1_PWS_MED MAINT _ Final.pdf

Performance Work Statement

Medical Device/Medical Device Systems

Maintenance and Repair Services

2 November 2021

1. GENERAL.

1.1 The contractor shall provide non-personal, medical device equipment/medical device equipment systems (MDE/S) maintenance and repair services in support of the Defense Health Agency (DHA) comprised of U.S. Army, Air Force, and Navy medical services. The Government will neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. The work described is not inherently Governmental and is excluded and prohibited in accordance with FAR

37.102(c), FAR 7.503, DFARS 207.503, PGI 207.503 and AFARS 5107.503.

1.2 BACKGROUND.

1.2.1 The Defense Health Agency seeks a high level maintenance enterprise solution to streamline and integrate the processes for efficient, expedient, and cost-effective MDE/S maintenance and repair services.

1.2.2 Medical Devices Equipment/Systems (MDE/S) consist of devices used in the medical diagnosis, therapy, and treatment of injury or disease including dental, aeromedical evacuation, Home

Station Medical Response, and veterinary items. MDE/S extends to commercial off-the-shelf (COTS) equipment and device systems approved by the Food and Drug Administration used primarily in

Medical Treatment Facilities (MTFs) to provide patient care. Lastly, MDE/S also refers to maintenance of significant instruments, apparatus, implements, machine, contrivance, implants, in vitro reagent, or other similar or related articles, including a component part or accessory; and, software directly connected to the MDE/S that when inoperative or outdated diminishes the MDE/S to a low level or inoperative condition. The latter are also considered a component or part, equally qualifying for repair maintenance support under this Performance Work Statement (PWS). The MDE/S are:

-intended for use in the diagnosis of disease symptomatology, related conditions, cure, and mitigation treatment, disease prevention programs with its associated modalities, directed at providing medical health services for military service members, and beneficiaries at inclusive Army, Air Force, and Navy sites. The MDE/S to be service also extends to participating military veterinary clinics under DHA.

- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. MDE/S may include but is not limited to:

Diagnostic equipment (i.e. CT systems, MRI systems)

Treatment equipment (i.e. infusion pumps, medical lasers)

Life support equipment (i.e. ventilators, dialysis machines)

Monitoring equipment (i.e. SPO2 monitors, vital signs monitors)

Medical laboratory equipment (i.e. blood gas analyzers, centrifuges)

Therapeutic equipment (i.e. physical therapy equipment)

Medical Software

Veterinary MDE/S

1.3 OBJECTIVE. To support DHA in maintaining MDE/S in a fully operational status.

1.4 SCOPE OF WORK.

1.4.1 The contractor shall provide all contract and task order (TO) management, all labor, material, supplies, tools, diagnostic software, and test equipment necessary to perform MDE/S maintenance and repair services at Army, Air Force, and Navy multiple MTFs, as identified in Attachments C, D and E.

The services shall be performed on equipment identified in Attachment F.

1.5 CONTRACTING OFFICER REPRESENTATIVE (COR).

1.5.1 As the Contracting Officer’s representative, the DHA shall monitor all technical aspects of the resultant contract, may monitor TO level technical aspects, perform inspections, and assist in contract administration. For the basic contract, a letter of appointment shall be issued to the DHA COR, a copy of which shall be sent to the contractor. A letter of appointment will outline the responsibilities and limitations placed upon the DHA COR’s authority. The DHA COR is not authorized to change any of the terms or conditions of the resultant contract and/or TOs.

1.5.2 Service-level CORs may be appointed to monitor all technical aspects and administration of TOs and may be appointed at any time during contract administration to monitor all technical aspects and administration of individual TOs. A letter of appointment may be issued to the service-level COR, a copy of which shall be sent to the contractor. A letter of appointment will outline the responsibilities and limitations placed upon the service-level COR’s authority. The service-level CORs are not authorized to change any of the terms or conditions of the contract and/or TOs.

1.5.3 When a TO is issued, a TO-level COR may be appointed to monitor all technical aspects and administration of individual TOs. A letter of appointment will be issued to the TO-level COR, a copy of which shall be sent to the contractor. A letter of appointment will outline the responsibilities and limitations placed upon the TO-level COR’s authority. The TO-level CORs are not authorized to change any of the terms or conditions of the TO. The DHA COR and service-level CORs may also serve as a

TO-level CORs.

1.6 KEY PERSONNEL.

1.6.1 The contractor shall designate a contractor manager, in writing, and submit to the Contracting

Officer (KO) prior to contract performance. The contractor manager shall have full authority to act for the contractor on all contractual matters relating to daily operation of the resultant contract. If/when the contractor changes the contractor manager, the contractor shall submit the change to the KO in writing not later than five (5) business days prior to change of the contract manager.

1.6.2 A designated contractor manager shall be available for Government contact via email and telephone, 24 hours a day, seven days a week, to include holidays.

1.7 PLACE/HOURS OF PERFORMANCE.

1.7.1 Place of Performance. The contractor shall provide services at the MTF locations listed in

Attachments C, D and E.

