Department of Defense Defense Health Agency

Pyxis Software User License and Support

Logistics Department Brooke Army Medical Center

Joint Base San Antonio, Fort Sam Houston, TX 78234

PART 1

GENERAL INFORMATION

HT940826QE042

1.1. Background

Brooke Army Medical Center (BAMC), a 425-bed Academic Medical Center at Joint Base San Antonio (JBSA)-Fort Sam Houston, Texas (TX), is the Department of Defense's largest inpatient hospital and only Level I Trauma Center within the Military Health System (MHS). This equipment supports the BAMC clinical mission by allowing medical providers to prescribe medication and the patient to receive the correct medication in a safe and timely manner. The Original Equipment Manufacturer (OEM) utilizes proprietary software/tools required to perform these services.

The Contractor shall provide software user license and software support, calibration, safety inspection, and limited corrective maintenance services for Government-owned medical equipment described in the equipment inventory (Technical Exhibit 3) in accordance with OEM recommendations, Centers for Medicare & Medicaid Services (CMS) hospital-equipment maintenance guidance, Defense Health Agency (DHA) Healthcare Technology Management Services (HTMS) policy, and applicable Department of Defense (DoD) / Food and Drug Administration (FDA) requirements.

1.2. Scope

The Contractor shall maintain Government-owned equipment in safe, reliable, mission-ready condition such that preventive maintenance (PM) events are completed on schedule, calibration is verified at each PM, safety/recall actions are completed, and field service documentation supports the BAMC Computerized Maintenance Management System (CMMS).

Services shall be executed in accordance with Pyxis Software Protection 1 Risk-Share Comprehensive Service Agreement.

In scope: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform firmware updates, software upgrades, and repairs as defined in this Performance Work Statement, except for those items specified as government furnished property and services.

Out of scope: Not Applicable (N/A)

1.2.1. Site Familiarization

Information concerning the systems to be serviced is furnished from the best available sources within the Government. However, this shall not relieve the Contractor from the responsibility of visiting the location of the systems listed, conducting site investigations as necessary, and becoming thoroughly familiar with all components associated with the items and the conditions under which the work is to be performed.

1.3. Requirement Type / Pricing Arrangement

a. Firm-Fixed Price (FFP)

1.4. Service Coverage

The following services are included under this requirement:

a. Manufacturer-authorized software / firmware updates

1.4.1. Preventive Maintenance Frequency

The Contractor performs the selected PM frequency in accordance with OEM specifications and coordinates expected arrival date and time with the Contracting Officer's Representative (COR) or designated Technical Point of Contact (TPOC). All scheduled PM events shall be completed by the twentieth (20th) business day of the scheduled month.

a. Event-based or usage-based interval (per OEM specification)

1.4.2. Periodic System Restore / Overhaul

Where an OEM requires a periodic system restore, overhaul, or factory recertification for a specific item identified in TE 4, the Contractor shall coordinate the restore event with the COR not later than 30 calendar days in advance.

1.5. OEM vs Third-Party / AEM Maintenance Basis

The Contractor shall not unilaterally apply an Alternate Equipment Maintenance (AEM) schedule. An AEM schedule may only be utilized when explicitly authorized in writing by the BAMC HTMS Working Group, supported by a formal risk assessment.

a. OEM (manufacturer) recommendations

b. OEM authorized service center / OEM service organization

1.6. PM Interval Basis

a. Manufacturer-recommended interval (default)

1.7. Parts / Software-Firmware Coverage

a. Manufacturer-authorized software / firmware updates included

1.8. Reserved.

1.9. Place of Performance

a. Brooke Army Medical Center (BAMC) JBSA-Fort Sam Houston, TX 78234

1.10. Key Government Personnel

Defense Health Agency Contracting Activity (DHACA)

a. 1.10.1. Contracting Officer (KO):

1. Name:

2. Email Address:

3. Telephone Number:

b. 1.10.2. Contracting Officer's Representative (COR):

