PWS Hologic Panther Plus DRAFT.pdf

PERFORMANCE WORK STATEMENT (PWS)

Maintenance and Repair Services

This is a non-personal services contract to provide Maintenance and Repair services for the Government owned equipment: Hologic Panther Plus. The period of services is 1 June 2025 through 31 May 2030 at Madigan Army Medical Center, Tacoma, Washington 98431.

EQUIPMENT LISTING:

Nomenclature ECN S/N Location Hologic Panther Plus 120287 1010910677 Dept. of Pathology, Microbiology laboratory

1. SCOPE OF WORK

The Contractor shall provide manufacturer certified/qualified technicians to perform the maintenance and repair services for the Government-Owned Hologic Panther Plus 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 Original E equipment Manufacturer (OEM) standard specifications. The manufacturer certified/qualified technicians training must be current and relevant. For the purpose of this PWS, current is defined as the technician completing manufacturer training within 24 months of contact award. For the purpose of this PWS, relevant is defined as the technician completing manufacturer training specific to the Hologic Panther Plus.

The Contractor shall have knowledge of and furnish and install all OEM sponsored modifications at no additional charge. This includes providing all the OEM published Equipment Changed Orders (ECO) and Fielded Change Orders (FCO); mandatory and elective updates/upgrades to equipment, software, and firmware; mandatory and elective enhancements to equipment design;

and all 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. The 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 completed in a manner 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 at no additional cost the Government.

2. CONTRACTOR POINT OF CONTACT: The Contractor shall provide a single point of contact (POC) for all work under this contract and associated task order to the Government Technical Point of Contact (TPOC) and Contracting Officer.

Technical Government Point of Contact:

Name: William Gibson Email: William.c.gibson26.civ@health.mil Title: Supervisory Microbiologist Telephone: 253-968-1751 mailto:William.c.gibson26.civ@health.mil

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 Hologic Panther Plus. Upon request by the Clinical Engineering Branch (CEB), 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 Clinical Engineering.

3.1 MAINTENANCE SERVICES/REPAIRS: The Contractor shall provide all mandatory and elective services to keep the Hologic Panther Plus in a fully functional operating condition that is in compliance with all published equipment requirements and standard specification listed by the OEM. The services include moving, reinstalling and certifications. Upon request by Contracting Officer Representative (COR) or Government Point of Contact (GPOC), the contractor shall provide proof of services on equipment during services performed. The preventive maintenance service and calibration service should be scheduled and provided on the same day.

3.2 PREVENTIVE MAINTENANCE (PM): O One (1) Annually periodic PM Service shall be performed during the annual contract period. 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 current leakage (or touch current) are within safe operating limits. All services performed will be documented and indicated on the service report.

The service reports will be given to the Contracting Officer Representative (COR) or Government Point of Contact (GPOC) for verification of contractors performance and approval of payment.

3.3 CALIBRATION SERVICE (CAL): One (1) periodic Calibration Verification Check (CVC) (month of July) will be performed for each contract period. 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 CEB 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 Contracting Officer Representative (COR) or 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 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 Contracting Officer Representative (COR) or 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, Clinical Engineering Branch (CEB), and a requisition shall be submitted to the Contracting Officer for negotiation under a separate contract.

d. Service will be included all hardware (mandatory and elective updates/upgrades);

firmware (mandatory and elective updates/upgrades); software (mandatory and elective updates/upgrades); installation, parts, labor. If equipment is down for greater than 3 consecutive business days, contractor will provide a comparable no charge loaner system for upon request. Contractor will provide telephone technical support through its Technical Support Call Center. Technical Support personnel are available 24hrs per day 7 days per week. 1-888-838-3222.

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, in writing. 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:

• All Original Equipment Manufacturer parts, labor and travel to perform maintenance service and repairs (preventive or corrective) shall be included in the offered price, including consumables; all mandatory and elective software (updates/upgrades); all mandatory and elective hardware (updates/upgrades) 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.

• Maintenance actions shall not be delayed by more than 24 hours due to the delivery of a repair part or item. All parts shall be of Original Equipment Manufacturer (OEM) and shall meet manufacturer specifications.

• All mandatory and elective hardware, firmware, software, installation, parts and labor will be included in service agreement and loaner service will be provided when device is down longer than 48 hours.

6. 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 modifications to improve the operation or reliability of the equipment;

b. Implement any 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. h ttps://www.fda.gov/medical-devices/surgery-devices/computer-assisted-surgical-systems

e. Provide the Chief, CEB, a complete copy of the schematics if there are any changes to the configuration or circuitry of the equipment or components as a result of modifications.

6.2 NOTE: No individual, including the Contracting Officer Representative (COR) and Government Point of Contact (GPOC), has the authority to approve modifications or changes that would result in an increase or decrease in the awarded contract price. This authority is vested with the Contracting Officer only and will not be delegated. If a question as to whether the application of an equipment modification or change would result in a change to the contract price, the Contractor shall not commence work without the prior approval of the Contracting Officer.

