PWS.pdf

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Maintenance Service for Terumo BCT Equipment
Solicitation number
PR0012099445
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About this file

This document is a Performance Work Statement (PWS) for a federal contract opportunity to provide scheduled and unscheduled maintenance, including parts and labor, on Terumo BCT units located at the Robertson Blood Bank Center within C.R. Darnall Army Medical Center in Fort Cavazos, Texas.

The PWS outlines the scope of work, which requires the contractor to provide two preventive maintenance (PM) visits per year for the Trima units and one PM visit per year for the Seal Safe units, as well as unlimited repair calls. The contractor must use only new or reconditioned parts of equal or better quality than the original equipment manufacturer's parts. The contractor must also provide documentation that the field service technicians are qualified and manufacturer-trained on the Terumo units. The contract will be a Firm Fixed-Price contract, with a focus on ensuring adequate competition from small businesses, including 8(a), HUBZone, Women-Owned, and Service-Disabled Veteran-Owned Small Businesses, as well as large businesses. The anticipated NAICS code is 811210 - "Electronic and Precision Equipment Repair and Maintenance", with a size standard of $34.0 million.

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Performance Work Statement

1. General:

Contractor shall provide scheduled and unscheduled maintenance to include parts, labor on the TERUMOBCT units located in the Robertson Blood Bank Center within C. R. Darnall Army Medical Center, Fort Cavazos, Texas.

EQUIPMENT LIST:

TRIMA ACCEL SEAL SAFE

ECN #’S SN #’S ECN #’S SN #’S

58024 1T06638 60570 0059CTI

58025 1T06641 60571 0063CTI

60342 1T05040 60572 3858 60698 1T05036 60700 4357

60699 1T05022 82780 5535SAN

2. Scope of Work:

The contractor shall provide all necessary trained experienced personnel, labor, tools, diagnostic equipment and software, material, supplies, transportation, parts and equipment, excluding expendable items to perform repair support of the Terumo units. Service shall consist of two (2) preventive maintenance (PM) for the Trima’s and one (1) preventive maintenance for the Seal Safe and unlimited repair calls for the Terumo units. Normal Duty Hours: Monday through Friday 7:30 am. To 4:30 p.m., excluding national holidays and weekends.

2.2. Contractor shall report or telephonically notify the Medical Maintenance Branch Contracting Officer’s Representative or NCOIC, (254) 288-XXXX or (254) 553-XXXX CRDAMC Bldg. 3XXX Room 40-XXX Fort Cavazos TX 76544.

2.3. After Duty Hours: Contractor shall report to the Administrative Officer of the Day (AOD) at the front desk of the hospital to be escorted to the appropriate work area.

3. Personnel Qualifications:

The contractor shall provide documentation that the field service technicians are qualified, and manufacture trained on the Terumo units. In addition to this training, the technicians must have proof of two years of working experience, effective with the current date. The contractor prior to service commencing shall present documented proof of successful completion of such training.

4. Contract Representative (POC).

The contractor shall provide in writing on the contract start date, the name and telephone number of a primary and alternate individual to act as their representative to be responsible for the coordination of the contract with the government. The contractor’s designated representative shall be the point of contact with the government and shall have the authority to act or make decisions for the contractor on all matters pertaining to the contract. The contracting officer shall be notified in writing within 72 hours, whenever changes are made.

5. Quality Control:

5.1. The contractor shall establish and maintain a Quality Control Plan to ensure that the quality of service and material provided meet or exceed the specifications, terms, and conditions of the contract. All repairs or modifications that are made shall be in compliance with the manufacturer’s specification and Food and Drug Administration guidance.

5.2. The government will establish and maintain a Quality Assurance Plan to ensure that the quality of service is being provided and meet and exceed the specifications, terms and conditions of the contract.

6. Definitions:

6.1. Scheduled Maintenance: The scheduled care and servicing of equipment for the purpose of the equipment in a serviceable condition in accordance with the manufacturer’s specifications.

