Performance_of_Work_Statement.pdf

PERFORMANCE WORK STATEMENT

1. SCOPE OF WORK

1.1 The purpose is to provide the best maintenance for medical equipment in accordance with the manufacturer's maintenance manuals, specification, and quality control policies and procedures governed by Brooke Army Medical Center (BAMC) Biomedical Engineering Services (BES) and the respective using activity. Information concerning the systems to be serviced is furnished from the best available sources. However, this shall not relieve the Contractor of the requirement for visiting the location of the systems listed and to be thoroughly familiarized with all components associated with the item(s) and conditions under which the work is to be performed.

1.2 The contractor shall provide repair, maintenance services and unlimited 24 hour phone support for

Elekta Nucletron Microselection High Dose Rate (HDR) Remote Afterloader, Treatment Control

Workstation, and Radiotherapy Treatment Planning System (TPS) and components, see equipment list for details. The medical devices are located at Radiation Oncology Department, BAMC, Fort Sam Houston, Texas. This service coverage shall include all travel, labor, parts and materials (excluding user consumable supplies), manufacturer's authorized field modification (FM's), OEM technical bulletins, individual tool and test equipment required to repair and maintain the equipment and listed components. The contractor will maintain a complete file of technical documentation on each type of equipment listed in the contract to include schematics, service manuals, and service update memos.

1.3 The contractor shall provide four (4) new Iridium-192 Nucletron Microselection HDR Remote

Afterloader sources per year (one per quarter):

a. With nominal activity of 10.0 Ci at time of service.

b. Source must be of type approved by FDA for use in Nucletron Microselectron HDR Remote

Afterloader (Iridium-192, Microselectron, Solid Iridium Stainless Steel AISI-316L Encapsulation with dimensions 0.9 mm diameter by 4.5 mm length).

d. Vendor must ship source to hospital in advance of service in accordance with NRC and DOT regulations including leak testing and all appropriate paperwork and certificates.

c. Vendor must provide all return packaging and documentation to return spent/decayed Iridium-

192 sources back to vendor.

1.4 Vendor shall provide all operating software updates and upgrades and any FDA mandated safety updates to workstation.

a. An update is defined as a bug fix or corrective action to a feature or functionality already within the software. Updates do not include marketable releases, new features, or new functionality.

b. An upgrade is defined as an enhancement to the functionality of the features already within the software. The upgrade improves the current functions, does not add new ones, and does not significantly change the product specification.

1.5 Vendor shall provide annual radiation safety training on equipment for emergency procedures.

1.6 The contractor shall provide field service technicians that are OEM authorized, certified, and trained in the repair and maintenance of Elekta equipment, provide annual radiation safety training on equipment for emergency procedures, and trained on the installation, removal, and handling of Iridium-192 source.

Additionally, the field service technician shall have a minimum of two years’ experience within the last 36 months. The service department or the field service technician shall coordinate expected arrival date and time with COR or designated representative for services on-site. The field service technician shall contact the Contracting Officer Representative (COR) as soon as technician arrives on-site and sign in at the BES front desk, Room L42-1. BAMC normal operating hours are Monday thru Friday, 0730 — 1630 hrs (7:30 am - 4:30 pm). Any services outside normal operating hours must be coordinated with the COR or designated representative.

1.7 The Contracting Officer Representative (COR) or designated representatives are the only authorized

BES personnel that can request scheduled or unscheduled (Repair) services. Department staff, equipment operators, or hand receipt holders are not authorized to request scheduled or unscheduled (Repair) services.

1.8 Any field service technician working on-site must pass a background check conducted by the 502 SFS

FSH Visitors Control Center in order of being issued a pass to access BAMC.

2. SCHEDULED SERVICES

Scheduled services are those actions relating to the preventive maintenance, operation verification and certification of the system and its components. The contractor shall perform one complete scheduled service inspection consisting of clean, calibrate, lubricate and align all mechanical and optical components to include all supplies. The contractor will adhere to the following when performing scheduled services:

a. Contractor must coordinate expected arrival date and time with (COR) or designated representative and be completed by end of the third week of scheduled month.

b. Any monthly scheduled services that are generated by the contractors automated system must be verified and coordinated with the COR or designated representative before the field service technician attempts to perform services on site.

3. UNSCHEDULED SERVICES (REPAIRS)

Unscheduled services are those services relating to the repair and/or replacement of parts in the system or components. The contractor shall provide unlimited on site repairs for unscheduled service request as follows:

a. One (1) hour telephonic response and 48 hours on-site response for a down system.

b. Provide unlimited phone support to department staff after it is cleared with the COR or designated representative.

