Attachment 4-SOW-July 2021.pdf

STATEMENT OF WORK

FOR

LABORATORY CLINICAL CHEMISTRY SERVICE

July 2021

SECTION 1: DESCRIPTION OF SERVICES

The Contractor shall furnish, via cost per reportable result lease basis over a period of one base year and four option years, two chemistry analyzers with technical support required to provide inpatient/outpatient chemical test analysis for the United States Government (hereinafter referred to as “Government”) beneficiaries. The Contract shall provide analyzers and services in Government supplied facilities at the 88th Medical Group, also referred to as the “Medical Treatment Facility” (MTF) herein. Contractor care includes furnishing all equipment, maintenance, supplies for operation of equipment, labor, transportation, reports, and technical assistance, including items provided in paragraph 1.4.2 below. Tests required shall be as comprehensive as Government requests and contractor supplied equipment permit. Performance shall be according to the requirements contained in the Statement of Work (SOW).

1.1. SCOPE OF CHEMISTRY AND IMMUNODIAGNOSTIC ANALYZER UNIT(S)

1.1.1. The contractor analyzer(s) shall be capable of providing the following tests as well as meet specific annual volume requirements as listed below:

Assay Annual Test Volume (Tests/Yr)

1.1.1.1 Acetaminophen 346

1.1.1.2 Albumin 27,711

1.1.1.3 Alkaline Phosphatase 19,913

1.1.1.4 Alanine Aminotransferase 20,194

1.1.1.5 Ammonia 101

1.1.1.6 Amphetamine 12,684

1.1.1.7 Amylase 205

1.1.1.8 Aspartate Aminotransferase 20,154

1.1.1.9 Barbiturate 12,684

1.1.1.10 Benzodiazepine 12,684

1.1.1.11 Bilirubin (Direct) 4,137

1.1.1.12 Bilirubin (Total) 19,454

1.1.1.13 Brain Natriuretic Peptide (BNP) or ProBNP 633

1.1.1.14 Blood Urea Nitrogen (BUN) 32,873

1.1.1.15 Calcium 33,532

1.1.1.16 Carbamazepine 50

1.1.1.17 Chloride 31,916

1.1.1.18 Cholesterol 12,898

1.1.1.19 Creatine Kinase (CK) 748

1.1.1.20 Creatine Kinase-Myocardial Band (CK-MB) 360

1.1.1.21 Carbon Dioxide 31,804

1.1.1.22 Cocaine 12,684

1.1.1.23 Cortisol 282

1.1.1.24 Creatinine 38,384

1.1.1.25 C-Reactive Protein (CRP) 2,066

1.1.1.26 C-reactive protein High Sensitivity (CRPhs) 209

1.1.1.27 Digoxin 51

1.1.1.28 Estradiol 406

1.1.1.29 Ethanol 1,335

1.1.1.30 Ferritin 2,409

1.1.1.31 Folate 1,988

1.1.1.32 Free Thyroxine (FT4) 2,672

1.1.1.33 Gentamicin 31

1.1.1.34 Gamma-Glutamyl Transferase (GGT) 1,043

1.1.1.35 Glucose 33,297

1.1.1.36 Human Charionic Gonadotropin (hCG) 857

1.1.1.37 High-Density Lipoprotein (HDL) 12,898

1.1.1.38 Iron 2,036

1.1.1.39 Lactate 760

1.1.1.40 Lactate Dehydrogenase (LDH) 1,271

1.1.1.41 Low-Density Lipoprotein (LDL) 13,020

1.1.1.42 Lipase 1,666

1.1.1.43 Lithium 56

1.1.1.44 Magnesium 4,026

1.1.1.45 Microalbumin 4,060

1.1.1.46 Opiate 12,684

1.1.1.47 Pencyclidine (PCP) 12,684

1.1.1.48 Phenobarbital 30

1.1.1.49 Phenytoin 50

1.1.1.50 Phosphorus 8,223

1.1.1.51 Potassium 32,192

1.1.1.52 Procalcitonin 550

1.1.1.53 Progesterone 131

1.1.1.54 Protein (Total) 20,410

1.1.1.55 Protein (Urine/CSF) 121

1.1.1.56 Prostate-Specific Antigen (PSA) 2,332

1.1.1.57 Parathyroid Hormone (PTH) 2,032

1.1.1.58 Intraoperative Parathyroid Hormone 20

1.1.1.59 Salicylate 30

1.1.1.60 Sodium 32,041

1.1.1.61 Tetrahydrocannabinol (THC) 12,684

1.1.1.62 Theophylline 33

1.1.1.63 Triglycerides 12,898

1.1.1.64 Troponin 3,486

1.1.1.65 Thyroid Stimulating Hormone 8,855

1.1.1.66 Iron-Binding Capacity 5,281

1.1.1.67 Uric Acid 771

1.1.1.68 Valproic Acid 74

1.1.1.69 Vancomycin 168

1.1.1.70 Vitamin B12 2,865

1.1.2. Where applicable, the system may or may not require an onsite water purification system for testing and rinsing between samples. If applicable, the Contractor shall provide a water purification system solution at no additional cost to the Government.

