Performance Work Statement_W81K0224Q0080.pdf

PERFORMANCE WORK STATEMENT

HOLOGIC 3D MAMMOGRAPHY SYSTEM

MADIGAN ARMY MEDICAL CENTER

TACOMA, WASHINGTON 98431

TABLE OF CONTENTS

SECTION TITLE

1.0 INTRODUCTION

2.0 BACKGROUND

3.0 SCOPE OF WORK

4.0 QUALITY MANAGEMENT

5.0 REQUIRED SERVICES

6.0 APPLICABLE TECHNICAL ORDERS, SPECS, REGULATIONS, AND MANUALS

7.0 ACRONYMS AND DEFINITIONS

1.0. INTRODUCTION

1.1. The Contractor shall provide the non-personal maintenance and repair services of the Government-owned Hologic 3D Mammography System and components for Madigan Army Medical Center (MAMC) which shall contribute to a stable workforce tasked with providing quality healthcare services to a diverse beneficiary population.

1.2. All services shall be provided in accordance with established standards, principles and ethics of the profession and applicable professional specialty organizations, The Joint Commission (JC) standards, applicable Department of Defense (DoD) and Army specific regulations, directives, and policies, and Military Treatment Facilities (MTF) specific policies, procedures, and job descriptions.

1.3. This contract is a non-personal services contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.0. BACKGROUND

2.1. The mission of the Military Healthcare System (MHS) is to ensure the nation has an available healthy military force supported by a combat ready healthcare system. Healthcare services for eligible MHS beneficiaries are provided at MTFs located on or near military installations or posts. The MTF may be a clinic, hospital, or medical center. Clinics are outpatient facilities offering primary care or simple specialty care (routine exams, tests, treatments). The clinic may be a stand-alone site or a satellite of a larger clinic, hospital, or medical center. Army Community Hospitals (ACH) offer more complex, resource-intensive secondary care (e.g., inpatient care, surgery under anesthesia) and primary care at outpatient clinics inside and outside the hospital. Army Medical Centers (MEDCENs) offer tertiary (sophisticated diagnosis/treatment of any ailment), secondary, and primary care, hospital services, preventive services, blood bank, and other services. In addition, all MEDCENs offer graduate medical education programs for physicians.

Madigan Army Medical Center comprises a network of Army medical facilities located in Washington and California that serve more than 100,000 active-duty service members, their families, and retirees. To accomplish this mission, Madigan uses three (3) Radiographic System, Digital, Mammographic units. These units require periodic preventative maintenance, calibration, repair, etc. To have units calibrated correctly they must be serviced by an approved service provider.

3.0. SCOPE OF WORK

3.1. The Contractor shall provide Original Equipment Manufacturer (OEM) fully certified/qualified technicians to perform the maintenance and repair services for the Hologic 3D Mammography System and components as described herein, to ensure that optimum operation and efficiency of the equipment is maintained, and that proper functioning of the equipment conforms to the OEM standard specifications. Contractor shall have knowledge of, furnish and install all OEM sponsored modifications at no additional charge. Additionally, the Contractor shall have access to all required OEM tools, technical repair or service manuals, software, firmware, and any other required parts or proprietary knowledge that would be reasonably necessary to perform through the life of this contract. This includes all the OEM published Equipment Changed Orders (ECO) and Fielded Change Orders (FCO). Mandatory modifications include equipment upgrades or enhancements to equipment design and changes necessary for operator and patient safety.

In addition, the Government may request the Contractor to install OEM sponsored modification if the Government obtained knowledge of the ECO or FCO before the Contractor. The Contractor will make all ECO and FCO modifications in a timely manner, but in no case shall it exceed sixty (60) calendar days after ECO or FCO is announced by the OEM. All such modifications shall be made so as not to interfere with the Government’s operation. If such modification is not possible during normal duty hours, the Contractor will do the modifications outside of normal duty hours (overtime) at no additional cost the Government.

3.2. EQUIPMENT LISTING

Nomenclature ECN S/N *Location

Radiographic System, Digital, Mammographic 125696 3DM160101483 Radiology Mammography Radiographic System, Digital, Mammographic 126221 3DM160101526 Radiology Mammography Radiographic System, Digital, Mammographic 134480 SDM131901821 Radiology Mammography Brevera Breast Biopsy System 147378 BVA01240 Radiology Mammography Affirm Breast Biopsy System N/A 82008224659 Radiology Mammography

*Location: Madigan Army Medical Center (MAMC), Joint Base Lewis-McChord (JBLM)

3.2.1. Points of Contact: At the time of award, the Contractor shall provide a single point of contact, for all work under this contract, to the Contracting Officer and Contracting Officer’s Representative.

