SOW-Chem Analyzer-DRAFT.pdf

Statement of Work (SOW)

CHEMISTRY ANALYZER

366 Military Treatment Facility/SGGA 90 Hope Drive Bldg 6000

Mountain Home AFB, ID 83648

1. Description of Services. The contractor shall provide the government with chemistry analyzer services over a period of one(1) base year and four (4) option years, on a cost per test/cost per reportable result basis. The cost per test/ per reportable result basis must include all necessary equipment, reagents, 24/7 technical/specialist support, equipment maintenance and repair or replacement. All items and services shall be provided in accordance with all federal, state, local laws, and regulations, manufacturers recommended standards, commercial requirements, and this Statement of Work (SOW).

2. Scope of Work. The government estimates the performance of 436 cost-per tests per day 5 days a week, and the contractor shall provide one (1) chemistry analyzer that has a self-contained waste management, does not require water, plumbing or drains. The contractor shall maintain, replace, repair, provide supplies, as required, in order to ensure the equipment is fully operational and within manufacturer specifications (see appendix A).

2.1. Maintenance. Contractor personnel shall be fully capable to test equipment, tools, perform troubleshooting, repair, preventative maintenance, software upgrades, firmware upgrades, operational checks, and adjustments to on-site equipment in order to ensure the equipment is fully operational during no less than 95% of the total hours of laboratory operation each month. The percentage will be determined by the total number of hours the equipment is fully operational divided by the number of hours the laboratory was staffed to provide services.

2.2. Maintenance Scheduling and Documentation. The contractor shall perform scheduled preventative maintenance (PM) inspections, per the manufacturer’s recommendations, for the equipment p r o v i d e d u n d e r t h i s SOW. The contractor shall provide a maintenance schedule, in writing to the assigned government representative for review.

2.3. Repairs. The contractor is responsible for all repair costs to include parts and labor for the Chemistry Analyzer.

2.4. Service calls for Emergency Repairs. The contractor shall effect repairs within twenty four (24) hours after notification of an emergency service call. This includes on-site emergency response from 0700-1700, seven (7) days a week.

DRAFT

2.5. Telephone Support. Contractor shall provide toll-free remote telephone support 7 days a week, 24 hours a day for diagnosing problems, delivering technical assistance to resolve complex equipment and scientific issues, and scheduling/responding to emergency repairs.

2.6. Training. The Contractor shall provide training for at least two government users at contract start, and one additional user with each contract option period.

3. Government Furnished Property and Services.

3.1 The government will provide utility (electricity, telephone, fax) and needed administrative support necessary for the contractor to perform maintenance and repairs.

4. General Information.

4.1. Hours of Operation. The normal hours of operation for the Medical Group Laboratory is 7:30 A.M. thru 4:30 P.M., Mountain Time, Monday-Friday excluding federal holidays, and family days. The following federal holidays are observed:

January 1 3rd Monday in January 3rd Monday in February Last Monday in May July 4 1st Monday in Sept 2nd Monday in Oct November 11 4th Thursday in Nov December 25

New Year’s Day Martin Luther King, Jr. Day President’s Day Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas

4.2. The contractor shall notify the Military Treatment Facility Service Contract Manager of any problems incurred during the performance of this contract.

4.3 Continuation of Mission Essential Functions. IAW DoDI 1100.22 (Policy and Procedures for Determining Workforce Mix), and any applicable Air Force implementation, unless otherwise directed by an authorized Government representative, it is determined that services and procedures identified in this SOW are not mission essential during a crisis.

5.0 Installation- Lab Chemistry Analyzer

5.1. Installation: Placement and installation of a clinical chemistry analyzer and all equipment components inclusive, but not limited to; the entire laboratory associated mechanical, electromechanical parts and supplies. Installation shall conform to Industry Standards and shall meet or exceed with all applicable codes to include Local/State Regulations, NFPA, building codes, communications codes, and other codes for each utility identified. The total footprint for the Chemical Analyzer and the Uninterrupted Power shall not exceed 78inches in length and 48 inches in depth (78”x48”). The contractor shall provide the following services for staff which shall include the following tasks and those listed in detail in paragraphs 5.2. through 5.5.

5.2 Uninterrupted Power Supply: The contractor shall provide an Uninterrupted Power Supply (UPS) for each analyzer and must be installed in the same room, to be positioned on the analyzer’s side with a minimum clearance of 4 (four) inches on all 4 sides for proper ventilation. This UPS is a self-operated unit that provides enough power, during a commercial power outage to the analyzer, to ensure that the chemistry analyzer system remains operational. The contractor shall provide the specific type of UPS required for their emergency use at the 366 MTF.

5.3 Complete daily clean-up and a final (upon installation completion) clean-up of the work area. To include any need for cosmetic repairs on walls, floorings, ceiling, etc.

5.4 The contractor shall provide a project manager to perform/oversee system installation, correlation, validation. The contractor shall provide all validation reagent/materials needed to perform these tasks.

5.5 The contractor is responsible for the removal of the clinical chemistry analyzers at the end of the contract period.

6.0 Health Insurance Portability And Accountability Act (HIPAA) Requirements Business Associate Agreement

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, shall mean GSL Solutions, Inc..

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 366th Medical Group, Mountain Home Air Force Base, ID.

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.

(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 such party’s address given below.

