PWS 12 MAY 25_Redacted.pdf

AUG 22

PERFORMANCE WORK STATEMENT (PWS)

Hematology Cost-Per-Test 12 May 2025

Part 1

General Information

1. 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 two (2) total hematology analyzers capable of performing on-board standard hematology analysis. Each analyzer must be adapted for and must meet the specific testing workload and workflow for Evans Army Community Hospital (EACH). EACH also has the additional requirement of a slide-maker stainer and digital cell image analyzer.

1.2 Background: Hematology testing is currently being performed at EACH, where approximately 40,000 test are performed annually.

1.3 Scope: The Contractor shall provide non-personal services. Cost Per Test pricing shall include costs covering:

a) All associated equipment

b) All associated supplies and consumables

c) Scheduled and emergency maintenance

d) Set-up, installation, and removal of equipment

e) Training and written procedures/records

1.4 Objectives: The objective of this contract is to provide in-house hematology testing for the patient population of EACH.

1.5 General Information:

1.5.1 Quality Control Plan (QCP): The Contractor shall develop and maintain a QCP to ensure services are performed in accordance with (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.

The Contractor’s Proposed QCP shall be submitted to the Contracting Officer (KO) through the Contracting Officer’s Representative (COR) for review within 10 days after date of contract.

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within 10 days. If the Government has provided comments, the Contractor shall then have 10 days to submit a Final QCP. After receipt of the

Final QCP, the Contractor may receive the Contracting Officer’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the Contracting Officer no later than 10 days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control Team;

(b) How the Contractor will monitor work to ensure performance complies with all deliverables (etc. timelines, deadlines, and goals);

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses;

(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including Department of Defense (DoD) Contractor Personnel Office (DOCPER) processes/approvals throughout contract performance;

(e) How the Contractor will ensure all keys issued will remain controlled items

(Paragraph 1.7 Key Control);

(f) How the Contractor will inventory and track maintenance of all Government Provided

Equipment / Materials;

(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

(h) How the Contractor will file and save all Quality Control related documents for the life of the contract plus 5 years.

1.5.1.1 An Analysis of Quality Control and Timeliness of Submittals (i.e. deliverables) shall be provided to the COR within 30 days upon completion of each option period or Task Order (Deliverable #1).

1.5.1.2 The Contractor shall inform the COR of issues or potential issues that might affect the performance within 24 hours of identifying those issues. Verbal reports shall be followed up by written reports within 3 working days (Delieverable #2).

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).

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 work day 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 Memorial Day 3rd Monday in Jan 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

1.5.3.2 Host Nation Holidays: N/A

1.5.4 Operating Hours: The Government facility office hours, facility operating hours, and the Contractor support hour requirements often coincide, however, they may differ. Please refer to the following.

1.5.4.1 Government Facility Office Hours: The Government facility office hours are Monday through Friday, between 0730 and 1630 local time, 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 Government Facility Operating Hours: The Government facility is operating 24 hours a day, seven days a week, to include holidays.

1.5.4.3 Contractor Support Hours: The Contractor shall provide support between the hours of 0730 to 1630 local time, Monday through Friday. No preventive maintenance or consumable deliveries may be made on Saturdays, Sundays, or federal holidays. If weather conditions exist which prevent a service technician from responding within 24 hours for on-site repairs, Clinical Laboratory staff and the COR shall be notified within 2 hours of the scheduled time the service technician is to arrive. 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.

1.5.4.3.1 Contractor Work Plan: N/A

1.5.5 Training Holidays: N/A

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

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

1.6.1 Security Program: Individuals shall appear at the host-installation Visitor Control Center or DHA security office to be identity-proofed and vetted IAW DHA-AI 5210.01.

1.6.2 Personnel Security Clearance Requirements: A security clearance is not required on this contract. Contractor personnel performing work under this contract will adhere to DHA-AI 5210.01.

1.6.3 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.

1.6.3.1 Installation Pass Log: In addition, the Contractor shall provide the Contracting Officer, via the COR, an Initial Installation Pass Log within 3 days after contract. The log must at a minimum contain the following information: names of individuals authorized to perform work on this contract, and the date of last security investigation. The log shall be updated as employees are added or removed. The Updated Installation Pass Log shall be current and available at any time upon request by the Government and submitted to the COR within five

(5) days after any changes to the log (Deliverable #3).

