9_-_RFQ_Attachments.docx

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Intraoperative Monitoring, Naval Medical Center Portsmouth
Solicitation number
N62645-16-T-0002
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Solicitation Attachments 1 through 7

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9_-_RFQ_Attachment_8_-_Medical_Device_Risk_Assessment.pdf PDF
9_-_RFQ_Attachment_9_-_MDRA_Instructions.pdf PDF

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ATTACHMENTS

1. Quality Assurance Surveillance Plan (QASP)

1. Historical Data

1. Past Performance Information Sheet

1. Business Associate Agreement

1. Lists of Acceptable Documents to Establish U.S. Citizenship

1. Malpractice Insurance Certification Form

1. CAP (Firm Fixed Price)

1. Medical Device Risk Assessment (MDRA)

1. MDRA Instructions

Attachment 1

QUALITY ASSURANCE SURVEILLANCE PLAN

Objective: This Quality Assurance Surveillance Plan (QASP) serves as the principal basis for assessing the overall quality of the contractor’s performance. It provides the methodology by which the contractor's performance will be monitored to determine compliance with required performance objectives and to determine if acceptable quality levels have been met. The plan is designed so that surveillance is limited to that which is necessary to verify that the contractor is performing at an acceptable level.

Performance Requirements Summary Table:

Deliverable or Service Requirement
Measurement/Metric
Performance Standard
Acceptable Quality Level (AQL)
Method of Surveillance
PWS Section 2 & 8
Technical Performance
Equipment/Supplies: Provide, set-up and operate all required intraoperative neurophysiologic monitoring system(s) and supplies need to perform services as described in the PWS, and provide troubleshooting, cleanliness, and inspection/maintenance of equipment in accordance with the manufacturer’s guidelines.
100%
Customer complaints, direct observation on a periodic basis and review of Contractor’s records, as requested by the Government
PWS Section 2
Technical Performance
Outcomes: The Contractor shall provide accurate detection of nerves leading to favorable patient outcomes. The Contractor shall provide clear communication/feedback to the surgeon during each procedure.
100%
100% inspection
PWS Section 2 & 3
Timeliness
Coverage for Scheduled and Emergency Procedures: Provide staff for procedures as scheduled and on an emergency basis within the timeframes indicated in the PWS.
100%
100% inspection
PWS Section 2
Satisfaction
Customer Feedback: COR and end users satisfied with Contractor’s overall performance.
No more than one (1) substantiated negative survey or complaint per year
User surveys or customer complaints

