PWS Diagnostic Medical Physics Services - DRAFT.pdf

PDF 327 KB Posted Oct 26, 2022

Attached to: Diagnostic Medical Physics Services Federal contract opportunity
Solicitation number: FA442723Q0003
Issued by: Department of the Air Force Air Mobility Command

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PERFORMANCE WORK STATEMENT

FOR

David Grant Medical Center

(DGMC)

Diagnostic Medical Physicists Support Services

Date: 26 October 2022

TABLE OF CONTENTS

Section Page Number

1. Description of Services 3

1.1. Background 3

1.2. Scope 3

2. General Information 3

2.1. Contractor Identification 3

2.2. Contractor Training 4

2.3. Contractor/Government Communication 4

2.4. Place of Performance 4

2.5. Travel Requirements 5

2.6. Mission/Emergency Essential 5

2.7. Duty Hours 5

2.8. Federal Holidays/Executive Order 5

2.9. Conduct of Contractor Personnel 5

2.10. Safety 6

3. Contract Requirements 7

3.1. Medical Support Services 7

3.2. Security Requirements 16

3.3. Manpower Reporting Requirements 16

3.4. Quality Control Plan 16

3.5. Post-Award Meeting 16

4. Performance Objectives 16

4.1. Services Summary 17

5. Government Furnished Property 17

6. Deliverables 18

APPENDICES

Appendix A - Anticipate Support Requirements Appendix B - Acronyms

PERFORMANCE WORK STATEMENT (PWS)

Qualified Medical Physicist Support Services

1. DESCRIPTION OF SERVICES

1.1. Background. Medical physics is primarily an applied branch of physics that deals with the application of physical principles to the diagnosis and treatment of human disease. Medical physicists are medical specialists recognized by the American Board of Medical Specialties (ABMS) who practice in one or more subfields of medical physics. The subfields include therapeutic medical physics (primarily radiation oncology), diagnostic medical physics, and nuclear medical physics. Medical physics support is a requirement for safety, efficacy, and compliance in several imaging and therapeutic modalities. This requirement was historically met by a small cadre of active-duty medical physicists. Development of this specialty within the Air Force was officially ended in Oct 2019 and rapid attrition has been ongoing. As a result, the Air Force’s internal medical physics capability is insufficient to meet current needs and is projected to degrade further with time. An inability to obtain requisite medical physics support for diagnostic imaging will lead to MTFs no longer being able to utilize advanced imaging devices (e.g. Computed Tomography Scanners). Contract services are needed to offset the growing gap in diagnostic medical physics coverage until a long-term solution is developed and effected.

1.2 Scope. This is a performance-based, non-personal services requirement to provide a diagnostic medical physics services to David Grant Medical Center's equipment list outlined in Appendix A. The principal scope of this requirement is diagnostic medical physics. The Government will neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to or prepare work schedules for Contractor personnel. It shall be the responsibility of the Contractor to manage its personnel and to guard against any actions that are personal services or give the perception of personal services. If the Contractor feels any actions constitute, or are perceived to constitute personal services, notify the Contracting Officer (CO) immediately.

These services shall not be used to perform work of a policy/decision making or management nature, i.e., inherently governmental functions. All decisions relative to programs supported by the Contractor shall be the sole responsibility of the Government.

2. GENERAL INFORMATION

2.1. Contractor Identification. All Contractor/subcontractor personnel will identify themselves as Contractor personnel during all forms of communications such as business meetings, telephone conversations, electronic mail, attendance sheets, coordination documentations, reports, and the signature blocks utilized in all correspondence. If a contract requires Government workspace, the Contractor/subcontractor personnel shall wear a picture identification badge and identify their workspace area with their name and company affiliation.

2.2. Contractor Training. No Government provided training of contract employees is anticipated during the performance of this contract. The Contractor is responsible for ensuring contract employees are appropriately trained.

2.3. Contractor/Government Communication. The Contractor shall designate a Point of Contract (POC) to be the single point of contact for all Contractor and Government correspondence. The POC shall provide clear and consistent written and verbal response to the Government within 24 business hours of Government initiated communication (e.g., return phone calls, emails or other communication). The POC shall be the only representative of the Contractor authorized to discuss any and all services required by the contract and ensure response to requests for performance of the contract with DGMC Radiology Flight Leadership (MDTS/SGQX CC) or Functional Requirement Evaluator Designee (FRED). The POC shall have the authority to make decisions for the Contractor. The CO and DGMC MDTS/SGQX CC or FRED shall be notified promptly whenever the POC changes. The proposed POC shall be submitted no later than 10 days after award of contract, and shall include at a minimum name, title, e-mail address and telephone number. The CO, POC, CORs and/or other designated representative will provide monthly performance feedback to the Contractor.

