HT940724Q00010 Attachment 1- PWS.pdf

Performance Work Statement Hematology Analyzer Lease

375th Medical Group (375 MDG) Scott AFB IL 16 September 2024

Period of Performance: Hematology Analyzer Base plus one (1) option year and two (2) one (1) year options.

CLIN 1: 1 October 2024 – 30 September 2025

Base PoP: 1 October 2024 – 30 September 2025 OY1: 1 October 2025 – 30 September 2026 OY2: 1 October 2026 – 30 September 2027

Description of Service: The contractor shall furnish one (1) complete fully automated stand-alone analyzer that performs CBC with a full differential (at least Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils) according to the entire menu of hematology testing as listed in this Statement of Work. In addition, the analyzer will perform a fully automated Reticulocyte count and Reticulocyte Hemoglobin. Our monthly Retic average is 25. Our monthly CBC with differential is 600. The analyzer, complete menu of tests, and all reagents will be Food and Drug Administration approved for clinical laboratory testing in accordance with Title 21 of the Code of Federal Regulations, Parts 800-898. The Laboratory will be able to use the analyzer at no cost other than the quoted cost-per-reportable. The operating system on the analyzer must be Windows 10 or higher. The analyzer must meet all DoD Cyber Security Measures with an authority-to-operate (ATO) and be compatible with the Department of Defense’s electronic health record system, MHS Genesis (Cerner), for Bi-directional interface on the Medical Community of Interest Network (Med-COI).

Instrument Specifications:

The analyzer will include Flow Cytometry technology for cell identification and have an autoloader with automated reflex and repeat testing.

The analyzer will perform a fully automated Reticulocyte count and Reticulocyte Hemoglobin.

The analyzer will include an on-board quality control monitoring program and a real time peer group analysis program in order to satisfy national accreditation requirements.

The contractor must provide data demonstrating that the machine has insignificant sample-to-sample carryover of < 0.1 ppm.

The instrument must require minimal routine daily maintenance and minor monthly maintenance.

The current allocated space for the hemoglobin analyzer is atop a table measuring 69” by 27” as outlined in the diagram as seen in Attachment 2. The analyzer as well as all peripheral equipment to include printer and UPS must fit on this desktop safely and conform to the outer space restrictions of 69” by 31”. The analyzer must fit securely within the dimensions above. A slight overhang is allowed in the front, if the foots are within 1 inch of the front edge of the table. If the table is not to be utilized and the contractor plans to provide a cart or stand for the equipment, the equipment as well as peripheral equipment must fit within the 78.5” by 31” space.

The contractor will provide the Uninterrupted Power Source (UPS).

Preventive Maintenance Services:

The contractor will provide scheduled preventive maintenance and emergent maintenance and repair. Maintenance inspection shall consist of inspection, disassembly, adjustment, replacement of worn/defective parts, reassembly, and calibration of the system (if needed). Worn or defective components will be replaced at no charge to the customer. The contractor must provide documentation of average annual maintenance visits for the machine to the 375 MDG Laboratory NCOIC. The contractor shall provide scheduled preventive maintenance (travel costs, labor, and parts) and any emergent maintenance necessary to fulfill the test requirements on the analyzer and UPS unit for the duration of this contract.

The contractor shall provide the 375 MDG NCOIC of the Laboratory with a designated point of contact and alternate for technical trouble calls. The contractor will perform emergency repair service within 24 hours of the time of notification. All labor and non-wearable parts needed to repair the malfunction will be provided by the contractor.

The contractor shall furnish a report to 375 MDG NCOIC of the Laboratory detail actions taken during all site visits whether for preventive maintenance or repair service calls to the 375 MDG upon completion of each service call. At a minimum, the report shall include the following: date and time of notification, date and time of arrival, serial number, type and model number of equipment, time spent for preventive maintenance or repair, description of actions taken for preventive maintenance or repair of malfunction, and proof of repair. Proof of repair will include, at a minimum, documentation of acceptable quality control results for all assays at the conclusion of the repair and prior to departure of the technical representative.

