DRAFT-PWS_-_Kosovo_Medical_Maintenance_DRAFT.pdf

PERFORMANCE WORK STATEMENT

Medical Equipment Maintenance

Camp Bondsteel, Kosovo

1. GENERAL:

1.1. Description of Services/Introduction: The Contractor shall provide all personnel, equipment, tools, test equipment, materials, repair parts, software, technical literature and diagrams, supervision, transportation and other items and services necessary to properly maintain all medical equipment identified in the Contract Line Items for the Camp Bondsteel- Medical Treatment Facility (MTF). Services to be performed include all unscheduled routine service calls, all emergency service visits and all scheduled service visits as required for all Contract Line Items (CLINs). The Contractor shall include troubleshooting, maintenance, preventive maintenance, including scheduled parts replacements, testing, calibration, adjustments, and repair onsite and off-site in accordance with U.S. Healthcare and Joint Commission (JC) standards. All repair parts provided by the Contractor shall be covered by the terms and conditions of this contract. All work shall be performed in a professional manner by an authorized trained service representative. If any deficiencies are found due to negligence of the service representative, the contractor will be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the U.S. Government.

1.2. Scope: Kosovo Force TF Medical requires continuous maintenance support for complex medical equipment at Camp Bondsteel Medical Treatment Facility (MTF) in Kosovo. The MTF provides level II+ medical support to all U.S. and NATO forces within Kosovo. The equipment used in a level II+MTFs far exceeds the technical expertise of a skill level 10 Medical Equipment Repair Technician. Services under this contract provides for:

1.3. Period of Performance (PoP): Award made referencing this PWS will have a PoP of

Base Year: 30 September 2019 to 29 September 2020 1st Option Year: 30 September 2020 to 29 September 2021 2nd Option Period: 30 September 2021 to 29 September 2022

1.4. General Information

1.4.1. Quality Control: The Contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor’s quality control program is the means by which he assures himself that his work complies with the requirement of the contract. After acceptance of the quality control plan the Contractor shall receive the Contracting officer’s acceptance in writing of any proposed change to his QC system.

1.4.2. Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.4.3. Recognized US Holidays:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day

1.4.3.1. The Contractor shall not be required to provide services on the following Local National Holidays:

New Year’s Day 1 January Independence Day 17 February Easter Monday 28 March Constitution Day 9 April Labor Day 1 May Europe Day 9 May Ramadan 7 July Christmas Day 25 December

1.4.4. Hours of Operation: The Contractor shall provide unscheduled routine/emergency services during normal workdays; Monday through Friday, between the hours of 0800-1700 excluding U.S.

and local national holidays. Unscheduled routine/emergency service calls shall be accepted only from the Contracting Officer’s Representative (COR) or an authorized representative.

1.4.4.1 Unscheduled Routine/Emergency Services.

1.4.4.2. The Contractor’s qualified service technician shall be on-site to provide routine services and service requiring immediate repair. Scheduled services for preventive maintenance, safety and calibration shall be performed in accordance with the manufacturer’s specifications and this performance work statement. The equipment shall be repaired and operational within 48 hours after the Contractor arrives on-site.

1.4.4.3. The Contractor shall respond to unscheduled repair service calls from the COR within one

(1) working day, Monday through Friday between the hours of 0800 and 1700 excluding local holidays. Unscheduled repair service calls shall be accepted only from the COR or an authorized representative.

1.4.4.4. Completion of Unscheduled Repairs. For on-site routine services, the Contractor’s technician must be on site within two (2) working days after COR notification and the repair must be completed within four (4) working days.

1.4.4.5. If the equipment is out of service for longer than 48 hours (from the time of service technician’s arrival on site), the Contractor shall notify the COR, in writing as to the reason(s) (i.e.

parts non-availability, etc.).

1.4.4.6. The U.S. Government will make the equipment available to the contractor for servicing at such time and duration necessary to perform needed repairs on-site.

