SOW_Rees Service.pdf

DHA PWS Template V13 November 16, 2021

Department of Defense Defense Health Agency

Performance Work Statement

Maintenance of Rees Temperature Monitoring System

60th Medical Group David Grant Medical Center

Travis AFB, California

Solicitation Number:

Version: 1

Date: 24 March 2025

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Maintenance of Rees Temperature Monitoring System for ECN 54683 for 60 MDG & ECN 59486 Armed Forces Whole Blood Processing Laboratory (ASWBPL).

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Maintenance of Rees Temperature Monitoring System as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background: The Rees monitoring system is designed to meet FDA and CAP requirements by tracking and trending the temperature of stored blood, pharmaceutical products, medications, and other temperature-controlled substances. A maintenance agreement is required to maintain continuous optimal performance of the system in order to maintain FDA and CAP accreditation

1.4 Objectives:

Annual Scheduled Maintenance/Validations Unscheduled Repair Services Technical Support Services Software Support

1.5 Scope: Full Maintenance Support Services includes annual validations, preventive maintenance services, unscheduled repairs, technical support and software support. The contractor shall perform annual validations, preventive maintenance services, unscheduled repairs, parts replacements.

1.6 Period of Performance (PoP):

ECN: 54683 For: 60 MDG

ECN: 59486 For: ASWBPL

Period Period of Performance Estimated Value Type of Funding

Base Period 09/13/25 - 09/12/26 $19,087.25 O&M Option Period 1 09/13/26 - 09/12/27 $19,468.99 O&M Option Period 2 09/13/27 - 09/12/28 $19,858.37 O&M Option Period 3 09/13/28 - 09/12/29 $19,977.08 O&M Option Period 4 09/13/29 - 09/12/30 $20,376.62 O&M Federal Acquisition Regulation (FAR) 52.217-8

09/13/30 – 03/12/31 $10,392.08 O&M

Total $109,160.39

1.7 Administrative specifications

Period Period of Performance Estimated Value Type of Funding Base Period 08/10/25 - 08/09/26 $32,137.42 O&M Option Period 1 08/10/26 - 08/09/27 $32,780.17 O&M Option Period 2 08/10/27 - 08/09/28 $33,435.77 O&M Option Period 3 08/10/28 - 08/09/29 $34,104.48 O&M Option Period 4 08/10/29 - 08/09/30 $34,786.58 O&M Federal Acquisition Regulation (FAR) 52.217-8

08/10/30 - 02/09/31 $17,741.16 O&M

Total $184,985.58

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1.7.1 Place of performance: The work shall be performed at David Grant Medical Center (DGMC) & ASWBPL.

1.7.2 Recognized Federal holidays: Not required

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

1.7.3 Hours of operation: The contractor is responsible for conducting business Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.10 Quality

1.10.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and 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 minimum acceptable defect rate(s).

1.12 Key personnel (Contractor): The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The contract manager or alternate 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 shall be available between 8:00 a.m. to 5:00 p.m., Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.14 Reporting

1.14.3 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. 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 CO and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, 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 contract.

1.14.4 Post award conference/periodic progress meetings: Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the CO will apprise the contractor of how the government views the contractor's performance and the contractor will 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.

1.15 Contractor Identification

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1.15.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity

(HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel. Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.15.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

1.15.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

1.17 Personnel Security

1.17.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI)

6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM

5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

1.17.1.1 Follow the DHA Personnel Security Office guidelines for submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275-6038.

1.17.1.2 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI).

1.17.1.3 DHA Personnel Security Office does not deny any access to any automated information system (AIS), network, or Controlled Unclassified Information (CUI). If a contractor receives an unfavorable background investigation, the request for access will be sent back to the FSO for further action. Any unfavorable adjudication will result in DHA Personnel Security Office not signing off on any access request.

November 16, 2021

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D-Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R-Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Nonpersonal services contract: a contract under which the personnel rendering the services 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.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.2 Acronyms:

AIS Automated Information System AQL Acceptable Quality Level ASWBPL Armed Forces Whole Blood Processing Laboratory CAP Cloud Access Point CE Computer Environment CDRL Contract Data Requirement List CO Contracting Officer(s) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative CUI Controlled Unclassified Information DAD-A Deputy Assistant Director for Acquisition DFARS Defense Federal Acquisition Regulation Supplement DGMC David Grant Medical Center DHA Defense Health Agency DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction DoDM Department of Defense Manual DUA Data Use Agreement FAR Federal Acquisition Regulation FDA Federal Drug Administration FE Facilities Enterprise FSO Facilities Security Officer HA Health Affairs HIPAA Health Insurance Portability and Accountability Act HCA Head of the Contracting Activity IGCE Independent Government Cost Estimate IA Information Assurance

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IO Initial Outfitting IS Information System IT Information Technology JCAHO Joint Commission on Accreditation of Healthcare Organizations MERC Medical Equipment Repair Center MHS Military Health System MIL-STD Military Standard MTFs Military Treatment Facilities PM Preventative Maintenance PMO Program Management Office OEM Original Equipment Manufacturer POA&M Plan of Action and Milestones POC Point of Contact PoP Period of Performance PP Personal Property PRS Performance Requirements Summary PSP Personnel Security Program PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan RFP Request for Proposal RFQ Request for Quotation SF Standard Form SP Special Publication SOW Statement of Work TOS Terms of Service US United States

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc.