1.7.2 Hours of Performance. The contractor shall provide services during the normal operational hours of the specific MTF, Monday – Friday, where maintenance and repair MDE/S services are being conducted or received. Any maintenance and repair MDE/S services ordered outside of normal operational hours shall be performed during normal duty hours, unless specifically authorized by the

DHA COR working directly with KO. Service-level and TO-level CORs shall seek authority from the

DHA COR before authorizing maintenance and repair MDE/S services outside normal business hours.

1.7.3 The contractor is generally not required to provide maintenance and repair MDE/S services when the military installation is unexpectedly closed due to emergencies, administrative actions, or similar

Government-directed closings. Completing delivery of maintenance and repair MDE/S services during an unexpected Government closure shall depend on factors such as the circumstances of the closure, the services to be delivered, and the availability of Government personnel and/or facilities, etc.

1.8 RECOGNIZED HOLIDAYS.

1.8.1 The contractor may be required to perform maintenance and repair MDE/S services on the holidays listed when specifically authorized by the DHA COR. Service-level CORs and TO-level CORs shall coordinate with the DHA COR.

New Year’s Day, January 1 Labor Day, 1st Monday in September

Martin Luther King’s Birthday, 3rd Monday in January Columbus Day, 2nd Monday in October

President’s Day, 3rd Monday in February Veteran’s Day, 4th Thursday in November

Memorial Day, last Monday in May Christmas Day, December 25

Independence Day, July 4th

1.9 SECURITY.

1.9.1 Security Policy and Procedures. All contractor and sub-contractor contract service providers

(CSPs) shall comply with applicable installation, facility, and area commander installation/facility access and local security policies and procedures of MTFs identified in Attachments C, D and E.

Policies and procedures will be provided to the contractor by an assigned COR within five (5) business days of a TO award. The contractor shall provide all information required for background checks to meet installation access requirements as performed by the installation Provost Marshal Office, Director of Emergency Services, or Security Office.

1.9.2 For access to the applicable installations, the contractor and all associated sub-contractor CSPs shall provide all documentation required to meet installation access requirements to the assigned COR.

The documentation will be forwarded to the installation Provost Marshal Office or MTF Security Office to be processed by the installation Provost Marshal Office, Director of Emergency Services or Security

Office. The CSPs shall comply with all personal identity verification requirements as directed by DoD, DHA, Headquarters Department of the Army (HQDA), Headquarters Air Force (HAF), and

Headquarters Navy (HN), including local policy in addition to the changes otherwise authorized by the changes clause of the resultant contract. Force Protection Condition (FPCON) changes at any individual facility or installation may require deviations in anticipated contractor security matters or processes.

1.9.3 Contractors and all associated CSPs that do not require a Common Access Card (CAC), but require access to a DoD facility or installation shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist

Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures to be provided by the assigned COR or ACOR.

1.9.4 Some locations will have limited access to installations/bases with controlled gate openings and closures. Unscheduled gate closures by Law Enforcement personnel may occur at any time and personnel entering or exiting the installation may experience a delay.

1.9.5 The CSP operating contractor or privately-owned vehicles on Federal property shall possess an operator's license for the category of vehicle being operated and automobile insurance as required by regulations/laws governing said Federal property. Privately owned and contractor vehicles are subject to being searched pursuant to applicable regulations.

1.10 REMOVAL FROM CONTRACT WORK.

1.10.1 The KO or any assigned COR may direct the contractor to immediately remove a CSP from the work site when it is determined that the CSP’s behavior is contrary to the public interest, inconsistent with the best interests of security, or is identified as a potential threat to the health, safety, security, general well-being or operational mission of the facility and its population.

1.10.2 Law enforcement officers of the Military Police/Department of Homeland Security

(DHS)/Immigration and Customs Enforcement (ICE)/Federal Protective Service (FPS) will have the authority to immediately remove any CSP from the work site when delay in removal would not be in the best interest of the Government, security, or is identified as a potential threat to the health, safety, security, general well-being or operational mission of the facility and its population. The KO and any assigned COR shall be notified as soon after the incident as practical or at the beginning of the next business day if an action happened after hours. The KO will make all official notifications to the contractor.

1.10.3 The contractor shall meet the terms and conditions of the contract, to include the PWS standards regardless of the CSP removal from work site.

1.11 SEXUAL HARASSMENT AND ASSAULT RESPONSE PROGRAM (SHARP).

1.11.1 The contractor shall comply with DoD Policy for Reporting Incidents of Sexual Assault and

Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013.

The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing maintenance and repair MDE/S services under this contract.

1.11.2 The contractor shall require all 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 maintenance and repair MDE/S services under the resultant contract, to report the incident to the contractor who shall report within 24 hours of gaining knowledge of the incident report the incident in writing to the assigned COR or ACOR. This reporting policy also applies to sexual assault incidents involving DHA, and service specific personnel that occur on the contractor’s owned or leased facility under the resultant contract. All incidents shall be reported whether they involve contractor personnel or

Government personnel, or other individuals, when the incidents occur on a Government facility or a

Government leased facility.