Attachment 2 – Historical Data

Date of Surgery
Surgery Type
Procedures
In Room Time
Out Room Time
Surgery Time
20 Dec 13
Orthopedic
External Fixator, Revision
7:46
12:55
5:09
30 Dec 13
Orthopedic
Lengthening of Growth Rods
7:28
9:43
2:15
07 Jan 14
Orthopedic
Hardware Exchange
8:32
13:05
4:33
07 Jan 14
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
13:50
16:27
2:37
14 Jan 14
Orthopedic
Arthrodesis, Posterior Lumbar
8:20
11:21
3:01
14 Jan 14
Orthopedic
Arthrodesis, Posterior Lumbar
12:05
14:43
2:38
23 Jan 14
Orthopedic
Acetabulum Fracture
10:04
19:22
9:18
04 Feb 14
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
14:14
17:25
3:11
06 Feb 14
Orthopedic
Arthrodesis, Posterior Lumbar
7:35
12:47
5:12
11 Feb 14
Orthopedic
Posterior Instrumentation and fusion, 1-6 vertibrae
8:25
14:10
5:45
12 Feb 14
Orthopedic
Vertical Expandable Prosthetic Titanium Rib Expansion Thoracostomy
7:30
10:18
2:48
18 Feb 14
Orthopedic
Arthrodesis, Posterior Lumbar
8:26
15:24
6:58
25 Feb 14
Orthopedic
Arthrodesis, Posterior Lumbar
8:23
13:50
5:27
27 Feb 14
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
7:33
11:57
4:24
27 Feb 14
Orthopedic
Arthrodesis, Posterior Lumbar
12:50
17:46
4:56
05 Mar 14
Orthopedic
Lengthening of Growth Rods
9:20
12:35
3:15
14 Mar 14
Orthopedic
Neuroforamial Decompression
7:36
10:00
2:24
14 Mar 14
Orthopedic
Neuroforamial Decompression
10:32
12:35
2:03
20 Mar 14
Orthopedic
Arthrodesis, Posterior Lumbar
12:48
16:20
3:32
27 Mar 14
Orthopedic
Arthrodesis, Posterior Cervical
7:51
11:03
3:12
27 Mar 14
Orthopedic
Arthrodesis Revision, Posterior Lumbar
11:59
20:10
8:11
31 Mar 14
Orthopedic
Vertical Expandable Prosthetic Titanium Rib Expansion Thoracostomy
9:33
11:33
2:00
08 Apr 14
Orthopedic
Hemilaminotomy/Facetectomy
8:24
11:00
2:36
10 Apr 14
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
7:53
13:04
5:11
22 Apr 14
Orthopedic
Arthrodesis, Posterior Lumbar
8:39
15:02
6:23
29 Apr 14
Orthopedic
Laminectomy Cervical - more than 2 vertebral segments
8:36
15:30
6:54
01 May 14
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
9:34
13:43
4:09
22 May 14
Orthopedic
Arthrodesis, Posterior Lumber
17:08
23:05
5:57
29 May 14
Orthopedic
Lumbar Laminectomy with Exploration
10:00
12:41
2:41
03 Jun 14
Orthopedic
Lumbar Laminotomy/Foraminotomy/Diskectomy
8:34
11:08
2:34
03 Jun 14
Orthopedic
Lumbar Laminotomy/Foraminotomy/Diskectomy
11:57
13:57
2:00
16 Jun 14
Orthopedic
Posterior Instrumentation and fusion, 7-12 vertibrae
7:24
14:19
6:55
26 Jun 14
Orthopedic
Neuroforaminal Decompression
7:29
9:13
1:44
26 Jun 14
Orthopedic
Lumbar Laminectomy with Exploration
9:41
13:33
3:52
08 Jul 14
Orthopedic
Arthrodesis Revision, Posterior Lumbar
10:40
16:31
5:51
10 Jul 14
Orthopedic
Posterior Instrumentation and fusion, 1-6 vertibrae
9:55
16:40
6:45
21 Jul 14
Orthopedic
Posterior Instrumentation and Fusion 13+ vertebrae
7:40
14:32
6:52
31 Jul 14
Orthopedic
Arthrodesis, Posterior Lumbar
7:24
12:15
4:51
07 Aug 14
Orthopedic
Vertebral Corpectomy, Lumbar Single Segment
7:52
12:55
5:03
12 Aug 14
Orthopedic
Posterior Instrumentation and fusion, 7-12 vertibrae
