PWS_(updated)_5Aug19.DOCX

PERFORMANCE WORK STATEMENT

Maintenance of DXH 600 Hematology Analyzer Irwin Army Community Hospital Fort Riley, Kansas

PART 1

GENERAL INFORMATION

1. General: This is a non-personal services contract to provide a Total Service Agreement for the Hematology Analyzer, SN: AY19721. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1. RESERVED

1.2. Period of Performance: The period of performance shall be for one (1) Base Year of 12-months.

1.3. Administrative Information

1.3.1. Quality Control: Quality Control is the responsibility of the Contractor. The Contractor is responsible for the delivery of quality services/supplies to the Government. A formal Quality Control Plan (QCP) is not required for this commercial service. However, the Contractor shall maintain an inspection system commensurate with commercial practices to ensure the Contractor only tenders for acceptance those items or services that conform to the requirements of this contract.

1.3.2. Quality Assurance: The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. Non-conforming services shall be re-performed at no increase in contract price. If non-conforming services are recurring, cannot be re-performed, or the services fail to achieve the Performance Requirements Summary (PRS), the Government may reject the nonconforming service(s) and document the Contractor’s performance record accordingly. The Government may also issue a Contract Discrepancy Report (CDR) in which the Contractor will be required to respond with the development of a corrective action plan (CAP), which identifies the root cause, corrective action (CA) for the root cause, CA for the specific nonconformance, and the date the CAs will be complete.

1.3.2.1. Non-conforming Supplies or Services: When a Contractor’s performance does not meet contract requirements and/or approved work schedules and/or timeframes, it is considered non-conformance. Non-conformance shall be classified in one of three categories: level I (Minor), level II (Major) or level III (Critical). The Government may re-inspect work designated for re-performance or late performance.

1.3.2.1.1. Level I (Minor) non-conformance: is defined as a non-conformance that is not likely to materially reduce the usability of the supplies or services for their intended purpose, or is a departure from established standards having little bearing on the effective use or operation of the supplies or services. Minor non-conformance usually can be corrected on the spot, where no further corrective action (CA) response is necessary, and can be issued by the Government Representative to the Contractor either through a verbal or written non-conformance report. Minor non-conforming services shall be re-performed within a specified time frame at no increase in contract price. If minor non-conformances are recurring or re-performance is not completed in full and within the specified time a Level II non-conformance may be issued to the contractor by the Contracting Officer.

1.3.2.1.2. Level II (Major) non-conformance: is defined as a non-conformance, other than critical, that is likely to result in failure of the supplies or services, or to materially reduce the usability of the supplies or services for their intended purpose. Recurring Minor non-conformances, or a non-responsive Contractor, indicating a trend or failure of the Contractor’s quality control, can also be classified as a Major non-conformance. Major non-conformance’s shall result in the issuance of a written CDR from the Contracting Officer to the contractor requiring the development of a CAP by the Contractor, which identifies the root cause, CA for the root cause, CA for the specific non-conformance and the date CAs will be completed.

1.3.2.1.3. Level III (Critical) non-conformance: is defined as a non-conformance that is likely to result in hazardous or unsafe conditions for individuals using, maintaining, or depending upon the supplies or services; is likely to prevent performance of a vital agency mission; is for a repeated or uncorrected level II CDRs; or is for a non-responsive contractor to a level II CDR. Critical non-conformances shall result in the issuance of a written CDR to the Contractor requiring the development of a CAP by the Contractor, which identifies the root cause, CA for the root cause, CA for the specific non-conformance and the date CAs will be completed.

1.3.2.1.4. Inspection Results: The Contractor will be notified of Government inspection results. The Contractor shall acknowledge receipt of the inspection results. The Contractor may be notified of inspection results verbally. Verbal notifications of defective work will be confirmed in writing. When Government inspectors are unable to contact the Contractor to notify the Contractor of inspection results, acceptance or rejection of work will be made on the basis of the initial inspection.

1.3.3. Customer Complaints: Complaints will be validated by the Government Representative and be reported in writing to the Contracting Officer and the 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.

1.3.4. Federal Government Holidays: The Contractor is not required to perform services on the following Federal Holidays.