375 MDG Laboratory personnel will perform daily routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. 375 MDG Laboratory personnel shall maintain appropriate daily records. The contractor shall deliver and install upgrades to the equipment hardware and operating software without additional charge to the government within sixty (60) days of their issuance or availability. The contractor will provide scheduled preventive maintenance and emergent maintenance and repair. The contractor must provide documentation of average annual maintenance visits for the machine to the Laboratory NCOIC.

The 375 MDG shall provide the contractor access to the equipment to perform the maintenance.

Personnel employed by the contractor or subcontractor will meet Security Requirements in accordance with Scott Air Force Base guidelines (see below).

Reagents, controls, and calibrators:

The Laboratory will be able to use the analyzer at no cost other than the quoted cost-per-reportable.

Supplies will be provided to the 375 MDG in regular, predetermined shipment intervals in amounts required by historical average test volumes.

Quality Control (QC) program:

The analyzer will include an on-board quality control monitoring program and a real time peer group analysis program in order to satisfy national accreditation requirements.

Installation and Training:

The contractor shall make the analyzer available for correlation and validation with the current 375 MDG analyzer, and the contractor will assist with correlation/validation. Installation and implementation shall include, but is not limited to, contractor performed method validation, calibration, precision, accuracy, mode-to-mode studies and data stream verifications, and correlation with current methods (comparison of methods study), validation of precision to ensure successful implementation and to meet the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) requirements.

The Contractor is responsible for all associated costs of analyzer install and set-up. All reagents, calibrators and linearity materials used in the method validation studies will be provided by the Contractor at no additional cost to the customer.

The contractor will provide for the training of one 375 MDG staff members in-residence at contractor’s training site on use and care of new analyzer.

ADDENDUM 1: SECURITY FORCES REQUIREMENT

Contractor Consent to Background Checks: The contractor and, as applicable, subcontractor shall not employ persons for work on this contract if such employee is identified as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population, nor shall the contractor or subcontractor employ persons under this contract who have an outstanding criminal warrant as identified by Law Enforcement Agency Data System (LEADS) through the National Crime Information Center. LEADS checks will verify if a person is wanted by local, state, and federal agencies. All contractor and subcontractor personnel must consent to LEADS background checks. Contractor and subcontractor personnel who do not consent to a LEADS check will be denied access to the installation. Information required to conduct a LEADS check includes full name, driver’s license number, and/or social security number, date of birth of the person entering the installation, and completion of a background check questionnaire. The contractor shall provide this information using the Scott AFB Form 21, Contractors Consent for Background Check, and shall submit it in conjunction with the contractor’s request for either base or vehicle passes. Completion of a successful

LEADS check does not invalidate the requirement for an escort when contractor or subcontractor personnel are working within controlled or restricted areas.

Contractors shall ensure their employees and those of their subcontracts have the proper credentials allowing them to work in the United States. Persons later found to be undocumented or illegal aliens will be remanded to the proper authorities. The contractor shall not be entitled to any compensation for delays or expenses associated with complying with the provisions of this clause. Furthermore, nothing in this clause shall excuse the contractor from proceeding with the contract as required.

Badges: The contractor is required to provide identification badges for their employees. All contractor personnel shall wear these badges while on duty on the government site. Badges are required to identify the individual, company name, and be clearly and distinctly marked as contractor. Size, color, style, etc. are to be mutually agreed to by contractor and government.

The contractor’s identification badge will not be used as an entry requirement for installation entry or into any government designated controlled or restricted area.

Contractor Registration of Vehicles on Scott AFB:

All contractor or contractor employees’ vehicles used for the performance of this contract shall comply with all local, state and federal regulations. Additionally, any pass shall be surrendered to Security Forces upon demand to positively identify a persons need to be on Scott AFB.

Access to Installation during Force Protection Conditions (FPCONs):

Contractors will be assigned a mission essential designation IAW requirements contained in SAFBI 31-101/Installation Security Instruction. Only the installation commander or the unit commander requesting contract support will assign the mission essential designation.