2.3. Contractor/Government Meetings.

2.3.1. The Government will host a post-award meeting with the Contractor within ten (10) business days after contract award. The CO shall contact the DGMC MDTS/SGQX CC or FRED and the Contractor to schedule this meeting. A teleconference is permissible for the post-award meeting. The purpose of the post-award meeting is to introduce the Contractor to the DGMC MDTS/SGQX CC or FRED and go over the contract. Takeaways from the meeting should be an exchange of contact information; a timeline of when direct support will start and an understanding by all parties of all the requirements to be performed by the Contractor and the support the Government will provide the Contractor to perform the requirements, safely and efficiently. The Contractor shall also attend an Initial Contract Performance Review meeting thirty (30) calendar days after the Contractor assumes full performance responsibilities (i.e. after completion of transition/mobilization) to ensure that the Contractor has successfully started performance, completed transition and is fully operational within the parameters of the contract.

2.3.2. The POC shall meet with the Government team monthly for the first three (3) months of the contract and then quarterly thereafter. Additional meetings may be requested by the Government or the Contractor as necessary. The CO, DGMC MDTS/SGQX CC or FRED, and/ or other designated representatives will provide monthly performance feedback to the Contractor.

2.4. Place of Performance. The work to be performed under this contract will be performed at David Grant Medical Center, Travis Air Force Base California. The Contractor shall provide support at Travis Air Force Base MTFs provided funds exist and the support is authorized by DGMC MDTS/ SGQX CC or FRED. An initial list of anticipated support requirements can be found in Appendix A..

2.5. Travel Requirements.

2.5.1. A list of initially anticipated support requirements can be found in Appendix A. The list is not binding and is subject to change.

2.5.2. Requirements for scheduling, coordination, and execution can be found in section 3.1.5.

2.6. Mission/Emergency Essential. The services outlined in this PWS are considered mission/ emergency essential. Inability to secure services on a timely manner can preclude use of medical equipment, cause compliance violations, and impair the provision of patient care.

2.7. Duty Hours. Work shall be performed during business hours of 7:30 am to 4:30 PM local time Monday through Friday, except Federal Holidays. Scheduling of work outside of these times is permitted provided it is agreed upon by the Government and Contractor on a case-by-case basis. Continuation of work outside of business hours to facilitate task completion and/or mission needs can be authorized by an agent of the MTF being supported provided no additional expenses are incurred. The Contractor is required to make accommodations at no additional expense if the inability to comply with previous arrangements is due to factors attributable to the contractor (e.g. the contractor arrived late.). Work outside of business hours that may incur additional expense must be authorized from the CO.

2.8. Federal Holidays/Executive Order. Federal offices are closed on New Year’s Day, Dr.

Martin Luther King, Jr. Birthday, Presidents Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day, and any other holidays declared by Executive Order.

2.9. Conduct of Contractor Personnel. The CO may require the Contractor to remove from the job site Contractor personnel working under this contract. Removal from the job site or dismissal from the premises shall not relieve the Contractor of the contract requirements.

2.9.1. The Contractor is responsible for the conduct of its employees. All services shall be provided in accordance with established standards, principles, and ethics of the profession and applicable professional certification, while always ensuring the highest regard for personnel, patients, and their dignity.

2.9.2. There should be no loud, profane or abusive language used on the job.

2.9.3. Contractor personnel shall present a neat well-groomed appearance. Neat, clean, casual business attire clothing shall be worn.

2.9.4. The Contractor shall ensure its personnel shall comply with the MTF smoking policies.

Alcoholic beverages and illicit drug use on the job are prohibited.

2.9.5. Complaints. Complaints will be validated by the Biomedical Equipment Technician (BMET) and be reported in writing to the COR, DGMC MDTS/SGQX CC or FRED, and Contractor for action, if it constitutes a failure to perform, as determined by the Government.

The Contractor shall have no more than one substantiated complaint for each period of performance.

2.9.6. Contractor personnel shall be required to observe Government facility parking, safety and traffic regulations that apply to all facility employees.

2.10. Safety. The Contractor shall ensure its personnel comply with all installation and MTF safety regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal. Copies of these regulations are on file may be obtained through the BMET. The BMET also reserves the right to direct cease and desist orders for any safety concerns.

2.10.1. The contract involves work associated with the following specific hazards: ionizing radiation, radioactive material, large static/dynamic magnetic fields, lasers, loud acoustic noises, radio-frequency radiation, electrical hazards, and cryogens. The Contractor is responsible for the safety of its personnel. The Contractor will ensure its personnel are adequately trained and equipped for these hazards. It is the responsibility of the Contractor to monitor its personnel for occupational radiation exposure and screen personnel for individual concerns that may affect their ability to perform duties safely (e.g. pregnancy, presence of medical implants that are unsafe in MRI environments).