1.11.3 The contractor shall require all CSP 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 of gaining knowledge of the incident) report the incident in writing to the

Government's COR. This reporting policy also applies to sexual harassment incidents involving DHA, and service specific personnel that occur on the contractor’s owned or leased facility under this contract.

All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility or a Government leased facility.

1.12 QUALITY CONTROL (QC).

1.12.1 The contractor shall maintain an industry quality standard-compliant process such as ISO 9000 or equivalent.

1.12.2 The contractor shall maintain a complete Quality Control Plan (QCP) to ensure the requirements of the resultant contract are provided as specified in this PWS. The contractor shall provide copies of the

QCP to the KO and the DHA COR no later than 30 calendar days after contract award. The QCP shall demonstrate how the contractor intends to ensure quality performance during the contract period of performance. The contractor shall maintain a QCP that includes performance metrics. As necessary, the contractor shall update/revise the QCP and submit updates/revisions to the KO and the DHA COR for review prior to implementation. The final updated/revised QCP shall be incorporated into the contract by reference as a compliance document. The contractor shall update/revise the QCP, as necessary, and submit the updated/ revised QCP to the KO and DHA COR not later than seven (7) calendar days for review/comments prior to implementation.

1.12.3 Quality Control Inspection Report. The contractor shall submit a quarterly written report to the

KO and DHA COR not less than three (3) business days prior to the quarterly review/meeting (see PWS

1.14). The report shall detail the contractor’s quality inspection results and actions.

1.13 QUALITY ASSURANCE (QA). The Government shall evaluate the contractor’s performance under the resultant contract in accordance with the Quality Assurance Surveillance Plan (QASP). The plan shall primarily focus on what the Government must do to ensure that the contractor has performed in accordance with the performance standards and contract quality requirements. The term “contract quality requirements” means the technical requirements in the contract relating to the quality of the service and those contract clauses prescribing inspection and other quality controls incumbent on the contractor to ensure the service conforms to the contractual requirements. It defines how the performance standards will be applied, the frequency of surveillance, and the performance thresholds.

1.14 POST AWARD CONFERENCE/PERIODIC PROGRESS MEETINGS.

1.14.1 The contractor shall attend the post award conference convened by the contracting activity.

1.14.2 The contracting officer, DHA COR, service-level COR, TO-level CORs, and other Government personnel, as appropriate, may meet periodically, but not less than quarterly, with the contractor to review the contractor’s performance. At these meetings, the KO or DHA COR will apprise the contractor how the Government views the contractor’s performance and the contractor will apprise the

Government of issues/concerns, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

1.14.2.1 Quarterly meeting will be conducted at no additional cost to the Government.

1.15 CONTRACTORS IN GOVERNMENT WORK AREAS.

1.15.1 Contract Service Providers (CSPs), including subcontractors, shall identify themselves as contractor personnel while performing tasks in Government work areas. The CSPs shall wear a contractor furnished, visible identifying badge (name tag) in a prominent location, on the front of the outer clothing above the waist, while performing services under the resultant contract. The badge shall have the name of the contractor as well as the full name and professional title of the individual CSP.

CSPs shall ensure their presence or participation does not construe the appearance or impression as a

Government employee.

1.15.2 CSPs attending meetings, providing maintenance and repair services, and/or working in other situations where contractor status is not obvious to third parties (such as phone, internet, or other distance methods) shall be required to identify themselves as such to avoid creating an impression in the minds of members of the public, Government employees, or members of Congress they are Government officials or employees.

1.16 TRAVEL.

1.16.1 The contractor may be required to travel during the performance of the resultant contract to attend meetings or other functions to provide maintenance and repair services in support of this PWS.

1.16.2 Although the Joint Travel Regulation (JTR) is not applicable to contractors, it may be used to determine the reasonableness and allowableness of reimbursable costs under the resultant contract. All reimbursable costs shall be considered to be reasonable and allowable only to the extent the costs do not exceed, on a daily basis, the maximum rates in effect at the time of travel as set forth in the JTR. There may be circumstances when the JTR authorizes a discretionary travel and transportation expense, but the resultant contract remains silent. In such circumstances, the expense is not allowable under the resultant contract and will not be reimbursed.

1.17 PHASE IN/PHASE OUT PERIOD.

1.17.1 The contractor shall ensure a smooth 60-day transition during the phase-in period. The contractor shall submit a phase-in plan to the KO and DHA COR via email not later than 10 days after contract award. The phase-in plan shall include, at a minimum, the following: key milestones to reflect the phase-in period of 60 days and chronological sequence of events and actions that will be accomplished. During the phase-in period, the contractor shall become familiar with performance requirements in order to commence full performance of services at the end of phase-in period.

1.17.2 As an incumbent, the contractor shall ensure a smooth transition with the successor during the phase-out period prior to completion of contractual performance. The contractor will provide an orderly transition of work acceptance and accomplishment so that full control by the successor is achieved by the end of the phase-out period.