Property Protection:

Property protection for facility where the contractors’ primary work center is located will be the responsibility of the local facility manager and local Government Security Manager, or their duly authorized representative IAW AFI 31-101, The Air Force Installation Security Program and command/local directives. The contractor shall safeguard all government-owned equipment and materials in his/her possession or use.

Safeguarding Classified or Unclassified Information: The contractor shall meet Air Force standards for storing, processing, and handling classified information and systems. Additionally, all resources (e.g. maps, publication/instructions, photos) provided by the government to assist the contractor in the performance of their contract will be surrendered upon termination of employment or the end of the contract performance period.

Non-Disclosure Agreements: To safeguard information, the contractor shall enter into non-disclosure agreements with the responsible local security manager.

Privacy Act: Work on this project requires that personnel have access to Privacy Information.

Personnel shall adhere to the Privacy Act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations.

Contractors Working in Controlled or Restricted Areas The unit requesting contract support will provide escort (s) for contractors at all times when within a controlled area. Contractors shall not escort other contractor employees within controlled or restricted areas. In addition, contractors shall fulfill, maintain, and comply with all security requirements IAW AFI 31-101, The Air Force Installation Security Program, and command/local directives.

Access To Government Facilities with Controlled or Restricted Areas The contractor shall comply with security regulations imposed by the installation commander and/or the agency responsible for the project location. Due to specific mission requirements inherent in the nature of controlled or restricted areas on Scott AFB, the government may direct the contractor to leave the controlled or restricted areas at any given time.

Contractors Responsibilities while Working within Controlled or Restricted Areas Only contractor personnel with proper authority and qualifications shall enter a controlled or restricted area. Certain facilities require the issuance of an AF Form 1199CD. The government, at any time, may revoke the AF Form 1199CD. The procedures for the issuance of an AF Form 1199CD are contained in SAFBI 31-101, Installation Security Instruction. Contractors shall not escort other contractor employees within controlled or restricted areas. In addition, contractors shall fulfill, maintain, and comply with all security requirements contained in SAFBI 31-101, Installation Security Instruction.

Access To Government Facilities with Controlled or Restricted Areas for Replacement Contractors The unit requesting contract support will continuously escort replacement contractors, not initially possessing the proper clearances and requiring entry to controlled or restricted areas.

Replacement contractors shall submit paperwork within 30 days of being assigned to obtain an approved security clearance or favorable review. Replacement contractor personnel shall obtain a security clearance prior to working with, or having direct access to, classified material. In addition, replacement contractor personnel shall obtain a “Favorable review” prior to having access to a Controlled Area. The above information shall be submitted to 375 SFS/S5I.

ADDENDUM 2: HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY

ACT (HIPAA) OF 1996

HIPAA is comprised of several different sections, each to be implemented by the Dept. of Health and Human Services. The medical facilities of the military services and the DOD health plans are specifically listed as covered by HIPAA. Currently, HIPAA Privacy and Security Rules, as set forth in the Code of Federal Regulations, are in effect for all MTFs.

The specific implementation of HIPAA Privacy for DOD medical facilities is set forth in DOD 6025.18-R, and for HIPAA Security, the requirements for AF MTFs are contained in DOD 8580.02-R and AFI 41-217, which also contains additional Information Assurance requirements for all AF MTFs. DOD 6025.18-R, DOD 8580.02-R and AFI 41-217 are incorporated herein by reference. MTFs are responsible to ensure overall compliance with HIPAA requirements, which includes incorporation of certain requirements in contracts entered or amended after the respective implementation dates.

IAW these regulations, the Contractor and its employees meet the definition of Business Associates. Therefore, a Business Associate Agreement is required by law to comply with both the HIPAA Privacy and Security regulations. This clause serves as that agreement for each MTF, whereby the Contractor and its employees agree to abide by all HIPAA Privacy and Security requirements regarding health information as defined in this clause, DoD 6025-18-R, DOD 8520.02-R and AFI 41-217. Additional HIPAA requirements will be addressed when implemented.

Definitions and Terms

(a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DOD 6025.18-R, DOD 8520.02-R or AFI 41-217.