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 Contracting Officer Representative (COR) or 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: Contractor and all associated sub-contracts employees must successfully complete Army presented Level One Anti-Terrorism training within 30 days of the beginning of this contract. New employees must attend the training within 10 days of their reporting for duty. 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 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). Real ID Act- Joint Base Lewis-McChord is in compliance with the REAL ID Act of 2005. This means visitors presenting drivers licenses and identification cards stating “Not Valid For Federal Purposes" or "Federal Limits May Apply” will need to provide supplemental documentation to prove identity in order to be issued a temporary installation pass. For additional information, visit https://home.army.mil/lewismcchord/index.php/about/Directorates-support-offices/directorate-emergency-services/provost-marshal/gate-information.

9.1 Madigan Army Medical Center:

9.1.1 Clinical Engineering Branch (CEB): Upon entering or departing the Medical Center, the Contractor’s technician shall physically sign in and sign out with the CEB Service Desk, Building 9040A, Room G-16-4, during standard hours of operation 0700 and 1700, Monday through Friday, excluding federal holidays.

9.1.2. Provost Marshal Office (PMO): MAMC Medical Mall, 2nd 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). Contractors shall comply with DoD Directive https://home.army.mil/lewismcchord/index.php/about/Directorates-support-offices/directorate-emergency-services/provost-marshal/gate-information https://home.army.mil/lewismcchord/index.php/about/Directorates-support-offices/directorate-emergency-services/provost-marshal/gate-information

5205.02 and any applicable service regulation and Army Regulation 530-1. The contractor shall develop an OPSEC Standing Operating Procedure (SOP) within 90 days of contract award, to be reviewed and approved by the cognizant Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the CDR. In addition, the contractor shall have an identified and Army Regulation 530-1 certified OPSEC officer. This OPSEC officer shall provide all contractor personnel OPSEC Awareness training within 30 days of the beginning of contract performance. The contents of the training shall comply with AR 530-1 chapter 4-2.

11. 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.

12. 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 COR.

13. REPORTS: The Contractor shall provide CEB 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 CEB Service Desk when signing out of the CEB. Services completed after standard hours, shall be faxed to CEB 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 h

d. Part number and price of parts replaced

e. Annotate either scheduled or emergency repair

14. EXCLUSIONS:

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

14.2 The Contractor is not required to provide routine repair service between the hours of 1800 hours and 0800 hours weekday or on weekends and federal holidays. The Contractor may provide services during these times, with prior approval of the Contracting Officer Representative, at no additional cost to the Government. If additional costs are required for work outside normal working hours, a modification to the contract must be completed prior to commencing work.

15. INVOICING:

15.1 Payment will be made in arrears [ ] Monthly [] Quarterly [ ] Semi-Annually [X] annually.

To be paid by WAWF. POC is Gibson, William at 253-968-1751 or william.c.gibson26.civ@health.mil.

15.2 The Government shall inspect all scheduled preventative and corrective maintenance, including reports resulting from the preventive and corrective maintenance. On-call corrective maintenance inspections will be performed periodically, as deemed necessary by the Contracting Officer Representative (COR) or Government Point of Contact (GPOC).

16. CONTRACTOR PERFORMANCE EVALUATIONS:

a. In compliance with FAR Subpart 42.15, Contractor Performance Information, an evaluation of contractor performance will be conducted at contract completion. Interim performance evaluations will be conducted at least annually for contracts with a period of performance, including options, exceeding one year. As a minimum, the evaluation shall include the information in FAR 42.1501 “General”.

b. Each completed evaluation will be provided to the contractor. The contractor will have a minimum of 30 calendar days to submit comments, rebut statements, or add additional information.

c. Disagreements between the parties regarding the evaluation will be handled in accordance with FAR 42.1503 (b).

d. Copies of the evaluation, contractor response, and review comments, if any, may be retained for up to three years after contract completion as part of the evaluation file.

e. Past performance information will be shared, as requested, with Government source selection officials to support award decisions and may be maintained in the government databases available to other Government personnel.

17. PERFORMANCE MEASURE:

a. Outcome: The contractor shall provide Madigan Army Medical Center’s Clinical Engineering Branch with maintenance service and repair of the equipment listed above.

b. Standards: The standard of performance for the listed measures is conformance to contract requirements and guaranteed equipment uptime is 96%.

c. How measured: Clinical Engineering Branch (CEB) personnel will monitor contractor performance by verifying service report documents upon completion of each repair or service.

Required Services

(Tasks)

Performance

Standards

Acceptable

Quality Levels

Incentive (Positive and/or Negative)

(Impact on Contractor Payments)

Service Report for scheduled / un-scheduled maintenance and repair, inspections services

Report should be provided to CEB, MAMC and

COR/GPOC

within two business days

100% Accuracy Evaluation (Negative/positive) will be submitted to SPM, PIEE and notify Contracting Officer

DMLSS Work order

DMLSS Work order is required to have any type of service under awarded contract

100% Occurrence

It will be reported as Unauthorized Commitment

Maintenance due to equipment malfunctions.