1.18 EXCLUSION FROM PARTICIPATION IN FEDERAL HEALTH CARE PROGRAMS

(OCTOBER 2015)

1.18.1 The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as “person”) to provide items or services that will be included in invoices submitted to the Government under the resultant contract if such person is listed on the Department of

Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at http://oig.hhs.gov/fraud/exclusions.asp, and the TRICARE Sanctioned Provider list at http://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of-

Healthcare/Program-Integrity/Sanctioned-Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as “the Lists.”

1.18.2 Prior to start of contract performance, the contractor shall (a) query the Lists to determine whether the name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and (b) certify to the

Contracting Officer that the contractor has queried the Lists and no such names appear on either of the

Lists. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter “new persons”) providing services or items under the contract, the contractor shall (a) query the Lists as in paragraph 2, and (b) certify to the

Contracting Officer that the names of such new persons do not appear on either of the Lists.

1.18.3 The contractor is advised that during performance of the resultant contract, MTF personnel will perform a recurrent recheck of the names of contractor personnel working in the MTF against the Lists.

The Government will notify the contractor in the event any contractor personnel working in the MTF appear on either of the Lists.

1.18.4 Should any person providing items or services under the contract appear on either of the Lists at any time during contract performance, the contractor shall (a) in cases where the contractor identified the person, notify the Contracting Officer, and (b) promptly remove that person from the contract?

1.18.5 Violation of any aspect of the above paragraphs shall be considered a material breach of the resultant contract and may result in termination of the contract.

1.18.6 The contractor is further advised that, in accordance with Civil Monetary Penalties Law [CMP]

(codified at 42 USC § 1320a-7a):

There are steep civil monetary penalties associated with billing the Government for providing items or services by a person on either of the Lists, and with failing to return to the Government any overpayments received for provision of such items or services.

Billing under the contract for provision of items or services by a person on either List may also result in exclusion of the person that employs or contracts with such person.

1.18.7 HHS OIG has issued a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs with additional information on the CMP. The Special Advisory

Bulletin may be found at http://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

2. DEFINITIONS/ABBREVIATIONS.

2.1. DEFINITIONS.

Administering Office. The contracting office delegated responsibility to issue site-specific TOs and administer those orders.

Army, Air Force and Navy Medical Services. Any medical organization as listed in the attachments under the direction of DHA Major Command (MAJCOM) that includes U.S. Army, U.S. Air Force, and

U.S. Navy medical centers, hospitals, and clinics.

Army Medical Command (MEDCOM). An organization that has command over one or more U.S. Army medical centers, medical department activities, or medical research activities. Includes U.S. Army

Medical Command, U.S. Army Medical Research and Materiel Command, and 18th Medical Command.

Calibration. The comparison of a medical system or device of unverified accuracy to a medical system or device of known accuracy for the purpose of detecting and (if necessary) correcting required performance specification deviations.

Calibration, Verification, and Certification (CVC). Services to determine compliance of MDE/S with applicable specifications or standards and to make the necessary corrections or to compare items with certified device, tool, or test equipment traceable to National Institute Standards and Technology (NIST) standards.

Configuration. The functional/physical characteristics of hardware/software set forth in technical documentation and achieved in a product to advance the device to full capable/functional status.

Contracting Officer (KO): The KO is the exclusive government official authorized to enter into, administer, execute changes and authorize deviations or variations from the contract and/or terminate contracts.

Contracting Officer’s Representative and Alternate Contracting Officer’s Representative (COR/ACOR):

The designated Government representative(s) of the KO.

Critical Characteristics. Features (tolerance, finish, material composition, manufacturing, assembly, software, or inspection process) of a product, material, or process that, if nonconforming or missing, could cause the failure or malfunction of the item.

Field Service Report (FSR). Written service report providing detailed information regarding the cause of equipment malfunction and corrective action take, to include the time required to complete the work, price of labor (hourly rate), a list of parts replaced with the cost of each part (See PWS 5.4.5).

Inspection. Inspection encompasses both electrical safety and performance inspection actions.

Inspections ensure that impacted devices perform in accordance with Original Equipment Manufacturer

(OEM) design specifications.

Maintenance. All actions necessary for retaining an item in or restoring it to an OEM specified condition. For this requirement, maintenance is defined as follows:

Scheduled Routine Maintenance. These services are performed on a recurring, scheduled basis at set intervals. Routine scheduled maintenance includes the care and servicing of the equipment (in accordance with manufacturer’s maintenance specifications) for the purpose of retaining the equipment in a serviceable condition. This inspection includes checking for proper operation, detection and correction of failures either before they occur or before they develop into major defects; and includes, but is not limited to, actions pertaining to periodic technical inspections, lubrications, adjustments, calibration, interior cleaning, and replacement of worn or deteriorated parts.