Individual has the same meaning as the term “individual” in 45 CFR 164.50 1 and 164.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

Protected Health Information has the same meaning as the term “protected health information” in 45 CFR 164.501, limited to the information created or received by The Contractor from or on behalf of the Government.

Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.

Required by Law has the same meaning as the term “required by law” in 45 CFR 164.501 and 164.103.

Secretary means the Secretary of the Department of Health and Human Services or his/her designee.

Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160,162 and part 164, subpart C.

Terms used, but not otherwise defined, in this Agreement shall have the same meaning as those terms in 45 CFR 160.103, 160.502, 164.103, 164.304 and 164.501.

(b) The Contractor agrees to not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law.

(c) The Contractor agrees to use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.

(d) The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

(e) The Contractor agrees to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Contract.

(f) The Contractor agrees to report to the Government any security incident involving protected health information of which it becomes aware.

(g) The Contractor agrees to report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Contractor becomes aware of.

(h) The Contractor agrees to ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the Contractor on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information.

(i) The Contractor agrees to ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.

(j) The Contractor agrees to provide access, at the request of the Government, and in the time and manner designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524.

(k) The Contractor agrees to make any amendment(s) to Protected Health Information in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government or an Individual, and in the time and manner designated by the Government.

(1) The Contractor agrees to make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Contractor on behalf of, the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner designated by the 'Government or the Secretary, for purposes of the Secretary determining the Government's compliance with the Privacy Rule.

(m) The Contractor agrees to document such disclosures of Protected Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

(n) The Contractor agrees to provide to the Government or an Individual, in time and manner designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

DEFINITIONS AND ACRONYMS

2. Definitions and Acronyms:

AF Air Force AQL Acceptable Quality Level BLS Basic Life Support CAC Common Access Card CE Continuing Education CHBC Criminal History Background Check CLIN Contract Line-Item Number COR Contracting Officer Representative CPARS Contractor Performance Assessment Reporting System DHA Defense Health Agency E-QIP Electronic Questionnaires for Investigations Processing FAR Federal Acquisition Regulation FRED Functional Representative Evaluator Designee FTE Full-Time Equivalent HCW Health Care Worker IDIQ Indefinite Delivery, Indefinite Quantity JTR Joint Travel Regulation MAC Multiple Award Contract MILDEP Military Department MHS Military Health System MQS Medical Q-Coded Services MTF Medical or Military Treatment Facility OA Ordering Activity PKO Procuring Contracting Officer PMO Program Management Office POC Point of Contact PRS Performance Requirements Summary PSC Product Service Code PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QCP Quality Control Plan TO Task Order TOKO Task Order Contracting Officer TOPR Task Order Proposal Request WAWF-RA Wide Area Workflow – Receipt and Acceptance

General Use and Disclosure Provisions

Except as otherwise limited in this Agreement, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIPAA Privacy Rule, DOD 6025.18-R, the HIPAA Security Rule, or DOD 8580.02-R if done by the Government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Agreement, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.

(b) Except as otherwise limited in this Agreement, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Agreement, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1).

Obligations of the Government

Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions

(a) Upon request the Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520, as well as any changes to such notice.

(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractor's permitted or required uses and disclosures.

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of

Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522.

Permissible Requests by the Government

The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, DOD 6025.18R, the HIPAA Security Rule, or DOD 8580.02-R, if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.

Termination

(a) Termination. A breach by the Contractor of this clause, may subject the Contractor to termination under any applicable default or termination provision of this Contract.

(b) Effect of Termination.

(1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below.

(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information.

(3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return, or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information.

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in DOD 6025.18-R, HIPAA Privacy Regulation or DOD 8580.02-R, HIPAA Security Regulation, or any CFR or AFI provision means the section as currently in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations of Business Associate under the "Effect of

Termination" provision of this Clause shall survive the termination of this Contract.

(c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with DOD 6025.18-R, the CFR HIPAA Privacy Rule, DOD 8520.02-R, the CFR HIPAA Security Rule and AFI 41-217.