1.1.3. Installation of any systems will not require the Government to perform any permanent structural changes or renovations to the medical facility, such as modifying facility to introduce new plumbing fixtures, or any other structural changes of a similar nature.

1.1.4. The standard of care provided must be in accordance with the College of American Pathologists (CAP) accrediting agency, The Joint Commission (TJC) and with existing laboratory practice guidelines. This will be periodically evaluated by the Chief of Clinical Laboratory Services and reported through the hospital Executive Committee of the medical staff.

1.1.5. The contractor shall provide the laboratory with exact or upgraded equipment in the event of replacement due to service/repair.

1.1.6. The contractor shall provide a fully integrated testing platform solution consisting of two identical analyzers capable of performing tests listed in Section 1.1.1.

1.1.7. The contractor shall provide a comprehensive solution that addresses the reduction, mitigation, or complete elimination of carryover between samples. Please provide mitigation plan in proposal.

1.1.8. Analyzer must be capable of testing serum, plasma, urine, CSF, and whole blood specimens.

1.1.9. Analyzer must have capability to run low volume and pediatric samples.

1.1.10. Analyzer must have throughput of at least 800 tests per hour.

1.1.11. Analyzer must have minimal maintenance requirements. Provide a detailed schedule of daily maintenance performed by the user with hands-on times listed.

1.1.12. Analyzer must have capability to read and manage reagent lot and information via bar-code scanner

1.1.13. Analyzer must have the ability to manage, add, and remove any reagent cartridges while actively performing patient testing.

1.1.14. Analyzer must sample directly from primary patient tube or an aliquot tube.

1.1.15. Analyzer must have universal compatibility with Sarstedt S-Monovette® and Greiner Vacuette® blood collection tubes: 5mL, 7mL, 10mL, pediatric collection tubes, and micro-sample cups.

1.1.16. Analyzer must recognize all standard barcode symbologies.

1.1.17. Analyzer must be capable of automatic test dilution and repeat tests automatically, i.e.

user definable reflex testing.

1.1.18. Analyzer automatically reflexes to different assays based on test parameters

1.1.19. Analyzer must be capable of general chemistry and immunochemistry testing from same sample tube without technician intervention.

1.1.20. Technical manual and help documents must be available onboard the analyzer

1.1.21. Analyzer system shall prevent patient test results from transmitting in the event of calibration or quality control failure.

1.1.22. Analyzer must have means of archiving patient result, quality control, calibration and maintenance data, such as a USB drive or read/write disk drive.

1.1.23. Analyzer must be compatible with the Data Innovations laboratory information system to include ability to upload results individually, by sample, or by group, and HL7 protocols.

1.1.24. Analyzer must store maintenance records onboard

1.1.25. The contractor shall possess and maintain an ATO to prior making any connecting to the network.

1.2 REAGENTS & CONSUMABLES

1.2.1 All reagents must have current FDA approval.

1.2.2 The contractor shall provide a means of reagent and consumable inventory management and delivery.

1.2.3 The contractor shall offer drop shipment of all reagents and consumables.

1.2.4 Reagents and consumables to perform the assay tests listed in 1.1.1. will be included in the cost per reportable pricing.