1.6.3.2 Individual Termination or Expiration of Employment: The Contractor shall collect the installation access passes the same day employment of an individual has expired or has been terminated and shall return them to the issuing office within 3 business days.

1.6.3.3 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 3 business days.

1.6.4 Background Checks: Individuals shall appear at the host-installation Visitor Control Center or DHA security office to be identity-proofed and vetted. A valid and unexpired driver’s license or ID card issued by a State, provided it contains a photograph and biographic information such as name, date of birth, gender, and address, may be used for proofing and vetting purposes. ID will be physically proofed (hands-on), cross-checked, and validated against authoritative databases. Additionally, a Federal, State, or local Government-issued ID card may be used provided it contains a photograph and biographic information such as name, date of birth, gender, and address.

1.6.4.1 U.S. Citizen: N/A

1.6.4.2 Local Nationals and Third Country Nationals: N/A

1.6.5 Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured IAW the Army Physical Security Program (AR 190-13.”)

1.6.6 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel.

1.7 Key Control: Keys will not be issued to any contractor, at anytime during the period of performance. All contractors will be escorted.

1.8 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.

1.8.1 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.

1.9 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.

1.10 Key Personnel: The Contractor shall provide a point of contact (POC) that shall be responsible for the performance of service work on the analyzers. The Contractor shall designate this individual, in writing, and provide contact information to the Government. An alternate POC may be designated, but the Contractor must identify those times when the alternate shall be the primary POC. The Point of Contact shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The Point of Contact shall be available between 0730 to 1630 local time, Monday through Friday.

a. Government Contract Manager and Alternate Contract Manager:

b. Authorized Callers: Only these individuals are authorized to place calls. Hematology

Awardee should not accept calls from anyone whose name does not appear on this list or for any items that are not included on the approved price list. The Government is not obligated to pay for any unauthorized items or calls placed by unauthorized personnel.

The person placing the order may be held personally liable for any unauthorized calls.

1.11 Identification of Contractor Employees: All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties must identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.12.1 Contractor Identification Badges: Contractor personnel shall be easily identifiable through the display of badges IAW Contractor Identification (AE Reg. 27-715). Contractors are expected to be badged through Medical Maintenance prior to being escourted to the work area.

1.13 Contractor Travel: N/A

1.14 Other Direct Costs (ODCs): N/A

1.15 Data Rights: N/A

1.16 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.

1.17 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.

1.18 Non-Disclosure Statements: N/A

1.19 Organizational Conflict of Interest (OCI): N/A

1.20 Phase In /Phase Out Period: The vendor shall complete correlation, precision, linearity, normal range, reportable range and any other required validation studies when the instruments are installed. The validation period for hematology testing can take up to 30 days.

1.21 Safety: The following provides information pertaining to Safety and Accident Prevention:

1.21.1 The Contractor shall ensure its personnel are familiar with facility safety regulations.

Such regulations include, but are not limited to, general safety, fire prevention and waste disposal. All Evans Army Community Hospital regulations are accessible through the Evans Army Community Hospital intranet or can be provided by the Lab and/or NCOIC upon written request from the Contractor.

1.21.2 The Contractor shall ensure its personnel comply with the local installation requirements regarding the use of company or privately owned vehicles and the operation of same on the military installation to include appropriate driving licensure and liability insurance coverage.

1.21.3 Contactor will ensure that any company owned/operated vehicles used in the course of providing these contracted services are maintained in a manner so as to not leak or otherwise contaminate the areas on which they are stationed. Contractor is fully responsible for the safe storage and disposal of any by-products produced in the course of performing these contracted duties.

1.22 Enviromental Compliance: N/A

1.22.1 Environmental Compliance Plan and Program: N/A

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

PART 2

DEFINITIONS & ACRONYMS

2. 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-furnishedand 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.

Work Day - 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.

ACOR Alternate Contracting Officer's Representative AE Army in Europe AFARS Army Federal Acquisition Regulation Supplement AHA Activity Hazard Analysis AOR Area of Responsibility AR Army Regulation AT Anti-terrorism ATCTS Army Training Certification Tracking System CAC Common Access Card CCE Contracting Center of Excellence CFE Conventional Forces Europe CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer’s Representative COTS Commercial-Off-the-Shelf DA Department of the Army DD250 Department of Defense Form 250 (Receiving Report) DD254 Department of Defense Contract Security Requirement List DFARS Defense Federal Acquisition Regulation Supplement DMDC Defense Manpower Data Center DoD Department of Defense EACH Evans Army Community Hospital EMB Equipment Management Branch FAR Federal Acquisition Regulation FRG Federal Republic of Germany GFP Government Furnished Property HLO High Level Objective HIPAA Health Insurance Portability and Accountability Act of 1996 IA Information Awareness IAC Installation Access Control IACO Installation Access Control Office IAW In Accordance With ID Identification IGCE Independent Government Cost Estimate IT Information Technology JTR Joint Travel Regulation