Unscheduled Routine Maintenance. These services are non-emergent and performed on a non-recurring, one-time basis. Unscheduled routine maintenance includes the services required to restore equipment to, or within the original equipment manufacturer’s specifications. It includes all services required due to minor or major malfunctions, or as a result of damage to the equipment by accident, neglect, abuse, power surge, power failure, or operation in an environment not compatible with the equipment’s published specifications, unless such damage is caused by the CSP. Unscheduled routine maintenance includes the inspection, testing, troubleshooting, servicing, re-calibration (if incidental to repair), and all other actions necessary to return the item to a fully serviceable status. Unscheduled routine maintenance services may include relocation with installation and de- installation of equipment.

Unscheduled Urgent Maintenance. These services are urgent, time-limited and are performed on a non- recurring, one-time basis. Unscheduled urgent MDE/MDE/S work requests are required for repair of a unit’s or activity’s mission essential MDE/MDE/S as soon as possible. Without these

MDE/MDE/S, the activity’s ability to perform the assigned operational mission(s) is impaired resulting in decreased healthcare efficiency, and/or, patient access, and/or quality of care. Unscheduled urgent maintenance includes the inspection, testing, troubleshooting, servicing, re-calibration (if incidental to repair), and all other actions necessary to return the item to a fully serviceable status.

Unscheduled Emergency Maintenance. These services are emergent, time-limited and are performed on a non-recurring, one-time basis. Unscheduled emergency MDE/MDE/S work requests are required for immediate repair of a unit’s or activity’s mission essential MDE/MDE/S. Without these

MDE/MDE/S, the activity is unable to perform the assigned mission(s). Loss of MDE/MDE/S functionality prevents patient’s access to health care resulting in cancellation, deferment, and/or rescheduling of all medical appointments and/or procedures (e.g.., CT becomes non-mission capable

(NMC) and patients are diverted to another facility outside the network.) Unscheduled emergency maintenance includes the inspection, testing, troubleshooting, servicing, re-calibration (if incidental to repair), and all other actions necessary to return the item to a fully serviceable status.

Maintenance Standard. A measure that specifies the minimum condition to which MDE/MDE/S must be restored by repair, overhaul, or some other maintenance function to ensure its satisfactory performance for a specified period of service.

Off-site Maintenance. Maintenance authorized to be performed by designated maintenance facilities not located where the equipment is operated.

On-site Maintenance. Maintenance authorized to be performed where the equipment is operated.

Preventive Maintenance. Preventive Maintenance (PM) is the scheduled care, servicing, inspection, detection, and correction of minor faults before these faults develop to become unscheduled services actions. PM is performed in an attempt to retain an item in a specified condition by providing systematic inspection, detection, and prevention of incipient failures.

Preventive Maintenance Checks and Services. PMCS are the systematic care, servicing, and inspection of MDE/S.

Repair. Return the device or component to OEM specifications as approved by the FDA including replacing non-working components or parts outside of routine or periodic upkeep.

Repair Part. A component or module of the existing equipment system or OEM-approved modification requiring replacement includes parts and components installed solely for cosmetic appearance. The parts shall meet OEM specifications.

Return Material Authorization (RMA)/Returned Goods Authorization (RGA). The process of returning a

MDE/S in order to receive a refund, replacement, and/or repair. The purchaser of the MDE/S must contact the manufacturer (or distributor or retailer) to obtain authorization to return the MDE/S. The resulting RMA or RGA number must be displayed on or included in the returned product's packaging;

no returns are accepted without this number.

2.2 ABBREVIATIONS.

AFI Air Force Instruction

AFMOA Air Force Medical Operations Agency

AFMS Air Force Medical Service

ACOR Alternate Contracting Officer’s Representative

AKO Army Knowledge Online

AR Army Regulation

BMET Biomedical Equipment Technician

CAC Common Access Card

CLIN Contract Line Item Number

COR Contracting Officer’s Representative

CSP Contract Service Provider

DoD Department of Defense

DoDI Department of Defense Instruction

FAR Federal Acquisition Regulation

FDA Food and Drug Administration

FPCON Force Protection Condition

FSR Field Service Report

FY Fiscal Year

HAF Headquarters Air Force

HQDA Headquarters, Department of Army

IA Information Assurance

IAW In Accordance With

IMD Information Management Division

KO Contracting Officer

MD/MDS Medical Device/Medical Device Systems

MTF Medical Treatment Facility

NFPA National Fire Protection Association

OEM Original Equipment Manufacturer

OSHA Occupational Safety and Health Administration

PMI Preventive Maintenance Inspection

POC Point of Contact

PWS Performance Work Statement

QA Quality Assurance

QC Quality Control

QCP Quality Control Plan

RGA Return Goods Authorization

RMA Return Material Authorization

SHARP Sexual Harassment/Assault Response and Prevention

TB Technical Bulletin

TBLC Total Billable Labor Costs

TMDE Test, Measurement, and Diagnostic Equipment

VVCWS Vendor's Verification/ Certification Worksheet

3. GOVERNMENT FURNISHED ITEMS AND SERVICES.

3.1 Facilities. The Government will provide the necessary workspace for contractor to support the tasks outlined in this PWS.

