PWS W81K0224Q0022 12-21-23 Redacted.pdf

Maintenance and Repair Services for Bayer Injectors System

This is a non-personnel services contract to provide Maintenance and Repair services for the Bayer Healthcare Systems and Components. Services to be performed at Madigan Army Medical Center, Tacoma, Washington 98431.

EQUIPMENT LISTING: The equipment listing below provides a current snapshot of machines owned and operated by Madigan Army Medical Center (MAMC). As equipment is replaced, purchased, or decommissioned, this list shall be updated via formal modification to the contract.

Nomenclature ECN Actual S/N Location Xperion 137519 311755 MRI Stellant Workstation 120064 301135 CT Stellant Flex 124490 100844 Oncology Stellant Flex 121380 Nuclear Medicine Stellant Flex 136058 121357 CT Stellant Dual 013382 27124 PET/CT Stellant Dual 054445 33891 Nuclear Radiology Solaris EP 041594 44719 MRI Solaris EP 115802 40667 MRI **Provis 071704 201013 Angiography/IR **Provis 077060 201215 Angiography/IR Arterion 114179 300097 Cardiac Cath Lab Arterion 091387 202273 OR/Surgery Arterion 138096 313117 Cardiac Cath Lab

** - Provis serial number 201013 & 201215 Require only Preventative Maintenance as described in Paragraph 3.2 herein.

1. SCOPE OF WORK

The Contractor shall provide Original Equipment Manufacturer (OEM) fully certified/qualified technicians to perform the maintenance and repair services for the Bayer Healthcare Injector Systems. As described herein, to ensure that optimum operation and efficiency of the equipment is maintained, and that proper functioning of the equipment conforms to the OEM standard specifications. Contractor shall have knowledge of, furnish and install all OEM sponsored modifications at no additional charge. This includes all the OEM published Equipment Changed Orders (ECO) and Field Change Orders (FCO).

Mandatory modifications include equipment upgrades or enhancements to equipment design and changes necessary for operator and patient safety. In addition, the Government may request the Contractor to install said OEM sponsored modification in the event that the Government obtained knowledge of ECO or FCO before the contractor.

Contractor will make all ECO and FCO modifications in a timely manner, but in no case shall it exceed sixty (60) calendar days after ECO or FCO is announced by the OEM. All such modifications shall be made so as not to interfere with the Government’s operation. If such modification is not possible during normal duty hours, the Contractor will do the modifications outside of normal duty hours (overtime) at no additional cost the Government.

2. CONTRACTOR POINT OF CONTACT: The Contractor shall provide a single point of contact (POC) for any calibration services and repairs.

Primary Government Point of Contact (GPOC):

a. NAME:

b. EMAIL:

c. TITLE:

d. TELEPHONE:

Secondary Government Point of Contact (GPOC):

a. NAME:

b. EMAIL:

c. TITLE:

d. TELEPHONE:

3. CONTRACTOR FURNISHED EQUIPMENT/MATERIALS: The Contractor shall provide any technical manuals, special tools, supplies, parts, or test equipment that are required for the servicing of the Bayer Healthcare Injector Systems.

3.1 MAINTENANCE SERVICES/REPAIRS: The Contractor shall keep the system in good operating condition, meeting all published equipment requirements and standard specification listed by the OEM. The Services include moving, reinstalling and certifications. Upon request by Government Point of Contact (GPOC), the contractor shall provide proof of services completed on equipment during services performed. The service report will include Inspection, mandatory/collective updates/upgrades of software and hardware (including OEM sponsored software modifications for installation), on-site emergency labor, comprehensive parts coverage and 98% uptime guarantee.

3.2 PREVENTIVE MAINTENANCE (PM): One (1) periodic PM service shall be performed per machine per

12 months of active contract performance. PM services shall include scheduled maintenance, inspections, replacement of defective and worn parts, and testing service in accordance with OEM specifications. Services during the time frame will include one (1) electrical safety test to determine the power cord resistance and whether current leakage (or touch current) is within safe operating limits. All services performed will be documented and indicated on the service report. The service reports will be given to the Government Point of Contact (GPOC) for verification of contractor’s performance and approval of payment. Proper corrective maintenance service will be provided as needed during the services.