Note: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a contract employee is scheduled to work is closed due to a holiday declared by an Executive Order and the employee is not required to report in, payment will not be made for those hours. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

1.3.5. Hours of Operation: The Contractor is responsible for conducting business, between the hours of 7:30am through 4:30pm. Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.3.6. Place of Performance: The work to be performed under this contract will be performed at Irwin Army Community Hospital 650 Huebner Rd. Fort Riley, KS.

1.3.7. Persons: Authorized to Make Calls. Only those people listed below and the Contracting Officer are authorized to give the Contractor instructions, place service calls, or request updates status. The Government representative will call and leave their name and number. The Contractor will return the call or come directly to the Clinical Engineering Branch to verify instructions prior to initiating any action.

1.3.8. Supervision of Contractor Employees: The Government will not exercise any supervision or control over Contractor or subcontractor employees while performing work under the contract. Such employees shall be accountable solely to the Contractor, not the Government. The Contractor, in turn, shall be accountable to the Government for Contractor or subcontractor employees.

PART 2

SECURITY POLICIES AND REQUIREMENTS

2.1. Access to Military Installation:

2.1.1. Vehicle Registration: 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.

2.1.2. Contractor Identification: The Contractor shall ensure its personnel comply with installation and MTF personnel identification and access requirements. The Contractor is responsible for absences due to expired identification and access documents.

2.1.2.1. When responding to a service call at Irwin Army Community Hospital, the Contractor shall provide each employee an identification badge which shall be displayed on their outer garment at all times. The badge shall include, at a minimum, the employees name, current picture, the Contractor’s name, and title.

2.1.2.2. Onsite Contractor service technician shall report to Irwin Army Community Hospital’s Clinical Engineering Branch to sign in and receive temporary badge before performing any services.

2.2. Antiterrorism (AT) and Operations Security (OPSEC)

2.2.1. AT Level I training. All Contractor employees, to include subcontractor employees, requiring access Army installations, 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. 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.

2.2.2. Access and general protection/security policy procedures. Contractor and all associated sub-contractor’s employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes.

2.2.3. For Contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub‐contractors employees 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 (provided by Government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

2.2.4. iWATCH Training. The Contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the Government Representative. 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 Government Representative NLT 30 calendar days after contract award.

2.2.5. For contracts that require a formal OPSEC program. The Contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it and why it needs to be protected. The Contractor shall implement OPSEC measures as ordered by the Commander. In addition, the Contractor shall have an identified certified Level II OPSEC coordinator per AR 530-1.

2.2.6. Identification of Contractor Employees: When responding to a service call at Irwin Army Community Hospital the Contractor shall provide each employee an identification badge, which shall be displayed on their outer garment at all times. The badge shall include, at a minimum, the employees name, current picture, the Contractor’s name, and title.

2.2.7. Threat Awareness Reporting Program. For all Contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting (TARP), Contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b of AR 381-12.

2.3. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) NON-DEFENSE HEALTH AGENCY (NON-DHA) BUSINESS ASSOCIATE AGREEMENT (BAA) (7 JULY 2014)

In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003, this document serves as a BAA between the signatory parties for purposes of the HIPAA and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

(a) Catchall Definition. Except as provided otherwise in this BAA, the following terms used in this BAA shall have the same meaning as those terms in the DoD HIPAA Rules: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

—Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

—Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of Business Associate signatory to this BAA].

—Agreement means this BAA together with the documents and/or other arrangements under which the Business Associate signatory performs services involving access to PHI on behalf of the MHS component signatory to this BAA.

—Covered Entity shall generally have the same meaning as the term “covered entity” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of MHS component signatory to this BAA].

—DHA Privacy Office means the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Director is the HIPAA Privacy and Security Officer for DHA, including the National Capital Region Medical Directorate (NCRMD).

—DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoD 6025.18-R (2003), DoDI 6025.18 (2009), and DoD 8580.02-R (2007).

—DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD 5400.11 (2007) and DoD 5400.11-R (2007).

—HHS Breach means a breach that satisfies the HIPAA Breach Rule definition of breach in 45 CFR 164.402.

—HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 CFR Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules, implementing the “HITECH Act” provisions of Pub. L. 111-5. See 78 FR 5566-5702 (Jan. 25, 2013) (with corrections at 78 FR 32464 (June 7, 2013)). Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

—Service-Level Privacy Office means one or more offices within the military services (Army, Navy, or Air Force) with oversight authority over Privacy Act and HIPAA privacy compliance.

I. Obligations and Activities of Business Associate

(a) The Business Associate shall not use or disclose PHI other than as permitted or required by the Agreement or as required by law.

(b) The Business Associate shall use appropriate safeguards, and comply with the DoD HIPAA Rules with respect to electronic PHI, to prevent use or disclosure of PHI other than as provided for by the Agreement.

(c) The Business Associate shall report to Covered Entity any Breach of which it becomes aware, and shall proceed with breach response steps as required by Part V of this BAA. With respect to electronic PHI, the Business Associate shall also respond to any security incident of which it becomes aware in accordance with any Information Assurance provisions of the Agreement. If at any point the Business Associate becomes aware that a security incident involves a Breach, the Business Associate shall immediately initiate breach response as required by part V of this BAA.

(d) In accordance with 45 CFR 164.502(e)(1)(ii)) and 164.308(b)(2), respectively), as applicable, the Business Associate shall ensure that any subcontractors that create, receive, maintain, or transmit PHI on behalf of the Business Associate agree to the same restrictions, conditions, and requirements that apply to the Business Associate with respect to such PHI.

(e) The Business Associate shall make available PHI in a Designated Record Set, to the Covered Entity or, as directed by the Covered Entity, to an Individual, as necessary to satisfy the Covered Entity obligations under 45 CFR 164.524.

(f) The Business Associate shall make any amendment(s) to PHI in a Designated Record Set as directed or agreed to by the Covered Entity pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy Covered Entity’s obligations under 45 CFR 164.526.

(g) The Business Associate shall maintain and make available the information required to provide an accounting of disclosures to the Covered Entity or an individual as necessary to satisfy the Covered Entity’s obligations under 45 CFR 164.528.

(h) To the extent the Business Associate is to carry out one or more of Covered Entity's obligation(s) under the HIPAA Privacy Rule, the Business Associate shall comply with the requirements of HIPAA Privacy Rule that apply to the Covered Entity in the performance of such obligation(s); and

(i) The Business Associate shall make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.

II. Permitted Uses and Disclosures by Business Associate

(a) The Business Associate may only use or disclose PHI as necessary to perform the services set forth in the Agreement or as required by law. The Business Associate is not permitted to de-identify PHI under DoD HIPAA issuances or the corresponding 45 CFR 164.514(a)-(c), nor is it permitted to use or disclose de-identified PHI, except as provided by the Agreement or directed by the Covered Entity.

(b) The Business Associate agrees to use, disclose and request PHI only in accordance with the HIPAA Privacy Rule “minimum necessary” standard and corresponding DHA policies and procedures as stated in the DoD HIPAA Issuances.

(c) The Business Associate shall not use or disclose PHI in a manner that would violate the DoD HIPAA Issuances or HIPAA Privacy Rules if done by the Covered Entity, except uses and disclosures for the Business Associate’s own management and administration and legal responsibilities or for data aggregation services as set forth in the following three paragraphs.

(d) Except as otherwise limited in the Agreement, the Business Associate may use PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate. The foregoing authority to use PHI does not apply to disclosure of PHI, which is covered in the next paragraph.

(e) Except as otherwise limited in the Agreement, the Business Associate may disclose PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate, provided that disclosures are required by law, or the Business Associate obtains reasonable assurances from the person to whom the PHI is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.

(f) Except as otherwise limited in the Agreement, the Business Associate may use PHI to provide Data Aggregation services relating to the Covered Entity’s health care operations.

III. Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions

(a) The Covered Entity shall provide the Business Associate with the notice of privacy practices that the Covered Entity produces in accordance with 45 CFR 164.520 and the corresponding provision of the DoD HIPAA Issuances.

(b) The Covered Entity shall notify the Business Associate of any changes in, or revocation of, the permission by an Individual to use or disclose his or her PHI, to the extent that such changes affect the Business Associate’s use or disclosure of PHI.