3.2 Government Services. The Government will provide copier and guest Wi-Fi services when available. The contractor shall request the guest Wi-Fi access code from the assigned COR.

3.3 Attachments. When required, the Government shall provide updated attachments.

3.4 Utilities. The Government will provide all standard facility utilities such as electricity, water, etc., for the contractor’s use in the performance of this PWS.

3.5 The contractor shall safeguard all Government property provided to the contractor for repair. If contractor causes damages to Government property, supplies, and/or equipment, while performing services on site, the contractor may be held liable.

3.6 The contractor shall be fully aware of the potential for hazardous contamination on any piece of

Government equipment being serviced. If the Government is aware of any potential contamination, it will be communicated to the contractor. The assigned COR and the contractor will exchange hazard communication information before the commencement of any repair.

3.7 All Government furnished items shall remain under the control of the Government.

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES.

4.1 The contractor shall provide all labor, material, supplies, tools, diagnostic software, test equipment, and portal/database necessary to perform MDE/S maintenance and repair services at multiple MTFs as identified in Attachments C, D and E.

4.2 The contractor shall furnish, or have access to, all necessary diagnostic software to include software updates (required application software patches/bug fixes, operating system patches, and modifications resulting from recall or hazard alerts) issued by the OEM. If it is a different version than currently installed, the contractor shall notify the assigned COR and ACOR prior to uploading software applications, patches, or modifications to medical devices.

4.2.1 For network connected devices, only Information Assurance-(IA) approved software versions shall be installed on MDE/S.

4.2.2 The contractor shall provide the Government any hard drives, DVDs, CDs, USBs, etc. used to transfer data (software, patches, drivers, etc.) to a MDE/S for pre-scanning viruses prior to the data transfer.

4.2.3 If maintenance includes any software installation to a MDE/S, the contractor shall perform a full functions check on the MDE/S upon completion of maintenance and services.

4.2.4 Only manufacturer approved patches shall be installed on Government medical devices equipment/systems.

4.2.5 Use of remote, business-to-business (B2B) connections shall be through DHA approved connections/gateways applicable to the desired optimum connectivity guidelines and safeguards relevant to the MTF receiving services.

5. DESCRIPTION OF WORK.

5.1 The contractor shall provide all services for the resultant contract, subsequent TO management and subsequent work orders including, but not be limited to, subcontract/preferred vendor network management and all labor, supervision, material, supplies, tools, diagnostic software, test equipment, all necessary material and services to perform MDE/S maintenance and repair services at multiple MTFs as identified in Attachments C, D and E. The services shall be performed on select equipment identified in

Attachment F. It may be necessary to add MTFs device specific equipment to the resultant contract based upon the needs of the DHA, Army, Air Force, and Navy MTFs.

5.1.1 Contract Management. The contractor shall ensure contractual compliance to basic contract, TOs, and contract changes via modifications. The contractor shall submit a monthly status report (MSR) to the DHA COR and the service-level CORs not later than 5th business day of each month. The MSR shall include such items as a description of activities of the past month, i.e., summary of work accomplished during the month and percent complete; a schedule of activities planned and estimated date and time of completion; and, a summary of the status of work initiatives and documentation updates.

5.1.2 Task Order Management.

5.1.2.1 The contractor shall effectively manage all DHA respective Army, Air Force and Navy portfolios of TOs covering the full spectrum of the PWS. The contractor shall track, monitor, and report quarterly to the KO, DHA COR and service-level COR the TO portfolio statuses to include performance trends by

TO. All services furnished under the resultant contract shall be ordered by issuance of TOs.

5.1.2.2 The contractor shall maintain procedures for establishing tracking and status of equipment sent to vendor for service (see PWS 5.4).

5.1.2.3 The contractor shall report TO performance through formal and informal meetings. The contractor shall take corrective action based upon trend analysis to improve TO performance.

5.1.3. Subcontracts Management.

5.1.3.1 Not later than 60 days after contract award, the contractor shall maintain a national, centralized network of subcontractors capable of providing 50% of the biomedical equipment technician (BMET)

Level 3 maintenance and repair services required in the PWS. The network shall consist of qualified, subcontractors to include traditional OEM, Independent Service Organizations (ISOs), or alternative vendors.

5.1.3.2 Not later than 90 days after contract award, the contractor shall maintain a national, centralized network of subcontractors capable of providing 75% of the BMET Level 3 and 50% of BMET Level 2 maintenance and repair services required in this PWS.

5.1.3.3 Not later than 120 days after contract award, the contractor shall maintain a national, centralized network of subcontractors capable of providing 90 % of the BMET Level 3, 75% of BMET Level 2, and

50% of BMET Level 1 maintenance and repair services required in this PWS.

5.1.3.4 Not later than 180 days after contract award, the contractor shall maintain a national, centralized network of subcontractors capable of providing 90% of all the maintenance and repair services required in this PWS.