4. ADMINISTRATIVE CONTROL

Vendor shall provide a service report within ten (10) working days for all services rendered. The service report shall include as a minimum the following information:

a. Nomenclature, location, model, and serial number

b. Purpose of visit/service (Scheduled or unscheduled)

c. Start date/time and completion date/time

d. Description of defect and corrective action taken

e. Itemized list of parts, if applicable f . Name of Service Technician

g. Service report can be emailed to , hand carried to BAMC BES

Room L42-10, or mailed to the following address:

COMMANDER

BROOEK ARMY MEDICAL CENTER

ATTN; MCHE-LOM, (Mr. Gerd Schwalbe)

BLDG 3600, 3551 ROGER BROOKE DRIVE

FORT SAM HOUSTON, TX 78234-6200

USA

5. GOVERNMENT WILL

5.1 Make laboratory equipment available to the contractor for services.

5.2 Provide access to medical device outside normal duty hours if applicable.

5.3 Have a BAMC BES technician observe a quality assurance test prior to the departure of the contractor's service technician, if applicable.

5.4 Have the COR or representative available to sign service report and update 2163 after services are rendered.

5.5 Reserve the right to obtain special services from other sources when required.

6. TECHNICAL DATA

The field service technician will maintain a complete file of technical documentation on each type of instrument listed in the contract to include schematics, service manuals, and service update memos.

7. CONTRACTING OFFICERS REPRESENTATIVE

, Electronic Technician, BAMC

, Electronic Technician, BAMC

8. TRANSPORTATION

No additional cost shall be charged to the government for transportation and shipment of all parts removed for service. Items shall not be shipped without prior authorization of the Contracting Officer or designated representative.

9. PAYMENT

9.1 Payment is processed upon receipt and acceptance of completed service report. Invoicing is processed via Wide Area Work Flow (WAWF). The service report is not to be confused with the billing or invoice document.

9.2 The contractor shall provide a separate invoice for repair or service calls attributed to medical device failure and/or damage through misuse, theft, fire, Acts of God, or deterioration caused by chemicals that are not for normal equipment operation. The cause listed above will be inspected and validated by the

Chief or NCOIC of Biomedical Engineering Services prior to a separate purchase order being issued.

10. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

PWS

Reference

Performance

Objective

Acceptable

Quality Level

Surveillance

Method

Performance Incentive

1.3 Provide Iridium 192

Source Four (4) Times a

Year

Satisfactory COR will monitor

Failure to comply with any of the performance standards shall be documented in assessments of the contractor’s performance.

These assessments are submitted to the Federal

Government’s Past

Performance Retrieval System.

If warranted, based on the terms and conditions of the contract, the contract could be terminated for cause (i.e., default on the part of the contractor).

1.4 FDA Mandated Updates Satisfactory COR will monitor

1.5 Annual Radiation Safety

Training

Satisfactory COR will monitor

1.6 Qualified Technician

Two (2) Years of

Experience

Satisfactory COR will monitor

All 2 Scheduled Services Satisfactory COR will monitor

All 3 Unscheduled Services Satisfactory COR will monitor

10.1 Method of Assessment (for each performance objective above):

Random monitoring and periodic inspections shall be performed by the COR or designated representative to document performance.

10.2 Ratings definitions:

a. Unsatisfactory – The contractor failing to follow or has not followed more than one of the terms and conditions written in the PWS and contract.

b. Marginal - The contractor failing to follow or has not followed one of the terms and conditions written in the PWS and contract.

c. Satisfactory - The contractor is following or has followed the terms and conditions written in the

PWS and contract.

d. Very Good - The contractor must provide one benefit, at no cost, to the government, above those requirements listed in the PWS.

e. Exceptional - The contractor must provide two or more benefits, at no cost, to the government, above those requirements listed in the PWS.

11. Reserved

12. Contractor Manpower Reporting

12.1 The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower

(including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address https://cmra.army.mil/. The required information includes:

a. Contracting Office, KO, COR

b. Contract number, including task and delivery order number

c. Beginning and ending dates covered by reporting period

d. Contractor name, address, phone number, e-mail address, identity of contractor employee entering data

e. Estimated direct labor hours (including subcontractor)

f. Estimated direct labor dollars paid this reporting period (including subcontractor)

g. Total payments (including subcontractor)

h. Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each subcontractor if different)

i. Contractual 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)

j. Locations where contractor and subcontractors 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)

k. Presence of deployment or contingency contract language

l. Number of contractor and subcontractor employees deployed in theater this reporting period

(by country)

12.2 The reporting period will be 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 COR by the 5th working day of November of each government fiscal year whether or not they have completed this report. If the COR is unavailable, the contractor will notify the

KO.