6.2. Unscheduled Maintenance: Repair action necessary to return the equipment to a totally operational condition as it was designed to operate in accordance with the manufacturer’s specifications.

6.3. Quality Control Plan: The contractors’ written plan describes how he will ensure the performance of the services required by the contract are met or exceeded. At a minimum, the contractor’s Quality Control Plan will include:

1. Method for acquiring acceptable replacement parts.

2. Inspection intervals and a copy of the checklist to be used by the contractors QA Inspector.

6.4. Replacement Part: A component or module of the existing system or approved upgraded/modified system requiring replacement through a fault developed through normal use or normal wear and tear. Replacement parts do not include consumable supplies.

Replacement parts include components that are installed solely for cosmetic appearance i.e.

cowlings, molding, keyboard keypads (when the key designation is work off), etc.

6.5. OEM: Original Equipment Manufacturer.

7. Government Furnished Services:

7.1. Equipment: The equipment covered under this contract will be made available to the contractor for the purpose of scheduled or unscheduled service. The contractor shall obtain Contracting Officer approval for the time and duration of the service to be conducted and shipping instructions.

7.2. Property: The contractor shall not use property provided by the government for any purpose other than in the performance of this contract.

7.3. Utilities: Reasonable amounts of electric power and other utilities will be provided to the contractor to perform required services. The contractor is responsible for conserving utilities while working in the installation.

7.4. Contractor Furnished: Only the property and services referenced in paragraph 7.1 and 7.2 will be provided to the contractor to perform required services. All other property and services required in the performance of this contract shall be furnished and held by the contractor. For example:

7.4.1. Tools

7.4.2. Test equipment

7.4.3. Current service manuals with guaranteed ability to provide product updates, guaranteed to provide factory mandated instrument modifications, schematics, wiring diagrams and troubleshooting guides (failure to provide product updates or factory mandated modifications is grounds for contract termination).

7.4.4. All other items necessary to perform service such as common hardware, connectors, tubing and etc.

8. Replacement Parts:

The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplies shall be compatible with the Terumo BCT units.

8.1. All replacement parts shall become the property of the government and the replaced malfunctioning part shall become the property of the contractor.

8.2. Freight, postage and storage charges associated with shipment and receipt of replacement parts and the return of work or defective parts shall be the responsibility of the contractor.

8.3. The contractor shall use only new or reconditioned parts for which the quality is equal to or better than the Original Equipment Manufacturer (OEM’s) original part. Any parts provided by the contractors that are considered by the OEM to be substandard may be replaced at the contractor’s cost. When discrepancies occur, the contracting officer will make the final determination about whether a replacement part is of equal or better quality.

8.4. The contractor shall provide all replacements and service necessary to restore the equipment to 100% operational condition as specified by the OEM.

9. Coordination for scheduled and unscheduled services:

Preventive maintenance shall be performed in accordance with the manufacturer’s specifications during the specified month. The contractor shall coordinate 15 days in advance with the Contracting Officer’s Representative or NCOIC, Medical Maintenance Branch, (254) 288-XXXX or (254)553-98XXX for preventive maintenance, certification, and calibration. The service technician shall provide online/internet support (IF APPLICABLE) within twenty-four

(24) hours of notification. Government request for remedial repairs will be placed telephonically by the contracting officer or his/her designated representative to the contractor’s POC.

The contractor’s response to requests for remedial repairs may include a telephone consultation between the equipment user/operator or Government’s Service Technician and a contractor’s FSE Technical Assistance Hot Line Agent. The purpose of this telephone consultation shall be:

9.1. To determine the most likely cause of the problem.

9.2. To determine if resolution of the problem requires the dispatch of a FSE once determination has been made that a contractor’s FSE is required on site. The contractor’s FSE shall have 24 hours (to equal three business days) to be on-site from the time of notification by the contracting officer to the contractor and restored fully operational within 40 hours (to equal five business days).