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

100%

Occurrence

Evaluation

(Negative/positive) will be submitted to SPM, PIEE and notify Contracting officer

18. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP):

18.1 Purpose: The purpose of this QASP is to provide a planned process for surveilling the Contractor’s actual performance and comparing that performance against the contractual requirements to determine conformity in accordance with the Performance Work Statement (PWS).

The policy of the Government for contractor quality control and Government quality assurance and applicable definitions are provided in the Federal Acquisition Regulations (FAR) in Part 46 Quality Assurance. The Government has the right to change or modify this quality assurance surveillance plan and methods at its discretion.

18.2 Surveillance Methods: The contractor’s performance will be monitored by the Government Point of Contact (GPOC) in conjunction with input from the customers. Completed delivery of services will be verified with the PWS prior to making any payment approvals.

Incomplete or delayed performance will be forwarded to the Contracting Officer.

18.3 Remedy: Should unacceptable performance occur, the government will document the contractor’s past performance, issue cure notices or may terminate the contract by default.

19. SERVICE CONTRACT REPORTING (FORMERLY CONTRACTOR

MANPOWER REPORTING):

a. ACCOUNTING FOR CONTRACT SERVICES: The contractor shall report ALL contractor labor hours (inclusive of subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. Reporting shall be accomplished online by going to web address: http://www.SAM.gov/, and then clicking on the “Service Contract Report” section of SAM. The reporting period is the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The contractor shall notify the Contracting Officer’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the Contracting Officer. The required information includes the following:

(1) Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative;

(2) Contract number, including task and delivery order number;

(3) Beginning and ending dates covered by reporting period;

(4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data;

(5) Estimated direct labor hours (including sub-contractor);

(6) Estimated direct labor dollars paid this reporting period (including sub-contractor);

(7) Total payments (including sub-contractor);

(8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different);

(9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information);

(10) Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website);

(11) Presence of deployment or contingency contract language, and,

(12) Number of contractor and sub-contractor employees deployed in theater this reporting period (by country).

b. As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. This cost will be reflected on a separate and can be invoiced upon completion of the report.

c. Reporting period will be the period of performance not to exceed 12 months ending 30 September of each government fiscal year and must be reported by 31 October of each calendar year.

d. The contractor shall notify the Government Point of Contact (GPOC) by the 5th working day of November whether or not they have completed this report. If the Government Point of Contact (GPOC) is unavailable, the contractor will notify the Contracting Officer.

e. The following information is provided for the Contractor’s use in completing the above report:

(1) Predominant Federal Service Code: J065

(2) Unit Identification Code for the Army Requiring Activity: W0Q1AA

ACCOUNTING FOR CONTRACT SERVICES REQUIREMENTS:

1. Contracting Office / Contracting Officer, Contracting Officer Tech. Rep

JB Lewis McChord Health Contract Branch

2. Contract Number

3. Beginning/Ending Dates covered

4. Contractor Name, Address, Phone Number, email, & POC

5. Estimated Direct Labor Hours (including sub-contractors)

6. Estimated direct labor dollars paid this reporting period (including sub-contractor)

7. Total Payments (including sub-contractor)

8. Federal Service Code J065

9. Army’s Organizational UIC W0Q1AA

10. Location of Work 98431

11. Deployment/Contingency None

12. Number of Contractor/Sub-contractor Employees deployed in theater

None

20. Exclusion from Participation in Federal Health Care Programs:

a. The Government is legally prohibited from paying for provision of items or services by persons listed on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The LEIE may be found at h ttp://oig.hhs.gov/fraud/exclusions.asp, and the TRICARE Sanctioned Provider list at h ttp: //www.health.mil/Military-Health-Topics/Access- Cost-Q uality-and-Safety/Quality-And-Safety-of-Healthcare/Program-Integrity/Sanctioned- Providers. The LEIE and TRICARE Sanctioned Provider List are collectively referred to as “the Lists.”

b. Prior to responding to this solicitation, the Contractor shall query the Lists to determine http://www.health.mil/Military-Health-Topics/Access-Cost-http://www.health.mil/Military-Health-Topics/Access-Cost-whether his/her name appears on either or both Lists. By responding to this solicitation, the Contractor certifies to the Contracting Officer that the Contractor has queried the Lists and his/her name does not appear on either of the Lists.

c. The Contractor is advised that during performance of the contract, MTF personnel will perform a recurrent recheck of the names of contractor personnel working in the MTF against the Lists, as specified in OTSG/MEDCOM Policy Memo 15-037. The Government will notify the Contractor if he/she appears on either of the Lists.

d. The Contractor shall promptly notify the Contracting Officer at any time he/she becomes aware of being on either of the Lists.

e. Should the Contractor appear on either of the Lists at any time during contract performance or otherwise violate the terms of this clause, the Contracting Officer will (a) not approve payment for items provided or services rendered by the Contractor during the time he/she appears on either of the Lists, and (b) promptly terminate the contract pursuant to FAR 52.249- 12.