2.10.2. The Contractor will ensure that its staff conduct operations in a matter that meets industry safety standards for the protection of DoD staff, patients, and public. The Contractor is responsible for unsafe conditions associated with the actions of its personnel.

2.10.3. For work involving radioactive material, the Contractor will comply with all applicable laws and regulations. Advance approval from the installation radiation safety officer is required prior to any work and conveyance of radioactive material on the installation. The Contractor is subject to non-personal services supervision by Government personnel when utilizing radioactive material. NOTE: Air Force installations are typically areas of exclusive federal jurisdiction and a NRC Form 241 will be required prior to bringing radioactive material operated under an agreement state license on to the installation. Obtaining this form requires advance coordination and a NRC filing fee.

2.10.4. The following individuals have the authority to direct cease and desist orders for safety concerns: DGMC MDTS/SGQX CC, FRED, Installation Radiation Safety Officers, Associate Radiation Safety Officers, Active Duty/GS medical physicists, MTF safety officers, bioenvironmental engineers, BMETs, radiologists, radiation oncologists, and Magnetic Resonance Safety Officers. Disruptions in work caused by safety concerns shall not relieve the Contractor of the contract requirements or incur additional expense to the Government.

2.10.5. The Contractor shall ensure its personnel comply with the local installation requirements for vehicle registration and operation on the military facility. Any vehicle operated by contract personnel on the military installation must have the minimum liability coverage required by the state in which the performance is located.

2.10.6. The Contractor shall ensure its personnel comply with installation and MTF personnel identification and access requirements. Facility access can typically be facilitated by MTF BMET or MDTS/SGQX personnel.

3.0. Contract Requirements.

3.1. Medical Support Services. The Contractor shall provide diagnostic medical physics support services consistent with the following:

3.1.1 Mandatory Medical Physics Support Services. The Contractor shall provide the following diagnostic medical physics services in support of DGMC located at Travis AFB, CA.

3.1.1.1. Medical physics equipment evaluations. This includes, but is not limited to, the evaluation of the following equipment types (i.e. modalities): radiographic systems (analog and direct digital), computed radiography scanners, computed tomography systems, dental systems (intraoral, pan/ceph, cone beam CT, etc.), fluoroscopy systems, mammography systems, MRI scanners, nuclear medicine systems (SPECT, PET, dose calibrator, etc.), DEXA, stereotactic breast biopsy systems, ultrasound systems, diagnostic reading workstations, acquisition workstation displays, and diagnostic imaging ancillary devices (view boxes, film printers, film scanners, etc.).

3.1.1.2. Radiation protection surveys (i.e. inspection for voids in lead shielding, leakage surveys, scatter surveys, etc.), shielding design calculations, and MRI safety surveys (i.e. magnetic fringe field surveys).

3.1.1.3. Medical physics site surveys, program/QC reviews, and meeting attendance required by regulation and/or accreditation.

3.1.1.4. Medical physics consultative support services that are not of an inherently governmental nature. NOTE: Fetal dose estimates, consultation on clinical decisions, and advisement on imaging protocol adjustment are examples of acceptable consultative support. Direct involvement in the creation of equipment acquisition contracts and policy making are not.

3.1.1.5. Support shall be provided, at no additional expense, within 30 calendar days of a routine request and within 14 calendar days of request for a device that cannot be used clinically.

Emergent requests can be made of the contractor for support within 72 hours at an additional expense if approved by the Contracting Officer (CO).

3.1.1.6. A list of initially anticipated support requirements can be found in Appendix A. This list can be used for creation of contract bids and as initial expectations for support. The list is not binding and is subject to change. Reasons for change include but are not limited to: equipment acquisitions/relocations/repairs/upgrades/disposal, changes in perceived need, scheduling concerns, inability of a Government agent to provide support, funding limitations, and consolidation of services.

3.1.2. Additional Medical Physics Support Services. Provision of other medical physics support services, can be provided on a case-by-case basis when mutually agreed upon by the Government and Contractor.

3.1.3. Medical Physics Support Service Requirements. Services provided by the Contractor shall comply with the following requirements.

3.1.3.1. Services shall be performed consistent with current Federal, DoD, DHA, AF, host state, Joint Commission (JC), American College of Radiology (ACR) and National Council of Radiation Protection & Measurement (NCRP) regulations/standards as applicable.

3.1.3.2. Equipment evaluations shall:

3.1.3.2.1 Assess the safety of the device, image quality, its ability to perform its clinical function, and the accuracy of reported radiation dose indices.