(c) The Covered Entity shall notify the Business Associate of any restriction on the use or disclosure of PHI that the Covered Entity has agreed to or is required to abide by under 45 CFR 164.522, to the extent that such changes may affect the Business Associate’s use or disclosure of PHI.

IV. Permissible Requests by Covered Entity

The Covered Entity shall not request the Business Associate to use or disclose PHI in any manner that would not be permissible under the HIPAA Privacy Rule or any applicable Government regulations (including without limitation, DoD HIPAA Issuances) if done by the Covered Entity, except for providing Data Aggregation services to the Covered Entity and for management and administrative activities of the Business Associate as otherwise permitted by this BAA.

V. Breach Response

(a) In general.

In the event of a breach of PII/PHI held by the Business Associate, the Business Associate shall follow the breach response requirements set forth in this Part V, which is designed to satisfy both the Privacy Act and HIPAA as applicable. If a breach involves PII without PHI, then the Business Associate shall comply with DoD Privacy Act Issuance breach response requirements only; if a breach involves PHI (a subset of PII), then the Business Associate shall comply with both Privacy Act and HIPAA breach response requirements. A breach involving PHI may or may not constitute an HHS Breach. If a breach is not an HHS Breach, then the Business Associate has no HIPAA breach response obligations. In such cases, the Business Associate must still comply with breach response requirements under the DoD Privacy Act Issuances.

If the DHA Privacy Office determines that a breach is an HHS Breach, then the Business Associate shall comply with both the HIPAA Breach Rule and DoD Privacy Act Issuances, as directed by the DHA Privacy Office, regardless of whether the breach occurs at DHA or at one of the Service components. If the DHA Privacy Office determines that the breach does not constitute an HHS Breach, then the Business Associate shall comply with DoD Privacy Act Issuances, as directed by the applicable Service-Level Privacy Office. The Business Associate shall contact the Covered Entity for guidance when the incident is not an HHS Breach.

This Part V is designed to satisfy the DoD Privacy Act Issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA Issuances. In general, for breach response, the Business Associate shall report the breach to the Covered Entity, assess the breach incident, notify affected individuals, and take mitigation actions as applicable. Because DoD defines “breach” to include possible (suspected) as well as actual (confirmed) breaches, the Business Associate shall implement these breach response requirements immediately upon the Business Associate’s discovery of a possible breach.

(b) Government Reporting Provisions

The Business Associate shall report the breach within one hour of discovery to the Covered Entity and to the US Computer Emergency Readiness Team (US CERT) -the other parties as deemed appropriate by the Covered Entity. The Business Associate is deemed to have discovered a breach as of the time a breach (suspected or confirmed) is known, or by exercising reasonable diligence would have been known, to any person (other than the person committing it) who is an employee, officer or other agent of the Business Associate.

The Business Associate shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report/. Before submission to US-CERT, the Business Associate shall save a copy of the on-line report. After submission, the Business Associate shall record the US-CERT Reporting Number. Although only limited information about the breach may be available as of the one hour deadline for submission, the Business Associate shall submit the US-CERT report by the deadline. The Business Associate shall e-mail updated information as it is obtained, following the instructions at http://www.us-cert.gov/pgp/email.html. The Business Associate shall provide a copy of the initial or updated US-CERT report to the -Covered Entity and the applicable Service-Level Privacy Office, if requested by either. Business Associate questions about US-CERT reporting shall be directed to the Covered Entity or Service-Level Privacy Office, not the US-CERT office.

The additional US Army and the US Army Medical Command (MEDCOM) reporting requirements are addressed in the PII Breach Reporting and Notification Policy. The latest version of this policy can be obtained from the Covered Entity or the MEDCOM Privacy Act/Freedom of Information Act (FOIA) Office at: usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil . If multiple beneficiaries are affected by a single event or related set of events, then a single reportable breach may be deemed to have occurred, depending on the circumstances. The Business Associate shall inform the Covered Entity as soon as possible if it believes that “single event” breach response is appropriate; the Covered Entity will determine how the Business Associate shall proceed and, if appropriate, consolidate separately reported breaches for purposes of Business Associate report updates, beneficiary notification, and mitigation.