13. Operations Security (OPSEC)

9.1 Investigation Requirements. The Contractor shall ensure all personnel performing under the contract are required to maintain a minimum of a favorably adjudicated Tier 1 (T1) formerly known as National Agency Check with written Inquires (NACI) for IT Level III access or Tier 3 formerly known as a National Agency Credit and Law Check (NACLC) for IT-II access. The contractor must coordinate with the Contracting Officer Representative (COR) to initiate the Request for Personnel Security Action prior to performance start date. U.S. Citizenship will be verified by presenting original or certified copy of birth certificate, certificate of citizenship/naturalization issued by INS, or born aboard certificate (Form FS-240 or DS-1350) or a valid U.S. Immigration Form 1-151 and Alien Registration Card ("Green Card") and is completed investigation document(s) to the BAMC Personnel Security Office at the time of in processing for all contract personnel assigned to the contract. In order to maintain the security requirements any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues must be reported to the COR and to the BAMC Personnel Security Office.

Access and general protection/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. 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. For Contracts That Require Handling or Access to Classified Information. Contractor shall comply with FAR 52.204-2, Security Requirements. This clause involves access to information classified "Confidential," "Secret," or "Top Secret" and requires contractors to comply with- The Security Agreement (DD Form 441), including the National Industrial Security Program Operating Manual (DoD 5220.22-M); any revisions to DOD 5220.22-M, notice of which has been furnished to the contractor. A Secret security clearance is required for the contract employee to perform the scope of work. The Contractor shall have a proper Facility Clearance (FCL). The Contractor's employee shall report to the workplace with a favorable National Agency Check with Law and Credit/T3/T3R and a Secret or Interim Secret clearance in order to gain access to the workplace.

DD254 shall be processed at no added cost to the contract.

9.2 Freedom of Information Act Program (FOIA and Privacy Act). The contractor shall comply with DOD Regulation 5400.7-R, DOD Freedom of Information Act Program requirements. The Freedom of Information Act sets policy and procedures for the disclosure of records to the public and for marking handling transmitting and safeguarding For Official Use Only materials.

9.3 Reporting Requirements. The contractor shall comply with DoD 5200.2-R, January 1987, Personnel

Security Program and AR 380-67, 9 September 1988, Department of the Army Personnel Security

Program Regulation. Contractor shall report to the BAMC Security Manager any information or circumstances which may pose a threat to DOD or contractor personnel, resources, or DOD information.

9.4 Removal of contract employee. The government reserves the right to require immediate temporary or permanent removal of any individual whose actions raise reasonable suspicion that patient care or services may be compromised in any way or that pose a threat of harm to other contractor/government personnel or self. The employee may be required to submit to drug/alcohol testing. The government reserves the right to require temporary or permanent removal of any individual who refuses testing.

Notification of all removals will be made by the Contracting Officer Representative (COR). Removal of any individual does not relieve the contractor of any performance requirement.

9.5 Physical Security. The contractor shall comply with all Force Protection Condition (FPCON) procedures, Random Antiterrorism Measures (RAMS) and local search/identification requirements.

9.6 Government Computer Access Requirements. If this contract requires contractor personnel to have access to government computers, contractor personnel requiring access to government computers shall successfully complete, Tier 1 (T1) formerly known as National Agency Check with written Inquires (NACI) for IT Level III access or Tier 3 formerly known as a National Agency Credit and Law Check (NACLC) for IT-II access to the computer. These investigations shall be submitted by the government at no additional cost to the contractor. Common Access Cards (CACs) for Contractor Personnel are required which is hereby incorporated by reference if not otherwise included. The contractor shall comply with Homeland Security Policy Directive (HSPD)-12, Army Directive 2014-05 “Policy and Implementation Procedures for Common Access Card Credentialing and Installation Access for Uncleared Contractors”, Policy for Common Identification Standard for Federal Employees and Contractors and Federal Information Processing Standard 201.

9.7 Keys and Lock Combinations. The contractor shall abide by all current BAMC key control and lock combination procedures The Contractor shall be responsible for any keys issued to the employee. The keys shall not be duplicated. The Contractor shall ensure that its employee’s not allow government-issued keys be used by personnel other than those currently authorized. No unauthorized personnel shall be allowed entry into the locked area. Keys shall not be used to open work areas for personnel other than personnel engaged in performance of their duties, unless authorized by the Government functional area chief. The employee shall use keys issued to them to secure/open areas only as directed by the COR and/or functional area chief. Lost keys and/or locks shall be reported to the issuing party and COR immediately upon recognition of the loss. The COR shall notify the PMO of the lost key. The employee shall be responsible for the replacement costs of any lost keys and any associated locks. Reimbursement shall be provided before the Government replaces lost keys or performs re-keying.