3.1.3.2.2. As applicable, include an assessment of the system’s quality control (QC) program.

3.1.3.2.3. For mammography, the evaluation shall meet ACR/MQSA standards. The supported MTF shall have discretion on whether to use the FDA approved, manufacturer quality control procedure or the ACR quality control procedure.

3.1.3.2.4. Follow ACR standards for CT, MRI, Nuclear Medicine, PET, US, and stereotactic breast biopsy. NOTE: This requirement applies for all systems regardless of whether they are accredited by the ACR.

3.1.3.2.5. For equipment modalities not addressed by paragraphs 3.1.3.2.3 or 3.1.3.2.4, the evaluation shall meet at least one of the following:

3.1.3.2.5.1. All recommendations from an applicable ACR-AAPM Technical Standard.

3.1.3.2.5.2. Future standards, as applicable/existent, that are either endorsed by the AFMPPMs or codified in DHA policy. NOTE: The DHA does not currently have technical standards for medical physics services. This is expected to change in the future.

3.1.3.2.5.3. Evaluation criteria and methodology that are approved, in advance and in writing, by either an AFMPPM or an AF active duty/civil service, board certified, medical physicist.

Submissions for consideration shall include a sample report, information on the assessment components (e.g. beam quality, artifact evaluation, inspection of posted signs, etc.), evaluation criteria (e.g. half value layer meeting FDA standards at 80 kVp, comparison to benchmark data, etc.), and a brief description on how the proposal varies from applicable industry standards (e.g.

AAPM guidance, manufacturer test recommendations, etc.). Recurrent submissions for approval on additional devices of the same make/model, to be evaluated in an identical manner, are not required. Approvals can be rescinded, however this will not require a reassessment of prior evaluation unless the evaluation did not meet applicable regulatory requirements or accreditation standards. If the evaluation failed to meet regulatory requirement or accreditation standards the evaluation shall be repeated in a compliant manner at no additional cost to the Government.

3.1.3.2.6. Initial Equipment Evaluations (i.e. Acceptance Test) shall meet the following additional requirements:

3.1.3.2.6.1. As applicable, a radiation protection survey or MRI safety survey shall be performed if one has not already been accomplished. NOTE: A survey may have already been included as a component of the system acquisition contract or performed by an agent of the Government.

3.1.3.2.6.2. The ability of the system to effectively communicate with the network (e.g. populate worklists, push images to the PACS), shall be assessed and documented.

3.1.3.2.6.3. The Contractor shall facilitate the development of a technologist quality assurance (QA) program. This includes obtaining, and documenting, baseline performance data and providing on-site training to technologists on how to perform QA procedures.

3.1.3.2.7. All existent MRI coils and US probes must be evaluated during an initial performance evaluation on a new MRI or US system. Subsequent system evaluations can be limited to coils/probes that are new, repaired, and clinically used. Exceptions must be specifically approved by the lead radiologist in charge of the pertinent department.

3.1.3.2.8. Evaluations prompted due to an equipment modification (i.e. repair, upgrade, relocation), when needed, may be limited in scope to that necessary for accessing compliance with potentially effected standards if doing so is legally permissible and does not violate applicable accreditation standards. However, evaluations that do not cover all components of a routine assessment cannot reset the evaluation cycle. The Contractor shall notify the DGMC MDTS/SGQX CC or COR, in advance, of any intent to perform a billable, limited scope, evaluation. The DGMC MDTS/SGQX CC may require a complete evaluation be conducted as a future cost saving measure.

3.1.3.2.9. Standard components of an evaluation that are not applicable on a specific device do not require evaluation. In such cases the non-applicability of the component must be clearly documented on the report.

3.1.3.2.10. Hybrid systems (e.g. PET/CT) shall have each of its components systems evaluated in a manner emulating a standard system to the extent that it is functionally capable. Additional, clinically relevant, standard evaluations unique to such hybrid systems shall also be evaluated.

(E.g. assessment of image co-registration).

3.1.3.2.11. For shielding design calculations the Contractor shall comply with UFC 4-510-01 and applicable industry standards (e.g. NCRP and AAPM reports). Reports for radiographic rooms and fluoroscopic rooms shall clearly annotate that UFC 4-510-01 requires at least 1/16” lead for room shielding. Standard calculations assumptions (e.g. occupancy factors) can only be used following a validation with the MTF that such factors are reasonable. The AF med physics program managers can mandate the use of non-standard calculation assumptions.