16:57
21:19
4:22
21 Aug 14
Orthopedic
Arthrodesis, Posterior Lumbar
10:14
15:33
5:19
25 Aug 14
Orthopedic
Posterior Instrumentation and Fusion 13+ vertebrae
7:29
17:25
9:56
02 Sep 14
Orthopedic
Foraminotomy, Lumbar
10:54
13:57
3:03
09 Sep 14
Orthopedic
Arthrodesis, Posterior Lumbar
11:28
15:25
3:57
30 Sep 14
Orthopedic
Lumbar Microdiscectomy
11:06
13:45
2:39
02 Oct 14
Orthopedic
Arthrodesis, Posterior Lumbar
14:43
19:11
4:28
09 Oct 14
Orthopedic
Decompression/Fusion L4-S1
13:40
17:54
4:14
21 Oct 14
Orthopedic
Lumbar Microdiscectomy
12:30
15:08
2:38
23 Oct 14
Orthopedic
Arthrodesis, Posterior Lumbar
10:28
14:18
3:50
28 Oct 14
Orthopedic
Lumbar Laminotomy/Foraminotomy/Diskectomy
12:05
15:15
3:10
30 Oct 14
Orthopedic
Central/Foraminal Decompression and IO Flex
10:07
14:36
4:29
06 Nov 14
Orthopedic
Lumbar Microdiscectomy
7:32
10:10
2:38
06 Nov 14
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
10:59
14:56
3:57
18 Nov 14
Orthopedic
Decompression/Fusion L5-S1
8:42
11:20
2:38
04 Dec 14
Orthopedic
Arthrodesis, Posterior Lumbar
15:14
19:40
4:26
11 Dec 14
Orthopedic
Arthrodesis, Posterior Lumbar
7:30
10:49
3:19
11 Dec 14
Orthopedic
Arthrodesis, Posterior Lumbar
11:29
15:11
3:42
06 Jan 15
Orthopedic
Laminoplasty, Cervical
12:15
17:05
4:50
08 Jan 15
Orthopedic
Lumbar Microdiscectomy
7:43
10:07
2:24
08 Jan 15
Orthopedic
Arthrodesis, Posterior Lumbar
11:05
17:12
6:07
15 Jan 15
Orthopedic
Arthrodesis, Posterior Lumbar
7:45
13:15
5:30
15 Jan 15
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
13:50
18:40
4:50
22 Jan 15
Orthopedic
Arthrodesis, Posterior Lumbar
7:29
12:58
5:29
26 Jan 15
Orthopedic
Arhtrodesis Revision, Poesterior Lumbar
7:24
14:19
6:55
27 Jan 15
Orthopedic
Laminectomy with right L5-S1 Neuroforaminotomy
11:42
16:09
4:27
03 Feb 15
Orthopedic
Arhtrodesis, Posterior Lumbar
8:30
12:09
3:39
04 Feb 15
Orthopedic
Revision of Instrumentation
9:30
15:38
6:08
05 Feb 15
Orthopedic
Arthrodesis, Posterior Lumbar
7:30
14:19
6:49
09 Feb 15
Orthopedic
Vertical Expandable Prosthetic Titanium Rib Expansion Thoracostomy
8:06
10:00
1:54
24 Feb 15
Orthopedic
Posterior Instrumentation and fusion, 7-12 vertibrae
8:30
15:55
7:25
03 Mar 15
Orthopedic
Arthrodesis, Posterior Lumbar
8:24
13:55
5:31
04 Mar 15
Orthopedic
Posterior Instrumentation and fusion, 1-6 vertibrae
7:30
15:35
8:05
05 Mar 15
Orthopedic
Arthrodesis, Posterior Lumbar
7:29
11:49
4:20
12 Mar 15
Orthopedic
Arthrodesis Revision, Posterior Lumbar
7:27
12:57
5:30
17 Mar 15
Orthopedic
Arthrodesis Revision, Posterior Lumbar
8:48
13:17
4:29
23 Mar 15
Orthopedic
Posterior Instrumentation and fusion, 7-12 vertibrae
7:29
13:28
5:59
24 Mar 15
Orthopedic
Foraminotomy, Lumbar
7:20
10:11
2:51
25 Mar 15
Orthopedic
Posterior Instrumentation and fusion, 7-12 vertibrae
7:30
14:50
7:20
02 Apr 15
Orthopedic
Arthrodesis, Posterior Lumbar
7:39
10:19
2:40
07 Apr 15
Orthopedic
Posterior Instrumentation and fusion, 1-6 vertibrae
8:33
11:58
3:25
08 Apr 15
Orthopedic
Posterior Instrumentation and Fusion 13+ vertebrae
7:30
13:39
6:09
09 Apr 15
Orthopedic
Arthrodesis, Posterior Lumbar
7:30
13:14
5:44
13 Apr 15
Orthopedic