JPAS Joint Personnel Adjudication System KO Contracting Officer OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPSEC Operations Security PA Property Administrator PII Personally Identifiable Information PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program RA Requiring Activity RCO Regional Contracting Office SIGE Safety and Health Protection Plan TE Technical Exhibit UOM Unit of Measure

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: The Government will provide all site-specific access clauses, processes and procedures will be provided by each site to the vendor for each respective site.

3.2 Facilities: Government will provide an adequate work environment to include proper heat, light, ventilation, and electrical outlets for use by the analyzer(s) and Contractor personnel when servicing the equipment.

3.3 Utilities: The Government will provide all utilities in the facility will be available for the contractors use in performance of the tasks outlined in the PWS. The Contractor shall instruct employees in utilities conservation practices. The Contractor shall operate under conditions that preclude the waste of utilities, which include turning off the water faucets or valves, light switches, etc. after using the required amount to accomplish tasks requiring the use of the utilities.

3.4 Equipment: Not applicable.

3.5 Special Tooling and Test Equipment: Not Applicable.

3.6 Materials: The Government will provide laboratory coat and gloves when the Contractor personnel are working in a potentially infectious area of the laboratory.

3.7 Training: The Government will provide the following training: iWATCH

3.8 Common Access Cards (CAC): Common Access Cards are not issued under this task order.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: The Contractor shall furnish all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the PWS and associated contract documents, except for those items specified in Part 3 Government Property and Services

4.2 Secret Facility Clearance: Not applicable.

4.3 Materials: The Contractor shall provide all materials necessary to perform services as described in the PWS.

4.4 Vehicles and Equipment: The Contractor shall provide all necessary vehicles (no GSA vehicles provided to Contractor for use on this contract) and equipment to perform the work described in this PWS. All Contractor provided vehicles and equipment shall have the company name prominently displayed on both sides of the vehicle or equipment and present a neat, professional appearance. Contractor's vehicles and equipment used in the performance of this contract shall meet all local, safety, and environmental requirements. Vehicles and equipment found to be unsafe shall be removed from the installation and replaced. The Contractor shall not use any Government-owned tools, materials, or parts to maintain Contractor vehicles and equipment without prior written approval of the Contracting Officer.

The COR may inspect the Contractor’s vehicles and equipment at any time.

4.5 Background Checks): The Contractor shall provide Background Checks in accordance with this PWS and as determined by the Government.

PART 5

SPECIFIC TASKS

5.1 Basic Services: The Contractor shall provide services for a Cost-Per-Test hematology analysis. The Hematology Analyzers required for this site will accommodate a variety of sample tubes to include primary collection tubes and micro sample tubes and shall meet the testing and volume requirements as provided in Attachment 1.

5.2 Tasks: Tasks consist of providing the following:

(a) All associated equipment

(b) All associated supplies and consumables

(c) Scheduled and emergency maintenance

(d) Set-up, installation, and removal of equipment

(e) Training and written procedures/records

(f) Personnel

5.2.1 Equipment

5.2.1.1 Two (2) Hematology Analyzers capable of performing on-board standard hematology testing with the following capabilities (to include tests but not limited to): complete blood count with a chartable six part differential with auto loader, differentiation of WBC precursors, enumerated nucleated RBC, reticulocyte count, reticulocyte hemoglobin, precise platelet measuring that will automatically detect platelet interference without operator intervention and body fluid capability with differential. Minimum throughput of 100 samples/hour; 2) Automated slide-maker stainer; and 3) Digital cell image analyzer. At no time will the Government take ownership of any equipment provided by the contractor.

(a) Analyzers must not be older than 1 years at time of deliver.

(b) Analyzers must be capable of bar code reading, cap piercing and sample level sensing, to include clot detection.

(c) Analyzers must provide platelet enumeration using a methodology that reduces the number of platelet flags requiring manual confirmatory procedures. Reduction of manual tests greatly increases the man- power utilization and enhances workflow. This results in quicker results to the clinicians. It also improves the speed and results of platelet counts necessary for epidural procedures, providing a definite OB/GYN patient benefit.

