ATT2_Performance Work Statement.pdf

Performance Work Statement

For

ABBOTT IntraLase® Femtosecond (FS) Laser

Service and Maintenance

At

Joint Base Elmendorf-Richardson, Alaska

28 April 2021

TABLE OF CONTENTS

LOCATION TITLE PAGE

Section 1

General Information

Section 2

Government-Furnished Property and Services

Section 3

Contractor-Furnished Items and Services

Section 4

Specific Tasks

Section 5

HIPAA Business Associate Agreement

Appendix 1

Acronyms

Attachment 1

Equipment

Section 1 Description of Services

1. GENERAL INFORMATION

1.1. SCOPE OF WORK. The contractor shall provide all personnel, equipment, tools, test equipment, transportation, regularly scheduled preventive maintenance parts, and other items and services necessary to perform preventive maintenance and calibration (on-site) for equipment items listed in attachment 1 and adhere to Abbott. Terms and Conditions listed in quote provided by the company. These units are located in the 673rd Medical Group, 5955 Zeamer Avenue, Joint Base Elmendorf-Richardson, Alaska.

1.2. CONTRACTOR PERSONNEL:

1.2.1. Contract Manager. The contractor shall provide a Contract Manager who shall be responsible for the performance of the work. The name of the person, and an alternate or alternates, who shall act for the contractor when the manager is absent, shall be designated in writing to the Contracting Officer.

1.2.1.1. 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.

1.2.1.2. The contract manager or alternate shall be available during normal duty hours within 24 hours to meet on the installation with government personnel (designated by the contracting officer) to discuss problem areas.

1.2.1.3. The contract manager and alternates must be able to read, write, speak, and understand English.

1.2.2. Contractor Employees. The contractor shall not employ persons for work on this contract if such employee is identified by the contractor as a potential threat to the health, safety, security, general well being or operational mission of the installation and its population.

1.2.3. Employee Training. All maintenance service shall be performed by professionally trained, technically qualified personnel. All contractor personnel performing services under this contract must have proof of factory training on these or like systems. If factory training occurred more than three years ago, proof must be presented that the individual has been actively engaged in repairing the system for 12 of the last 18 months. The contractor shall provide to the contracting officer a written list of technicians qualified to work on the equipment prior to contract award date.

Contractor’s personnel credentials shall be approved by the contracting officer and the NCOIC of Medical Equipment Repair Center (MERC) prior to award of the contract. Personnel changes will be coordinated through the contracting officer for addition and deletion from the qualified technician list.

1.3. QUALITY CONTROL. The contactor shall maintain all systems in accordance with directives and manufacturer specifications. All preventive maintenance shall be completed prior to end of the 12th month from the date of last completed preventive maintenance. Upon completion of service, the contractor shall provide service reports, to include calibration results, to the MERC. If preventive maintenance/calibration cannot be completed in this prescribed timeframe, and the delay is not as a result of the customer, the contractor will provide in writing if the device is safe/accurate for use until services can be performed.

1.4. QUALITY ASSURANCE. The MERC will inspect the contractor’s work on a random basis to ensure requirements of this contract are being met. The MERC will also accept customer complaints from the equipment users to determine the quality of the contractor’s work.

1.5. PHYSICAL SECURITY. The contractor shall be responsible for safeguarding all government property provided for contractor use. At the end of each work period, all government facilities, equipment, and materials shall be secured.

1.6. HOURS OF OPERATION:

1.6.1 Normal Hours of Operation. The contractor shall perform preventive maintenance services and software upgrades required under this contract between normal duty hours 7:30 AM to 4:30 PM, Alaska Time, Monday through Friday excluding Federal Holidays.

1.6.2. Holidays. The contractor shall not be required to perform preventive maintenance services and/or software upgrades on-site during these federal holidays: New Year’s Day, Martin Luther King’s birthday, President’s Day, Memorial Day, Juneteeth, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day. However, emergency and unscheduled maintenance requests will be addressed on a case-by-case basis.

1.7. CONSERVATION OF UTILITIES. The contractor shall make sure employees practice utility conservation.

1.8. RECORDS/DOCUMENTATION. The MERC will report and maintain a sign-in log noting date called, date scheduled, date & time arrived, and date and time completed. This sign-in log will provide the government data to determine if uptimes and response times are being met and will be available for review by the contractor.