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

9.4. The Government and the contractor will exchange hazard communication information before the commencement of any repair.

9.5. When required, the contractor will comply with the OSHA lockout/tagout standard while performing maintenance on electrical equipment.

10. Scheduled/Unscheduled Maintenance documentation:

All scheduled and unscheduled maintenance shall be documented on a service report. This form will be furnished upon completion of service within five working days to the Medical Maintenance Branch NCOIC/Contract Officer Representative via email.

10.1 In the event all information is not available to the contractor's service representative when services are performed, the initial service report shall include all available information. The contractor shall provide the balance of the required information to the clinical engineering manager no later than 48 hours after services are completed.

10.2 Service Reports:

The contractor shall prepare a service report for each job performed. During duty hours, the service reports will be authenticated with the Medical Maintenance Branch during normal duty hours and with the AOD after normal duty hours. The service reports shall include the following information as a minimum:

1. Government contract number

2. Equipment identification data

3. System nomenclature, room number, location, model and serial number

4. Purpose of service (scheduled service or unscheduled service call)

5. Start date/time and completion date/time

6. Description of defect and corrective action taken

7. List of parts and cost. Total cost of service to include labor and parts

8. Explanations of any deferred or delayed repair action with an estimated get well date.

10.3 Calibration Documentation; All calibration services shall be documented by the contractor on the service report and a DD 2163 Calibration/Verification Certification label is attached to the medication management system if needed. The verification shall be affixed to the units with the service date, initials and date next service due annotated. If the contractor does not have labels, the medical maintenance shop will furnish the government form DD 2163 Verification/Certification.

10.4. Calibration Documentation of X-Ray systems; the contractor shall complete DD Form 2164 in accordance with the instructions provided in TB 38-750-2. A continuation sheet shall be attached to the DD Form 2164 indicating the manufacturer, model, serial number and date of calibration expiration of all items of test and measurement equipment used to perform the calibration. Required forms and extracts from pertinent directives will be furnished to the contractor by the government.

10.5. Maintenance Logs: A maintenance log will be maintained with the service technician for the system. The log will be documented for any service performed. The log will remain on-site with the system.

10.6. Scheduled Maintenance documentation: All scheduled maintenance shall be documented on a service contract. This form will be furnished upon completion of service to the Medical Maintenance Branch NCOIC.

11. Equipment Modification/Alteration/Upgrades:

11.1. The contractor shall perform/incorporate only OEM specified modifications, alterations, and upgrades. Approval shall be obtained from the contracting officer representative (COR) prior to the contractor’s installation of the modification, alteration, or upgrade.

11.2. The contractor shall perform or cause to be performed all OEM field modifications and safety alert inspections.

11.3. The contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these field modifications are in accordance with the time schedule set forth by the OEM.

11.4. The contractor will make known to the contracting officer representative of minor or routine OEM software upgrades when they become available by the manufacturer.

11.5. Hardware and software changes not supported by the OEM are not authorized.

12. Contractor Reporting Requirements:

During normal duty hours, the contractor’s FSE shall notify the contracting officer in person upon arrival at the government site and again prior to departure. Contractor representative shall sign in and out at the Medical Maintenance Branch, room 40-251, basement, Building 36000. In the event that the contractor performs authorized service beyond the normal duty hours, he shall sign-in and out with the Administrative Officer of the Day (AOD) at the information desk located on the main floor in the front lobby.

13. Repair Parts:

All repair parts shall meet exact manufacturer’s specifications and be the most current revision level. All parts shall be new or remanufactured by the manufacturer of the instruments.

14. Services beyond the scope of the performance work statement:

The contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the COR (in writing) of the existence or development of any defects in/or repairs required to the equipment covered under this contract especially which the contractor considers they are not responsible under the terms of the contract. At the same time of the notification, the contractor shall furnish the contracting officer with a written estimate of the cost to make the necessary repairs.