(d) Analyzer must provide either six part or five part automated differential to meet each site’s individual requirements.

(e) Analyzers for Evans Army Community Hospital must provide body fluid cell enumeration. These criteria reduce manual counting and serve to eliminate operator error. Body fluid counts, while a routine test, occur with a small enough frequency that operator retraining is often needed. Having a fully automated body fluid procedure with a large reporting range provides improved results.

(f) Analyzer should be composed of modular components which will allow for future expansion as workload dictates.

(g) Analyzers at Evans Army Community Hospital must be able to be physically connected to each other and work in tandem in order to allow efficient through-put and load balancing, thereby minimizing operator intervention and improving workflow.

Connected slide-maker stainer and digital cell image analyzer further increase efficiency by providing reflexive slide preparation and examination.

(h) The Contractor shall furnish all software upgrades at no additional cost to the

Government.

(i) Analyzer operating systems must include the capability to track and store, at a minimum, 90 days of calibration, quality control (QC) and patient result data and provide for visual display of graphs and curves for QC data. The operating system must interface with the customer’s laboratory information system (LIS) via RS 232C bidirectional interface and accommodate ASCII query capability to process specimen identification, work orders from the LIS. The operating system must be capable of auto-validation with the LIS. The system will utilize random access sampling to allow for STAT or ASAP sample loading.

(j) If an operating system is being utilized either on the instrument, or through a middleware or workstation, it must be Windows 10 or Win SQL Server 2008 RS SP2 compatible or better.

(k) System must already have an available driver built in coordination with Data

Innovations to ensure the instrument will be able to interop with the existing LIS system Composite Health Care System (CHCS), or Genesis, and/or other government Electronic Health Record and ordering systems, unless the instrument will function as a standalone.

(l) The contractor shall provide operable printers and toner for said printer at each site.

5.2.2 Supplies and Consumables

(a) The Contractor shall provide all parts, accessories, reagents, calibrators, linearity products, controls, etc., required for installation and operation.

(b) The Government will request consumables/supplies based on each institution’s needs. The supply levels required and provided will be based on the needs of each institution. Evans Army Community Hospital operates seven-days per week, three-shifts per day.

(c) Controls and reagents should have the longest shelf life and stability to reduce reagent handling and storage space utilized.

5.2.2.1 Reagents

(a) All reagents should be “ready-to-use” and require no user performed reagent preparation for any standard testing method.)

(b) Reagents must have a bar-code identification containing the lot number, expiration date, and unique identification code.

(c) Bulk deliveries of reagents must contain the same lot number for each analyte delivered.

(d) Reagents and consumables will be shipped to:

5.2.2.2 Maintenance

(a) Maintenance support for Evans Army Community Hospital will be required 24 hours per day/7 days per week.

(b) Preventative maintenance must be self-contained and automated to further increase laboratory productivity. The automated process must not take longer than 15 minutes to ensure that patient resulting is possible at all times.

(c) Calibration intervals will be specifically matched to testing performed by each

Government institution.

(d) The Contractor shall provide their commercial service/maintenance schedule/agreement for each piece of equipment provided under this requirement.

(e) The Contractor shall provide 24/7 telephone access to a troubleshooting service.

(f) The Contractor shall respond to all emergency service calls within one (1) hour by phone, and if required, arrive on-site within 24 hours or at a mutually agreed upon time.

(g) The Contractor shall coordinate preventive maintenance scheduling through each

Government institution as necessary.

Routine or preventive maintenance will be scheduled during daytime business hours, Monday through Friday, between 0730 and 1630 local time.

(h) Emergency service can be coordinated outside of normal business hours. No preventive maintenance or consumable deliveries may be made on Saturdays, Sundays, or federal holidays. If weather conditions exist which prevent a service technician from responding within 24 hours for on-site repairs, Clinical Laboratory staff must be notified within 2 hours of the scheduled time the service technician is to arrive.

(i) If on-site service is required, the Contractor must arrive on-site within: 24-hours from the time of the service call if the analyzer is inoperable; within 48-hours if the analyzer is operating, but with difficulty; and within 3 work days, if the system is exhibiting minor problems which do not inhibit analyzer operation or patient result quality.

(j) The Contractor shall be responsible for cleanup of any and all areas where maintenance has been performed.