1. Name: Kathy Clayton

2. Email Address: kathy.g.clayton.civ@health.mil

3. Telephone Number: 210-539-1164

c. 1.10.3. Technical Point of Contact (TPOC):

1. Name: David Quintanilla

2. Email Address: david.a.quintanilla2.ctr@health.mil

3. Telephone Number: 210-916-5267

1.11. Key Contractor Personnel

1. Program/Project Manager:

2. Service Manager / Lead Field Service Engineer (FSE) / HTMS:

3. Quality / Quality Control Plan (QCP) Point of Contact (POC):

1.12. Personnel Qualifications

Field Service Engineer (FSE) personnel performing services under this contract shall be OEM certified to perform maintenance on the systems covered by this agreement. If requested by the Government, the Contractor shall provide FSE certification documentation. Contractor personnel shall at all times present a neat, professional appearance and be recognizable as an employee of the Contractor. The Contractor shall also ensure that all personnel working within the medical facility are up-to-date on all required immunizations and shall submit proof of vaccination for their FSEs upon Government request.

1.13. Test Equipment / Calibration Traceability

All Test, Measurement, and Diagnostic Equipment (TMDE) used by the Contractor shall maintain current National Institute of Standards and Technology (NIST)-traceable calibration.

1.14. Hours of Performance / Coverage Window / Holidays

BAMC standard hours of operation are 0730–1600 CT, Monday–Friday, excluding Federal holidays and Government closures. The Contractor shall at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this performance of work statement (PWS) when the government facility is open. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. No services will be performed on Federal holidays as there are no Government staff to act as escort.

Recognized Federal Holidays:

a. New Year’s Day, January 1st

b. Martin Luther King, Jr.’s Birthday, 3rd Monday in January

c. President’s Day, 3rd Monday in February

d. Memorial Day, Last Monday in May

e. Juneteenth, June 19th

f. Independence Day, July 4th

g. Labor Day, 1st Monday in October

h. Columbus Day, 2nd Monday in October

i. Veteran’s Day, November 11th

j. Thanksgiving Day, 4th Thursday in November

k. Christmas Day, December 25th

1.15. Security, Installation Access, and Infection Control

Security / access requirements:

a. Visitor / Escorted access only

Infection prevention and clinical-area access:

a. Adheres to BAMC Infection Prevention policies. Contractor personnel entering patient-care areas shall comply with policies including hand hygiene, Personal Protective Equipment (PPE), isolation precautions, and equipment cleaning/disinfection. Equipment serviced in clinical areas shall be cleaned and disinfected per BAMC / OEM instructions before returning to service.

1.15.1 Safety and Accident Reporting: The Contractor shall ensure its personnel comply with all applicable installation and Military Treatment Facility (MTF) safety regulations.

Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal. The Contractor shall report immediately to the COR any accidents which may arise out of or in connection with the performance of services required within the scope of this contract."

1.16. Non-Personal Services Declaration

This is a Firm Fixed Price (FFP) non-personal services requirement. The Government shall not exercise any supervision or control over Contractor personnel.

1.17. Post-Award Conference / Periodic Progress Meetings

The Contractor shall attend any post-award conference in accordance with Federal Acquisition Regulation (FAR) Subpart 42.5.

1.18. Identification of Contractor Employees

Contract employees shall be clearly identified as Contractors at all times, including conversations, mail, e-mail, fax, and other electronic communication. At a minimum, contract employees shall wear badges that clearly and legibly identify themselves as Contractors and identify themselves as a Contractor in all telephone and virtual conversations to avoid creating the impression that they are Government officials.

1.19. Non-Disclosure Agreements (NDA)

Not Required — Reserved. No NDA is required; however, Contractor personnel remain bound by Health Insurance Portability and Accountability Act (HIPAA), the Privacy Act, and all applicable confidentiality requirements.

1.20. Information Assurance (IA) / Cybersecurity

a. Government network access required (DoD IA training)

b. Connected medical device / Internet of Things (IoT) (additional cyber)

Where applicable, Contractor personnel shall complete DoD IA awareness training before issuance of network access and annually thereafter; shall comply with Department of Defense Directive (DoDD) 5144.02 and DoD 8570.01-M; and shall comply with Department of Defense Instruction (DoDI) 8500.01 and DoDI 8510.01 Risk Management Framework (RMF) and applicable Security Technical Implementation Guide STIGs.