3.3 CALIBRATION SERVICE (CAL): One (1) periodic Calibration Verification Check (CVC) will be performed at a minimum of once per machine per 12 months. The Contractor shall comply with the manufacturer’s specified frequency, duration and calibration procedures for the equipment listed above. Upon completion of the CVC, the Contractor’s technician will complete the following items:

a. DD Form 2163 shall be affixed to the unit by a HTM-S technician in accordance with the instructions in TB-38-750-2, paragraph 2-12.

b. DD Form 2164 (applicable for use with the Radiotherapy System, Linear Accelerator equipment only) in accordance with the instructions in TB-38-750-c, paragraph 2-13, and a continuation sheet for DD Form 2164 listing the manufacturer, model, serial number, and date of calibration. Required Department of Defense Forms or regulations may be furnished to the Contractor by the Government upon request.

3.4 CORRECTIVE MAINTENANCE:

a. The Contractor shall provide unlimited on-call technical support during standard hours of operation, 0800 – 1700 PST, Monday through Friday when notified by the Government Point of Contact (GPOC) of equipment malfunction. Minimum standard response time is established as no later than the following workday after notification of equipment malfunction. During each On-site service call, the Contractor shall take all steps to restore the equipment to proper operating conditions and replace components and parts determined by the Contractor’s technician to be defective.

b. All repairs shall be completed in a minimum amount of time, but not to exceed Two (2) working days.

All maintenance actions that exceed Two (2) working days shall be reported to the Government Point of Contact (GPOC) and the Contractor’s technician shall provide a report that includes as a minimum the explanation for any maintenance delays and the estimated time to complete the repair.

c. Repairs required outside the scope of this contract are not authorized. Should acquisition of such services be deemed necessary by the Chief, HealthCare Technology Management Sustainment (HTM-S), a requisition shall be submitted to the Contracting Officer for negotiation under a separate contract. The Contractor shall not accomplish any repairs outside the scope of this PWS until authorized via formal modification to the contract via the Contracting Officer.

4. LOCATION OF THE SERVICES:

4.1 ON-SITE SERVICES: On-site repairs are to be accomplished at MAMC, JBLM, whenever possible.

4.2 OFF-SITE SERVICES: If work to be performed is too complex, or inappropriate to perform on-site, such work may be performed at local or factory repairs facilities with approval of the Contracting Officer via a formal modification. All preparation to necessitate such a move, packing, transportation, and reinstallation, shall be performed by the Contractor at no additional cost to the Government. If the equipment must be removed and transported to the Contractor’s facility for repair, the Contractor shall immediately notify the Contracting Officer, Contract Specialist, and the Government Technical POC. The Contractor shall provide the below information. The Contractor SHALL NOT remove the equipment from the installation until the contract has been modified via the Contracting Officer to provide the Contractor a Government Furnished Property attachment.

a. Anticipated Date of removal (This is pending formal modification and approval by Contracting Officer).

b. Make, model, serial number, and Medical Materiel Control Number (MMCN)

c. Reason(s) for removal

d. Contract number

5. REPLACEMENT PARTS:

5.1 All Factory Certified parts, labor, and travel to perform maintenance service and repairs (preventive or corrective) shall be included in the contract price, including (i.e., consumables, software updates, etc., that could affect price). Parts requiring replacement to maintain the equipment in accordance with manufacturer’s specifications and applicable regulations are to be replaced on a manufacturer's rebuilt or new part basis. Installation of government-furnished parts and part(s) furnished by the Contractor shall be installed by the Contractor.

5.2 Maintenance actions shall not be delayed by more than 24 hours due to the delivery of a repair part or item. All parts shall meet OEM specifications.

6. EQUIPMENT MODIFICATIONS:

6.1 The Contractor shall with the concurrence of the Contracting Officer or its representative, at no additional cost to the Government:

a. Make equipment modifications to improve the operation or reliability of the equipment.

b. Implement any equipment modification in circuitry or otherwise upgrade the equipment/system to effect current configuration to ensure optimum performance.

c. Make manufacturer recommended engineering changes that have been issued since MAMC’s acquisition of listed equipment or its components.

d. Provide all OEM and/or Food and Drug Administration (FDA) mandated software corrections and upgrades.

e. Provide the Chief, HTM-S, a complete copy of the schematics if there are any changes to the configuration or circuitry of the equipment or components because of equipment modifications.

NOTE: The Government Point of Contact monitors all technical aspects of the contract and assists in contract administration. The GPOC 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 furnished property, and provide site entry of Contractor personnel.

The GPOC is NOT authorized to change any of the terms and conditions of this contract. Only the warranted Contracting Officer is authorized to make modifications/changes to the terms and conditions of this contract. If the Contractor believes any Government personnel has effectively issued a change resulting in a change in effort and price/cost of the contract, the Contractor shall immediately notify the Contracting Officer in writing.

7. IWATCH TRAINING: The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the typed of behavior to watch for and instruct employees to report suspicious activity to the Government Point of Contact (GPOC). This training shall be completed within 30 calendar days of contract award and within 10 calendar days of new employees commencing performance with the results reported to the Government Point of Contact (GPOC) NLT 40 calendar days after contract award.

