Attachment 1 - PERFORMANCE WORK STATEMENT.docx

Department of Defense Defense Health Agency

Performance Work Statement

INTRAOPERATIVE NEUROPHYSIOLOGIC MONITORING (IONM)

David Grant Medical Center

60th Medical Group, Travis AFB, CA

Version: 1 Date: 31 December 2024

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Intraoperative Neurophysiologic Monitoring Services.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, transportation, tools, materials, supervision, and other to perform Intraoperative Neurophysiological Monitoring (IONM) to patients at David Grant Medical Center (DGMC), Travis AFB, CA also referred to as the MTF (Medical Treatment Facility) as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall abide by MTF rules, regulations and by-laws including applicable standard operating procedures established by the MTF. The quality of care shall meet all recognized standards established by The Joint omission (TJC).

1.3 Background: Current services are provided by a contracted vendor.

1.4 Objectives: Intraoperative neurophysiological monitoring incorporating various neurodiagnostic modalities including but not limited to: evoked potentials, electromyography, electroencephalograms and pulse oximetry. Services shall be available 24 hours a day, 7 days a week and fees will include patient preparation, set actual monitoring, and supplies to provide the services. Except for those items listed as Government Provided.

1.5 Scope: A certificate in Neurophysiologic Intraoperative Monitoring (CNIM) through the American Board of Registration of Electroencephalographic and Evoked Potential Technologists (ABRET), or certification from the American Board of Neurophysiologic Monitoring (ABNM).

1.6 Period of Performance (POP):

Base Period: 1 Feb 25 – 31 Jan 26 Option #1: 1 Feb 26 – 31 Jan 27 Option #2: 1 Feb 27 – 31 Jan 28 Option #3: 1 Feb 28 – 31 Jan 29 Option #4: 1 Feb 29 – 31 Jan 30 6-Month Extension: 1 Feb 30 – 31 Jul 30

1.6.1 Transition: Transition-in/transition-out period.

1.6.1.1 Transition-in period: The contractor shall provide the Government with a transition plan for phasing-in contractor performance. Refer to Part 10, Technical Exhibit 1

1.6.1.2 Transition-out period: The transition-out plan shall facilitate the accomplishment of a seamless transition from the incumbent to an incoming contractor/Government personnel at the expiration of the contract. See Part 8, Exhibit 3.

1.7 Administrative Specifications

1.7.1 Place of performance: The work shall be performed at 60 MDG, David Grant Medical Center, Travis AFB, CA

1.7.2 Recognized Federal holidays: Contractor is not required to perform services on holidays.

Independence Day

1.7.3 Hours of Operation: The contractor is responsible for conducting business 24 hours a day, 7 days a week, 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.

1.8 Quality

1.8.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is how the work complies with stated requirements. Quality Control Plan (QCP) will be submitted with contractor’s proposal. A comprehensive written QCP shall be submitted to the CO and COR within 5 working days when changes are made thereafter. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system. See Part 8, Exhibit 3 - CDRL A001.

1.8.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.8.3 Key Personnel (Contractor): The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 7:30 AM to 4:30 PM., Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.9. Reporting

1.9.1 Government’s COR (Contracting Officer Representative) and FRED (Functional Requirements Evaluator Designee) responsibilities: The COR monitors all technical aspects of the contract and assists in contract administration. The COR will monitor contractor's performance and notifies both the CO (Contracting Officer) and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract. The FRED 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 COR concerning technical aspects and acceptance of the contract services monthly or more frequent if necessary.

1.9.2 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the CO will inform the contractor of how the government views the contractor's performance. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.10 Contractor Identification

1.10.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel. Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.11 Personnel Security

1.11.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI) 6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM 5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

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 business associate agreement (BAA) between the signatory parties for purposes of the Health Insurance Portability and Accountability Act (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 THE CONTRACTOR/COMPANY.

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 60 MDG, DAVID GRANT MEDICA CENTER.

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/or 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 this 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 this 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 this 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, and corresponding DoD HIPAA Issuances, 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 and corresponding DoD HIPAA Issuances.

(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, and corresponding DoD HIPAA Issuances.

(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 and corresponding DoD HIPAA Issuances.

(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 the 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 this 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 this 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 this 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 this 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 this 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 notify the Business Associate of any limitation(s) in the notice of privacy practices of the Covered Entity under 45 CFR 164.520 and the corresponding provision of the DoD HIPAA Issuances, to the extent that such limitation may affect Business Associate’s use or disclosure of PHI.