1.21. HIPAA / Privacy Act

a. Incidental Protected Health Information (PHI) exposure possible during service events

b. Routine access to PHI

c. PII handled by Contractor

d. Business Associate Agreement (BAA) required if PHI access occurs

Where applicable, the Contractor and its personnel shall comply with HIPAA, DoDI 6025.18, and the Privacy Act of 1974 with respect to all PHI/ Personally Identifiable Information (PII), and shall execute a Business Associate Agreement (BAA) where required by 45 Code of Federal Regulations (CFR) 164.

1.22. Organizational Conflict of Interest (OCI)

Contractor and subcontractor personnel performing work under this contract may receive, have access to, or participate in the development of proprietary or source selection information or perform evaluation services which may create a current or subsequent Organizational Conflict of Interest (OCI) as defined in the FAR. The Contractor shall notify the KO immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the KO to avoid or mitigate any such OCI.

1.23. Media and Public Communications

The Contractor shall not respond to media or public inquiries about this contract, BAMC, DHA, or DoD activities without prior written approval from the KO.

1.24. Data Rights

Field Service Reports, calibration records, CMMS data entries, and other deliverables shall be Government property. Pre-existing OEM service-tool source code, proprietary diagnostic software, and OEM trade secrets remain the property of the OEM/Contractor and are licensed to the Government only to the extent necessary for use of the maintained equipment.

1.25. Invoicing

Invoices shall be submitted in accordance with and Wide Area Workflow (WAWF) instructions. Invoices shall include: order number, contract line item number (CLIN), period of performance, services rendered, deliverable references, Government-accepted maintenance reports, and CMMS event summary.

Invoice Submission Timing:

a. Monthly in arrears (after Government acceptance of monthly maintenance report).

b. Per milestone / per service event, in case of unscheduled repair.

1.26. English Requirement

The Contractor shall ensure that all contract employee providing services under this contract are able to read, write, and speak English fluently to effectively communicate with clinical staff, understand OEM manuals, and accurately document Field Service Reports (FSRs) in the BAMC Computerized Maintenance Management System

(CMMS).

1.27. Suspension of Personnel Pending Investigation

The Government reserves the right to immediately suspend facility access pending the outcome of an active law enforcement, clinical quality, safety, or command investigation. Upon written notification from the KO or COR directing the suspension of a contract employee, the Contractor shall immediately remove the individual from the MTF. The Government shall not be liable for any compensation, lost wages, or damages to the Contractor or the suspended contract employee during the investigative period. The suspended individual shall not be permitted to return to the facility without written clearance from the KO.

1.28. Prohibition of Contractor Corporate Activities

To ensure the full, uninterrupted utilization of procured maintenance time, the Contractor shall not conduct internal corporate business, company-specific training, virtual or on-site town halls, or routine employer-employee administrative meetings during BAMC duty hours unless directed by the COR. All such Contractor corporate activities must be conducted outside of BAMC hours and shall be at the Contractor's sole expense.

1.29. Maintenance of CMMS Systems Access

The Contractor assumes full responsibility for ensuring that all contract employees maintain active physical and network access required to perform their scheduled duties.

To prevent automated deactivation of BAMC network and CMMS accounts, the Contractor shall ensure that all active personnel log into these systems no less than once every 30 calendar days. If a contract employee is unable to fulfill their required maintenance duties or document FSRs due to a loss of system access resulting from inactivity, the missed productivity shall not constitute an excusable delay.

PART 2

DEFINITIONS AND ACRONYMS

2.1. Definitions

AEM: Alternate Equipment Maintenance — a program approved by the Government that differs from OEM recommendations and is supported by a documented risk assessment.

Business Day: Monday through Friday, 0730 to 1600 Central Time, excluding

Recognized Federal Holidays and authorized Government closures.