Applicable Publications (Current Editions): The Contractor shall abide by all applicable regulations, publications, and manuals. Following is a list of basic publications applicable to the PWS. The most current version of the publication applies. Publications not on the internet or MTF policies and procedures can be obtained from the MTF.

Current issues of publications and links to other service publications can be accessed at the following websites:

http://www.apd.army.mil/ http://www.defenselink.mil/pubs http://www.dtic.mil/whs/directives/ http://www.e-publishing.af.mil

Contractors are obligated to follow these codes as mandatory only to the extent that they apply to the contract.

Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract.

Advisory publications may be used for information and guidance but are not binding for compliance.

DEPARTMENT OF DEFENSE (DoD) REGULATIONS/MANUALS INSTRUCTIONS/DIRECTIVES

PUB NO. TITLE

DoDD 5500.7 Standards of Conduct DoDI 5400.7-R Freedom of Information Act

November 16, 2021

DoD 6025.18-R Health Information Privacy Regulation Jan 03 DoDD 8500.1 Information Assurance DoD 8580.02-R HIPAA Security Rule DODI 3020.37 Continuation of Essential DOD Contractor Services During Crises AFI 33-332 Air Force Privacy and Civil Liberties Program DHA-IPM 18-013 Interim Procedures 18-013, Risk Management Framework DFARS 239.7602-2 Required Storage of Data within the United States or Outlying Areas

AIR FORCE INSTRUCTIONS/MANUALS

DAFI—Department of the Air Force Instruction DAFMAN- Department of the Air Force Manual AFP--Air Force Pamphlet AF Form--Air Force Form DD Form--Department of Defense Form MDGI – Medical Group Instruction

Pre-Market Approval Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation.

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

☒ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

3.2 Facilities: The Government:

☒ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

3.3 Utilities: The Government:

☒ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

3.4 Equipment: The Government:

☒ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

3.5 Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

November 16, 2021

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

☒ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

4.2 General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

November 16, 2021

PART 5

5.0 SPECIFIC TASKS

5.1 Task Headings:

5.1.1. The Contractor shall provide non-personal services consisting of management, labor, tools, supplies, material, transportation and travel, parts, and replacement parts, diagnostic equipment and other equipment necessary to maintain and provide preventive and corrective maintenance service for the Rees Scientific Temperature Monitoring System located at 60th Medical Group and ASWBPL, David Grant Medical Center, Travis Air Force Base, California. The Contractor shall submit reports and documentation as identified throughout this Statement of Work

(SOW).

5.1.2. All work under this contract shall be performed in compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Federal Drug Administration (FDA) standards, Health Insurance Portability and Accountability Act (HIPPA) in accordance with 45CFR 160 and 164, National Fire Protection Association Standard NFPA 99 (Electrical Equipment in Healthcare Facilities), Original Equipment Manufacturer (OEM) specifications as required.

5.1.3. The Contractor shall be authorized/qualified by the OEM in the repair of all equipment listed under this contract. Contractor shall maintain authorization/qualifications throughout entire contract period. Qualification includes but not limited to the certification of all repair persons and repair facilities by the OEM as being authorized/qualified to perform required repairs. The Government shall maintain the right to seek proof of qualification prior to award and anytime during contract period of performance. Only OEM authorized/OEM trained personnel shall perform services under this contract.

5.2. Scheduled Maintenance Inspections. The Contractor shall provide one scheduled preventive maintenance inspection and system certification with corresponding reports per year performed by OEM authorized/OEM trained personnel. The Contractor shall complete scheduled maintenance to the current published OEM specifications.

Service shall consist of: review of system operation, inspection, and functional testing checks of all equipment in accordance with the latest OEM established service procedures.

5.2.1. Schedules shall be developed and approved within 30 days after contract award. Contractor shall finalize the date and time of preventive maintenance services with Medical Equipment Repair Center (MERC) at least two weeks prior to performing services. All services shall be performed during normal duty hours 8:00 AM to 5:00 PM, Monday through Friday, excluding Federal holidays as listed in paragraph 2.4.1. The Contractor shall check in at the MERC both upon arrival and upon completion of on-site work in accordance with paragraph 2.5 of this SOW.

5.3. Unscheduled/Corrective/Repair Services. The Contractor shall provide unlimited on-site corrective services per year performed by OEM-trained and authorized technicians. The Contractor shall complete corrective maintenance to the current published OEM specifications in order to return the equipment/system to fully operational status within current OEM specifications.