1.2.5 Reagents and consumables shall have minimum 3 month shelf life upon delivery.

1.2.6 Reagents must be ready for use without reconstitution. Provide a list of any reagents that require preparation.

1.2.7 Reagents and must be barcoded and traceable when on board the analyzer.

1.2.8 Reagents shall require a minimum of two levels of quality control daily.

1.2.9 Reagents shall have less than 5% wastage due to system or reagent problems. The contractor must assume cost of any wastage greater than 5%.

1.2.10 The contractor shall have a system for managing the reagent inventory level on board the analyzer system.

1.2.11 Upon request, the contractor will provide sufficient reagents for in-house evaluation and troubleshooting of each analyte.

1.2.12 New reagents lots must exhibit at least 95% agreement with reagent lots currently in use.

1.2.13 The contractor shall provide assistance troubleshooting any issues that result from College of American Pathologists (CAP) proficiency testing.

1.2.14 Reagents must have sufficient onboard stability. Provide a list of any reagents with less than 14 days onboard stability.

1.2.15 Assays must have sufficient calibration stability. Provide a list of calibration stabilities for each assay.

1.3 SAMPLE INTEGRITY

1.3.1 The contractor shall provide an analyzer capable of clot detection, air bubble detection, and short sample detection. When a clot, air bubble, or short sample is detected for a pediatric/low volume sample, the analyzer must be capable of being reintroduced and prioritized for testing.

1.3.2 The contractor shall provide an analyzer capable of assessing and flagging hemolysis, icterus, and lipemia in testing samples. If an interfering agent/substance is present it should flag the associated sample and any individual test results affected by that interfering agent/substance only. The level of acceptance or rejection must be user definable.

1.3.3 Must detect sample volume and alert technician when sample volume is not sufficient before testing starts.

1.3.4. The contractor shall provide an analyzer that is capable of performing dedicated “STAT” testing and procedures during a routine testing cycle followed by automatic completion of the routine testing cycle.

1.3.5 The contractor shall provide an analyzer capable of preserving samples, including pediatric, when there is a problem with aspiration, i.e. returning the sample to the test tube or analyzer cup.

1.4 INSTALLATION & REMOVAL

1.4.1 The contractor shall ensure the analyzer system is fully installed and operational by company engineers and product specialists.

1.4.2 The contractor shall provide initial setup of analyzer, perform initial validation calibration, linearity, instrumental validation, “within run” precision, “between run” precision, and patient comparison between existing on site analyzers and normal range studies. The product/report must be in accordance with CAP/TJC guidelines and approved by the Lab Director. The presentation/data will be bound in notebook form for presentation to the lab’s accrediting bodies, CAP and TJC.

1.4.3 The contractor must provide a full uninterruptable power supply (UPS) for the analyzer system and incidental accessories.

1.4.4 The contractor must supply a sufficient number of printers dedicated to analyzer.

1.4.5 The contractor must provide necessary logistics for transport, delivery, unpacking, assembly, and installation of new analyzer and incidentals.

1.4.6 The contractor must assume all responsibility for clean-up and disposal of any transport/packaging related waste materials post installation.

1.4.7 The contractor shall be responsible for removal of equipment after contract expiration.

1.5 TRAINING

1.5.1 The contractor must provide training to include onsite and offsite training. Onsite training will be a minimum of once per year to accommodate rotation of personnel. Offsite training will be a minimum of two per year over the length of the contract. The contractor will provide all travel, lodging, meals, and any additional expenses that are training specific.

1.6 SERVICE

1.6.1 The contractor shall provide 7 days a week, 24 hours hotline technical support in which a live person is available to provide verbal assistance.

1.6.2 The contractor shall provide in-house technical maintenance support, within 24 hours of call being placed, if laboratory personnel are unable to troubleshoot/resolve any analyzer issues, failures, or errors.

1.6.3 The contractor shall schedule and provide preventative maintenance on the analyzer when required.

1.6.4 The contractor shall provide all parts, labor, and services on the analyzer system.

1.6.5 The contractor shall be able to provide onsite and remote support for the analyzer system as permitted by the Government network regulations.