Calendar Day: Any day of the week, including weekends and holidays.

CMMS: Computerized Maintenance Management System.

Contracting Officer (KO): A person with authority to enter into, administer, or terminate contracts, and make related determinations and findings on behalf of the Government. The KO is the only individual who can legally bind the Government.

Contracting Officer's Representative (COR): A civilian or military employee of the

United States (U.S.) Government appointed in writing by the Contracting Officer to administer the contract. The COR monitors all technical aspects of the contract, performs necessary inspections, issues written interpretations of technical requirements, and coordinates government-furnished property. The COR provides technical direction but is not authorized to change any of the terms, conditions, cost, price, estimates, or delivery dates of the contract.

Field Service Report (FSR): Contractor-issued record of a service event documenting equipment ID, work performed, parts used, technician, date/time, and acceptance status.

HTMS: Healthcare Technology Management Services / Field Service Engineer —

The Contractor's qualified personnel performing maintenance services.

OEM: Original Equipment Manufacturer.

PM: Preventive Maintenance.

PM Due Window: Calendar window in which a PM event may be performed and counted as on-time.

Restoration: Return of an item of equipment to clinical use.

Technical Point of Contact (TPOC): Serves as the designated on-site government representative within a specific BAMC clinic, department, or clinical engineering shop.

Identified and authorized by the COR, the TPOC provides day-to-day technical monitoring, operational coordination, and oversight of contractor performance. The TPOC functions strictly in a monitoring and coordination capacity; they do not exercise supervisory authority over contract employees and cannot alter contract terms.

TMDE: Test, Measurement, and Diagnostic Equipment.

UDI: Unique Device Identifier.

2.2. Acronyms

AAMI - Association for the Advancement of Medical Instrumentation AEM - Alternate Equipment Maintenance ANSI - American National Standards Institute AQL - Acceptable Quality Level ATO - Authority to Operate BAA - Business Associate Agreement BAMC - Brooke Army Medical Center BLS - Basic Life Support HTM\S – Healthcare Technology Management Services CAC - Common Access Card CBET - Certified Biomedical Equipment Technician CBMH - Community Based Medical Home CFR – Code of Federal Regulations CLIN - Contract Line Item Number CM - Corrective Maintenance CMMS - Computerized Maintenance Management System CMS - Centers for Medicare & Medicaid Services COR - Contracting Officer's Representative Cyber - cyberspace domain DFARS – Defense Federal Acquisition Regulation Supplement DHA - Defense Health Agency DHACA – Defense Health Agency Contracting Activity DMLSS - Defense Medical Logistics Standard Support DoD - Department of Defense DoDD - Department of Defense Directive DoDI - Department of Defense Instruction ECN – Equipment Control number EVS - Environmental Services FAR - Federal Acquisition Regulation FDA - Food and Drug Administration FFP - Firm-Fixed Price FHP – Force Health Protection FMR – Financial Management Regulation FSE - Field Service Engineer FSR - Field Service Report GFP - Government-Furnished Property

HIPAA – Health Insurance Portability and Accountability Act HTMS - Healthcare Technology Management Services IA - Information Assurance ID - Identification IoT - Internet of Things JTR - Joint Travel Regulations JBSA - Joint Base San Antonio KO - Contracting Officer MHS - Military Health System MTF - Military Treatment Facility NA – Not Applicable NACI - National Agency Check with Inquiries NDA - Non-Disclosure Agreement NFPA - National Fire Protection Association NLT – No Later Than NIST - National Institute of Standards and Technology OCI - Organizational Conflict of Interest OEH – Occupational and Environmental Health OEM - Original Equipment Manufacturer OS - Operating System PCC - Primary Care Clinic PDF - Portable Document Format PHI - Protected Health Information PII - Personally Identifiable Information PM - Preventive Maintenance POC – Point of Contact PoP - Period of Performance PPE - Personal Protective Equipment PRS - Performance Requirements Summary PWS - Performance Work Statement QA - Quality Assurance QCP - Quality Control Plan RCA - Root Cause Analysis RMF - Risk Management Framework SCS – Supply Chain Specialist SOH - Safety and Occupational Health STIG - Security Technical Implementation Guide TB – Technical Bulletin TE - Technical Exhibit TMC - Troop Medical Clinic TMDE - Test, Measurement, and Diagnostic Equipment TPOC - Technical Point of Contact TX - Texas UDI - Unique Device Identifier U.S. – United States WAWF - Wide Area Workflow