1.8.1. Sign-in/Service Report. Upon arrival and prior to beginning work, service technicians are to report to the MERC section (Room LC110) to sign the contractor log. Upon completion of each preventive maintenance inspection (PMI) or corrective maintenance call, the contractor shall provide the MERC section a legible service report. The government representative shall countersign the report. Failure to sign in or provide the service report may result in payment for service being delayed until the service report is received by the MERC section. Service reports shall include:

1.8.1.1. Type of service, PMI, scheduled or unscheduled service call.

1.8.1.2. System nomenclature, model, serial number, and room number.

1.8.1.3. Description of all services rendered during the visit.

1.8.1.4. Listing of all discrepancies, if any, still existing with any item covered under this contract.

1.8.1.5. If replacement parts are used, a complete list of parts used, by part number. If units require parts that are not covered under routine scheduled maintenance, the contractor will notify MERC to obtain these specified parts/service. The completed service report shall be turned in to the MERC section prior to the contractor’s representative departing the hospital.

1.8.1.6. Contractor shall provide a certification, in writing, at a minimum, that the system performs to or better than the manufacturer’s specifications.

1.8.1.7. If service is completed after normal duty hours, or parts costs are not immediately available, service reports shall be placed in the contractor sign-in log book at the entrance of the MERC section.

1.8.1.8. After completing systems calibrations, the contractor shall complete a AF Form 4368, Medical Equipment Verification/Certification, affixed to each major system.

Section 2

Government-Furnished Property and Services (Reserved)

2. GENERAL INFORMATION. The government will provide the equipment listed in attachment 1.

Section 3 Contractor-Furnished Items and Services

3.1. GENERAL INFORMATION. Contractor shall furnish all items needed to perform this contract according to all its terms.

3.1.1. SCOPE. The contractor shall provide all personnel, equipment, tools, test equipment, transportation, parts, materials, supervision and other items and services necessary to perform preventive maintenance and calibration for the equipment listed in attachment 1. The service shall include any hardware or software updates, trouble shooting, re-programming and software documentation. The contractor shall ensure the equipment functions as designed by the manufacture with no degradation in system performance.

3.1.2. EQUIPMENT UPDATES. The contractor shall furnish and install all software updates and equipment modifications normally provided by the manufacturer, and installed at next PMI after they are made available by the manufacturer.

3.1.3. REPLACEMENT PARTS. The contractor shall have available any special tools, supplies, parts, transducers, and test equipment which are required for the servicing of the imaging systems. The contractor shall use only original or factory refurbished replacement parts and be quality assurance tested by the manufacturer. If required replacement parts are not immediately available to the contractor while performing Preventive Maintenance Inspections

(PMIs) or service repair call, the contractor shall notify MERC personnel in room LC110, of the deficiency. The contractor’s service personnel shall carry or have available in the local area the manufacturer’s “recommended stock” for each system covered by this contract. Replacement parts shall be returned to the manufacturer, by the contractor. Maintenance actions shall not be delayed by more than 24 hours due to delivery of a repair part or item.

3.1.4. SPECIAL TOOLS/TEST EQUIPMENT REQUIREMENTS. All tools, test equipment, and supplies used for preventive and corrective maintenance are included in this contract. No charge will be made for them during the period of this contract.

3.1.5. TECHNICAL DATA. The contractor shall have and maintain a complete file of technical documentation on each system listed in the contract to include schematics, wiring diagrams, service manuals, troubleshooting guides, and service update memos.

3.1.6. SPECIAL WORKING CONDITIONS. All equipment, parts, materials, and services supplied by the contractor shall conform to the applicable safety standards as indicated in the current code of Federal Regulations, Occupational Safety Heath Act (OSHA).

3.1.7. ACCESS TO SOFTWARE. The contractor shall have full access to all original software and all software necessary for troubleshooting, calibrating, and revising original software.

Section 4 Specific Tasks

4. GENERAL INFORMATION. The contractor shall furnish maintenance support to include, as a minimum, preventive maintenance for the systems listed in attachment 1. The contractor’s maintenance service support shall provide preventive maintenance parts, labor, travel time and expense to perform preventive on all systems listed in attachment 1.

4.1. Point of Contact. The contractor shall provide a single point of contact for any maintenance that is required. This information should include name, title, address, and telephone number of the contractor’s service personnel.

4.2. Maintenance Actions. Once a maintenance action is started, it shall be continued until the task is completed. Compliance shall be manifested by the continuous presence of the engineers on the job site, but not to include the waiting for arrival of parts. This requirement applies to normal hours. Contractor employees desiring to work after normal hours, do so at the contractor’s expense. The contractor may communicate with the end users to rectify system malfunctions, coordinate repair site visits, but the MERC must be notified of any and all such actions.