(k) All non-consumable service parts for the analyzer are the responsibility of the

Contractor. Any parts removed or replaced from the equipment shall remain property of the Contractor. After receipt of replacement parts, the Government shall return all defective parts as instructed by the Contractor via surface carrier. Shipping expense of all parts is the responsibility of the Contractor.

(l) All Contractor employees shall check in and check out within the standard operating procedures for each Government institution. For any Contractor visits for maintenance and repairs for E

(m) All equipment must be returned to fully operational condition before a laboratory technician accepts the work. The laboratory technician will inspect the work for completion and sign a work order prior to the service repair technician’s departure.

Immediately following each preventive maintenance or repair visit, the Contractor’s service technician will submit a written report to the EMB according to their commercial practices that explains the repairs and/or maintenance performed.

5.2.2.3 Installation

(a) The vendor shall complete correlation, precision, linearity, normal range, reportable range and any other required validation studies when the instruments are installed.

(b) All analyzers should be delivered, installed and fully functioning NLT 1 Oct 2025.

(c) Analyzers shall be capable of performing testing with minimal to no manual preparation of samples by technicians.

(d) The Contractor shall remove all equipment at the conclusion of the task order.

5.2.2.4 Training/Records

(a) The Contractor shall provide training on all equipment provided to respective Government personnel at each site at time of delivery/installation.

(b) Due to the high turn-over rate of military staff operators, the Contractor will provide

Government personnel annual training.

(c) Evans Army Community Hospital will be allotted 1 training slot per year for advanced users.

(d) The Contractor shall provide hard copies of the manufacturer’s manual(s) for use in the event that the automated management system is non-functional.

(e) If training provided is off-site for the Contractor, airfare, lodging, meals, and local transportation will be at the Contractor’s expense.

(f) In the event of any changes or revision in test methodology, the Contractor shall provide such changes in writing to the Government within five (5) days from publication of changes.

(g) The Contractor shall be responsible for creating, maintaining, and disposing of only those records specifically required by provisions of mandatory directives, specifically those identified by the College of American Pathologists (CAP) accreditation guidelines.

(h) If requested by the Government, the Contractor will provide the original record, or a reproducible copy of any such record within two (2) working days of receipt of the request.

5.2.2.5 Personnel

(a) Licensing and Certification: The Contractor shall provide evidence of reapplication for any state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certifications such as those issued by CAP to the Government within 60 days prior to license expiration. The Contractor shall provide a copy of the renewed licenses or certificates to the Government prior to expiration.

5.3 Service Contract Reporting

5.3.1 System for Award Management (SAM) Service Contract Report (SCR): The Contractor shall report ALL Contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the hematology cost-per-test via a secure data collection site. The Contractor is required to completely fill in all required data fields through the following web address: www.sam.gov. Reporting inputs will be for the labor executed during the period of performance during each Government FY, which runs from October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. Contractors may direct questions to the help desk by clicking “View Assistance for SAM.gov” which is located at the top of the SAM.gov website. From there, you can the select “Contact Our Service Desk” which will allow you to contact SAM.gov directly. If contract period of performance ends prior to September 30, the Contractor has 30 calendar days from end date of the contract to complete the SAM SCR requirement.

Steps for Submitting a Service Contract Report (SCR)

1. Go to www.sam.gov and log in.

2. Select Entity Registrations and then select Service Contract Reporting.

3. SAM displays your entities which have service contracts and meet the reporting criteria.

Select View by entity to see the service contracts for each entity.

4. Next, select Add for the service contract against which you want to create a Service

Contract Report. Each service contract which meets the FAR Subpart 4.1703 reporting thresholds is displayed.

5. You will be taken to the Complete Service Contract Report page. SAM displays the contract details and allows you to report. You are required to enter the following information:

• Total Amount Invoiced: Total dollar amount invoiced for services performed during the previous Government fiscal year under the contract (this amount should include the prime and any subcontract amount).

• Prime Contractor Hours Expended: Prime contractor direct labor hours expended on the services performed during the previous Government fiscal year. The amount you enter is automatically divided by 2,080 hours to calculate a Full Time Employee (FTE) equivalent, displayed under the Prime Contractor Hours Expended as Prime Contractor FTEs.

6. Report any required Tier 1 subcontractor information by selecting the Add Tier 1 Subcontract Information button.

7. When you are ready to submit the report, select Submit. This saves your report and returns you to the Select Service Contract page where you can create other SCRs or edit an existing SCR.