PART 3

GOVERNMENT FURNISHED PROPERTY, INFORMATION, AND SERVICES

3.1. General

The Government will furnish the following as required for Contractor performance at no cost to the Contractor unless otherwise stated:

a. Government-owned medical equipment to be maintained (TE 3 inventory)

b. Workspace at the BAMC Clinical Engineering Shop for on-site repair

c. Coordination with BAMC Cybersecurity for network-connected device service

d. The Government will provide a Supply Chain Specialist (SCS) to observe a quality assurance test prior to the departure of the Contractor’s Field Service Engineer (FSE).

e. Secure internet access required for the contractor to diagnose software issues and install OEM-authorized software updates and upgrades.

3.2. Facility Access / Workspace

When work is performed on Government premises, the Government will furnish workspace, utilities (heat, air conditioning (A/C), electricity, water/sewer), custodial services for shared spaces, and Government-related telephone service. Personal long-distance calls are not authorized. The Contractor shall instruct employees in utilities conservation practices. The Contractor shall be responsible for operating under conditions that preclude the waste of utilities, which includes turning off water faucets or valves after using the required amount to accomplish cleaning of equipment.

3.3. Identification / Access Badges

The Government will issue an MTF identification/access base pass to Contractor personnel requiring on-site access. The Contractor shall establish and implement methods to ensure all passes issued by the Government are not lost, misplaced, duplicated, or used by unauthorized persons. The Contractor shall include procedures for access pass control within their Quality Control Plan (QCP). The Contractor shall immediately report any occurrence of a lost, stolen, or duplicated pass to the KO and COR. The Contractor shall ensure each pass is returned to the COR upon expiration of the contract, when an employee no longer requires access, or on the last day of duty for that individual.

3.3.1. Identification Pass Renewals

The Contractor and their personnel shall take proactive ownership of tracking the expiration dates of all issued BAMC identification/access passes. The Contractor must notify the COR in writing and initiate the required renewal procedures no later than 30 calendar days prior to the expiration date of any credential. Failure to perform scheduled Preventive Maintenance (PM) or respond to Corrective Maintenance (CM) service calls within the required timeframes due to an expired facility access pass shall not constitute an excusable delay.

3.4. Government Cybersecurity Coordination

For network-connected medical devices, the Government will provide the Contractor with the applicable device's Risk Management Framework (RMF) / Authority to Operate (ATO) status and any Security Technical Implementation Guide (STIG) baseline (or equivalent guidance) needed to perform manufacturer-authorized software/firmware updates and configuration changes.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1. General

The Contractor shall furnish all personnel, OEM-approved tools, TMDE, transportation, consumable PM materials (e.g., cleaning solutions, calibration gases), and incidentals required to perform the services described in this PWS that are not specified as Government-furnished.

4.2. Subcontracting

The Contractor shall obtain Government approval for any subcontracted performance not already identified in the proposal. Subcontractors shall comply with the same PWS requirements as the prime Contractor, including personnel qualifications and TMDE calibration.

4.3. Quality Control Plan (QCP)

The Contractor shall submit a QCP to the KO not later than 30 calendar days after award. The QCP shall describe the Contractor's processes for ensuring PM completeness, calibration verification, FSR quality, parts traceability, recall compliance, and customer-feedback management.

At a minimum, the QCP shall detail the Contractor's inspection system and processes to ensure that all services conform to the requirements of this contract. This shall include the methods for monitoring, identifying, and correcting deficiencies in the quality of service, including PM completeness, FSR timeliness and accuracy, and management of customer feedback.