If to the Business Associate: If to the Covered Entity:

Attn: Attn: Lisa Miller Title: Title: MTF HIPAA Privacy Officer Company: Unit: 366th Military Treatment Facility Address: Address: 90 Hope Drive, Building 6000

Mountain Home AFB, Id 83648

Phone: Phone: (208) 828-7498 Fax: Fax:

E-mail: E-mail: lisa.r.miller30.civ@mail.mil

With a copy to:

Name: Name:

Company: Title:

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.

Attachments:

1. Appendix A - Salient Characteristics- Chemistry Analyzer

2. Appendix B - Test Menu Requirements

APPENDIX A – SALIENT CHARACTERISTICS – CHEMISTRY ANALYZER

A.1. Analyzer: The contractor shall provide one (1) analyzer that meets the requirements and the performance characteristics identified in this SOW for accuracy and precision as defined in the 1988 Clinical Laboratory Improvement Act (CLIA '88) and the Clinical Laboratory Standards Institute (CLSI formerly NCCLS) as follows:

A.2. The chemistry analyzer s h a l l h a v e a self-contained waste management, does not require water, plumbing or drains. The contractor shall maintain, replace, repair, provide supplies, and replacement as required, in order to ensure the equipment is fully operational and within manufacturer specifications.

A.3. Instruments and assays shall be FDA approved (the contractor shall provide proof of approval), and had no FDA warning letters or no more than 3 FDA recalls issued over the past 24 months.

A.4. The chemistry analyzer shall not have a standby mode system, always be available/in normal operation including no manual priming, purging or tubing maintenance, and liquid reagents must be capped while onboard.. It shall be ergonomically designed with flat touch screen monitor and on-board instructions, and help functions.

A.5. The unit shall have an on-board test capacity for 125 reagent/diluent positions for multiple assays. Must have stability tracking and predict user needs. Must be able to house all current assays packs plus at least one spare. Must be able to load packs while instrument is running. No preparation, mixing or reconstitution shall be required for integrated reagent packs and the packs shall have on-board stability of 30 days and a shelf life of up to 18 months from date of manufacture.

A.6. The unit must have self-contained onboard waste management and must not require external water/plumbing, drains, stirring mechanisms, mixing assemblies, or floor vents.

A.7. The Chemistry Analyzer shall utilize disposable tips. The system must not use reusable probes to aspirate the sample and reagent.

A.8. The analyzer shall be able to aspirate the sample from a track, using point in space metering, with a sample throughput up to 30 primary tubes/samples.

A.9. No dedicated reagent positions shall be required, and the unit shall have minimal reagent preparation.

A.10. The analyzer shall be able to run up to 10-user defined channel/assays at one time and have flexible processing for routine and STAT testing. Can utilize universal sample trays which can accommodate primary tubes including these sample containers:

Collection Tubes (10ml, 5ml 3ml, , 2-4ml), Micro-tube (1 ml), Micro-sample cups (.5ml and 2ml) without adapters.

A.11. Have positive patient identification via on-board barcode scanner. Have turnaround time for a single result of 2.5 to 16 minutes with an estimated throughput of approximately 30 samples per hour for chemistry assays.

A.12. Able to utilize Direct ISE Potentiometric (Na/K/CI), Colorimetric/Rate, immuno-rate testing methods and use the direct ISE method to measure sodium, potassium and chloride.

A.13. Have on-board dilution; specifically, auto dilution, auto repeat and auto reflex capability.

Be self-monitoring and alert operators to prompt action.

A.14. Provide sample management with clot detection, bubble detection, liquid level-sensing, short-sample detection. The system must save the sample if a clot or bubble is detected during primary aspiration.

A.15. Be able to determine hemolysis, icterus and turbidity levels without additional patient sample, reagents, consumables and no effect on throughput. It must flag only assays affected by the interfering substance. It must send notification and levels to the LIS or data management system.

A.16. Support multiple lots onboard, have random access and capable of performing automatic calibration/lot switching with on-board linearity program and the use of ready-to-use calibration materials. Shall have stable (six month or longer) calibrations and only require calibration every 6 months or as indicated after change of reagent lot use; when critical system parts are changed due to service or maintenance, if quality control results are consistently outside acceptable ranges, or when government regulations require.

A.17. Foot print - for analyzer, analyzer clearance, monitor, keyboard, CPU, printer and

UPS.

A.18. Provide Cost-Per-Test (CPT) or Cost-Per-reportable Result (CPRR) pricing for 100% of tests listed in Appendix C. The price shall include costs covering:

A.21. All necessary maintenance to keep the equipment in good operating condition. This includes both preventive maintenance and emergency repairs.

A.22. The contractor shall provide during initial install on-site technical support and new test validation reagent & materials needed to bring the analyzer to full operational status.

A.23. System must be capable of interfacing with current laboratory management software:

Composite Health Care System (CHCS ver. R2W).

A.24. The chemical analyzer system must have a windows-based printer, read/write disk drive for data input and archiving up to 25,000 results using CD-ROM or USB flash drive.

APPENDIX B - TEST MENU REQUIREMENTS

Acetaminophen Albumin

ALT

ALK P

Alcohol Amylase

AST

BuBc Bilirubin Calcium Carbon Dioxide Chloride Cholesterol

CK

Creatinine dHDL dLDL d%A1c

GGT

Glucose HbA1c Lactate

LDH

Lipase Magnesium Microalbumin Phosphorus Potassium Salicylates Sodium Total B-hCG Generation II Total Bilirubin Total Protein Triglycerides

TSH

Urea Uric Acid Urine Protein