1.4.4.7. Prior to and after the performance of any service, the Contractor's service representative shall report to the Medical Maintenance Section. When performing service at a section within the hospital (i.e., Lab, X-ray, Dental, etc.) the service representative shall report to the Non-commissioned Officer In-Charge (NCOIC), Officer In-Charge (OIC) or Technical Assistant (X-ray Technician). The Contractor’s service representative shall sign-in the Contractor’s Log Book located in the Medical Maintenance Section when reporting for the job and sign-out when the job is completed.

1.4.5. Place of Performance: The work to be performed under this contract shall be performed at Camp Bondsteel, Kosovo.

1.4.6. Type of Contract: The Government will award a hybrid FFP with T&M CLINs type contract.

1.5. Security:

1.5.1. Access to Work Site: Prior to the initial visit of a service technician, the Contractor must submit appropriate identification (i.e., copy of Passport, Driver License, etc.) for the purpose of obtaining an Installation Security Pass. This information shall be submitted not less than three (3) working days prior to the visit unless otherwise approved by the Installation Security Manager.

1.5.2. Once on-site at Camp Bondsteel, the Contractor’s service technician will be escorted to the appropriate work site by U.S. Military personnel or a U.S. Government Employee.

1.5.3. Contractor personnel will be required to wear a U.S. Government issued installation pass on their outer garment at all times when on the installation.

1.5.4. Operation Security (OPSEC): Prior to departing the Clinical Engineering Branch, the Government shall provide Contractor personnel with the required OPSEC briefing/orientation. The orientation shall include at a minimum:

1.5.5. Access and General Protection Policy and Procedures: Access to the Government’s information system/network and information technology. The Government will ensure that all Contractor personnel receive appropriate information assurance (IA) training before being granted access to the firewall/VPN equipment that supports this Army AIS/network device and data transmission function.

1.5.6. The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data to ensure the confidentiality, integrity, and availability of encrypted data.

1.5.7. Special Requirements for PHI: Since this contract centers on the ability of Contractor personnel to access PHI on Government beneficiaries whose data is stored in the CHCS Archives, the Clinic require that the Contractor monitor, regulate, and limit the number of and extent to which their service personnel have access to the patient data passing through it.

1.5.8. Protected Health Information (PHI): PHI has the same meaning as the term “Protected Health Information” in 45 CFR 160.103, limited to the information created or received by the Contractor from or on behalf of the Government pursuant to the Contract.

1.5.9. The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

1.5.10. All personnel employed by the Contractor in the performance of this contract, or any Representative of the Contractor entering the installation, shall abide by all security regulations of the installation. The Government reserves the right to direct the removal of any representative for misconduct or security reasons. This action does not relieve the Contractor from performance of the contract requirements specified herein. The U.S. Government has the right to search any vehicle entering the installation.

1.5.11. PHYSICAL Security: Once on-site at Camp Bondsteel, the Contractor’s service technician will be escorted to the appropriate work site by U.S. Military personnel or a U.S. Government Employee. Access to the Government’s information system/network and information technology.

The Government will ensure that all Contractor personnel receive appropriate information assurance (IA) training before being granted access to the network. The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all government data to ensure the confidentiality, integrity, and availability of encrypted data.

1.5.12. iWATCH Program: The Contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR or Authorized Representative. This training/orientation shall be provided/briefed by the Medical Maintenance NCOIC or Logistics OIC prior to the performance of work.

1.5.13. Sexual Harassment/Assault Response and Prevention (SHARP): The Contractor shall ensure all Contract Service Providers (CSPs) receive Sexual Harassment/Assault Response and Prevention (SHARP) training under this contract. Details can be found under PART 6, paragraph 8 in this contract)

NOTE: If the contract will be for services in other than Army owned or Army leased facilities, the Contracting Officer must use a note in solicitation and award to specify that the SHARP reporting requirements do NOT apply to other than Army owned/leased facilities.

1.6. Special Qualifications:

1.6.1. Corporate Capabilities: The Company/Corporation must have at a minimum, experience in one of the following disciplines: Medical Equipment Maintenance or any Clinical or Biomedical Engineering Science and 5 years experience in the specified field of Clinical Engineering or the maintenance of Medical Devices and Equipment (MDE). They should be able to show from past performance their ability to repair, service and oversee the maintenance of medical equipment in accordance with OEM specifications and industry standards.