(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 and the corresponding DoD HIPAA Issuances, 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.

(1) In the event of a breach of PII/PHI held by the Business Associate, the Business Associate shall report the breach to the Covered Entity in accordance with Section VII, assess the breach incident, take mitigation actions as applicable, and notify affected individuals, as directed by the Covered Entity.

(2) The Business Associate shall coordinate all investigation actions with the Covered Entity, and at a minimum, 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.

(3) 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.

(b) Government Reporting Provisions

(1) If the Covered Entity 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 Covered Entity, regardless of where the breach occurs. If the Covered Entity 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.

(2) 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.

(3) The following provisions of Part V set forth the Business Associate’s Privacy Act and HIPAA breach response requirements for all breaches, including but not limited to HHS breaches.

(i) The Business Associate shall report the breach within one hour of discovery to the US Computer Emergency Readiness Team (US CERT), and, within 24 hours of discovery, to the Covered Entity, and to 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.

(ii) 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 https://www.cisa.gov/report. The Business Associate shall provide a copy of the initial or updated US-CERT report to the Installation Privacy Act Officer, MTF HIPAA Privacy Officer, and the Contracting Officer (if applicable), if requested. Business Associate questions about US-CERT reporting shall be directed to the Installation Privacy Act Officer or MTF HIPAA Privacy Officer, not the US-CERT office.

(iii) The Business Associate shall comply with the Breach Timeline and Notification Flow Chart processes attached to this Agreement, to include the timelines established for completing the DD Form 2959 and the HIPAA Privacy Incident Report.

(4) 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.

(i) When a Breach Report Form 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, and follow-up. The Business Associate shall submit these report updates within three (3) business days 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 Reporting Form. 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.

(ii) In the event the Business Associate is uncertain on how to apply the above requirements, the Business Associate shall consult with the Covered Entity and Contracting Officer when determinations on applying the above requirements are needed.

(c) Individual Notification Provisions

(i) If the Covered Entity 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.

(ii) 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 VII. for their review, and for approval by the] Contracting Officer, in consultation with the Covered Entity. Upon request, the Business Associate shall provide the Contracting officer and Covered Entity 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 Contracting Office or Covered Entity. The Business Associate’s notification to the individuals, at a minimum, shall include the following:

(A) 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.

(B) 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.

(C) 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.

(D) A brief description of what the covered entity involved is doing to investigate the breach, to mitigate harm to individuals, and to protect against any further breaches; and

(E) Contact procedures for individuals to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address

(F) 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. The Contracting Officer, in consultation with the Covered Entity will determine the appropriate level of support services.

(iii) 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., “Important information – do not destroy,” 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, e-mail address, and postal address.

(iv) 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 Form. 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 Covered Entity, 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 the Covered Entity approval.

(d) 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 underlying Contract.

(b) Effect of Termination.

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

(2) If this Agreement does not have records management requirements, except as provided in the following paragraph (3), upon termination of this 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 this 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 this 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. Notices. Any notices to be given hereunder will be made in the most expedient manner, via e-mail, facsimile, U.S. Mail, or express courier to such party’s address given below.

Attn:

Title:

Company:

Unit:

Address:

Travis AFB, Ca 94535

Phone:

Fax:

Fax:

E-mail:

With a copy to:

Name:

Name:

Company:

Address:

Address:

Phone:

Phone:

Fax:

Fax:

Email:

Email:

Each party named above may change its address and that of its representative for notice by the giving of notice thereof in the manner provided in this subsection.

VIII. Miscellaneous

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

(b) Interpretation. Any ambiguity in this 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 Issuances.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.2 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated, and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Functional Requirements Evaluator Designee (FRED): Technical personnel receiving services who will evaluate and report performance to the COR as required.

2.1.5 Nonpersonal services contract: a 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.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.2 Acronyms:

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc. N/A

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government will provide general supplies: Medical and non-medical supplies commonly used in the facility for the care and management of patients or services. Commonly used supplies are those routinely stocked by the MTF. The Government will provide motor strip grids (Ix8) for brain mapping when brain mapping is required.

3.2 Facilities: The Government will provide a secured space to store company owned equipment and materials required to support service, if requested by the contractor

3.3 Utilities: The Government will provide basic facility utilities in support of the services conducted on site at 60 MDG, Travis AFB, CA.