3.1.4. Medical Physics Surveyor Requirements

3.1.4.1. All work must be performed in accordance with current/applicable qualification requirements promulgated by the federal government, the Joint Commission, and the American College of Radiology (ACR). Additionally, all work shall be performed by a Qualified Medical Physicist (QMP) or by an individual under the general supervision of a QMP that signs the final report. Excepting mammography applications, a Qualified Medical Physicist is a person who is certified as a medical physicist by the American Board of Radiology, American Board of Medical Physics, or the Canadian College of Physicists in Medicine. For mammography applications a QMP is a person who meets MQSA and ACR qualification requirements for the make/model of device to be evaluated. The Air Force/Defense Health Agency may establish additional provisions for QMP status in the future. The Contractor must provide qualifications of a prospective QMP to the COR prior to their conducting any services in support of the Air Force. Updated qualifications shall be provided as appropriate and/or upon request. The DGMC MDTS/SGQX CC or FRED can deem an individual ineligible to provide support based on their qualifications or concerns with past performance.

3.1.4.2. Contractor represents and warrants that all personnel provided by Contractor to do work on DGMC equipment are legally eligible to work in the United States of America; and that Contractor complies with all applicable federal and state wage and employment laws, and with all other applicable laws and regulations pertaining to the services provided to the Government.

3.1.4.3. The Contractor shall not have any work performed by an individual with an undisclosed conflict of interest pertinent to the work at hand. (E.g., an individual with an interest in an equipment manufacturer should not be hired to conduct an initial acceptance test on a device made by that manufacturer or its competitor.) The Contractor can submit an individual for consideration for a specific task with an overt disclosure of a relevant conflict of interest to both the COR and CO. Both the CO and COR must approve of any such individuals.

3.1.5. Medical Physics Scheduling, Coordination, and Execution Requirements

3.1.5.1. Only the COR and DGMC MDTS/SGQX CC or FRED is authorized to request, schedule, or reschedule services. The DGMC MDTS/SGQX CC and COR can preauthorize defined quantities of support services in order to facilitate rapid task completion and DGMC convenience (e.g., preauthorize 10 fetal dose calculations, 5 hours consultative support, etc.).

No actions taken by any party without the approval of the Contracting Officer (CO) that can incur an additional expense under this contract.

3.1.5.2. The CO shall notify the contractor in the event of changes to the COR and DGMC MDTS/SGQX CC or FRED.

3.1.5.3. The Contractor, COR, and DGMC MDTS/SGQX CC or FRED shall have routine meetings in accordance with paragraph 2.3. During these meetings, projected requirements shall be discussed. Routine services shall be projected as far out as possible and scheduled no later than 30 days before the support date. The COR and DGMC MDTS/SGQX CC or FRED shall notify the POC as soon as possible following the identification of an unanticipated requirement requiring on-site support within the next 30 days.

3.1.5.4. The Contractor shall maintain a list of services provided, and services projected, under this contract. This list shall be provided to the COR and DGMC MDTS/SGQX CC or FRED prior to meetings and upon request.

3.1.5.5. For duties covered under paragraph 3.1.1, support shall be able to be provided, at no additional expense, within 30 calendar days of a routine request and within 14 calendar days of request for a device that cannot be used clinically. Emergent requests can be made of the contractor for support within 72 hours at an additional expense if approved by 60 CONS.

Support for duties covered under paragraph 3.1.2 have a support timeframe subject to case-by-case negotiation.

3.1.5.6. The Contractor may communicate directly with DGMC being supported. However, the Contractor will not commit to support a service requirement without the approval of the Contracting Officer 60 CONS. Work performed without approval of a Contracting Officer cannot lead to increased net costs under this contract.

3.1.5.7. The 60 CONS will provide the Contractor with COR information for at least one (1) individual at DGMC.

3.1.5.8. The Contractor will provide the CO, COR and DGMC MDTS/SGQX CC or FRED with information on the surveyor who will be providing support.

3.1.5.9. The COR and DGMC MDTS/SGQX CC or FRED will facilitate base access for the Contractor (contingent on the contract personnel meeting base access requirements), assist with logistics, and coordinate access to the equipment to be evaluated.

3.1.5.10. The supporting Contractor personnel has to be local within 300-mile radius.

3.1.5.10.1. The Contractor travel is not authorized.

3.1.5.11. The surveyor is required to check-in with the MTF POC upon arrival to the facility.

3.1.5.12. The surveyor shall comply with queries on evaluation methodology be subject to observation by DoD personnel during the performance of services.

3.1.5.13. The surveyor shall leave the job site in the same condition as found upon arrival.

3.1.6. Medical Physics Survey Documentation

3.1.6.1 Any significant safety concerns shall be communicated to the department and BMET immediately. Other deficiencies, or non-conformances discovered shall be verbally communicated to the department and BMET prior to the surveyor leaving the facility. An informal written report of pertinent findings, or lack of findings, shall be provided within 48 hours of departure from the facility. Formal reports with full details of services rendered shall be provided within 15 calendar days. Formal and informal reports shall be transmitted to a representative of the supported clinic, the facility Biomedical Engineering department, and DGMC MDTS/SGQX CC or FRED.