1.6.2. Technical Education: The Contractor’s Technicians must possess at a minimum, an Associate’s Degree or equivalent in any biomedical maintenance or clinical engineering discipline from a reputable/accredited college, university or technical institution; or be a graduate of the U.S.

Military Biomedical Equipment Maintenance Course (or equivalent) and have 3 years experience in the specified field. College Examples are: Regis College/University, Colorado Technical University, Texas State Technical College, etc.

1.6.3. The Contractor’s service representatives shall be trained by the manufacturer on each item of equipment in the contract line items (CLINs) and have a minimum of 3 years of experience working on contracted equipment.

1.6.4. Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The Contracting Officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the Contracting Officer will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

1.6.5. Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR 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. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates.

The COR is not authorized to change any of the terms and conditions of the resulting order.

1.6.6. Key Personnel: NA

1.6.7. Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. [This contract does not require on-sit personnel, therefore, the only badges that are required are those issued for access to the installation.]

1.6.8. Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5.

The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.6.9. Phase In/Phase Out Period: To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the first 30 days phase in period. During the phase in period, the Contractor shall become familiar with performance requirements in order to commence full performance of services on the contract start date.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS: Following is a list of basic definitions.

2.1.1. Contractor. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

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

2.1.3. Contracting Officers Representative (COR). A government employee selected and designated in writing by the Contracting Officer to act as his/her designated representative in administering a contract, but without authority to change the terms or conditions of the contract.

Note that due to the MTF being serviced under this contract being staffed by different personnel on a rotational basis, there will be multiple CORs over the life of the contract. The contractor will be notified in writing of any changes to the COR for this contract.

2.1.4. Medical Treatment Facility (MTF). For this contract, a military hospital or outpatient clinic where licensed healthcare practitioners provide diagnostic, medical, and surgical services to eligible personnel.

2.1.5. Contract Discrepancy Report (CDR). A formal report initiated by a Contracting Officer Representative (COR) and completed by the Contractor. It's issued to the contractor for nonperformance or when overall performance is unsatisfactory. The CDR requires the Contractor to explain, in writing, why his performance was unsatisfactory; how performance will be returned to a satisfactory level; and how recurrence of the problem will be prevented in the future.

2.1.6. Authorized Representative is defined as Contracting Officer and Contracting Officer Representative.

2.1.7. Quality Assurance. A methodology used by the US Government to ensure that the quality of goods and services received is acceptable in accordance with established standards and requirements of a contract.

2.1.8. Quality Control. A methodology used by the Contractor to ensure the quality of goods and services are provided.

2.1.9. Response Time. The elapsed working hours from the time a routine work request is received by the Contractor until the time service personnel arrive on the job site.

2.1.10. Timely Repair. This is the standard repair time based on the type and complexity of equipment.

2.1.11. Medical Devices and Equipment (MDE). An FDA regulated instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.

2.1.12. Preventative Maintenance (PM's). The care and servicing of equipment for the purpose of retaining the equipment in a serviceable condition IAW manufacturer's maintenance specifications as listed in their technical literature. This inspection includes check for proper operation, detection and correction of incipient failures either before they occur or before they develop into major defects, and includes but are not limited to actions pertaining to periodic technical inspections, lubrication, adjustments, calibration, interior cleaning and replacement of worn or deteriorated parts.

2.1.13. Calibration, Verification, Certification (CVC). Refers to checking and adjusting the accuracy of an imaging systems based to the manufacturers specifications. CVCs must be performed using the proper Test, Measurement, and Diagnostic Equipment (TMDE) based on the intervals identified by the manufacturer or after the replacement of critical repair parts that require CVC.

2.1.14. POC. Point of Contact. The person who has been designated by the Chief, Clinical Engineering to sign the Contractor in and out and monitor the Contractor’s activity while performing at a Health Clinic.

2.1.15. Equipment Schedule. This is the list of the equipment (Exhibit A) to be serviced and maintained under this contract. Equipment may be listed by Location, Make, Model, Serial Number, and Equipment Control Number (ECN).

2.1.16. Scheduled Services are those actions relating to preventive maintenance, safety, calibration verification and certification of the system and its components.