When a Breach Report initially submitted is incomplete or incorrect due to unavailable information, or when significant developments require an update, the Business Associate shall submit a revised form or forms, stating the updated status and previous report date(s) and showing any revisions or additions in red text. Examples of updated information the Business Associate shall report include, but are not limited to: confirmation on the exact data elements involved, the root cause of the incident, and any mitigation actions to include, sanctions, training, incident containment, follow-up, etc. The Business Associate shall submit these report updates promptly after the new information becomes available. Prompt reporting of updates is required to allow the Covered Entity to make timely final determinations on any subsequent notifications or reports. The Business Associate shall provide updates to the same parties as required for the initial Breach Report. The Business Associate is responsible for reporting all information needed by the Covered Entity to make timely and accurate determinations on reports to HHS as required by the HHS Breach Rule and reports to the Defense Privacy and Civil Liberties Office as required by DoD Privacy Act Issuances.

In the event the Business Associate is uncertain on how to apply the above requirements, the Business Associate shall consult with the Covered Entity (or the Service-Level Privacy Office, which will consult with the DHA Privacy Office as appropriate) when determinations on applying the above requirements are needed.

(c) Individual Notification Provisions

If the DHA Privacy Office determines that individual notification is required, the Business Associate shall provide written notification to individuals affected by the breach as soon as possible, but no later than 10 working days after the breach is discovered and the identities of the individuals are ascertained. The 10 day period begins when the Business Associate is able to determine the identities (including addresses) of the individuals whose records were impacted.

The Business Associate’s proposed notification to be issued to the affected individuals shall be submitted to the parties to which reports are submitted under paragraph V (a) for their review, and for approval by the DHA Privacy Office. Upon request, the Business Associate shall provide the DHA Privacy Office with the final text of the notification letter sent to the affected individuals. If different groups of affected individuals receive different notification letters, then the Business Associate shall provide the text of the letter for each group. (PII shall not be included with the text of the letter(s) provided.) Copies of further correspondence with affected individuals need not be provided unless requested by the Privacy Office. The Business Associate’s notification to the individuals, at a minimum, shall include the following:

—The individual(s) must be advised of what specific data was involved. It is insufficient to simply state that PII has been lost. Where names, Social Security Numbers (SSNs) or truncated SSNs, and Dates of Birth (DOBs) are involved, it is critical to advise the individual that these data elements potentially have been breached.

—The individual(s) must be informed of the facts and circumstances surrounding the breach. The description should be sufficiently detailed so that the individual clearly understands how the breach occurred.

—The individual(s) must be informed of what protective actions the Business Associate is taking or the individual can take to mitigate against potential future harm. The notice must refer the individual to the current Federal Trade Commission (FTC) web site pages on identity theft and the FTC’s Identity Theft Hotline, toll-free: 1-877-ID-THEFT (438-4338); TTY: 1-866-653-4261.

—The individual(s) must also be informed of any mitigation support services (e.g., one year of free credit monitoring, identification of fraud expense coverage for affected individuals, provision of credit freezes, etc.) that the Business Associate may offer affected individuals, the process to follow to obtain those services and the period of time the services will be made available, and contact information (including a phone number, either direct or toll-free, e-mail address and postal address) for obtaining more information.

Business Associates shall ensure any envelope containing written notifications to affected individuals are clearly labeled to alert the recipient to the importance of its contents, e.g., “Data Breach Information Enclosed,” and that the envelope is marked with the identity of the Business Associate and/or subcontractor organization that suffered the breach. The letter must also include contact information for a designated POC to include, phone number, email address, and postal address.

If the Business Associate determines that it cannot readily identify, or will be unable to reach, some affected individuals within the 10 day period after discovering the breach, the Business Associate shall so indicate in the initial or updated Breach Report. Within the 10 day period, the Business Associate shall provide the approved notification to those individuals who can be reached. Other individuals must be notified within 10 days after their identities and addresses are ascertained. The Business Associate shall consult with the DHA Privacy Office, which will determine which media notice is most likely to reach the population not otherwise identified or reached. The Business Associate shall issue a generalized media notice(s) to that population in accordance with Privacy Office approval.