3.4 Equipment: The Government will not provide equipment in support of the contract.

3.5 Materials: Unless otherwise stated, all materials will be provided with exception of those identified in Part 4.

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor: will provide Contractor Furnished Items required in support of this PWS.

4.2 Equipment: The contractor shall provide necessary equipment to meet the requirements under this PWS.

4.3 Proof of equipment maintenance will be provided in writing to the 60 MDG Equipment Medical Repair Center, Travis AFB.

PART 5

5.0 SPECIFIC TASKS

5.1 Contractor shall provide Intraoperative Neurophysiological Monitoring incorporating various neurodiagnostic modalities including but not limited to: evoked potentials, electromyography, electroencephalograms, and pulse oximetry.

5.1.2. Anatomical and prep direction of pad/myotome placement on patient.

5.1.3. Set up and self-testing of equipment and leads.

5.1.4. Direction in use of equipment and diagnostic features inter-operatively for the entire length of procedure to include but not limited to resolution of problems and correction of operating system/ software malfunctions.

5.1.5. Technical informal action affecting the interpretation of data.

5.1.6. Monitor the patient and defer interpretation to the Staff Surgeon.

5.1.7. Ensure the Surgeon and Anesthesiologist are informed at all times during a procedure of the patients’ neurophysiological status.

5.1.8. Intraoperative neurophysiological monitoring incorporating various neurodiagnostic modalities including but not limited to: evoked potentials, electromyography, electroencephalograms and pulse oximetry.

5.1.9. During surgery, the intraoperative neurophysiological monitoring (IONM) will identify deleterious changes in the conduction of electrical impulses through the spinal cord and/or related neural structures.

5.1.10. Neuro technologist is responsible for equipment set-up, recording and evaluation of data. Neuro technologist will and report abnormal findings in the sensory and/or motor systems in patients during the surgical procedure.

5.1.11. DGMC staff physicians may request neurodiagnostic studies to be performed on DGMC patients that may include, but are not limited to evoked potentials, nerve conduction tests and electroencephalograms.

5.1.12. Provide an in-service training, regarding contractor’s system to the MTF operating room staff every six months.

5.2. Scheduling Protocol

5.2.1. The request for intraoperative monitoring services will originate from the DGMC surgeon's office or operating room. A call to schedule intraoperative monitoring for upcoming surgery is placed by the FRED (Functional Requirements Evaluator Designee).

5.2.2. The contractor will provide a telephone number for placement of calls on a 24-hour basis to include method for cancellation. Scheduled intraoperative neurophysiological monitoring services may be cancelled twenty-four (24) hours in advance of the scheduled start time. Cancellation may be delivered via telephone or facsimile, or other means, dependent on vendor’s required procedures.

5.2.3. For routine cases, the contractor will be notified at least 48 hours in advance of a case scheduling. The contractor’s technologist or required staff will be in place at the MTF at least two hours before the scheduled surgery.

5.2.4 For emergency/unscheduled surgeries, the contractor’s technologist or require staff will be in place at the MTF within 2 hours after placement of call.

PART 6

6.0 INFORMATION TECHNOLOGY & SECURITY

6.1 All work under this contract is unclassified.

6.1.1. The contractor shall appoint a primary Point of Contact (POC) to be responsible for the performance of the work to manage scheduling or any other performance issues. POC will be available during normal duty hours Monday – Friday 7:30 am – 4: 30 pm.

6.2 Personally Identifiable Information (PII)/Protected Health Information (PHI), Procurement, and Federal information requirements: (The following section is an excerpt from DHA PGI 224.1 effective 23 May 19. The numbering in this section follows the numbering in the PGI)

1. General Requirements Overview - Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Laws This Section addresses the Contractor’s requirements under The Privacy Act of 1974 (Privacy Act), The Freedom of Information Act (FOIA), and The Health Insurance Portability and Accountability Act (HIPAA) as set forth in applicable statutes, implementing regulations and Department of Defense (DoD) issuances. In general, the Contractor shall comply with the specific requirements set forth in this Section and elsewhere in this Contract. The Contractor shall also comply with requirements relating to records management as described herein.

This Contract incorporates by reference the federal regulations and DoD issuances referred to in this Section. If any authority is amended or replaced, the changed requirement is effective when it is incorporated under contract change procedures. Where a federal regulation and any DoD issuance govern the same subject matter, the Contractor shall first follow the more specific DoD implementation unless the DoD issuance does not address or is unclear on that matter. DoD issuances are available at http://www.dtic.mil/whs/directives.