2.1.17. Unscheduled maintenance and repair services are those services required to correct a malfunction. These services are routinely not performed during a scheduled preventive maintenance, safety or calibration service. However, if they are identified during these services they must be performed in an effort to prevent any further lost in system performance.

2.1.18. Contractor. In this contract this term is used to refer to the Company, Firm, Agency, Institution, Corporation, etc. and all its associated personnel, i.e., service representatives, service or repair technicians and field service engineers selected to perform the tasks under this contract will be referred to as the “Contractor”.

2.1.19. Up-time. Up-time is defined as the state when the system is usable and working according to the performance specifications of the original equipment manufacturer and available for use during service coverage hours. Percentage up-time is calculated as total hour’s up-time in hours divided by the sum of total up-time and downtime in hours. Up- time will be calculated based on 90-day intervals.

2.1.20. Center for Devices and Radiological Health (CDRH). This is a division of the FDA that regulates all radiation emitting products in the USA.

2.1.20. Field Service Report (FSR). This is the “work order” or “service ticket” provided by the service technician or individual performing the maintenance and repair services. For this contract the Field Service Report must be in English and include at a minimum: Labor cost, man- hours expended, parts replaced, parts cost, Government Contract Number, start date/time and completion date/time. A file of all field service reports must be maintained by the Contractor for one year after the contract period ends.

2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract.

CDRH Center for Devices and Radiological Health CLIN Contract Line Item Number COR Contracting Officer's Representative CPARS Contractor Performance Assessment Reporting System CVC Calibration, Verification, and Certification DA Department of the Army DoD Department of Defense DODI Department of Defense Instruction ECN Equipment Control Number FFP Firm Fixed Price FDA Food and Drug Administration FSR Field Service Report IAW In Accordance With JC Joint Commission KO Contracting Officer MEDDAC Medical Department Activity MTF Medical Treatment Facility NCOIC Non Commissioned Officer In Charge NFPA National Fire Protection Association OCI Organizational Conflict of Interests OEM Original Equipment Manufacturer OSHA Occupational Safety and Health Administration/Act Pam Pamphlet PAR Performance Assessment Report PM Preventive Maintenance PoP Period of Performance T&M Time and Material TMDE Test, Measurement, and Diagnostic Equipment QA Quality Assurance QA&I Quality Assessment & Improvement QC Quality Control

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. General. The Government will provide, without cost to the Contractor, the facilities, equipment, materials and services listed below. The Contractor will maintain government furnished supplies, equipment and work areas in a safe, orderly and clean condition.

3.1.1. KFOR Badges. KFOR badges are the property of the US Government and use must be carefully maintained. Any attempt to misuse KFOR badges to gain access to KFOR base camps for reasons other than related to this contract will result in the immediate removal of the contractor’s employee from the base camp, confiscation of the KFOR badge, and prohibited re- entry.

3.1.2. Facilities. The Government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the equipment to function properly as specified by the original equipment manufacturer (OEM).

3.1.2.1. Equipment. Limited material handling equipment (i.e., pallet jacks, forklifts, etc.) will be provided when in the best interest of the Government.

3.1.3. Materials. The following are materials provided under this contract:

3.1.3.1. The Government will make available only operator’s manuals for the equipment identified in the schedule.

3.1.3.2. The Government will provide directives and regulations applicable to the contract.

3.1.3.3. DD Forms 2163 (Calibration Label): The Government will furnish all required calibration labels (Calibration, Verification and Certification) which the Contractor must complete, update, and sign/initial after each Calibration/Verification and validation service prior to departure from facility.

3.1.3.4. DD Form 2164 (X-ray Calibration/Verification/Certification Worksheet). The Government will furnish these documents which the Contractor must complete and sign after each calibration/verification service prior to departure from facility.

3.1.5. Services. The following services will be provided under this contract:

3.1.5.1. First-Call Services. First-call or First-responder services are programmed to be provided by trained in-house military or civilian personnel, including the 30th Medical Brigade. However, in the event First-responder services are required by the Contractor, services will be in accordance with para 1.4.4.1.

3.1.5.2. The Government will provide the ability to process or display ultra sound and X-ray digital image via Computed Radiology (CR).