8. AT LEVEL 1 TRAINING: This standard language is for contractor employees with an area of performance within an Army controlled installation, facility, or area. All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 10 calendar days after completion of training by all employees and subcontractor personnel.

AT level I awareness training is available at the following website: http://jko.jten.mil.

ACCESS and General Protection / Security Policy and Procedures. The contractor and all associated subcontractors’ employees shall comply with applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by the government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. The contractor shall comply with all personal identity verification requirements as directed by DoD, HQDA, and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes. Upon receipt of the awarded contract, the Contractor’s technician is responsible for reporting to the following locations:

9. Fort Lewis – Main Gate, I-5 exit 122:

Vehicle pass and parking briefing (Required documents: Valid Driver’s license, vehicle registration and proof of insurance)

9.1 Madigan Army Medical Center:

9.1.1 HealthCare Technology Management Sustainment (HTM-S): Upon entering or departing the

Medical Center, the Contractor’s technician shall physically sign in and sign out with the HTM-S Service Desk, Building 9040A, Room G-16-4, during standard hours of operation 0800 and 1700, Monday through Friday, excluding federal holidays.

9.1.2 Provost Marshal Office (PMO): MAMC Medical Mall, 2

nd Floor, Room 2-56-40. Visit PMO for access and general protection language/security policy and procedures. This standard language is for contractor employees with an area of performance within Army controlled installation, facility, or area. Contractor and all associated sub-contractors’ employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. The Government may require additional changes to requirements in contractor security matters and processes as dictated by Force Protection Condition (FPCON) at any individual facility or installation.

10. OPSEC (OPERATION SECURITY): Per AR 530-1 Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

11. IA CONTRACTOR TRAINING AND CERTIFICATION: All contractor employees and associated sub-contractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working in IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01-M and AR 25-2 within six months of appointment to IA/IT functions. These persons must also comply with IS access requirements.

12. CONTRACTORS NOT REQUIRING COMMON ACCESS CARD (CAC) BUT REQUIRE ACCESS

TO A DOD FACILITY OR INSTALLATION: The contractor and all associated sub-contractors’ employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-111) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or at OCONUS locations, in accordance with the status of forces agreements and other theater regulations.

13. SAFETY AND HEALTH PLAN: The contractor shall comply with Occupational Safety and Health Administration (OSHA) standards as a minimum level of safety and health performance and establish more stringent standards where necessary. The contractor shall comply with the requirements of Army Safety Program "AR 385-10", "Department of Defense Instruction "DODI 6055.1, MAMC and other applicable directives and regulations. The contractor shall report all accidents, incidents, mishaps, near misses and spills to the GPOC.

14. REPORTS: Upon request by the HealthCare Technology Management Sustainment (HTM-S), the Contractor shall provide service report for the maintenance services during the Period of Performance (POP) and it will be considered as downtime without service report to Healthcare Technology Management Sustainment (HTM-S). The Contractor shall provide HTM-S a detailed or itemized Service Report of all services performed, and parts replaced upon completion of each repair or service. Report shall be delivered to the HTM-S Service Desk when signing out of the HTM-S. Services completed after standard hours, shall be faxed to HTM-S at (253) 968-1048. Minimum details for inclusion

a. Make, model, serial number, and Medical Materiel Control Number (MMCN).

b. Malfunction and repairs performed.

c. Time in hours for repair(s) and technician’s hourly rate.

d. Part number and price of parts replaced.

e. Annotate either scheduled or emergency repair.

15. EXCLUSIONS: The Contractor is not responsible for maintenance service, repairs, or replacement parts, resulting from the fault or negligence by government personnel or acts of God. This Agreement specifically excludes labor, parts, and expenses necessary to repair equipment.

a. The Contractor is not required to provide repair service between the hours of 1700 hours and 0800 hours weekday or on

The Joint Commission (TJC) Manual (Current Edition)

Defense Health Agency:

DHA-AI 001 Telework Program DHA-AI 003 Physical Security Program DHA-AI 034 Drug-Free Workplace Program DHA-AI 050 Accounting of Disclosures of Personally Identifiable Information (PII) and Protected Health Information (PHI) DHA-AI 5015.01 Records Management DHA-AI 5200.02 Information Security Program DHA-AI 5200.03 Operations Security (OPSEC) Program