Arthrodesis, Posterior Lumbar
7:37
15:30
7:53
21 Apr 15
Orthopedic
Arthrodesis, Posterior Lumbar
8:24
12:44
4:20
30 Apr 15
Orthopedic
Arthrodesis Revision, Posterior Lumbar
7:30
12:38
5:08
04 May 15
Orthopedic
Revision of Instrumentation
7:28
14:36
7:08
05 May 15
Orthopedic
Posterior Instrumentation and Fusion 13+ vertebrae
7:50
14:18
6:28
13 May 15
Orthopedic
Arthrodesis Revision, Posterior Lumbar
7:30
14:05
6:35
18 May 15
Orthopedic
Posterior Instrumentation and fusion, 1-6 vertibrae
7:28
14:22
6:54
18 May 15
Orthopedic
Foraminotomy, Lumbar
15:05
17:00
1:55
19 May 15
Orthopedic
Posterior Instrumentation and fusion, 1-6 vertibrae
8:30
12:24
3:54
21 May 15
Orthopedic
Posterior Instrumentation and fusion, 1-6 vertibrae
7:35
11:15
3:40
26 May 15
Orthopedic
Arthrodesis Revision, Posterior Lumbar
8:27
10:47
2:20
16 Jun 15
Orthopedic
Posterior Instrumentation and fusion, 7-12 vertibrae
8:51
16:45
7:54
23 Jun 15
Orthopedic
Arthrodesis, Posterior Lumbar
8:30
11:14
2:44
13 Jul 15
Orthopedic
Unlisted Procedure, Pelvis or Hip Joint
8:07
10:23
2:16
21 Jul 15
Orthopedic
Artificial Disc Replacement, Cervical
8:37
10:42
2:05
28 Jul 15
Orthopedic
Arthrodesis, Posterior Lumbar
8:30
12:39
4:09
28 Jul 15
Orthopedic
Aritificial Disc Replacement
13:10
15:29
2:19
30 Jul 15
Orthopedic
Arthrodesis Revision, Posterior Lumbar
10:02
13:26
3:24
18 Aug 15
Orthopedic
Arthrodesis, Posterior Lumbar, Axial LIF
8:30
12:43
4:13
20 Aug 15
Orthopedic
Artificial Disc Replacement, Cervical
7:40
9:31
1:51
25 Aug 15
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
8:28
11:11
2:43
01 Sep 15
Orthopedic
Arthrodesis, Posterior - each additional level
8:41
11:25
2:44
08 Sep 15
Orthopedic
Arthrodesis, Posterior Lumbar
8:29
12:38
4:09
15 Sep 15
Orthopedic
Arthrodesis, Posterior Lumbar
8:34
12:13
3:39
15 Sep 15
Orthopedic
Artificial Disc Replacement, Cervical
12:51
15:04
2:13
29 Sep 15
Orthopedic
Laminectomy Cervical - more than 2 vertebral segments
8:55
12:33
3:38
29 Sep 15
Orthopedic
Arthrodesis, Posterior Cervical
13:20
17:25
4:05
01 Oct 15
Orthopedic
Arthrodesis, Posterior Lumbar
7:30
12:20
4:50
06 Oct 15
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
8:22
11:27
3:05
06 Oct 15
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
12:00
15:24
3:24
13 Oct 15
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
13:23
16:20
2:57
20 Oct 15
Orthopedic
Arthrodesis, Posterior Lumbar
8:30
12:05
3:35
20 Oct 15
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
12:55
17:40
4:45
03 Nov 15
Orthopedic
Arthrodesis Revision, Posterior Lumbar
10:19
14:16
3:57
05 Nov 15
Orthopedic
Arthrodesis, Anterior Cervical w/ Discectom
7:36
11:49
4:13
10 Nov 15
Orthopedic
Artificial Disc Replacement, Cervical
8:33
10:31
1:58
10 Nov 15
Orthopedic
Arthrodesis, Posterior Lumbar
11:06
14:12
3:06
17 Nov 15
Orthopedic
Artificial Disc Replacement, Cervical
12:21
15:11
2:50
17 Nov 15
Orthopedic
Artificial Disc Replacement, Cervical
15:46
19:22
3:36
19 Nov 15
Orthopedic
Arthrodesis Revision, Posterior Lumbar
7:37
11:10
3:33
19 Nov 15
Orthopedic
Arthrodesis Revision, Posterior Lumbar
11:50
14:30
2:40