3.1.5.3. Lodging and Mess Support. These services will be provided when on-site maintenance support requires the service technician to perform overnight or for more than one day.

3.1.5.4. Transportation of Personnel for on-site Support. In support of installation security, when necessary and with prior coordination and approval, transportation support will be provided to and from the Pristina Airport for visiting service personnel.

3.1.5.5. Equipment off-site Support. Equipment requiring off-site support (outside the Balkan Region) will be shipped via the U.S. Army Medical Materiel Center, Europe (USAMMCE) (Pirmasens, Germany) for pick-up and delivery to the appropriate location. Returning the item to the USAMMCE for shipment to Kosovo will be at the expense of the Contractor.

3.1.5.6. Repair Parts Support. All repair parts required in support of this contract shall be shipped via the U.S. Army Medical Materiel Center, Europe (USAMMCE) (Pirmasens, Germany).

The exception is for repair parts hand delivered by the servicing technician.

3.1.5.7. Equipment shipped off-site must be requested through the COR and approved by the Hospital Commander.

3.1.5.8. Utilities. The Government will provide the normal range of utilities, electricity, water, heating, refuse collection, etc., as is provided for other personnel.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1. The Contractor shall furnish all supplies/services required in the performance of this contract as listed:

4.1.1. Condition of Existing Equipment. The Contractor accepts full responsibility for the equipment described in the schedule in “as is” condition. Failure to inspect the equipment prior to contract award shall not relieve the Contractor from performance of the requirements of the contract.

4.1.2. The Contractor shall furnish all required Special Tools, Diagnostic Software, Test Equipment, Schematics, Technical Documentation, Drawings, and Service Manuals required to maintain all the equipment identified in the schedule.

4.2. Updates. The Contractor shall be responsible for providing and installing all manufacturer designed and issued field modifications, safety corrections and revisions for correcting software and equipment deficiencies.

4.2.1. Software Upgrades. The Contractor shall source and provide all available/required software upgrades for the duration of this contract.

4.3. Spare Parts. All replacement parts shall be "new" or “remanufactured” and Quality Assurance (QA) tested by the manufacturer. Any exceptions must be approved by the Regional Health Command Europe (RHCE) Clinical Engineering Representative or USAREUR Command Surgeon (CSURG). The Contractor shall be held liable for any damages that may result from not using manufacturer approved parts.

4.3.1. All repair parts provided under this contract that are ‘not’ identified as a Scheduled Part Replacement (SPR) for scheduled services are reimbursable and shall be invoiced separately.

4.3.2. Examples or SPR items may include parts kits, minor accessories, and other required materials for scheduled services.

4.3.3. Glassware, X-ray Tubes, Camera Pick-up Tubes, Detectors, Image Intensifiers and Ultrasound Transducers are not covered under this contract and will be invoiced separately. Note:

Prior to replacement of any glassware the Contractor shall contact the COR for approval.

4.4. Accessories. These items are not traditionally defined as repair parts but items required to support the safe operation and use of a MDE. These items shall also be reimbursable if provided by the Contractor.

4.5. Test Equipment used during the calibration of X-ray equipment. The Contractor shall provide a list of all Test Equipment used during the calibration of X-ray equipment. The list must include the following:

a) Make/Manufacturer

b) Model (include model number)

c) Serial Number

d) Date of Last Calibration

4.6. Telephonic Support. The Contractor shall provide unlimited telephonic and electronic communications support at no additional cost during their normal business hours.

4.7. Installations, Deinstallations, and Relocations. These services are typically performed as an unscheduled service and shall be invoiced as a Time and Materials service.

4.8. Misuse or Abuse:

4.7.1. Claims of Government Misuse or Abuse. If the Contractor claims any service call is the result of Government abuse or misuse, the damage must be shown on the Field Service Report and a copy immediately forwarded to the COR for review. A request for a Financial Liability Investigation of Property Loss (FLIPL) shall be requested by the COR to determine the cause of the damage and liability.

4.8. Overtime. Any work performed outside normal duty hours (0800 - 1700) is at the Contractor’s expense and shall not be reimbursed. Any requirement to work outside normal duty hours must be coordinated in advance with the hospital. Note: There are no provisions in this contract for overtime charges/reimbursement.