3.1.6.2. Formal reports for remote consultative services (e.g. skin dose estimates), shall be provided within 7 days of request.

3.1.6.3. Formal reports shall comply with the following:

3.1.6.3.1. The reports shall meet requirements from applicable regulatory and accreditation agencies. Reports shall meet industry professional standards.

3.1.6.3.2. Reports shall be typed, clearly worded, and submitted in electronic “pdf” format.

Signatures can be electronic or scanned “wet” signatures. The final document shall be legible.

3.1.6.3.3. Amended/revised reports shall indicate that they are amended, the context of the amendment, and the date of the original report.

3.1.6.3.4. Reports shall be devoid of any privacy act or HIPAA information. If a report pertains to a specific patient (e.g. a skin dose calculation) a military assigned identifier that cannot be publicly correlated to the patient is preferred. (E.g. the study accession number that prompted the assessment).

3.1.6.3.5. Reports for equipment evaluations shall include the following information on a summary page: System modality (e.g., CT scanner), Site visited, room identification, survey date, report date, system make/model, ECN number, surveyor name, QMP name (if different from surveyor), QMP signature, and survey purpose, (i.e. “evaluation following replacement of x-ray tube”). This summary shall also include an itemized listing of the component tests involved, the results of each component test, and narrative comments. Instances of non-applicability of a given standard component test shall be noted. The report shall also include make, model, serial number, and calibration date of pertinent test equipment (e.g., kVp meter).

Information on test equipment may be listed on the summary page.

3.1.6.3.6. Failures on a component test must be substantiated with a written finding. Findings identify a problem, imply correction is needed, and can be made regardless of whether they are directly attributable to a component test failure. Recommendations for improvement do not require the existence of a definitive problem. They also do not suggest that the action is necessary.

3.1.6.3.7. Findings must be accompanied with a clear explanation and explicitly associated with at least one of the following categories:

3.1.6.3.7.1. Category A: Violation of an applicable regulation or accreditation standard. For Category A violations, a reference to the regulation or standard shall be provided.

3.1.6.3.7.2. Category B: Comprises a significant safety hazard or clinical efficacy concern.

3.1.6.3.7.3. Category C: Comprises a minor safety hazard or clinical efficacy concern.

3.1.6.3.7.4. Category D: A discrepancy that does not pose any regulation, accreditation, safety, or clinical efficacy concerns.

3.1.6.3.8. The QMP shall align corrective action recommendations with the following guidance based on the finding categories in paragraph 3.1.6.3.7. (Note: More than one category may apply).

3.1.6.3.8.1. Category A: Identified discrepancies of applicable regulations or accreditation requirements shall be managed consistent with those requirements. Utilize corrective action timelines that are established in these standards. Use 30 days if the standard does not define a corrective action timeline.

3.1.6.3.8.2. Category B: Discrepancies deemed by a QMP to pose a significant safety hazard or significant compromise in clinical efficacy must be addressed before further use in an effected manner.

3.1.6.3.8.3. Category C: Discrepancies deemed by a QMP to pose a minor safety hazard or compromise in clinical efficacy must be addressed within 60 days.

3.1.6.3.8.4. Category D: Resolution of discrepancies deemed by a QMP to pose no regulation, accreditation, safety or clinical efficacy impact are at the discretion of the equipment owning organization.

3.1.6.3.9. The QMP may offer any recommendations for improvement they deem prudent.

However, they shall not mandate departments to modify programs in a manner inconsistent with Air Force standards/policies. Significant concerns with Air Force standards/policy shall be brought to the attention of the AFMPPM.

3.1.6.3.10. The Contractor shall provide timely responses to queries about the content of their reports at no additional charge.

3.1.6.3.11. The Government can require modifications to reports, at no additional expense, if it perceives the above criteria are not met. It can also require the inclusion/completion of additional documents in reports (Government developed report summaries, surveyor qualifications, etc.).

3.1.7. Medical Support Services Contract Expenses

3.1.7.1. Work performed without approval of the Contracting Officer, COR, and DGMC MDTS/SGQX CC or FRED cannot lead to increased costs to the Government.

3.1.7.2. The Contractor shall define a pricing model for submission with their contract bid that will be fixed for the duration of the contract. The pricing model may contain predefined option year price increases.

3.1.7.2.1. The pricing model shall accommodate all expenses that may arise in the fulfillment of services described in paragraph 3.1.1. The Government is not liable for any expenses associated with paragraph 3.1.1 services that are not consistent with the pricing model.

3.1.7.2.2. The Contractor, in their discretion, can define provisions in the pricing model that accommodate some, or all, expenses associated with the fulfillment of paragraph 3.1.2 duties.

