A.09.03_W81K00-18-R-0035-0002.pdf

W81K0018R0035

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: RALPH E. HOUSEMAN

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

This Amendment is issued in response to the follow ing vendor questions.

See summary of changes

1. CONTRACT ID CODE PAGE OF PAGES

1 21

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 31-May-2018

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X W81K0018R0035

X 9B. DATED (SEE ITEM 11)

11-May-2018

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

31-May-2018

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

JBSA FT SAM HOUSTON TX 78234-0000

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

This Amendment is issued in response to the following vendor questions Statement: Sub-factor 1B- We understand that we are to use Attachment II (Pricing Template) format to supply a listing of items that would support one of the following categories as listed in paragraph 4: prosthetic-orthotic supplies, fabrication supplies, cosmetic supplies that meet the requirements in paragraphs 1, 2, and 3 which are not utilized in the cross reference of Attachment I (Cross Reference) covered under Sub-factor 1D. This list would not include pricing as indicated in instructions to offerors under the first bullet as this is part of Volume I.

Therefore, for Sub-factor 1D- We understand that we are to use Attachment II format to supply a listing of cross reference items specific to attachment I and provide a minimum of 3 cross references where applicable. This list is a different listing of items from that would not be duplicated in sub-factor 1B. Again, this list would not include pricing as indicated in instructions to offerors under the first bullet as this is part of Volume I. The lists of items for Sub-factors 1B and 1D would be combined and include pricing for Volume II.

Question 1. Please confirm our understanding of sub-factors 1B and 1D Volume I and Volume II and/or clarify.

Response: Offerors shall identify the category of prosthetic supplies (identified in attachment II) that can be supported by the items provided on their own comprehensive price listing.

Response: Volume I shall consist of the vendor’s technical capability submittals. Volume II will consist of the vendor’s comprehensive pricing data. There shall be no pricing data included in Volume(s) I or III.

Response: Not all vendors are capable of delivering all items listed in attachment 1 (Cross Reference Matrix). The government intends to issue multiple awards. Thus the purpose of Attachment I is to isolate specific vendors for specific products.

Response: Attachment II format is to be used for a comprehensive vendor’s price listing. Not to say that some items listed on Attachment I may or may not be included in Attachment II. In any event all items listing a price are to be included in Volume II.

Question 2. Would the product lists for sub-factor 1B and 1D be excluded from the 20 page maximum under Volume 1?

Response: The comprehensive price list and product list will not be included in the 20 page limit.

Vendors shall submit their offer in three separate volumes. Volume I shall consist of the technical capability submittals. Volume II will consist of the pricing data. Volume III shall consist of the administrative submission. There shall be no pricing data included in Volume I or III. Any pricing data listed in Attachment I (cross reference) shall be included in Volume II (pricing data).

Question 3. The SOO indicates a requirements solicitation for prosthetics and orthotic supplies, however, the characteristics and requirements in paragraphs 1-4 do not provide a description of orthotics. The single orthotic reference the knee immobilizer on Attachment I. Are off the shelf orthotics out of scope for this solicitation or should they be included under Sub-factor 1B under supply category?

Response: Orthotics are to be included in the comprehensive price list. No specific salient characteristics. Vendors that have orthotics pricing should be included in their whole catalog and address in their technical capabilities.

Question 4. Sub-factor 1C - Delivery terms. Since instrumentation was removed from the requirements, please clarify which products or order procedures would require 48 hour lead time and/or when routine orders lead time to be submitted by offeror would be applicable.

Response: There are no products that require 48 hour lead time. Sub-factor 1C - Delivery terms is removed in its entirety.

Question 5. It appears that Amendment 0001 the fifth bullet under the MPK requirements is a partial statement. Please clarify.

Response: Paragraph c: Microprocessor Knee (MPK) fifth bullet is deleted in its entirety.

Question 6. 52.212-4: All contractors shall ensure all service providers receive SHARP training within 60 calendar days after contractor personnel begin performance under this contract. As a contractor under this BPA products will be delivered to facilities by commercial carriers. Please define the scope of contractor personnel would be required to complete this training.

Response: SHARP training is not a requirement in a supply contract in which no work is to be performed at the government facility..

The following have been modified:

STATEMENT OF OBJECTIVES (SOO)

The Regional Health Contracting Office - Central has a requirement for various prosthetic-orthotic supplies.

When ordered, the prosthetic supplies item must pass a Technical Inspection performed by the regional healthcare facility’s Chief of Prosthetic prior to being accepted for use by the Government. The date/time of the product and case number will be provided to the vendor upon placement of an order. An order number shall be provided to the vendor by the Ordering Officer.

The government intends to award multiple Blanket Purchase Agreements (BPA) to offers that are determined technically acceptable and offer a fair and reasonable price. BPA(s) will be established under Federal Acquisition Regulation (FAR) Part 12 and 13. BPA(s) issued as a result of this solicitation will have a single bulk call limit of up to $350,000.00 for a 3 months delivery period, with a maximum overall BPA limit of $7,000,000.00.