1.6.6 The contractor shall provide all software/hardware upgrades for the analyzer system.

1.6.7 The contractor shall provide a comprehensive solution that addresses scheduled system downtime for any required daily, weekly, monthly, etc., maintenance and quality control. The duration of required downtime will be agreeable to the Government based on mission requirements at that time.

1.6.8 The contractor shall provide a comprehensive solution that addresses unscheduled downtime due to analyzer error, failure, etc., and the duration of downtime will be agreeable to the Government and based upon mission requirements at that time.

1.7 SUPPORT STAFF

1.7.1 The contractor shall provide the names, contact information, locations, and extent of service engineers, product specialists, and company personnel with whom the organization will have contact.

1.7.2 Contractor personnel shall be trained and knowledgeable of the analyzer system.

1.8 ENVIRONMENTAL SITE VISIT

1.8.1 The contractor must perform a site visit to access the environmental concern of cooling, space, and electrical feasibility.

1.8.2 The contractor shall provide both onsite and remote support for the analyzer system.

SECTION 2: GOVERNMENT FURNISHED PROPERTY AND SERVICES

2.1 GOVERNMENT FUNISHED PROPERTY: Except at noted below, the contractor shall provide everything to perform the services in this statement of work. The contractor will be responsible for safeguarding all government property provided for contractor use. The contractor shall use this property for performance of this contract only.

2.1.1 The MTF will provide appropriate space allocation for rental/leased analyzer system.

2.1.2 The MTF will provide appropriate wiring for network connection within 5 feet of the analyzer system.

2.1.3 The MTF will be responsible for supplying the appropriate 220V electrical outlets for the analyzer system.

2.2 GOVERNMENT FURNISHED FACILITIES: Contract personnel will be authorized to use all common areas (i.e. conference and break rooms) of the MTF available to active duty and civil service personnel of like position. The contract personnel will not be allowed to access to restricted areas of the MTF.

2.3 GOVERNMENT FUNISHED MATERIALS (SUPPLIES):

2.3.1 Personnel Protection Equipment (PPE) laboratory coat, face shields, goggles, gloves, and sharps containers will be available for contractor use.

2.3.2 All equipment will be inventoried upon check-out and return.

2.4 GOVERNMENT FURNISHED SERVICES/EQUIPMENT ACCOUNTABLILITY:

2.4.1 The MTF will provide a point of contact for Laboratory, Bioenvironmental, and Facilities personnel where necessary as deemed by the Government. The MTF will account for all leased/rental equipment via barcode tags and equipment lists.

2.4.2 Contractor personnel will be authorized to use all administrative support equipment available to Government employees. This will include but not be limited to copy machines, fax machines, and Class A telephone lines. The same restrictions to use these items for Government official business apply.

2.5 GOVERNMENT FURNISHED RECORDS: A copy of all preventive maintenance records and service visits will be left with a government representative before the contractor leaves the site. Maintenance of such records and visits will be in accordance with MTF and accrediting body criteria.

2.5.1 Patient information and test results shall be treated as privileged information. Therefore, subject to the Privacy Act of 1974, the Freedom of Information Act, and the Health Insurance Portability and Accountability Act. Policy is delineated in Department of Defense (DoD) Directive 6025.18R, Health Information Privacy Regulation, AFPD 37-1, Air Force Information Management, Air Force Instruction 33-332, Air Force Privacy Act Program, AFI 37-123, Management of Records and AFI 41-210, Patient Administration Functions. These establish procedures designed to protect personnel information from unauthorized use or release and prescribe use and disclosure of Protected Health information, maintain and dispose of records created as a result of prescribed processes, in accordance with the Air Force Records Information System (AFRIMS). These publication are available at http://e-publishing.af.mil.

2.5.2 Contractor personnel shall not release medical information obtained during the course of this contract to other organizations.

SECTION 3: GENERAL INFORMATION

3.1 CONTRACTOR PERSONNEL

3.1.1 The contractor shall provide a technical support and engineer staff that shall be responsible for any service conducted on the analyzer system. The contractor shall designate these individuals in writing to the Contracting Officer before the contract start date. An alternate may be designated, but the contractor shall identify those times when the alternate shall be the primary point-of-contact.