Attachment 3

PAST PERFORMANCE INFORMATION SHEET

1. POC information to include name, title, phone number, e-mail address, agency name, and address:

2. Contract Number and Task Order number(s), if applicable:

3. Name of contractor to whom the contract was awarded. Provide the CAGE Code and DUNS numbers of the awardee:

4. Dates when services were provided:

5. Place(s) of performance:

6. Provide a description of the intraoperative monitoring services provided. Specify if services were scheduled or on an emergency basis, response time, and provide information on the annual volume of services provided:

7. The contractor shall provide information on problems encountered on the identified contract(s) and the contractor’s corrective actions:

Attachment 4

BUSINESS ASSOCIATE AGREEMENT

This Business Associate Agreement (BAA) incorporates HIPAA/HITECH Act requirements under the HHS Final Omnibus Rule (78 FR 5566, published 25 Jan 2013), effective 23 Sep 2013. This BAA is for use by MHS components outside of DHA.

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 12 Nov 2013 Page 2 of 10 persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean the contractor.

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 the Government facility(s) and office(s) that are supported under this contract.

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

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

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

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

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

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

I. Obligations and Activities of Business Associate

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

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

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

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

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

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

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

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

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

II. Permitted Uses and Disclosures by Business Associate

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

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

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

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

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

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

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

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

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

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

IV. Permissible Requests by Covered Entity

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

V. Breach Response

(a) In general.

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

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

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

(b) Government Reporting Provisions

The Business Associate shall report the breach within one hour of discovery to the US Computer Emergency Readiness Team (US CERT), and, within 24 hours of discovery, to the DHA Privacy Office and the other parties set forth below. The Business Associate is deemed to have discovered a breach as of the time a breach (suspected or confirmed) is known, or by exercising reasonable diligence would have been known, to any person (other than the person committing it) who is an employee, officer or other agent of the Business Associate.

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

The Business Associate report due within 24 hours shall be submitted by completing the New Breach Reporting Form DD 2959 at the Breach Response page on the DHA Privacy Office web site and emailing that form to, as applicable, the DHA Privacy Office, the Service-Level Privacy Office, the Contracting Officer (CO) and Contracting Officer’s Representative (COR) and the Business Associate’s DoD point of contact (POC) unless the POC specifies another addressee for breach reporting. Encryption is not required, because Breach Report Forms should not contain PII/PHI. The email address for notices to the DHA Privacy Office is provided at the Privacy Office website breach response page. If electronic mail is not available, telephone notification is also acceptable, but all notifications and reports delivered telephonically must be confirmed by email as soon as technically feasible.

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 DHA Privacy Office as soon as possible if it believes that “single event” breach response is appropriate; the DHA Privacy Office will determine how the Business Associate shall proceed and, if appropriate, consolidate separately reported breaches for purposes of Business Associate report updates, beneficiary notification, and mitigation.

When a Breach Report 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, follow-up, etc. The Business Associate shall submit these report updates promptly after the new information becomes available. Prompt reporting of updates is required to allow the DHA Privacy Office 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 DHA Privacy Office to make timely and accurate determinations on reports to HHS as required by the HHS Breach Rule and reports to the Defense Privacy and Civil Liberties Office as required by DoD Privacy Act Issuances.

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

(c) Individual Notification Provisions

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

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

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

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

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

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

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

If the Business Associate determines that it cannot readily identify, or will be unable to reach, some affected individuals within the 10 day period after discovering the breach, the Business Associate shall so indicate in the initial or updated Breach Report 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 DHA Privacy Office, which will determine which media notice is most likely to reach the population not otherwise identified or reached. The Business Associate shall issue a generalized media notice(s) to that population in accordance with Privacy Office approval.