5.1.3.5 The contractor shall identify, evaluate, qualify, select, and supply subcontractors with capability expertise in support of select equipment listings under Attachment F. The contractor shall manage all subcontractors and subcontracting capability for necessary MDE/S maintenance and repair services. The contractor shall comply with the Electronic Subcontracting Reporting System (eSRS) requirements at https://www.esrs.gov/ and implement subcontract management best practices along with associated measurement metrics and standards in accordance with (IAW) contractor best practice policies.

5.1.3.5 The contractor shall actively seek and pre-qualify multiple subcontractors who can provide the skills and materials the Government requires to ensure that DHA, Army and Navy MTFs can accomplish their missions with low TO execution risk. The contractor shall continuously evaluate the performance of its subcontractors and their ability to accurately deliver successful results. The contractor shall take action to add new subcontractors to align subcontractor support capability to the evolving

DHA and aligned medical service mission requirements (select equipment listings in Attachment F.

5.1.3.6 The contractor shall maintain policies and procedures for vetting potential vendors, negotiating service agreements, and maintaining a national, centralized network of qualified subcontractors. A qualified subcontractor/preferred vendor is a service provider that possesses a documented quality management system and the necessary facilities, Tools, Measurement, and Diagnostic Equipment

(TMDE), skills, and manpower required to repair a specific component(s) to the OEM standard. The qualifications of subcontractors dispatched by the contractor to perform work on a specific MDE/S shall match the level of service requirement.

5.1.3.7 Level 1 Maintenance and Repairs: technician shall have a DoD equivalent certification from an accredited school of learning AND have a minimum of 12 months experience servicing the specific equipment type.

5.1.3.8 Level 2 Maintenance and Repairs: technician shall be trained by the OEM or third-party equivalent on the specific piece of equipment being serviced OR technicians shall be accredited as a

Certified Biomedical Equipment Technician (CBET) by the Association for the Advancement of

Medical Instrumentation (AAMI) of Arlington, VA OR have at a minimum an Associate’s Degree in

Biomedical Technology or Electronics from an Accreditation Board for Engineering and Technology

(ABET) accredited school of learning AND have a minimum of 12 months experience servicing the specific equipment type.

5.1.3.9 Level 3 Maintenance and Repairs: only OEM trained technicians shall be accepted for Level 3 repairs on the specific piece of equipment being serviced AND have a minimum of 12 months experience servicing the specific manufacturer and model of the MDE/S for which service was requested.

http://www.esrs.gov/

5.1.3.10 Qualified Maintenance and Repair Technicians must be available to respond to

Schedule/Unscheduled, Routine/Urgent/Emergency, Repair/Maintenance calls.

5.1.3.10.1 Scheduled Routine Maintenance. The contractor shall provide scheduled routine maintenance services (as defined in Section 2, Definitions) on a requested, work order basis.

5.1.3.10.2 Unscheduled Routine Maintenance and Repair. The contractor shall provide unscheduled routine maintenance and repair services (as defined in Section 2, Definitions) on a requested, work order basis.

5.1.3.10.3 Unscheduled Urgent Maintenance and Repair. The contractor shall provide unscheduled urgent maintenance and repair services (as defined in Section 2, Definitions) on a requested, work order basis.

5.1.3.10.4 Unscheduled Emergency Maintenance and Repair. The contractor shall provide unscheduled emergency maintenance and repair services (as defined in Section 2, Definitions) on a requested, work order basis.

5.1.3.11 The contractor shall maintain policies and procedures for requesting quotes and determining price reasonableness from subcontractors, documenting price reasonableness in sole source scenarios, reconciling, billing, and issuing direct payments to subcontractor within six months of subcontractor/preferred vendor services. The contractor shall be responsible for ensuring subcontractor/preferred vendor billing is completed not later than six months of work order completion.

Subcontractor’s final invoice with supporting documentation (e.g., prime contractor’s price reasonableness determination) shall be included with the contractor’s invoice. After six months of TO completion, the Government will initiate TO closeout proceedings for final TO closeout.

5.1.4 MEDICAL DEVICE EQUIPMENT/MEDICAL DEVICE EQUIPMENT SYSTEMS

MAINTENANCE AND REPAIR SERVICES

5.1.4.1 The contractor shall provide all labor, material, supplies, tools, diagnostic software, and test equipment to accomplish the required maintenance services for scheduled (routine) and unscheduled

(routine, urgent, and emergency) maintenance services as requested, on a work order basis at multiple

MTFs for select equipment identified in Attachment F and in accordance with Table 1.