PART 5

SPECIFIC TASKS

5. Specific Tasks:

5.1. The Contractor shall provide non-personal service to include, but not limited to, providing all labor, personnel, travel, parts, special tools, test equipment, materials, supervision, unlimited telephonic support, and other items necessary to maintain the equipment listed in the schedule, Technical Exhibit (1) in accordance with (IAW) industry standards, Joint Commission (JC), and OEM specifications.

5.1.1. Level of Performance. The Contractor’s level of performance shall support an equipment uptime of 95%.

5.1.2. Spare Parts Support. The Contractor shall furnish all spare parts on a reimbursable basis.

The Contractor shall retain and dispose of all defective parts for which a replacement part is furnished. Turnaround-time and continuous status updates on repair parts shall not exceed 24 hours.

5.1.3. Spare Parts Delivery. The Contractor shall process and track all repair parts delivery via the US Army Medical Materiel Center Europe (USAMMCE) in an effort to avoid delays presented by local Customs Clearance requirements.

5.1.4. Scheduled Parts Replacement (SPR). To ensure replacement parts are replaced as recommended by the manufacturer, the Contractor shall ensure required replacement parts are ordered and on-site prior to a scheduled services (PM and Calibrations) visit which requires part to be replaced.

5.1.3. All work shall be performed in a safe, efficient and professional manner.

5.1.4. The Contractor shall remove/dispose of all trash from the work areas and leave the surrounding work area clean.

5.1.5. The Contractor and US Government service technician shall confirm equipment is operational and the Contractor shall provide a copy of the Field Service Report to the government service technician prior to departure. The government service technician will retain and file a copy of the field service report and provide a copy to the COR and Joint Contracting Center Kosovo as needed.

5.2. Preventative Maintenance (PM):

5.2.1. Preventive maintenance and inspections shall be performed in accordance with the manufacturer’s standards and procedures. The preventive maintenance inspection shall include, but is not limited to safety, calibration, complete operational testing, lubrication, adjustments and cleaning of equipment. It also includes installation of all parts required to ensure proper operation.

5.2.2. The Contractor’s representative shall perform Preventive Maintenance Inspections (PMI & Scheduled Parts Replacement), Calibrations, Safety and unscheduled repair services in accordance with procedures prescribed by the equipment manufacturer.

5.2.3. The Contractor shall maintain the equipment in proper operating condition as described in the manufacturers’ service manual.

5.2.4. Coordinated scheduled preventive maintenance, safety, and calibration inspections shall be performed at the intervals specified under each Contract Line Item Number (CLIN). Scheduled calibration and preventive maintenance services shall include written documentation of all services performed, i.e., lubrications, cleaning, adjustments, testing and calibration/verification in accordance with the manufacturers’ specifications and all applicable government regulations, both foreign and domestic. All repairs/replacement of defects and malfunctions discovered during preventative maintenance services cannot be charged against the unscheduled maintenance CLINs.

5.2.5. Safety inspections shall be performed during preventive maintenance in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the hospital’s Medical Maintenance Section. When required, the Contractor’s service representative will comply with the Occupational Safety and Health Administration lockout/tagout standards while performing maintenance on equipment. The government and the Contractor’s service representative will exchange hazard communication information before the commencement of any repair.

5.2.6. Preventive Maintenance (PM). The Contractor will perform PM services in accordance with each OEM. For X-ray equipment, one of these inspections will be scheduled to coincide with the annual Calibration, Verification/Certification (CVC).

5.2.7. CR Reader Preventive Maintenance. The Contractor shall perform all services required to confirm CR Reader Communications to the RHCE DIN-PACS Archive via the MedWeb Teleradiology network. The Contractor shall provide configuration support to ensure the CR Reader settings and “S” Numbers is compliant with the RHCE settings/standards. The PM inspection shall also include, but not be limited to software updates and security patches to ensure operation per manufacturer specifications.

5.2.8. The Contractor shall perform PM services to ensure that the equipment performs in accordance with the OEM specifications. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) and provide them to the Medical Maintenance Section. This document may represent all or part of a field service report.