The Business Associate shall, at no cost to the government, bear any costs associated with a breach of PII/PHI that the Business Associate has caused or is otherwise responsible for addressing.

Breaches are not to be confused with security incidents (often referred to as cyber security incidents when electronic information is involved), which may or may not involve a breach of PII/PHI. In the event of a security incident not involving a PII/PHI breach, the Business Associate shall follow applicable DoD Information Assurance requirements under its Agreement. If at any point the Business Associate finds that a cyber security incident involves a PII/PHI breach (suspected or confirmed), the Business Associate shall immediately initiate the breach response procedures set forthhere. The Business Associate shall also continue to follow any required cyber security incident response procedures to the extent needed to address security issues, as determined by DoD/DHA.

VI. Termination

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

(b) Effect of Termination.

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

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

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

VII. Miscellaneous

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

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

Attachment 5

Lists of Acceptable Documents to Establish U.S. Citizenship

Excerpt from SECNAV M-5510.30 of June 2006, Appendix F

4. All documents submitted as evidence of U. S. citizenship must be original documents or certified copies. Uncertified copies are not acceptable. The following documents are acceptable proof of citizenship:

a. The original U. S. birth certificate with a raised seal issued at the time of birth from one of the 50 states, or outlying territories or possessions.

b. A hospital birth certification (clinic and commercial birth center certification is not permitted) with an authenticating raised seal or signature provided all vital information is given.

c. A delayed birth certificate provided it shows the birth record was filed within one year after birth, it bears the registrar's seal and signature, and cites secondary evidence such as a baptismal certificate, certificate of circumcision, affidavits of persons having personal knowledge of the facts of the birth or other official records such as early census, school or insurance.

d. U.S. Passport (current or expired) or U.S. passport issued to individual’s parent in which the individual is included.

e. FS-240 Report of Birth Abroad of a Citizen of the United States of America/Consular Report of Birth.

f. FS-545 Certification of Birth issued by a U.S. Consulate or DS-1350 the Department of State Certification.

g. INS N-550/570 U.S. Immigration and Naturalization Service Naturalization Certificate.

h. INS N-560/561 U.S. Immigration and Naturalization Service Certificate of Citizenship. If the individual does not have a Certificate of Citizenship, the original Certificate of Naturalization of the parent(s) may be accepted if the naturalization occurred while the individual was under 18 years of age (or under 16 years of age before 5 October 1978) and residing permanently in the U.S.

i. Certificate of birth issued by the Canal Zone government indicating U.S citizenship is only acceptable if verified by direct government inquiry to: Vital Records Section, Passport Services, 1111 19th Street NW, Suite 510, Washington, D.C. 20522-1705.

j. DD 372, Verification of Birth is acceptable for military members (officer and enlisted) provided the birth data is listed and verified by the Department of Vital Statistics.

k. DD 1966, Application for Enlistment into the Armed Forces of the United States are acceptable provided the documents sighted are listed and attested to by a recruiting official.

5. If none of the above forms of evidence are obtainable, a notice from the registrar issued by the state with the individual’s name, date of birth, which years were searched for a birth record and that there is no birth certificate on file for the applicant should be presented.

*The registrar's notice must be accompanied by the best combination of the following secondary evidence:

a. Baptismal certificate

b. Census record

c. Certificate of circumcision

d. Early school record

e. Family Bible record

f. Doctor’s record of post-natal care

g. Newspaper files and insurance papers

* NOTE: These documents must be early public records showing the date and place of birth, created within the first five years of life. The individual may also submit an Affidavit of Birth, Form DSP-10A, from an older blood relative, i.e., a parent, aunt, uncle, sibling, who has personal knowledge of the birth. It must be notarized or have the seal and signature of the acceptance agent.