3.1.2 The Government will not be responsible for any reasonable damage or loss occurring to the analyzer system while performing under this contract. This does not include malicious, willful destruction of contractor equipment.

3.1.3 Contractor’s service, telephone support, and trainers shall be able to read, understand, fluently speak, and legibly write English.

3.1.4 The contractor shall have the responsibility and prerogative of selection, assignment, transfer, supervision, management, an control of contractor personnel in performance of this SOW. However, the contractor shall not employ persons for work on this contract if such persons are identified to the contractor by the Contracting Officer as a potential threat to the health, safety, security, general wellbeing or operational mission of the installation and its population.

3.1.5 The contractor shall not employ any person who is an employee of the Government if that person would create a conflict of interest nor shall the contractor employ any person who is an employee of the Department of the Air Force, either military or civilian, unless such person seeks and receives approval in accordance with DODD 5500-7. In addition, the contractor shall not employ any person who is an employee of the Department of the Air Force if such employment would be contrary to the policies contained in AFI 64-106.

3.2 CONTRACTOR PERSONNEL TRAINING

3.2.1 The contractor shall ensure that all personnel performing services under the requirements of this contract, particularly in operation of the analyzer system are qualified and adequately trained.

3.2.2 All contractor personnel shall comply with all MTF infection control and safety procedures, practices, and standards located in the Laboratory Flight. If in the event of a conflict between the MTF’s procedures and the contractor’s procedures, the contractor and Contracting Officer shall attempt to resolve the matter by mutual agreement.

3.3 SECURITY REQUIREMENTS:

3.3.1 The contractor shall ensure all reagents are delivered to 4881 Sugar Maple Dr., Wright- Patterson AFB, OH 45433, ATTN: 88 MDSS SGSLA, BLD 830 Area A. The contractor, or subcontractor if used, shall comply with installation entry procedures in accordance with AFFARS 5352.242-9000, Contractor Access to Air Force Installations.

3.4. ENVIRONMENTAL CONTROL:

3.4.1 If any contractor personnel spills or releases any toxic/hazardous substances into the environment, that individual shall immediately contain the spill and report the incident to any Laboratory staff member who in turn will report the spill to appropriate Government agencies.

3.4.2 The contractor shall provide for housekeeping while servicing the analyzer system at no cost to the Government.

3.4.3 The MTF shall provide for solid, chemical, and hazardous waste disposal.

3.5 PARTNERING AGREEMENT: It is the Government’s objective to foster a team based environment that promotes continuous improvement in contractor performance that results in no-grow cost to the Government throughout the life of this contract. Partnering agreements between the contractor and the Government are highly encouraged to achieve these objectives. Partnering is the creation of a government-contractor relationship that promotes achievement of mutually beneficial goals. It involves an agreement in principle to share risks involved in completing the project and to establish and promote a nurturing “win-win” relationship. All costs and savings for the partnership agreement should be shared equally between the government and contractor.

SECTION 4: APPENDIX

4.1 DEFINITIONS, ABBREVIATIONS, AND ACRONYMS

4.1.1 GENERAL DEFINITIONS: As used throughout this work statement, the following terms shall have the meaning set forth below.

4.1.2 CONTRACTING OFFICER: A person duly appointed with the authority to enter into, administer, and terminate contracts on behalf of the Government.

4.1.3 GOVERNMENT: The federal Government of the United States of America.

4.1.4 GOVERNMENT QUALITY ASSURANCE: Those actions taken by the Government to assure the services meet the requirements of the contract.

4.1.5 MEDICAL TREATMENT FACILITY (MTF): Government hospitals or clinics, including clinical laboratory services.

4.1.6 PERFORMANCE WORK STATEMENT (PWS): A document that accurately describes a service to be performed.

4.1.7 CONTRACTOR REPRESENTATIVE: An individual who is providing direct services analyzers within the 88th Medical Group Clinical Laboratory Flight.

4.1.8 QUALITY CONTROL (QC): Those actions taken by a contractor to control the quality of output to ensure conformity with contract requirements and reasonable standards of medical care.

4.1.9 ANALYZER(S): Laboratory Clinical Chemistry analyzers required to provide quality patient care services.

5.0 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPPAA) OF

Introduction

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.

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 4th 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 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 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.

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.