For purposes of this Section, the following definitions apply. DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD 5400.11 (October 29, 2014) and DoD 5400.11-R (May 14, 2007)

PART 7

7.0 HEALTH REQUIREMENTS

7.1 HCW (Health Care Workers) Health Requirements

7.1.2. The Contractor shall comply with all health requirements in the contract. Prior to physical performance of services by the HCW, the Contractor shall provide documentation certifying health requirements such as immunizations, annual vaccinations, medical testing (i.e., tuberculosis, N95 particulate respirator duckbill mask fitting) and physical examination when required at the time of initial placement and annually thereafter, as required. The expense for all health requirements, to include monitoring and tracking annual requirements, shall be borne by the Contractor at no additional cost to the Government.

7.1.3. Annual Immunizations: The Contractor shall ensure HCWs are immunized annually with the seasonal influenza vaccine and any other vaccine recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) for HCWs or service/MTF specific guidance as outlined in DoDD 6205.02e, Policy and Program for Immunizations to Protect the Health of Service Members and Military Beneficiaries. The annual influenza vaccine may be provided by the Government, if available, as determined by the MTF. If the HCW chooses to be immunized by the Government, the HCW shall sign a waiver releasing the Government from the legal liability IAW local procedures and policies. Alternately, the HCW may obtain the vaccine at another facility, at no cost to the Government, and provide proof of vaccination to the Government. If the HCW declines vaccination, a signed declination form will be provided to the COR IAW CDC recommendations and MTF policy.

7.1.6. Occupational Health: If required, the HCW shall obtain, at contractor expense, documentation of required physical testing, and a statement from the HCW's licensed medical practitioner or a report of a physical examination. The physical examination shall indicate that the HCW is free from mental or physical impairments that would restrict the HCW from providing the services described in the contract.

7.1.7. Universal Precautions: HCWs shall comply with the CDC’s “Universal Precautions” for the prevention of the transmission of the human immunodeficiency virus (HIV). HIV positive HCWs will be managed IAW the current CDC guidelines and Section 503 of the Rehabilitation Act (29 U.S.C. Section 793) and any implementing regulations (41 CFR § 60-741). 1.6.20.5. Tuberculosis Screening: Prior to reporting for service at an MTF, each contract HCW shall be screened at contractor expense for risk of exposure to tuberculosis (TB) as part of the health examination and immunization/screening requirement. If the HCW is determined to have a low risk of exposure, no further screening or testing is required under this contract. The initial screening may be waived, at the discretion of the MTF, if the Contractor provides evidence of a prior low risk assessment by a licensed physician. If the initial screening results in a determination that the HCW has an increased risk of exposure to TB, the contractor is responsible for ensuring that the HCW receives targeted screening and testing IAW CDC Guidelines for Health- Care Settings at Contractor expense and submitting timely records of subsequent screening or testing to the COR. MQS Basic Contract PWS (8 Jan 24) Page 10 of 42

7.1.8. Health Notifications: The Government will notify the Contractor of any work hazards. If work hazards exist, it will be the Government’s decision whether the HCW continues work in the environment.

7.1.9. Medical Tests: No medical tests or procedures required by the contract will be performed by the Government with the exception post blood borne exposure protocols after exposure; and occupational exposure programs such as the Thermoluminescent Dosimetry (TLD) monitoring program.

PART 8, EXHIBIT 1

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

Performance Requirements Summary (PRS) # 1.

The contractor shall provide onsite IONM to patients. Onsite services shall be available 24 hours a day, 7 days a week.

PRS # 2

Contract staff must provide specific tasks during on site scheduled procedures

PRS # 3

Scheduling Protocol

PRS #4

Equipment and diagnostic features inter-operatively for the entire length of procedure

PART 8, EXHIBIT 2

ESTIMATED WORKLOAD DATA

PART 8, EXHIBIT 3

DELIVERABLES SCHEDULE

Applicable to:

CDRL A001 – Quality Control Plan

Transition-out: 1 month prior to close of contract or unexercised option.

Paragraphs 1.6.1.1 and 1.6.1.2.

DHA PWS Template V13 November 16, 2021 image1.png image2.emf

CDRL 1 Quality Plan A001.pdf

DD FORM 1423-1, FEB 2001

CONTRACT DATA REQUIREMENTS LIST

(1 Data Item)

PREVIOUS EDITION MAY BE USED.

Form Approved OMB No. 0704-0188

The public reporting burden for this collection of information is estimated to average 110 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.