PART 5

SPECIFIC TASKS AND PERFORMANCE REQUIREMENTS

5.1. Preventive Maintenance (PM) Services

The Contractor shall perform scheduled PM events on the equipment listed in Technical Exhibit 3. Each PM shall be completed strictly within the PM Due Window per TE 3 and in accordance with OEM specifications (or approved AEM schedule). Each PM must be fully documented in the CMMS with an accompanying Field Service Report (FSR).

5.2. Corrective Maintenance (CM) / Unscheduled Services

The Contractor shall provide unscheduled repair services for equipment within the scope of this requirement.

a. Routine Service Calls: The Contractor shall document acknowledgment by email and phone within 4 business hours of receipt.

b. Urgent Service Calls: The Contractor shall acknowledge receipt within 1 hour (24/7) and initiate remote or on-site troubleshooting within 4 hours.

5.2.1 Service Beyond the Scope of the Contract

The Contractor shall immediately notify the COR, in writing, of the existence of any defects in, or repairs required to, the scheduled equipment which the Contractor considers are not their responsibility under the terms of this contract. The Contractor will furnish the COR with a written estimate of the cost to make the necessary repairs.

Repairs considered by the Contracting Officer to be outside the scope of this PWS will not be covered under this contract but may be ordered under a separate purchase order.

5.3. Field Service Reports (FSR) and Documentation

The Contractor shall provide a full Field Service Report (FSR) within two (2) business days after completion of all on-site service performed by uploading it to the CMMS. The FSR shall include, but not be limited to:

a. Contract number, equipment description (model, serial number, Equipment Control Number (ECN)).

b. Contractor’s service order number.

c. Detailed description of the service(s) performed.

d. Replacement part(s) information (part number, nomenclature, manufacturer, if not OEM, and whether the part is new, used, or reconditioned).

e. Explanations of any deferred or delayed repair action with a projected completion date.

f. The completion date and time, man-hours expended, and the full printed and signed name of the Contractor field service technician performing the service.

5.4. TMDE Calibration Maintenance

The Contractor shall ensure that all Test, Measurement, and Diagnostic Equipment

(TMDE) utilized in the performance of this contract maintains current NIST-traceable calibration at all times. Expired TMDE shall not be used under any circumstances.

5.5. PHI / PII Confidentiality Management

The Contractor shall maintain strict confidentiality of all Protected Health Information (PHI) and Personally Identifiable Information (PII) encountered during service events.

The Contractor shall ensure zero unauthorized disclosures and must report any suspected HIPAA/Privacy Act incidents in accordance with DoDI 6025.18 within 24 hours of detection.

5.6. Recalls and Safety Alerts (FDA / OEM)

The Contractor shall monitor manufacturer service bulletins, OEM recalls, and FDA medical device recall/safety alerts (21 CFR 803 framework) for the equipment serviced under this PWS. The Contractor shall notify the COR in writing within 48 hours of receipt of any actionable alert and complete recall actions within manufacturer/FDA timeframes.

5.7. Cybersecurity for Connected Medical Devices

For network-connected medical devices, the Contractor shall coordinate manufacturer-authorized software/firmware updates and configuration changes with BAMC Cybersecurity. The Contractor shall not perform unauthorized configuration changes, shall not connect non-OEM service tools to the BAMC network without approval, and shall report suspected cybersecurity incidents to the COR and BAMC Cybersecurity within 24 hours.

5.8. Travel

Travel shall be reimbursed only when pre-authorized in writing by the COR and the KO, and only at rates not exceeding the Joint Travel Regulations (JTR).

5.9. Performance Requirements Summary (PRS)

The specific performance objectives, measurable standards, Acceptable Quality Levels (AQLs), and associated contractual remedies for the tasks outlined above are detailed in Technical Exhibit 1 (TE 1) - Performance Requirements Summary (PRS). Failure to meet an AQL may result in payment deductions, cure notices, or termination as provided by the FAR (see FAR Part 46).

