DoDI 6025.18, Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs, March 13, 2019, and DoDI 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs, August. 12, 2015. Defense Health Agency (DHA) Privacy Office is the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Chief is the HIPAA Privacy and Security Officer for DHA.

7.2. Records Management: When creating and maintaining official government records, the Contractor shall comply with all federal requirements established by 44 United States Code (U.S.C.) Chapters 21, 29, 31, 33 and 35, and by 36 CFR, Chapter XII, Subchapter B – Records Management. The Contractor shall also comply with DoD Administrative Instruction No. 15 (DoD AI‐15), “OSD Records and Information Management Program” (May 3, 2013) and Records Management requirements outlined in the current TRICARE Operations Manual (TOM).

7.3. Freedom of Information Act (FOIA): The Contractor shall comply with the following procedures if it receives a FOIA request and immediately contact the DHA FOIA Officer for evaluation/action:

7.3.1. The Contractor shall inform beneficiaries that DHA FOIA procedures require a written request preferably sent via the National FOIA Portal at: www.FOIA.gov. However, requesters may also submit requests via email at DHA.FOIA@mail.mil; or via postal delivery addressed to the DHA Freedom of Information Service Center, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042‐5101. All FOIA requests shall describe the desired record as completely as possible to facilitate its retrieval from files and to reduce search fees which may be borne by the requestor. Contract and/or Modification numbers must be included in all FOIA requests seeking DHA procurement records.