Table 1: Description and Requirements for MD/MDS Services

Description Definition Work Order

Initiation

Work Order

Confirmed by

Contractor

Work Order

Scheduled

Contractor on site to accomplish work

Scheduled

Routine

PWS

2.13.1

Direct contact by

Task Order COR

Via email or telephone within one business day of notification

Within three business days of confirmation

Within 20 calendar days of confirmation

Unscheduled

Routine

PWS

2.13.2

Direct contact by

Task Order COR

Via email or telephone within two hours of notification during normal operational hours

Within one business day of confirmation

Within 101 business days of confirmation

Unscheduled

Urgent

PWS

2.13.3

Direct (person-to-person) contact by Task Order

COR via email or telephone

Confirmed and Scheduled via email or telephone within two hours of notification

Within 48 hours2 of initiation

Unscheduled

Emergency

PWS

2.13.4

Direct (person-to-person) contact by Task Order

COR via email or telephone

Confirmed and Scheduled via

“Hotline” at time of initiation Within 24 hours3 of initiation

5.1.4.2 Materials are defined as direct materials, including supplies transferred between divisions, subsidiaries, or affiliates of the contractor under a common control; subcontracts for supplies (e.g., repair parts) and incidental services for which there is not a labor category specified in the contract;

other direct costs (e.g., incidental services for which there is not a labor category specified in the contract); subcontracts for services which are specifically excluded from the hourly rate; and indirect costs.

5.1.4.3 When the contractor furnishes material (as defined in PWS 5.2.2.1) it must meet the definition of a commercial item at FAR 2.101, the price to be paid for such materials shall not exceed current market price adjusted to reflect the quantities being acquired. To the extent able, the contractor shall obtain materials at the most advantageous prices available with due regard to securing prompt delivery of satisfactory materials and give credit to the Government for cash and trade discounts, rebates, scrap, commissions, and other amounts that are identifiable to the contract.

5.1.4.4 When a TO is requested to repair and/or service a MDE/S which requires software update and/or replacement, the contractor shall conduct repairs with authorized OEM replacement software that meets all the original manufacturer specification, equal to or greater to software performance at the time of

FDA review and approval. Contractor shall conduct software repairs/replacement in association with an

OEM fully vetted qualified technician in association with local IT and Biomedical services. All software repair/replacement shall be directly for the purpose of bringing malfunctioning MDE/S to original working condition and communication. When repairs require software update and/or replacement, the contractor is not responsible for the ability to operate (ATO), when required, associated therein, the

OEM with who the contractor shall partner to deliver services shall coordinate with DOD facilities to establish Cyber Security protocols that meet DOD requirements.

5.2 REPAIR PARTS.

5.2.1 Contractor shall provide repair parts associated with a maintenance or repair actions described above in Table 1: Description and Requirements for MDE/ S Services. Repair parts include replacement of parts of components or modules of MDE/ S or OEM approved modifications to MDE/S.

5.2.2 Contractor shall provide routine and emergency repair parts not associated with a contractor or subcontractor/preferred vendor maintenance action or service.

5.2.2.3 Routine and emergency repair parts purchased specifically for, and are identifiable solely with, performance under the resultant contract, shall not exceed current market price, adjusted to reflect the quantities being acquired.

5.2.2.4 Routine Repair Parts. Assigned DHA COR shall directly contact contractor to initiate a work order. Contractor shall provide email or telephonic acknowledgment (work order confirmation) of the

Government’s work order within one business day. Contractor shall order routine repair parts within two business days of direct communication. Once the order has been placed, the contractor vendor shall provide a timeline and tracking number to the assigned COR. The Government will reimburse the contractor for the expedited shipping costs for emergency repair parts. Shipping cost must be rolled up in the part cost.

5.2.2.4 New or Certified Refurbished Parts. The contractor or subcontractor shall provide only OEM new or OEM certified refurbished parts. All refurbished parts shall be certified as meeting the OEM’s minimum requirements. Certified refurbished parts must be approved by the assigned COR or ACOR on a work order basis.

5.2.2.5 Repair of MDE/S by Replacement. A MDE/S may be replaced with a new or OEM certified refurbished MDE/S of the same manufacturer and model with the same options and features with approval of the assigned COR or ACOR in the following situations:

5.2.2.5.1 When the required repair equals or exceeds the cost of a new or OEM certified refurbished

MDE/S.

5.2.2.5.2 When OEM or OEM certified refurbished parts are no longer available for repair.

5.2.2.5.3 When the standard operating procedure of the OEM for the MDE/MDE/S is repair by replacement.

5.3 WORK ORDERS

5.3.1 The contractor shall commit to work orders only from the DHA COR, service-level CORs or

TO-level CORs. The Government will provide the names of Government personnel assigned as the authorized and approved TO-level COR upon award of each task order.

5.3.2 Once the work order is approved by the DHA COR, or service-level COR or task order-level

COR, the contractor shall directly coordinate the maintenance, repair, or parts services with the COR who initiated the TO. The CSP shall report in person to the clinical engineering designated representative prior to commencing services during normal duty operating hours. During other than normal operating hours, the CSP shall report to the MTF designated representative.

5.3.3 The Government and the contractor will exchange hazard communication information before the commencement of any repair. When required, the CSP will comply with the Office of Safety and Health

Administration (OSHA) lockout/tag-out standards while performing sustainment on MDE/S.

5.3.4 Upon completion of services by the contractor, a service report shall be provided to the clinical engineering activity who requested the services. The service report shall provide detailed information

(see PWS 5.4.5) regarding…