5.10. Acceptance (FAR Subpart 46.5)

Acceptance is the Government's acknowledgment that services performed conform to the requirements of this PWS. Acceptance shall be performed by the COR (or designated TPOC). Acceptance shall be evidenced by FSR review and COR sign-off in CMMS for each service event, and by Government acceptance of the maintenance reports for the period. Where health factors are involved, the responsible health official shall concur before any nonconforming item is accepted (FAR 46.407).

5.11 Phase-in/Phase-out Period

To ensure continuity of services, the Contractor shall notify the Government, in writing, no less than one year prior to the end-of-life or end-of-support date for any equipment or software covered under this contract. This notification will allow the Government sufficient time to arrange for equipment replacement or alternate service contracts.

PART 6

OTHER TERMS, CONDITIONS, AND PROVISIONS

The Contractor shall comply with the current versions of the following publications, as applicable:

FAR 37.602: Performance Work Statement FAR Part 46: Quality Assurance (including Subparts 46.4, 46.5, and 46.407) FAR 52.217-8 / 52.217-9: Option to Extend Services / Term of the Contract FAR 52.232-18: Availability of Funds FAR 52.232-25: Prompt Payment CMS S&C 14-07: Hospital Equipment Maintenance Requirements American National Standards Institute (ANSI) / Association for the Advancement of Medical Instrumentation (AAMI) EQ56: Recommended Practice for a Medical Equipment Management Program

DHA AI 6430.11, “Healthcare Technology Management Biomedical Equipment Program,” 14 October 2021 DoD 8510.01, “Risk Management Framework for DoD Information

Technology,”12 May 2014 DoDD 6200.04 Force Health Protection (FHP) DoD Financial Management Regulation (FMR) 7000.14-R, Volume 12, Chapter 7, "Financial Liability for Government Property Lost, Damaged, Destroyed, or Stolen.

DoD Manual 5200.08, Volume 3, "Physical Security Program: Protection of DoD

Assets DoDI 4140.01, "DoD Supply Chain Materiel Management Policy DoDI 4151.18, "Maintenance of Military Materiel DoDI 5101.15, DoD Medical Materiel Management DoDI 6055.01 & 6055.05 Safety and Occupational Health (SOH) / Occupational and Environmental Health (OEH) DoDI 6200.03, Public Health Emergency Management Within the Department of

Defense DoDI 6430.02, Defense Medical Logistics Program.

DoDI 6490.03, Deployment Health National Fire Protection Association (NFPA) 99, “Health Care Facilities Code,”

2021 Edition SB 8-75-11, “Army Medical Department Supply Information,” 20 November 2018 Technical Bulletin (TB) 38-750-2, “Maintenance Management Procedures for

Medical Equipment,” 12 June 1987 TB 43-180, “Calibration and Repair Requirements for the Maintenance of Army Materiel,” 1 May 2022 TB Medical (MED) 750-1, “Operating Guide for Medical Equipment

Maintenance,” 1 June 1998

PART 7

ATTACHMENT / TECHNICAL EXHIBIT LISTING

TECHNICAL EXHIBIT 1 (TE 1) — PERFORMANCE REQUIREMENTS SUMMARY

(PRS)

1. PM Completion on Schedule

a. PWS Reference: 5.1

b. Standard: Each PM completed within the PM Due Window per TE 3;

recorded in CMMS with an FSR.

c. Acceptable Quality Level (AQL): 100%

d. Method of Surveillance: Deliverable review + System report (CMMS)

e. Deliverable / Frequency: Monthly PM Compliance Report / Monthly

f. Remedy: Failure to meet AQL results in a cure notice and partial-month payment deduction proportional to overdue PMs.

2. Routine Service-Call Acknowledgment

a. PWS Reference: 5.2

b. Standard: Documented acknowledgment in CMMS within 4 business hours of receipt.

c. Acceptable Quality Level (AQL): ≥ 95%

d. Method of Surveillance: System report (CMMS)

e. Deliverable / Frequency: Monthly Service Call Report / Monthly

f. Remedy: Root Cause Analysis (RCA) delivered within 2 business days for any miss.