Such provisions, if provided, will be binding if applicable paragraph 3.1.2 services are exercised unless mutually agreed upon by the contractor and 60 CONS, CO.

3.1.7.2.3. The pricing model shall accommodate any charges the contractor may levy from an extended support trip (e.g., overnight lodging, travel, incidentals, etc.).

3.1.7.2.4. Fees charged on a per unit time basis shall be able to be prorated to time increments of 15 minutes. Quick inquires (i.e. less than 15 minutes) shall be either free or billable at the 15 minute rate.

3.1.7.3. The Contractor shall support, at no additional charge, the following: efforts needed to coordinate required services, clarification requests on Contractor activities/reports, documentation requirements by regulatory and accreditation agencies (e.g., maintaining documentation of physicist credentials at mammography clinics), and inspector inquiries (FDA, Joint Commission, etc.).

3.1.7.4. The Government may discriminate between contract bids based on anticipated costs from the pricing model, the model’s simplicity, and its inherent flexibility.

3.1.7.5. Delays caused by Government will not be counted as contractor “down time” for the purpose of this contract.

3.1.8. Medical Support Services Applicable Forms and Publications: Publications documents and forms applicable to this PWS are listed below. The Contractor shall use reasonable efforts to comply with these directives. Supplements or amendments may be issued during the life of the contract and will be considered to be in full force and effective immediately upon receipt by the Contractor. If compliance with such supplements and amendments changes the contract cost, scope or purpose, it shall be a change within the meaning of the “Changes” clauses of the contract.

AFMAN 40-201: Radioactive Materials (RAM) Management AFMAN 48-148: Ionizing Radiation Protection DHA AI 087: Radiation Safety Program (RSP) and Radiation Safety Committee (RSC) DHA AI 108: Non-Ionizing Radiation Safety

3.2. Security Requirements.

3.2.1. Security Clearance Requirements. The Contractor personnel shall have a Tier 1 (NACI) investigative clearance/background investigation prior to performing work on this contract. The Contractor shall request personnel security clearances at the company’s expense.

The Contractor shall provide documentation received from the appropriate Government agency as to the verification of contract personnel’s Tier 1 certification. Due to costs involved with security investigations, requests for personnel security clearances shall be kept to the minimum required to perform contract requirements.

3.2.2. List of Contractor Personnel: The Contractor shall maintain a current listing of Contractor personnel. The list shall include Contractor personnel’s name, social security number, and level of security clearance. The list shall be validated and signed by the company Radiation Safety Committee (FSO) and provided to the COR and DGMC MDTS/SGQX CC or FRED prior to performance on this contract. Updated listings of contract personnel shall be provided upon request and prior to any previously unlisted Contractor personnel performing services for the Government.

3.2.3. Local Area Network (LAN). All Contractor employees requiring access to the Government unclassified computer network shall have a valid Tier 1 investigation verified through the Joint Personnel Adjudication System (JPAS). No Contractor employee will be provided access to unclassified computer network or its inherent capabilities (i.e., internet access, electronic mail, file and print services) without a valid Tier 1 investigation. The Contractor shall be aware of and abide by all Government regulations concerning the authorized use of the Government’s computer network including the restriction against using the network to recruit Government personnel or advertise job openings.

3.2.4. Disclosure of Information. In the performance of this contract, the Contractor may have access to data and information proprietary to a Government agency or to another Government Contractor, or of such nature that its dissemination or use, other than as specified in this contract, would be illegal or otherwise adverse to the interests of the Government or others. The Contractor and its personnel shall not divulge, or release data or information developed or obtained under performance of this contract, except as authorized by Government personnel or upon written approval of the CO. The Contractor and its Contractor personnel shall not use, disclose, or reproduce proprietary information bearing a restrictive legend, other than as specified in the contract.

3.2.5. Non-Disclosure Agreement (NDA). All Contractor employees shall sign the non-disclosure statement provided as an attachment prior to beginning of contract performance. The Contractor must then provide a copy of the signed/dated NDA to the COR prior to beginning work.

3.3. Manpower Reporting Requirements. N/A.

3.4. Quality Control Plan (QCP). N/A.

3.5. Post-Award Meeting. The Government will host a post-award meeting with the Contractor within ten (10) business days after contract award. The CO shall contact the COR, DGMC MDTS/SGQX CC or FRED and the Contractor to schedule this meeting. A teleconference is permissible for the post-award meeting. The purpose of the post-award meeting is to introduce the Contractor to the Government representatives (60 CONS/COR) and go over the contract.

Takeaways from the meeting should be an exchange of contact information; a timeline of when direct support will start, if not yet started; and an understanding by all parties of all the requirements to be performed by the Contractor and the support the Government will provide the Contractor to perform the requirements, safely and efficiently.