Steps for Editing a Submitted Report

1. Follow steps 1-4 above. Any previously submitted SCR will have a View/Edit button instead of an Add button.

2. Select View/Edit. You will be able to view the current SCR, edit available fields, and resubmit the record. You can also delete previously entered information altogether.

STD: All information provided by the Contractor shall be accurate, complete, and not exceed suspense dates noted in corresponding paragraph above.

AQL: 100% Compliant

5.4 Department Management Framework

5.4.1 Department of Risk Management Framework (RMF) Implementation Plan

5.4.2 The Contractor shall provide information for the Risk Assessment Analysis to the government for all networking IT applicability.

5.4.3 Contractors shall only offer equipment which already have an Authorization to Operate

(ATO).

5.4.4 Contractor shall deliver instruments within 60 calendar days after award for instrument validation

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

Relocation or movement of equipment will not be done without permission of the COR and the Contractor is responsible for replacing the equipment and meeting the standard of conduct of the contract.

5.4.6 Contractors shall provide a completed Joint Medical Device Risk Assessment Questionnaire (v1.1) for the offered system along with their offer. These should be provided by DHA Cyber Logistics or local IMD.

5.4.7 Contractors shall meet all the below RMF minimum requirements along with any additional RMF requirements listed/attached to the RFO.

5.4.8 Submitting a quote for any requirement under this initiative constitutes full agreement to all specific Service IA requirements.

5.4.9 Failure to agree to the attached Service IA requirements and to provide a completed Joint Medical Device Risk Assessment Questionnaire shall result in rejection of the contractor’s quote. Failing to disclose that a system cannot meet IA requirements, failure to meet certification timeframes or failure to receive/maintain ATO may result in termination for cause in accordance with FAR 52.212-4(m). Contractor must stay current with ATO annually and cannot allow it to lapse.

PART 6

APPLICABLE PUBLICATIONS

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

6.1.1 Department Of Defense Contract Security Classification Specification (DD Form 254)

6.1.2 Department of Defense Security Agreement (DD Form 441)

6.1.3 National Industrial Security Program Operating Manual (DoD 5220.22-M)

6.1.4 Installation Access Control (AE Reg 190-16)

6.1.5 The Army Physical Security Program (AR 190-13)

6.1.6 Contractor Identification (AE Reg 27-715)

6.1.7 U.S. Army Corps of Engineers Safety and Health Requirements Manual (EM 385-1-1)

6.1.8 Information Assurance Workforce Improvement Program (DoD 8570-M)

6.1.9 Information Assurance Training Certification and Workforce Management Directive (DoDD 8570.01)

6.1.10 Information Assurance (AR 25-2)

6.1.11 Electromagnetic Compatibility Directive (2004/108/EC)

6.1.12 Policies and Procedures for Property Accountability (AR 735-5)

6.1.13 Defense Health Agency Physical Security Program (DHA-AI 5210.01)

PART 7

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

7. Attachment and Technical Exhibit List

7.1 Technical Exhibit A – Performance Requirements Summary

7.2 Technical Exhibit B – Deliverables Schedule

7.3 Attachment 1 – Estimated Workload Data

7.4 Attachment 2 – Historical Workload Data

7.5 Attachment 3 – Government Property (GP) N/A

Government within 60 days prior to license expiration.

The Contractor shall provide a copy of the renewed licenses or certificates to the Government prior to expiration.

PRS #5 - Service Contract Reporting

(SCR)

PWS 5.3

The Contractor shall completely fill in all the information in the format using the following web address www.sam.gov The contractor shall provide the estimated total cost (if any) incurred to comply with this reporting requirement.

Reporting period shall be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. If contract period of performance ends prior to September 30, the contractor has 30 days from end date of the contract to complete the SCR requirement.

Zero Deviation from Standard

100% Inspection

TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

ATTACHMENT 2

HISTORICAL WORKLOAD DATA

ITEM NAME ESTIMATED QUANTITY

Oct 1 2020 – 30 Sep 2021 Ordering Period

Tests 48,652

1 Oct 2021 – 30 Sep 2022 Ordering Period

Tests 35,312

1 Oct 2022 – 30 Sep 2023 Ordering Period

Tests 36,566

1 Oct 2023 – 30 Sep 2024 Ordering Period

Tests 39,274

1 Oct 2024 – 30 Sep 2025 Ordering Period *est.based off Q1*

Tests 39,567