5.3.1. The Contractor shall provide on-site troubleshooting in accordance with the OEM’s latest established service procedures. These services shall only be provided by OEM authorized/OEM trained personnel.

5.3.2. Government request for corrective maintenance will be placed by MERC to the Contractor's POC. The Contractor OEM authorized/OEM trained personnel shall respond immediately within 4 hours telephone support line and will coordinate either on-site support or shipment of replacement parts within 24 hours. All corrective maintenance service shall be accomplished during normal duty hours 8:00 AM to 5:00 PM, Monday through Friday, excluding Federal Holidays unless first coordinated with the MERC. The Contractor will coordinate corrective maintenance visits with the MERC prior to arrival on site. The Contractor shall check in at the MERC both upon arrival and upon completion of on-site work.

5.4. Technical Support Services

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5.4.1. The Contractor shall provide unlimited remote technical support via phone or email, 24 hours a day, seven (7) days a week. The Contractor shall provide support communications with the Government to discuss technical matters relating to the performance of this contract such as technical questions regarding system operations, and applications. The Contractor shall provide instructions and training to the government equipment user/operators on the proper care and operation of the equipment through telephone.

5.4.2. The Contractor shall provide telephone or email troubleshooting in accordance with the OEM’s latest established service procedures. These services shall only be provided by OEM authorized/OEM trained personnel.

5.4.3. The Contractor shall response to requests for service through telephone consultation or email with the Government equipment user/operator and the Contractor OEM authorized/OEM trained personnel. Telephone consultation shall:

1. provide instruction in determining operator error;

2. to determine the most likely cause of the problem;

3. to determine if resolution of the problem requires the dispatch of an OEM authorized/OEM trained personnel;

4. to identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

5.5. Software Support.

5.5.1. The Contractor shall provide software updates, patches, and field corrections in accordance with the OEM’s latest established service procedures. The Contractor shall receive advance approval for the installation of all software updates and revisions from the Government and shall be coordinated though MERC. Defective software shall be replaced at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment by the OEM, contractor shall provide installation within ten business days of release regardless of Preventative Maintenance Schedules.

5.6. Service Reports.

5.6.1. A service report is required for any maintenance service performed at any time. The original service report must be presented to the MERC upon completion of the work prior to departure or must be emailed to the MERC POC within five (5) business days. The service report must include the following as a:

1. Date and time of service

2. Company and service representative name

3. Contract number

4. A detailed description of any services performed including labor and any parts used.

5. OEM PM/Calibration checklists with results may serve as the service report.

5.7. OEM Replacement Parts.

5.7.1. The Contractor shall provide all replacement parts, excluding consumables, necessary for scheduled and corrective services. The Contractor shall have ready access to all OEM replacement parts. All parts supplied shall be compatible with the existing system. All parts must be either new OEM parts or parts refurbished by the OEM of the covered medical equipment. In the event that replacements parts are required to be shipped, shipping shall be performed in the fastest reasonable means possible (i.e., next day air) at no additional cost to the Government. Parts used during scheduled and corrective services shall become the property of the Government. Replaced parts shall become the property of the Contractor and shall be removed from the hospital and disposed of at no additional cost to the Government.

5.7.2. Whenever the repair of equipment cannot be performed at the Government site as determined by the Contractor, the Contractor shall notify MERC who will make arrangements for the Contractor to remove the item to the Contractor's designated site. The Contractor shall be required to sign a Government form accepting responsibility for the Government equipment. The Contractor shall provide a detailed description of removed items including as a minimum the manufacturer serial numbers of all equipment/items removed.

5.7.3. In the event that items/sub-assemblies /accessories are repaired via "Repair by Replacement," a detailed description of replaced items is to be included upon return of repaired components. All charges resulting from a Contractor-determined requirement to transport Government-owned property covered by this contract to and from an alternate repair location shall be the responsibility of the Contractor.

November 16, 2021

PART 6

6.0 INFORMATION TECHNOLOGY & SECURITY

6.1 All work under this contract is unclassified.

PART 7, ATTACHMENT 1

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

PWS Reference

Acceptable Quality Level

(AQL)

Method of Surveillance

Performance Requirements Summary (PRS) # 1.

Preventive Maintenance and tech support meet requirements for availability and response

PWS Part 5, Para 5.2 100% of the time 100% Surveillance

PRS # 2

Response time: phone contact within 4 hours

PWS Part 5, Para 5.3.2 100% of the time 100% Surveillance

PRS # 3

Service Reports

PWS Part 5, Para 5.6.1 100% of the time 100% Surveillance

November 16, 2021

PART 7, TECHNICAL EXHIBIT 1

DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To Applicable to:

CDRL A001 – Quality Control Plan

CDRL 1 Quality Plan

Within 30 days of task order award

Contractors discretion CDRL A001 to CO All, See PWS 1.10.1