4.0 Performance Objectives.

4.1 Services Summary.

4.1.1. Performance Requirements Summary (PRS)

Performance Objective (General)

SOW

Paragraph Performance Measure

Method of Surveillance

1. Provide quality service

3.1

No more than three (3) validated customer complaint/Corrective Action Report received annually or no more than three (3) substantiated negative feedbacks in a six month period.

Valid Customer Complaint in accordance with 6.3.2 of the QASP.

Customer Feedback in accordance with

6.3.4 of the QASP.

2. Provide timely response to contract emergencies

Respond to COR within 24 hours of the COR validated emergency, 100% of the time.

Valid Customer Complaint in accordance with 6.3.2 of the QASP.

Customer Feedback

3. Provide timely and accurate reporting to the Government

Accomplish timely reporting 100% of the time per occurrence with no more than 2 errors per occurrence.

No more than three (3) validated customer complaint/Corrective Action Report received annually, or No more than three (3) substantiated negative feedbacks in a six-month period.

Valid Customer Complaint in accordance with 6.3.2 of the QASP.

Customer Feedback

4. Submit travel vouchers with invoices and any trip reports to the COR

3.1.5

No later than five (5) business days after the trip.

100% Inspection in accordance with 6.3.1 of the QASP.

Valid Customer Complaint in accordance with 6.3.2 of the QASP.

Customer Feedback

4.1.2. Inspection and Acceptance: The inspection and acceptance point for all services rendered under this contract will be by the designated BMET. The performance by the Contractor technician, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the BMET, DGMC MDTS/SGQX CC or FRED, or designated representative.

Other performance evaluation factors will be monitored that are not quantified by numerical measurements to include Contractor technician relationship with hospital staff/Government and contracting personnel as well as overall compliance with hospital policy and procedures.

4.1.3. Reports. See paragraph 3.1.5. and 3.1.6.

5.0. Government/Contractor Furnished Property.

5.1. Government. The Government will provide the following for the performance of tasks stipulated in this contract.

5.1.1. The Government will provide the Contractor access to the equipment subject to contract support services.

5.1.2. The Government will provide a Biomedical Equipment representative to provide access and assist in operating the equipment being tested and surveyed as well as performance monitoring, on-site review and other assistance as needed.

5.1.3. The Government will provide the necessary workspace for the Contractor to include access to fax machines, printers, and lighting that as needed.

5.1.4. The Government will provide radiopharmaceutical doses in reasonable quantities/types as needed for the evaluation of Nuclear Medicine systems per industry standards and as requested by the Contractor. This provision will be restricted to the limitations of the MTF’s DHA Radioactive Materials Authorization. The Contractor may be required to cover the costs of excessive radiopharmaceuticals if atypical quantities/types are required, or material is wasted.

(NOTE: Radiopharmaceuticals are subject to rapid decay. In some cases, purchased material may be unusable in a matter of hours. Last minute changes in schedule can lead to wasted radioactive material.)

5.1.5. Government provided assets are incidental to the place of performance and remain accountable to the Government. All Government assets used by the Contractor will remain the property of the Government and the Contractor shall return them upon the request or at the end of the contract period of performance (whichever is sooner).

5.2. Contractor.

5.2.1. The Contractor shall provide each employee an identification badge which shall be always displayed on their outer garment when responding to a service call at the MTF. The badge shall include, as a minimum, the employee’s name, current picture, the Contractor’s name, and title identification.

5.2.2. All materials, test equipment, and phantoms necessary for testing, other than those materials specified as Government furnished, required in the performance of this contract shall be furnished by the Contractor or the Contractor employee.

5.2.3. The Government will not be responsible for any damage to or loss of Contractor supplies, materials, or equipment nor is the Government responsible for any damage to or loss of the Contractor employees’ personal belongings, due to fire, theft, accidents or any other causes.

5.2.4. The Contractor shall report immediately to the Primary Point of Contact or the Chief of Equipment Management Branch, all accidents which may arise out of or in connection with the performance of services required within the scope of this contract.

5.2.5. Upon request, the Contractor employee will provide calibration certification documentation of test equipment used.

6.0. DELIVERABLES

6.1. The Contractor shall submit all deliverables as specified in the PWS.

6.2. All deliverables must be submitted electronically to the COR(s) and DGMC MDTS/ SGQX CC or FRED

6.3. The 60 CONS/COR may approve extensions to the delivery timeline based on magnitude and complexity of the document topic.

6.4. Provide informal reports by e-mail as requested by the COR and DGMC MDTS/SGQX CC or FRED.

Appendix A - Anticipate Support Requirements

Installation

Organization