4.2.1. Preventive Maintenance Inspections (PMIs). PMIs are the care and servicing of the equipment in a serviceable condition in accordance with manufacturer’s scheduled and specifications listed in their technical literature. This inspection includes, but is not limited to, verification of proper operation, detection and correction of incident failures either before they occur or before they develop into major defects; and includes actions pertaining to periodic technical inspections, lubrications, adjustments, calibrations, interior cleaning, and replacement of manufacturer’s recommended preventive maintenance parts. If units require additional parts not covered under this contract, the contractor’s service representative will contact the MERC at 907- 580-6397 to arrange for payment of parts/service. The contractor shall incorporate all the manufacturer’s published PMIs and be in sufficient detail as to meet industry standards set forth by The Joint Commission (TJC), National Fire Protection Association (NFPA) 99, and OSHA.

The contractor shall comply with the manufacturer’s specified frequency, duration, and PMI procedures required for each system. PMI’s shall be performed between the hours of 7:30 AM and 4:30 PM, Alaska Time. All preventive maintenance visits will be coordinated with the MERC personnel prior to any action being taken.

4.2.2. PMIs will consist of the following minimum requirements:

4.2.2.1. Consulting with equipment operators regarding equipment performance.

4.2.2.2. Visually inspecting exterior of all systems for damage and cleanliness, and reporting discrepancies to the MERC personnel.

4.2.2.3. Performing operational checks on all systems and correcting any deficiencies noted.

4.2.2.4. Cleaning and lubricating mechanical parts in accordance with manufacturer’s service manual.

4.2.2.5. Making mechanical adjustments to ensure proper operation.

4.2.2.6. Verifying the system’s internal and external calibrations are within manufacturer’s specifications.

4.2.2.7. Performing an electrical check of the equipment and all accessories included in this contract, and making electrical adjustments as required to ensure compliance with manufacturer’s specifications.

4.2.2.8. Performing electrical safety inspection after each PMI or repair of the electrical system in accordance with NFPA 99 - Standard for Health Care Facilities.

4.2.3. Scheduled Maintenance. As a minimum, the contractor shall perform PMIs and system calibration according to the following schedule.

PMI 12 Months Annually Calibration 12 Months Annually

4.2.4. Corrective Maintenance. The contractor shall provide on-site repair support to correct all malfunctions that occur. All tools, test equipment, parts, and supplies necessary to return the equipment to original operating specifications will be the responsibility of the contractor. The contractor shall respond on-site within (4) four business day hours of the initial call for services, depending on equipment availability and surgery schedule.

4.2.5. Claims of Operator Misuse or Abuse. The Contractor shall not be responsible for expenses incurred for corrective maintenance of repairs that are directly related to operator misuse or abuse. If the contractor claims any service calls are the result of operator abuse or misuse, the damage must immediately be shown to, and verified by, the MERC personnel before repairs are made. Disagreements of responsibility will be resolved by the Base Contracting Office.

Section 5 Business Associate Agreement

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 [INSERT NAME OF

BUSINESS ASSOCIATE].

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 673d Medical Group.

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 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 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 (if applicable) 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 the CO, COR and 673d Medical Group HIPAA Officer.

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.

Appendix 1 Acronyms

AFMAN Air Force Manual AFI Air Force Instruction BAA Business Associate Agreement CFR Code of Federal Regulations CO Contracting Officer COR Contracting Officer Representative DHA Defense Health Agency DoD Department of Defense FC Functional Commander HHS Health and Human Services HIPAA Health Insurance Portability and Account Act IAW In Accordance With ID Identification MDG Medical Group MDGI Medical Group Instruction MERC Medical Equipment Repair Center MHS Military Health System MTF Medical or Military Treatment Facility NCOIC Non Commissioned Officer in Charge NFPA National Fire Protection Association OSHA Occupational Safety and Health Administration PHI Protected Health Information PII Personally Identifiable Information PMI Preventative Maintenance Inspection POC Point of Contact PUB Publication PWS Performance Work Statement TJC The Joint Commission

Attachment 1

Manufacturer Model Serial Nomenclature ECN Location

Abbott INTRALASE

FS 0211-60371 LASER, HO:YAG, SURGICAL 024344 REFRACTIVE

EYE CLINIC