Government Point of Contact:

Contracting Officer’s Representative (COR)

a. NAME: Cheng Liu

b. EMAIL: cheng.liu4.civ@health.mil

c. TITLE: COR

d. TELEPHONE: 253-968-5985

3.3. ADMINISTRATIVE

3.3.1. Contractor Representative. The Contractor shall designate, in writing, a primary point of contact for contract coordination and implementation not later than five (5) business days after receiving notice of contract award.

Changes in the primary point of contact (POC), at any time, shall require the Contractor to notify the Contracting Officer (KO) and COR of the new representative at least five (5) working days prior to the change. This notification shall be in writing and shall state the name and contact information for the new point of contact.

3.3.2. The Contracting Officer’s Representative (COR). The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor Contractor's performance and notifies both the KO and Contractor of any deficiencies;

coordinate availability of Government furnished property, and provide site entry of Contractor personnel.

The COR is NOT authorized to change any of the terms and conditions of this contract. Only the warranted Contracting Officer is authorized to make modifications/changes to the terms and conditions of this contract. If the Contractor believes any Government personnel has effectively issued a change resulting in a change in effort and price/cost of the contract, the Contractor shall immediately notify the KO in writing.

3.4. CONFLICT OF INTEREST

3.4.1. The Contractor or contract personnel shall not bill the patient for services rendered under this contract. The Contractor or contract personnel shall not request or accept compensation of any kind for patients treated, procedures performed, or any other actions performed, except under the terms and conditions of this contract, at the rate specified.

3.4.2. The Contractor or contract personnel shall not, while performing services under this contract, advise, recommend, or suggest to persons eligible to receive medical care at Government expense that such persons should receive care from the Contractor, contract personnel or from any third party at any place other than as designated under this contract.

3.4.3. Confidentiality of Information. Unless otherwise specified, all financial, statistical, personnel, and/or technical data, which is furnished, produced or otherwise available to the Contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of healthcare services under this contract. The Contractor shall not release any of the above information without prior written consent of the KO. The Contractor/contract personnel shall not use patient care rendered pursuant to this contract as part of a study, research project, or publication. The contract personnel shall prepare medical records, forms and documents as required, in accordance with the regulations and established guidelines listed in the contract.

3.4.4. The Contractor shall abide by Federal employment statutes and the Federal ethics regulations in the selection and hiring of contractor personnel.

3.5. AT/OPSEC REQUIREMENTS

3.5.1. AT Level I Training. This standard language is for contractor employees with an area of performance within a DHA-controlled installation, facility, or area. All contractor employees, including subcontractor employees, requiring access to DHHQ, Direct Reporting Markets (MTFs), Small Markets and Stand Alone (SSO) facilities and controlled access areas, shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable and annually thereafter. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the Contracting Officer, if a COR is not assigned, within 05 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

3.5.2. Access and General Protection/Security Policy and Procedures. This standard language is for contractor employees with an area of performance within a DHA controlled installation, facility, or area. Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, DHHQ and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

3.5.3. For contractors that do not require CAC but require access to a DoD facility or installation. Contractor and all http://jko.jten.mil/ associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by Government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

3.5.4. iWATCH/Suspicious Activity Reporting Training. This standard language is for contractor employees with an area of performance within a DHA-controlled installation, facility, or area. The Contractor and all associated subcontractors shall brief all employees on the local Suspicious Activity Training program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 05 calendar days of new employees commencing performance, with the results reported to the COR NLT 30 calendar days after contract award.

3.5.5. For contracts that require OPSEC Training. Per DHA-AI 5200.03, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

4.0. QUALITY MANAGEMENT

4.1. The Contractor shall have a planned and systematic quality management process for monitoring and analyzing its contract performance.

4.2. The Contractor shall ensure that all contract employees comply with the MTF quality management/process improvement activities.

4.3. PERFORMANCE REQUIREMENTS SUMMARY

4.3.1. Inspection. The inspection and acceptance point for all services rendered under this contract will be the COR.

The performance by the contract personnel, 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 KO or COR. Any services rendered by the contract personnel to patients or interaction with military/civilian personnel deemed unprofessional, threatening, or dangerous by the KO will be grounds for immediate termination for default or cause. Quality Assurance procedures established by the MTF shall be used for continuous monitoring.