5.2.9. Defects and malfunctions discovered during PM. Any defect or malfunction found during the PM process shall be included in the service report and immediate steps must be taken to effect a repair.

5.2.10. Preventive Maintenance (PM) includes the replacement of faulty and worn parts and/or parts which are likely to become faulty, fail, or become worn before the next PM Service.

5.2.11. If the scheduled PM requires a PM Kit, the Contractor must provide and install per manufacturer recommendation or have it installed by an in-house service technician as a first-call service. This type service shall be referred to as a Scheduled Parts Replacement (SPR).

5.2.12. Steam Sterilizer. A SPR is considered standard practice for sterilization equipment which complements the routine PM checks and services such as the inspection and testing of the system chassis, housings, circuit breakers, fuses, electrical cables, fittings, supports, etc.

5.2.13. The testing of “Glassware” is a standard requirement of the PM process for X-ray equipment. Any glassware that may be failing must be brought to the immediate attention of the

COR.

5.2.14. Scheduled Services shall include the following where applicable:

5.3. X-ray Equipment Calibration, Verification and Certification (CVC). The second Scheduled Service will include a complete system CVC.

5.3.1. For X-ray Equipment only - Calibration documentation will include a list of all Test, Measurement and Diagnostic Equipment (TMDE) used to perform the calibration service. The list will include nomenclature, manufacturer, model, serial number, date of last calibration and the date the next calibration is due.

5.3.2. All services affecting the X-ray system’s calibration shall be documented on the following forms:

a) DD Form 2164, X-Ray Verification/Certification Worksheet. The Contractor shall complete this form in accordance with instructions provided in TB 38-750-2 if the equipment requires such documentation. A continuation sheet shall be attached to the DD Form 2164 indicating the manufacturer, model, serial number and date of the calibration expiration of all items of test, measurement, and diagnostic equipment used to perform the calibration. The required forms and extracts from pertinent directives will be furnished to the contractor by the government.

Procedures for completing DD Form 2164 can be provided by the Medical Maintenance Section.

b) DD Form 2163, Medical Equipment Verification Label must ‘updated’ and initialed by the Contractor after every calibration. No exceptions.

b) Local Forms as provided by the MTF. All required documentation will be supplied by the

MTF.

5.3.3. The Contractor’s representative shall attach and complete or update a DD Form 2163 (calibration sticker), entitled “Medical Equipment Verification/Certification” to the equipment upon completion of calibration services. The DD Form 2163 will be provided to the contractors' representative by the Medical Maintenance Section. If the DD Form 2163 is already attached to the equipment, the contractors' representative shall update the existing DD Form 2163. Procedures for updating the DD Form 2163 will be provided by the Medical Maintenance Section.

5.3.4. The Contractor shall furnish all software upgrades and updates issued by the equipment manufacturer.

5.3.5. The Contractor shall have access to all necessary diagnostic software. Diagnostic software is not Government provided.

5.3.6. If the Contractor’s calibration equipment produces a printed summary of the calibration procedure used, attach the printed summary to the DD Form 2164. Ensure the heading of the DD Form 2164 is filled out and the form is properly signed.

5.4. The Contractor shall only accept calls for service/repairs from the COR or authorized representative.

5.5. Prior to and upon completion of any scheduled or unscheduled service, the contractor service representative shall report to the NCOIC, Medical Maintenance Section or his/her designated representative.

5.6. Field Service Reports (FSRs):

5.6.1. If not available prior to departure, the Contractor shall provide a copy of the Field Service Report within seven calendar days after completion of a repair or service. The Contractor’s representative shall furnish one (1) copy of the FSR for all services performed. The service report shall be in English, legible and shall contain, as a minimum, the following information:

(1) Location and Services Performed

(2) System Name, Model, and Serial Number

(3) The Systems or Component(s) That Failed

(3) Start and Completion Date/Time

(4) Name and Signatures of Service Technician

(5) Part Numbers, Nomenclatures, and Quantities of Replaced Parts

5.7. Receipt of Services:

5.7.1. Receipt of services will be acknowledged after receipt of all completed service reports.

Receiving reports will not be prepared and submitted if there is an inquiry about a delinquent service report from the Hospital. Invoice will not be approved until a complete FSR is provided by Contractor.