The Business Associate shall, at no cost to the government, bear any costs associated with a breach of PII/PHI that the Business Associate has caused or is otherwise responsible for addressing. Breaches are not to be confused with security incidents (often referred to as cyber security incidents when electronic information is involved), which may or may not involve a breach of PII/PHI. In the event of a security incident not involving a PII/PHI breach, the Business Associate shall follow applicable DoD Information Assurance requirements under its Agreement. If at any point the Business Associate finds that a cyber security incident involves a PII/PHI breach (suspected or confirmed), the Business Associate shall immediately initiate the breach response procedures set forth here. The Business Associate shall also continue to follow any required cyber security incident response procedures to the extent needed to address security issues, as determined by DoD/DHA.

VI. Termination

(a) Termination. Noncompliance by the Business Associate (or any of its staff, agents, or subcontractors) with any requirement in this BAA may subject the Business Associate to termination under any applicable default or other termination provision of the Agreement.

(b) Effect of Termination.

(1) If the Agreement has records management requirements, the Business Associate shall handle such records in accordance with the records management requirements. If the Agreement does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below. If the Agreement has provisions for transfer of records and PII/PHI to a successor Business Associate, or if DHA gives directions for such transfer, the Business Associate shall handle such records and information in accordance with such Agreement provisions or DHA direction.

(2) If the Agreement does not have records management requirements, except as provided in the following paragraph (3), upon termination of the Agreement, for any reason, the Business Associate shall return or destroy all PHI received from the Covered Entity, or created or received by the Business Associate on behalf of the Covered Entity that the Business Associate still maintains in any form. This provision shall apply to PHI that is in the possession of subcontractors or agents of the Business Associate. The Business Associate shall retain no copies of the PHI.

(3) If the Agreement does not have records management provisions and the Business Associate determines that returning or destroying the PHI is infeasible, the Business Associate shall provide to the Covered Entity notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Covered Entity and the Business Associate that return or destruction of PHI is infeasible, the Business Associate shall extend the protections of the Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as the Business Associate maintains such PHI.

VII. Miscellaneous

(a) Survival. The obligations of Business Associate under the “Effect of Termination” provision of this BAA shall survive the termination of the Agreement.

(b) Interpretation. Any ambiguity in the Agreement shall be resolved in favor of a meaning that permits the Covered Entity and the Business Associate to comply with the HIPAA Rules and the DoD HIPAA Rules.

2.4. TOBACCO FREE MEDICAL CAMPUS (TFMC)

The Contractor shall ensure that all employees comply with the U.S. Army Medical Command and MTF smoking policies while performing services under this contract. Smoking restrictions will apply at any location or building where health care activities are performed under this contract.

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and (4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The Contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where Contractor personnel may perform under this contract and shall instruct Contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.

2.5. SEXUAL HARASSMENT/ASSAULT RESPONSE AND PREVENTION

The Contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, 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 services under this contract. The Contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the Contractor is providing services under this contract, to report the incident to the Contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals. The Contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the Contractor is providing services under this contract, to report the incident to the Contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve Contractor personnel or Government personnel, or other individuals.

PWS/Government Unique Training

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

PWS/Advisory publications

Army Regulation 600-20, Army Command Policy, 20 Sep 2012. OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Responses Program (SHARP), 12 Nov 2013.

PART 3

3. GOVERNMENT FURNISHED ITEMS AND SERVICES.

3.1. General: The Government shall supply an area for the Contractor to perform services outlined in this PWS.

PART 4

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES.

4.1. General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS.

4.2. Off Duty Employees: The Contractor shall not hire off-duty Government employees who serve as inspector or CORs in their Government position, or any other persons whose employment would result in a conflict of interest.

4.3. Service Literature: Availability of manufacturer’s service literature needed in the performance of the contract will be Contractor’s responsibility and will remain Contractor owned at the termination of the contract. The Contractor shall obtain the currently available literature of the original equipment manufacturer (OEM).

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

4.5. 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 in the medical activity safety office or may be obtained through the Government Representative. The use of cellular phones and 2-way radios is expressly forbidden in all Medical Treatment Facilities and Health Clinics. “The Government and the Contractor’s service representative will exchange hazard communication information before the commencement of any repair." “When required, the Contractor’s service representative will comply with the Office of Safety and Health Administration (OSHA) lockout/tag-out standards while performing sustainment on MD/MDS.”