Attachment 6

MALPRACTICE INSURANCE CERTIFICATION FORM

Contractors shall complete the following and submit it with their quote. Awardee shall update and resubmit form annually.

1. Contractor has or will maintain(ed) malpractice insurance in compliance with the terms and conditions of this solicitation (including FAR Clause 52.2377, Indemnification and Medical Liability Insurance).

______ Yes _____ No Reasons:

2. Insurer:____________________ Insuree: ____________________ Address ____________________ ____________________ Phone ____________________ ____________________

3. Is or will yours be a group plan or are proposed physicians individually insured?

_______ Group ________ By individual

4. Is malpractice coverage ______ occurrence or ______ claims made?

5. If claims made, is extended reporting endorsement (tail) provided? ______(Yes/No/NA) For how long a period? ______ years Can the tail be invoked within 90 days of notification by the Government? _____(Yes/No)

6. What is the extent of coverage?

$_____________ per incident $_____________ aggregate

Do these limits apply to each individual practitioner? _____ (Yes/No) If no, explain. _________________________________________________

7. Will your malpractice insurance coverage be in effect immediately upon award? _______ (Yes/No) If "no," when will coverage begin?______________________________________________

If yes, attach proof of malpractice coverage to this form and include with your quote.

Signature of Authorized Insurance Company Agent Title: _________________ Date: _________________

Attachment 7

CONTRACT ADMINISTRATION PLAN (CAP)

FOR FIXED PRICE CONTRACTS

In order to expedite the administration of this contract, the following delineation of duties is provided. The names, addresses and phone numbers for these offices or individuals are included elsewhere in the contract award document. The office or individual designated as having responsibility should be contacted for any questions, clarifications, or information regarding the administration function assigned.

1. The Procuring Contract Office (PCO) is responsible for:

a. All pre-award duties such as solicitation, negotiation and award of contracts.

b. Any information or questions during the pre-award stage of the procurement.

c. Freedom of Information inquiries.

d. Changes in contract terms and/or conditions.

e. Post award conference.

2. The Contract Administration Office (CAO) is responsible for matters specified in the FAR 42.302 and DFARS 42.302 except those areas otherwise designated as the responsibility of the Contracting Officer's Representative (COR) or someone else herein.

3. The paying office is responsible for making payment of proper invoices after acceptance is documented.

4. The Contracting Officer's Representative (COR) is responsible for interface with the contractor and performance of duties such as those set forth below. It is emphasized that only the PCO/CAO has the authority to modify the terms of the contract. In no event will any understanding, agreement, modification, change order, or other matter deviating from the terms of the basic contract between the contractor and any other person be effective or binding on the Government. If in the opinion of the contractor an effort outside the scope of the contract is requested, the contractor shall promptly notify the PCO in writing. No action may be taken by the contractor unless the PCO or CAO has issued a contractual change. The COR duties are as follows:

a. Technical Interface
(1) The COR is responsible for all Government technical interface concerning the contractor and furnishing technical instructions to the contractor. These instructions may include: technical advice/recommendations/clarifications of specific details relating to technical aspects of contract requirements; milestones to be met within the general terms of the contract or specific subtasks of the contract; or, any other interface of a technical nature necessary for the contractor to perform the work specified in the contract. The COR is the point of contact through whom the contractor can relay questions and problems of a technical nature to the PCO.

(2) The COR is prohibited from issuing any instruction which would constitute a contractual change. The COR shall not instruct the contractor how to perform. If there is any doubt whether technical instructions contemplated fall within the scope of work, contact the PCO for guidance before transmitting the instructions to the contractor.

b. Contract Surveillance

(1) The COR shall monitor the contractor's performance and progress under the contract. In performing contract surveillance duties, the COR should exercise extreme care to ensure that he/she does not cross the line of personal services. The COR must be able to distinguish between surveillance (which is proper and necessary) and supervision (which is not permitted). Surveillance becomes supervision when you go beyond enforcing the terms of the contract. If the contractor is directed to perform the contract services in a specific manner, the line is being crossed. In such a situation, the COR's actions would be equivalent to using the contractor's personnel as if they were government employees and would constitute transforming the contract into one for personal services.