9.8 Key Control. The contractor shall safeguard all keys issued by the government and insure they are used only by authorized contractor personnel. The contractor shall not duplicate issued keys and shall report lost keys to the contracting officer immediately the contractor will be charged for lost keys, re-keying, and lock replacement as applicable

14. Anti-Terrorism (AT) Requirements

14.1 Key Control. The contractor shall safeguard all keys issued by the government and insure they are used only by authorized contractor personnel. The contractor shall not duplicate issued keys and shall report lost keys to the contracting officer immediately the contractor will be charged for lost keys, re-keying, and lock 1.1.1 Security Requirements: Work under this contract is UNCLASSIFIED. The

Contractor shall comply with all applicable DoD security regulation and procedures during the performance of this contract. The Contractor shall not disclose and must safeguard procurement sensitive information, computer systems and data, Privacy Act data, and Government personnel work products obtained or generated in the performance of this contract. Contractor employees will be issued by the

Government a Common Access Card (CAC) which is required for access to Government computer databases and entrance to the installation. Additionally, all Contractor employees must be issued a special identification card issued by BAMC PMO Badge and ID Office prior to reporting for duty. The

Contractor shall be responsible for the control and safe keeping of all Government issued IDs and ensure all badges are returned to the COR upon termination of an employee or the contract end date. The

Contractor shall ensure all contractor employees are aware that in the event either of the Government IDs are lost or stolen that they are to advise the PM or alternate immediately upon discovery. The Contractor shall ensure that the COR is notified the same day the employee reports an ID lost or stolen.

The Government shall conduct criminal background checks on all Contractor employees in accordance with the procedures set forth in Public Law 100-235, DoD Directive 5200.28, DoD Directive 5200.2-R, DoDI 1402.5. and submit to the PM or the Alternate. The Contractor is responsible for ensuring all

Contractor employees must complete the SF86, Authorization for Release of Information form and ensure all background check submittals are initiated in accordance with this PWS prior to employees providing services at BAMC facilities. Background checks shall be based on fingerprints of individuals obtained by qualified Government law enforcement or security personnel, inquiry’s conducted through the Federal

Bureau of Investigation (FBI) and the State Criminal History Repository check, and a local Installation

Record Check., if required. The procedures for completing the required background check are outlined in the Department of Defense Instruction (DoDI) 1402.5. Government will not allow any employees to start work until clearance of criminal background check has been completed.

14.2 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use at the end of each business day. The Contractor shall ensure all government facilities, equipment, and materials shall be secured at the close of each duty day.

14.3 Antiterrorism (AT) / Operations Security (OPSEC) Requirements: For OPSEC to be effective, all

Contractors must be aware of OPSEC and understand how OPSEC complements traditional security programs. All personnel must know how to apply and practice OPSEC in the performance of their daily tasks. OPSEC must become a mindset of all Contractor employees and be performed as second nature.

To accomplish this level of OPSEC vigilance, OPSEC training programs must be action and job-oriented, enabling the workforce to put into practice the knowledge and tactics, techniques, and procedures (TTPs) they learned in training. Training should maximize the use of lessons learned to illustrate OPSEC objectives and requirements. In order to ensure accomplishment of training, the Government will include

OPSEC training as a part of their organization’s annual training guidance. Contractor employees must complete Level I OPSEC and AT Awareness training within 30 calendar days of reporting to duty in according to Army Regulation 530-1 and 525.13. AT Level I awareness training is also available at https://atlevel1.dtic.mil/at.

14.4 iWATCH Training: The Government will brief all Contractor personnel on the local iWATCH program. This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to their COR. Contractor employees must complete iWATCH training within 30 calendar days of reporting to duty.

15. Equipment Listing

ECN Description Model Serial # Location

0F5452 Brachytherapy system, Remote

Afterloading

Microselectron 31038 Radiation Oncology

Room 119-16

0F5453 Control Unit 903 32061 Radiation Oncology

Room 119-12

65633 Radiotherapy Treatment Planning Systems Oncentra 85625 Radiation Oncology

70395 Monitor, Flat Screen Flat Screen OC888A-

74445-966

Radiation Oncology