Other performance evaluation factors will be monitored that are not quantified by numerical measurements which include: Contractor providing personnel not meeting the minimum qualification standards; inappropriate prescriptions; patient customer service comments; Contractor relationship with hospital staff/Government contracting personnel; compliance with hospital healthcare policies and procedures.

5.0. REQUIRED SERVICES. Maintenance and Repair service for Hologic 3D Mammography System and components.

5.1. REPORTS. Submit all required reports to the Contracting Officer’s Representative.

5.2. QUALIFICATIONS

5.2.1. The Contractor shall ensure that all contract personnel providing services under this contract shall be able to read, write, and speak English well enough to effectively communicate with all parties and other health care providers.

5.2.2. The contract personnel shall have the required education, training, experience and documented current competence in the required specialty position description.

5.3. SPECIFIC DUTIES/TASKS

5.3.1. Contractor Furnished Equipment/Materials: The Contractor shall provide any technical manuals, special tools, supplies, parts, or test equipment that are required for the servicing of the Hologic 3D Mammography System and components. Upon request by the Healthcare Technology Management Sustainment (HTM-S), the Contractor shall provide service report for the maintenance services during the period of performance (POP) and it will be considered as downtime without service report to Healthcare Technology Management Sustainment (HTMS).

5.3.2. Maintenance Services/Repairs: The Contractor shall keep the system in good operating condition, meeting all published equipment requirements and standard specification listed by the OEM. The services include moving, reinstalling and certifications. Upon request by COR, the Contractor shall provide proof of services on equipment during services performed. The service contract will include inspection, mandatory/collective updates/upgrades of software and hardware (including OEM sponsored software modifications for installation), on-site emergency labor, comprehensive parts coverage, and 98% uptime guarantee.

5.3.3. Preventive Maintenance (PM): One (1) periodic PM service shall be performed during each period of performance of the contract on each item listed in Paragraph 3.2. PM services shall include scheduled maintenance, inspections, replacement of defective and worn parts, and testing service in accordance with OEM specifications.

Services during the time frame will include one (1) electrical safety test to determine the power cord resistance and current leakage (or touch current) are within safe operating limits. All services performed will be documented and indicated on the service report. The service reports will be given to the COR for verification of Contractor’s performance and approval of payment. Proper corrective maintenance service will be provided when it is needed during the services.

5.3.4. Calibration Service (Cal): One (1) periodic Calibration Verification Check (CVC) will be performed for each contract period for each item listed in Paragraph 3.2. The Contractor shall comply with the manufacturer’s specified frequency, duration and calibration procedures for the equipment listed above.

5.3.5. The Contractor shall provide unlimited on-call technical support during standard hours of operation, 0800 – 1700 PST, Monday through Friday, when notified by the COR of equipment malfunction. Minimum standard response time is established as no later than the following workday after notification of equipment malfunction.

During each service call, the Contractor shall take all steps to restore the equipment to proper operating conditions and replace components and parts determined by the Contractor’s technician to be defective.

5.3.6. All repairs shall be completed in a minimum amount of time, but not to exceed two (2) working days. All maintenance actions that exceed two (2) working days shall be reported to the COR, and the Contractor’s technician shall provide a report that includes as a minimum the explanation for any maintenance delays and the estimated time to complete the repair.

5.3.7. Repairs required outside the scope of this contract are not authorized. Should acquisition of such services be deemed necessary by the Chief, Healthcare Technology Management Sustainment (HTM-S), a requisition shall be submitted to the KO for negotiation under a separate contract.

6.0. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS

Following is a list of basic publications applicable to this performance-based statement of work. The Contractor is obligated to follow these publications.

Applicable Publications

Public Law:

Public Law 91-596 Occupational Safety and Health Act of 1970 Public Law 104-191 Health Insurance Portability and Accountability Act of 1996

Accreditation Manuals:

The Joint Commission (TJC) Manual (Current Edition)

Defense Health Agency:

DHA-AI 001 Telework Program DHA-AI 003 Physical Security Program DHA-AI 034 Drug-Free Workplace Program DHA-AI 050 Accounting of Disclosures of Personally Identifiable Information (PII) and Protected Health

Information (PHI) DHA-AI 5015.01 Records Management DHA-AI 5200.02 Information Security Program DHA-AI 5200.03 Operations Security (OPSEC) Program

DHA-AI

DHAPI 6000.03 Life Support Training Certification Requirements and Guidance DHAPI 6010.02 MHS Prescription Drug Monitoring Program DHAPI 6015.02 Beneficiary Counseling and Assistance Coordinator (BCAC) and Debt Collection Assistance