DHA-AI

DHAPI 6000.03 Life Support Training Certification Requirements and Guidance DHAPI 6010.02 MHS Prescription Drug Monitoring Program DHAPI 6015.02 Beneficiary Counseling and Assistance Coordinator (BCAC) and Debt Collection Assistance Officer (DCAO) DHAPI 6025.04 Pain Management and Opioid Safety in the MHS DHAPI 6025.06 Standardized Templates for Primary Care Clinical Encounter Documentation DHAPI 6025.10 Standard Processes, Guidelines, and Responsibilities of the DoD Patient Bill of Rights and Responsibilities in the Military Health System (MHS) Military Medical Treatment Facilities (MTFs) DHAPI 6025.20 Medical Management (MM) Program within the Military Health System (MHS) DHAPI 6025.26 Standard Processes for the Military Health System (MHS) Nurse Advice Line (NAL) DHAPI 6025.27 Integration of Primary Care Behavioral Health (PCBH) Services into Patient-Centered Medical Home (PCMH) and Other Primary Care Service Settings within the Military Health System (MHS) DHAPI 6025.28 Standard Processes and Procedures for Communication of Laboratory and Radiology Results DHAPI 6025.29 Provision of Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP) for Persons at High Risk of Acquiring HIV Infection DHAPI 6025.33 Acupuncture Practice in Military Treatment Facilities DHAPI 6025.39 Medical Ethics in the Military Health System DHAPI 6025.42 Routine Adult Transthoracic Echocardiogram (TTE) Standards for all Military Medical Treatment Facilities

(MTFs) DHAPI 6040.07 Medical Coding of the DOD Health Record DHAPI 6401.01 Dental Sedation Medical Management DHAPI 6490.02 Behavioral Health (BH) Treatment and Outcomes Monitoring DHAPM 6025.01 Primary Care Behavioral Health (PCBH) Standards DHAPM 6025.13, Volumes 1-7 Clinical Quality Management in the Military Health System

Department of Defense (DoD):

DoD 5200.1-R Information Security Program DoD 5200.2 Personnel Security Program DoDI 5200.46 DoD Investigative and Adjudicative Guidance for Issuing the Common Access Card DoD 5210.42-R Nuclear Weapons Personnel Reliability Program (PRP) Regulation DoD 5400.7-R DoD Freedom of Information Act DoD 5400.11-R Department of Defense Privacy Program DoD 6010.13-M Medical Expense and Performance reporting System for Fixed Military Medical and Dental Treatment Facilities

Manual DoD 6010.15-M Military Treatment Facility Uniform Business Office (UBO) Manual DoD 6015.1-M Glossary of Healthcare Terminology DoD 6025.18-R DoD Health Information Privacy Regulation DoD 6055.5-M Occupational Medical Examinations and Surveillance Manual DoD 8580.02-R HIPAA Security Rule DoDD 5144.02 Information Technology Standards in the DoD DoDD 5205.2 DoD Operations Security (OPSEC) Program DoDD 5400.11 DoD Privacy Program DoDD 5500.07 Standards of Conduct DoDD 6000.14 Patient Bill of Rights and Responsibilities in the Military Health System (MHS)

DODM 6025.13 Medical Quality Assurance (MQA) in the Military Health System (MHS) DoDD 6040.41 Medical Records Retention and Coding at Military Treatment Facilities DoDD 6205.02E Policy and Program for Immunizations to Protect the Health of Service Members and Military Beneficiaries DoDD 8190.3 Smart Card Technology DoDD 8500.01E Information Assurance DoDI 1100.22 Policy and Procedures for Determining Workforce Mix DoDI 1402.5 Criminal History Background Checks on Individuals in Child Care Services DoDI 3020.37 Continuation of Essential DoD Contractor Services During a Crises DoDI 5200.02 DoD Personnel Security Program (PSP) DoDI 6000.11 Patient Movement DoDI 6015.23 Delivery of Healthcare at Military Treatment Facilities: Foreign Service Care; Third Party Collection;

Beneficiary Counseling and Assistance Coordinators (BCACs) DoDI 6025.8 Ambulatory Procedure Visit (APV) DoDI 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health System

DODI 6055.1 MAMC

DoDM 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health System (MHS) DoDI 6025.18 Privacy of Individual Identifiable Health Information in DoD Health Care Programs DoDI 6040.40 Military Health System Data Quality Management Control Procedures DoDI 6040.42 Medical Encounter and Coding at Military Treatment Facilities DoDI 6040.43 Custody and Control of Outpatient Medical Records DoDI 6205.2 Immunization Requirements DoDD 6459.01 Sexual Assault and Response (SAPR) Program

Army Regulations:

AR 530-1

Army Directive 2014-05/AR 190-13 TB-38-750-2, paragraph 2-12

AR 385-10