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

4.6. Physical Security: The Contractor shall be responsible for safeguarding all Government equipment, information and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

4.7. Services beyond the scope of the performance work statement: The Contractor shall immediately notify the Government representative (in writing) of the existence or development of any defects in/or repairs required to the equipment covered under this contract, at the same time of the notification, the Contractor shall furnish the Government representative with a written estimate of the cost to make the necessary repairs. Any service performed without prior Government approval shall be at no cost to the Government.

PART 5

5. SPECIFIC TASKS:

5.1. Basic Services: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform preventive maintenance and repair service for the equipment referenced in this PWS. All labor, travel and expenses during the performance of on-site service is included with the cost of the contract. On-site services must be performed during normal business hours. Overtime is not authorized.

5.2. Technical and Application Telephone Assistance: The Contractor shall provide 24/7 technical and application telephone assistance. The Contractor shall use reasonable efforts to respond telephonically within 30 Minutes during normal duty hours and within 2 Hours after normal duty hours.

5.3. On-site Scheduled and Unscheduled Services: Contractor shall work with Clinical Engineering to schedule on-site service.

5.3.1. The Contractor technical representative will be dispatched within 2 business days of initial request for service. Contractor shall make reasonable efforts to have service call completed by close of business on the day of the service call.

5.4. Preventive Maintenance: The Contractor shall provide preventive maintenance services, and parts necessary for equipment to remain in compliance to OEM standards.

5.4.1. Contractor shall work with Clinical Engineering POC to set up service appointment for preventive maintenance.

5.5. Parts: Contractor shall repair or replace any parts that are in need of repair or replacement. Parts will meet or exceed OEM standards.

5.5.1. Contractor shall provide an approximate date of availability for parts required but not in stock with the Contractor or original equipment manufacturer.

5.5.3. Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of work or defective parts shall be the responsibility of the Contractor.

5.6. Updates: Contractor shall provide authorized product updates and modifications for improved product performance reliability. Software updates that cannot be performed by the user will be furnished by the Contractor at no cost to the Government.

5.7. Calibration Documentation: If applicable, upon completion of calibration, Contractor shall remove and replace DD Form 2163 (Calibration/Verification) sticker, confirming system serviceability. Contractor technician must specify completion date along with their initials.

5.8. Service Reports: The Contractor shall submit reports to the Government Representative or Contracting Officer as requested for use in monitoring Contractor performance.

5.8.1. Upon completion of scheduled and unscheduled services by the Contractor’s service representative, an initial service report shall be provided in writing or via email to the Clinical Engineering staff before the close of business on the service completion date. The initial service report shall include at a minimum:

· Contractor’s name (full printed and signed name), Equipment Control Number and/or serial number of MD/MDS being sustained.

· Detailed information regarding MD/MDS malfunction and corrective action(s) taken, preventive maintenance, and calibrations verified and/or performed.

· A list of parts replaced with part numbers, and/or serial numbers.

5.8.2. The Contractor shall provide the balance of the required information to the Government Representative no later than 48 hours after services are completed. On weekends and after normal duty hours, service reports shall be given to the Government representative no later than two (2) business days after service is completed. The complete service report will include the information listed above as well as the information listed below:

· Contract number

· Equipment identification data.

· System nomenclature, site name, model.

· Start date/time and completion date/time.

· The time required to complete the work, price of labor (hourly rate). Hours are in tenths and rounded up to the nearest tenth of an hour.

· List prices for each part used.

· Explanations of any deferred or delayed repair action with a projected completion date.

5.9. Invoices and Payment Information:

5.9.1 The Contractor shall submit monthly, in arrears, itemized invoices in accordance with DFARS 252.232-7003, for services rendered under this contract. Information regarding IRAPT is available on the Internet at https://wawf.eb.mil/.

5.9.2. Contractor Management Reporting (CMR): The Contractor shall report ALL Contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via secure data collection site. The Contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/, and then click on "Department of the Army CMRA" or the icon of the DoD organization that is receiving or benefitting from the contracted services.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year.