3. Urgent Service-Call Acknowledgment & Troubleshooting

a. PWS Reference: 5.2

b. Standard: Documented acknowledgment within 4 hour (24/7);

troubleshooting (remote or on-site) initiated within 4 hours.

c. Acceptable Quality Level (AQL): 100% acknowledgment within 4 hour; ≥

98% troubleshooting within 4 hours.

d. Method of Surveillance: System report + COR spot-check

e. Deliverable / Frequency: Monthly Service Call Report / Monthly

f. Remedy: Material breach for repeated missed-acknowledgment; cure notice.

4. FSR Timeliness and Completeness

a. PWS Reference: 5.3

b. Standard: FSR uploaded to CMMS with all required fields (equipment ID, work performed, parts, technician, date/time, acceptance) within 2 business days.

c. Acceptable Quality Level (AQL): ≥ 98%

d. Method of Surveillance: Deliverable review (FSR sample)

e. Deliverable / Frequency: FSR per service event / Monthly Review

f. Remedy: Resubmit deficient FSRs within 2 business days; chronic deficiency triggers cure notice.

5. TMDE Calibration

a. PWS Reference: 5.4

b. Standard: All TMDE used has current NIST-traceable calibration; expired

TMDE not used.

c. Acceptable Quality Level (AQL): 100% (continuous)

d. Method of Surveillance: Periodic inspection of Contractor TMDE records;

COR audit

e. Deliverable / Frequency: TMDE Calibration Log / Quarterly

f. Remedy: Discovery of expired TMDE in use requires stop-work for affected events; rework at Contractor cost.

6. PHI / PII Confidentiality

a. PWS Reference: 5.5

b. Standard: Zero confirmed unauthorized disclosures; HIPAA / Privacy Act incident reporting per DoDI 6025.18 within 24 hours of detection.

c. Acceptable Quality Level (AQL): 0 leaks / 100% reporting within 24 hours

d. Method of Surveillance: Periodic inspection + customer feedback + incident review

e. Deliverable / Frequency: Incident Report / Continuous

f. Remedy: Confirmed unauthorized disclosure is a material breach; possible cure notice, suspension, or termination.

TECHNICAL EXHIBIT 2 (TE 2)

DELIVERABLE SCHEDULE

Quality Control Plan (QCP)

a. Due: NLT 30 calendar days after award.

b. Format: One (1) electronic Portable Document Format (PDF).

c. Submit To: KO, COR, and TPOC.

Monthly Maintenance Report (PM compliance, service calls, parts, recalls)

a. Due: NLT 7 calendar days after the end of each month.

b. Format: One (1) electronic PDF or Excel file.

Field Service Reports (FSRs)

a. Due: Within 72 hours of each service event.

b. Format: Electronic PDF.

c. Submit To: Upload directly into CMMS.

Schedule Confirmation of Scheduled Service

a. Due: Two (2) weeks prior to the start of each calendar month containing a scheduled PM event.

b. Format: Electronic communication (email).

c. Submit To: COR and TPOC.

TMDE Calibration Log

a. Due: Quarterly, and upon COR request.

b. Format: One (1) electronic PDF or Excel file.

Incident Report (HIPAA / Cyber)

a. Due: Within 24 hours of detection.

Recall / Safety Alert Action Report

a. Due: Within 48 hours of receipt of the alert, and again at completion of the action.

IA Training Completion Records

a. Due: Upon COR request.

TECHNICAL EXHIBIT 3 (TE 3

EQUIPMENT INVENTORY

Equipment within the scope of this contract is included as Attachment 2. The inventory shall be reconciled with the BAMC CMMS at award and kept current for the life of the order.

TECHNICAL EXHIBIT 4 (TE 4)

PM SCHEDULE / DUE DATE ROLL-UP

The Contractor shall confirm PM due dates with the CMMS at award and submit a draft annual PM schedule within 30 calendar days after award.

PM to be conducted annually based on due dates in Defense Medical Logistics Standard Support (DMLSS) for each piece of equipment.