15. Conduct of Personnel:

The contracting Officer may require the Contractor to remove from the job site any employee working under this contract for reasons of misconduct, security, or found to be or suspected to be under the influence of alcohol, drugs or other incapacitating agent. Contractor employees shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary and in the interest of the Government. In accordance with applicable directives and 18 U.S.C. 1382 (1972), the Installation Commander has the authority to bar individuals from the installation. The removal from the job site or dismissal from the premises shall not relieve the contractor of the requirement to provide sufficient personnel to perform the services as required by this work statement.

16. Security Requirements:

16.1. Contractor personnel or any representative of the contractor entering Fort Hood Army Installation shall abide by all security regulations and shall be subject to security checks.

16.2. Contractor personnel and property shall be subject to search and seizure upon entering the confines of Fort Hood Army Installation and while on the installation in accordance with AR 190-13 (The Army Physical Security Program).

16.3. All personnel entering a military reservation are subject to background screening and search at any time. Contractor and subcontractor will ensure that personnel requiring access to the installation or military treatment facility are able to comply with U.S. Government requirements for installation access. Contractor workforce must 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.

16.4 Access and general protection/security policy and procedures. Contractor and all associated sub-contractor 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 and/or the CRDAMC. 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 all CRDAMC security requirements. 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.

16.5 For contractors that do not require CAC, but require access to a DoD facility or installation.

Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander access and local security policies and procedures.

16.6 AT Level I training. 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 CRDAMC COR, within 5 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/courses/atl1/launch.html. Training is required to be updated annually. In person training is available for groups through the CRDAMC Provost Marshal Office at 553-1278.

16.7 iWatch Training. The contractor and all associated sub-contractors shall brief all employees on the local watch program. All personnel will view the IWatch video on at http://www.crdamc.amedd.army.mil/videos/iwatch.aspx. All personnel on CRDAMC property must understand to contact 288-COPS (288-2677) or the CRDAMC Provost Marshal Office at 553-9832 if any suspicious activity is observed. This training will be completed by all contractors working in CRDAMC facilities for any period of time. This training shall be completed within 14 calendar days of contract award or within 14 calendar days of new employees commencing performance with the results reported to the COR within 5 days of completion.

16.8 Access to Treatment Areas by Non-Clinical personnel. All non-clinical contractor employees, to include subcontractor employees that require access to treatment areas including visual access from the outside must receive the following briefing: The privacy of our patients is an important concern. You must limit time in treatment areas and wards to the absolute minimum possible to perform your required tasks. Always make contact with nursing staff when entering a ward or treatment area as soon as possible and let them know about your presence and purpose. Do not go inside patients rooms without checking with the nursing staff first. NEVER conduct work outside patient wards with windows without coordinating that work with the nursing staff immediately beforehand.

17. Identification Badge:

Contractor personnel shall wear a vendor identification badge at all times when performing services at the Government site. Identification badges shall be worn in a clearly visible area of the Field Service Engineers (FSE’s) outer garment. The badge will be furnished at the Medical Maintenance Branch during duty hours and by the Administrative Officer of the Day (AOD) after duty hours.

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

EXAMPLES:

Submit a PM report of scheduled, completed, and outstanding tasks for one scheduled

PM

Administer quality control program with vendor/ FSE that is on site

Equipment fully mission capable

(PWS 1, 5.1, 6.1)

100% of reports accurately depict current status

Contractor is in compliance with QCP 99% of the time

100% of reports accurately depict current status

100%

99%

100%

BMET review inspection and COR random observations, customer observance of fully mission capable equipment random observations, customer observance random observations, customer observance

Required Services (Tasks)

Performance Standards

Acceptable Quality Levels

Methods of

Surveillance

Incentive (Positive and/or

Negative) (Impact on Contractor Payments)

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

File details come from the government source that posted it. Updated .