(2) The COR shall monitor contractor performance to see that inefficient or wasteful methods are not being used. If such practices are observed, the COR is responsible for taking reasonable and timely action to alert the contractor and the PCO to the situation.

(3) The COR will take timely action to alert the PCO to any potential performance problems. If performance schedule slippage is detected, the COR should determine the factors causing the delay and report them to the PCO, along with the contractor's proposed actions to eliminate or overcome these factors and recover the slippage. Once a recovery plan has been put in place, the COR is responsible for monitoring the recovery and keeping the PCO advised of progress.

(4) If the Contractor Performance Assessment Reporting System (CPARS) is applicable to the contract you are responsible for completing a Contractor Performance Assessment Report (CPAR) in the CPARS Automated Information System (AIS). The initial CPAR, under an eligible contract, must reflect evaluation of at least 180 days of contractor performance. The completed CPAR, including contractor comments if any, (NOTE: contractors are allowed 30 days to input their comments) should be available in the CPARS AIS for reviewing official (PCO) review no later than 270 days after start of contract performance. Subsequent CPARs covering any contract option periods should be ready at 1-year intervals thereafter.

c. Invoice Review and Approval/Inspection and Acceptance

(1) The COR is responsible for quality assurance of services performed and acceptance of the services or deliverables. The COR shall expeditiously review copies of the contractor's invoices or vouchers, certificate of performance and all other supporting documentation to determine the reasonableness of the billing. In making this determination, the COR must take into consideration all documentary information available and any information developed from personal observations.

(2) The COR must indicate either complete or partial concurrence with the contractor's invoice/voucher by executing the applicable certificate of performance furnished by the contractor. The COR must be cognizant of the invoicing procedures and prompt payment due dates detailed elsewhere in the contract.

(3) The COR will provide the PCO and the CAO with copies of acceptance documents such as Certificates of Performance.

(4) The COR shall work with the Contractor to obtain and execute a final invoice no more than 60 days after completion of contract performance. The COR shall ensure that the invoice is clearly marked as a “Final Invoice.”

d. Contract Modifications. The COR is responsible for developing the statement of work for change orders or modifications and for preparing an independent government cost estimate of the effort described in the proposed statement of work.

e. Administrative Duties

(1) The COR shall take appropriate action on technical correspondence pertaining to the contract and for maintaining files on each contract. This includes all modifications, government cost estimates, contractor invoices/vouchers, certificates of performance, DD 250 forms and contractor's status reports.

(2) The COR shall maintain files on all correspondence relating to contractor performance, whether satisfactory or unsatisfactory, and on trip reports for all government personnel visiting the contractor's place of business for the purpose of discussing the contract.

(3) The COR must take prompt action to provide the PCO with any contractor or technical code request for change, deviation or waiver, along with any supporting analysis or other required documentation.

f. Government Furnished Property. When government property is to be furnished to the contractor, the COR will take the necessary steps to insure that it is furnished in a timely fashion and in proper condition for use. The COR will maintain adequate records to ensure that property furnished is returned and/or that material has been consumed in the performance of work.
Enclosure (1)
g. Security. The COR is responsible for ensuring that any applicable security requirements are strictly adhered to.

h. Standards of Conduct. The COR is responsible for reading and complying with all applicable agency standards of conduct and conflict of interest instructions.

i. Written Report/Contract Completion Statement.

(1) The COR is responsible for timely preparation and submission to the PCO, of a written, annual evaluation of the contractors performance. The report shall be submitted within 30 days prior to the exercise of any contract option and 60 days after contract completion. The report shall include a written statement that services were received in accordance with the Contract terms and that the contract is now available for close-out. The report shall also include a statement as to the use made of any deliverables furnished by the contractor.

(2) If the Contractor Performance Assessment Reporting System (CPARS) is applicable to the contract you are responsible for completing a…

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