Officer (DCAO) DHAPI 6025.04 Pain Management and Opioid Safety in the MHS DHAPI 6025.06 Standardized Templates for Primary Care Clinical Encounter Documentation DHAPI 6025.10 Standard Processes, Guidelines, and Responsibilities of the DoD Patient Bill of Rights and

Responsibilities in the Military Health System (MHS) Military Medical Treatment Facilities (MTFs)

DHAPI 6025.20 Medical Management (MM) Program within the Military Health System (MHS) DHAPI 6025.26 Standard Processes for the Military Health System (MHS) Nurse Advice Line (NAL) DHAPI 6025.27 Integration of Primary Care Behavioral Health (PCBH) Services into Patient-Centered Medical

Home (PCMH) and Other Primary Care Service Settings within the Military Health System

(MHS)

DHAPI 6025.28 Standard Processes and Procedures for Communication of Laboratory and Radiology Results DHAPI 6025.29 Provision of Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP) for Persons at High Risk of Acquiring HIV Infection DHAPI 6025.33 Acupuncture Practice in Military Treatment Facilities DHAPI 6025.39 Medical Ethics in the Military Health System DHAPI 6025.42 Routine Adult Transthoracic Echocardiogram (TTE) Standards for all Military Medical Treatment

Facilities (MTFs) DHAPI 6040.07 Medical Coding of the DOD Health Record DHAPI 6401.01 Dental Sedation Medical Management DHAPI 6490.02 Behavioral Health (BH) Treatment and Outcomes Monitoring DHAPM 6025.01 Primary Care Behavioral Health (PCBH) Standards DHAPM 6025.13, Volumes 1-7 Clinical Quality Management in the Military Health System

Department of Defense (DoD):

DoD 5200.1-R Information Security Program DoD 5200.2 Personnel Security Program DoDI 5200.46 DoD Investigative and Adjudicative Guidance for Issuing the Common Access Card DoD 5210.42-R Nuclear Weapons Personnel Reliability Program (PRP) Regulation DoD 5400.7-R DoD Freedom of Information Act DoD 5400.11-R Department of Defense Privacy Program DoD 6010.13-M Medical Expense and Performance reporting System for Fixed Military Medical And Dental

Treatment Facilities Manual DoD 6010.15-M Military Treatment Facility Uniform Business Office (UBO) Manual DoD 6015.1-M Glossary of Healthcare Terminology DoD 6025.18-R DoD Health Information Privacy Regulation DoD 6055.5-M Occupational Medical Examinations and Surveillance Manual DoD 8580.02-R HIPAA Security Rule DoDD 5144.02 Information Technology Standards in the DoD DoDD 5205.2 DoD Operations Security (OPSEC) Program DoDD 5400.11 DoD Privacy Program

DoDD 5500.07 Standards of Conduct DoDD 6000.14 Patient Bill of Rights and Responsibilities in the Military Health System (MHS) DODM 6025.13 Medical Quality Assurance (MQA) in the Military Health System (MHS) DoDD 6040.41 Medical Records Retention and Coding at Military Treatment Facilities DoDD 6205.02E Policy and Program for Immunizations to Protect the Health of Service Members and Military

Beneficiaries DoDD 8190.3 Smart Card Technology DoDD 8500.01E Information Assurance DoDI 1100.22 Policy and Procedures for Determining Workforce Mix DoDI 1402.5 Criminal History Background Checks on Individuals in Child Care Services DoDI 3020.37 Continuation of Essential DoD Contractor Services During a Crises DoDI 5200.02 DoD Personnel Security Program (PSP) DoDI 6000.11 Patient Movement DoDI 6015.23 Delivery of Healthcare at Military Treatment Facilities: Foreign Service Care; Third Party

Collection; Beneficiary Counseling and Assistance Coordinators (BCACs) DoDI 6025.8 Ambulatory Procedure Visit (APV) DoDI 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health

System DoDM 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health

System (MHS) DoDI 6025.18 Privacy of Individual Identifiable Health Information in DoD Health Care Programs DoDI 6040.40 Military Health System Data Quality Management Control Procedures DoDI 6040.42 Medical Encounter and Coding at Military Treatment Facilities DoDI 6040.43 Custody and Control of Outpatient Medical Records DoDI 6205.2 Immunization Requirements DoDD 6459.01 Sexual Assault and Response (SAPR) Program

(END OF PERFORMANCE WORK STATEMENT)