5.7.2. The POC for technical questions is the Contracting Officer’s Representative (COR) or authorized representative. Services to be acknowledged by receipt of service reports and invoices submitted to and acknowledged by the appointed COR or authorized representative.

5.8. Smoking. Smoking is prohibited within the hospital its departments or sections and within 15 meters of any hospital building.

5.9. Monitoring Methods:

5.9.1. The COR will maintain surveillance checklists covering areas in Attachment 1:

Performance Requirements Summary (PRS) (See Attachment 1). The COR or authorized representative will use the PRS to evaluate the Contractor’s performance (Performance Objective, Performance Standard, AQL, Monitoring Method, and Incentive/De-incentive). All work is subject to inspection and acceptance by the Government. Monitoring method is 100% inspection by COR or authorized government representative for Performance Requirements Summary items listed in Attachment 1.

5.10. Performance Assessment Reporting:

5.10.1. A year-end performance rating will be entered into the Government’s Contractor Performance Assessment Reporting System (CPARS) by the Contracting Officer. CPARS collects Contractor Past Performance Information (PPI), and is one of the tools which support Army effort to acquire best value. PPI may be used to evaluate performance risk in source selection. It may also be used to aid in determining potential sources (e.g. market research), developing contracting and acquisition strategies, and determining contractor responsibility. Additionally, the collection of PPI facilitates regular communications between government and contractor concerning performance on current contracts. The feedback provided by the government to the contractor in collecting PPI, and knowledge that PPI will be used in future source selection decisions, should result in improved performance and a greater contractor focus on customer satisfaction.

PART 6

APPLICABLE PUBLICATIONS

6. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND

MANUALS:

6.1. The following is a list of basic publications applicable to this contract. Current issues of many DA publications can be accessed at http://www.usapa.army.mil . Current issues of many forms can be accessed via “google.com” or at http://www.usapa.army.mil . Publications and forms not on the internet can be obtained from the MTF.

6.1.1. The Publications have been coded as mandatory or advisory. The contractor is obligated to follow those coded as mandatory only to the extent they apply to this contract. Supplements, amendments or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance, but are not binding for compliance.

6.2. Publications.

6.2.1. Mandatory:

6.2.1.1. 21 CFR 1020.30, Federal Performance Standard for Diagnostic X-Ray Equipment.

6.2.1.2. NFPA 99, Chapter 7, Standard for Health Care Facilities

6.2.1.3. TB 38-750-2, Maintenance Management Procedures for Medical Equipment.

6.3. The following is a listing of required Department of Defense Forms:

DD 2163 - Medical Equipment Verification/Certification DD 2164 - X-Ray Verification Certification Worksheet

7.0. Contracting Manpower Reporting: The Contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the U.S. Army via a secure data collection site. The Contractor is required to completely fill in all required data fields at the following web address: http://www.ecmra.mil/.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at help desk at:

http://www.ecmra.mil.

7.1. Contractor Manpower Report (CMR): 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:

(1) Contracting Officer’s Technical Representative;

(2) Contract 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 - J066) 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: W3VA9M) 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).

(13) As part of its Submission, the Contractor will also provide the Estimated Total Cost (if any) incurred to comply with this reporting requirement.

7.2. 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 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.

8. SHARP

8.1. The Contractor shall comply with OTSG/MEDCOM Policy Memo 19-019, Sexual Harassment/Assault Response and Prevention (SHARP) Program, 21 March 2019. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

8.2. The Contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the Contractor who shall immediately (within 24 hours) report the incident in writing to the Government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

8.3. The Contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the Contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

8.4. The Contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after contractor personnel begin performance under this contract. Training can be obtained either online or in person as offered at the installation where services are being provided. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp

8.5. Sexual Assault Reporting. The contractor will immediately (within 24 hours) report an incident of sexual assault to the COR.

9. Antiterrorism/Operations Security (AT/OPSEC) Requirements.

9.1. Antiterrorism Training. AT Level I Training. This provision/contract text is for contractor employees with an area of performance within an Army controlled installation, facility or area.