BPA calls/orders will be based on patient need and physician preference. The Medical Treatment Facility (MTF) will schedule deliveries against the bulk call as needed based on a case by case basis. Offerors are reminded that, in the event they receive a BPA, calls/orders are not guaranteed. Funds are not obligated on the BPA, but only on any issued calls/orders.

The anticipated period of performance is 1 July 2018 through 30 June 2023. The associated North American Industrial Classification System (NAICS) code for this procurement is 339113 -Prosthetic Appliance and Supplies Manufacturing, Size Standard: 750. This procurement is being conducted as a full and open competition.

Medical Treatment Facilities requiring prosthetic-orthotic supplies are listed below:

San Antonio Military Medical Center, Fort Sam Houston, TX

NOTE 1: The terms “offer” and “offeror” should be interpreted to mean the same as “quote” and “quoter” wherever they appear in the solicitation.

NOTE 2: A price list template is included as Attachment II. Offerors may submit their own format, but should include as a minimum the headings/categories listed on the template.

SCOPE

The following points represent the Government’s requirements for the prosthetic supplies. Designed to restore function by replacing or reinforcing a damaged structure. The government is seeking vendors that are capable of providing prosthetic-orthotic supplies externally fitted to patients for one or more of the following areas;

1. SALIENT CHARACTERISTICS for externally powered prosthetic elbows, hands, waterproof microprocessor prosthetic knees, and powered ankles.

a. Externally Powered Hands

(a) Hands must be capable of myoelectric or switch control

(b) Hands must have individual articulations of each finger and thumb

(c) Individual digits must be clinician replaceable

(d) Each digit must have individual motor driven control

(e) Hand must be available in multiple sizes

(f) Hands must be programmable in up to 24 grip patterns.

(g) Hands must be capable of gesture control

(h) Touch screen capable fingertips must be available

(i) Powered thumb positioning must be available

b. Externally Powered Elbows

• Elbow must integrate an axon bus controller

• Elbow must be capable of a 0.5 second extension to flexion range

• Elbow must be available with a black forearm shell and cover

• Elbow must be capable of independent adjustment of the motor speed at the terminal device, wrist and elbow independently

• Elbow must provide a minimum of 3 switching strategies to toggle between motors Must provide an externally powered hand with an auto grasp feature

c. Microprocessor Knees (MPK)

MPK must have a manual lock option for full knee extension

MPK must use a weight activated stance control MPK will be Bluetooth programmable MPK must have 275lb weight capability MPK must be both PC and Apple IOS compatible for Bluetooth connection and programming MPK incorporates magnetorheological (MR) fluid and rotary blades to control knee flexion resistance.

Must provide an MPK option for both powered knee extension and flexion MPK will incorporate load cells that sample force measurements at a rate of at least 1000 times per second MPK will have no more than a 9 ¼” build height

d. Waterproof Microprocessor Knees (MPK)

• MPK must be ISO tested for submersion in one meter of water

• MPK have at least 5 programmable function modes

• MPK will have a stair mode to allow knee flexion with weight applied

• MPK will eliminate flexion and extension resistance when in a seated flexion

• MPK must be capable of locking in variable ranges of knee flexion when weight is applied.

• MPK must be capable of programming a safe mode that initiates in the event of electronic malfunction MPK utilizes hydraulic fluid to control knee flexion resistance.

• MPK incorporates a magnetic charger head with LED charge level indicators

• MPK must provide vibration and audible signals for battery life and malfunction indication

e. Externally Powered Ankles

• Ankle must provide proportional powered plantar flexion across all walking speeds

• Ankle must provide at least 22 degrees of plantarflexion range

• Ankle must move into passive plantarflexion when user is seated

• Ankle adjustments must be programmable with a clinician interface

• Ankle must self-adjust for toe clearance on stairs

• Ankle must adjust to heel height changes by the end user

2. SPECIFIC REQUIREMENTS: The requirements for the prosthetic-orthotic patient casting, fabrication, and fitting supplies item are:

a. Patient Casting Must provide a full selection of plaster bandage in rigid, elastic and splint configurations Must provide fiberglass bandage in roll form with multiple colors Must provide duplicating materials for reproduction of prosthetic sockets

b. Prosthetic-Orthotic Fabrication Supplies

Must have acrylic resin compatible with all standard laminating fabrics Will provide epoxy resin for use with carbon fiber braid and sheet materials.

Will provide carbon fiber laminating materials for use in prosthetic and orthotic fabrication procedures Must provide full range of available thermoplastic materials to include those for drape and blister forming.

Must provide standard laminating stockinettes in all sizes and materials to include nyglass, fiberglass, nylon, cotton.

Will provide all hand and power tools necessary for fabrication of prosthetic orthotic devices

c. Fitting Supplies

Will provide a full range of silicone gel liners, elastomeric liners and fitting socks Will provide a full range of locking mechanisms to include ratchet type, smooth pin, internal and external locks.

Will provide suspension sleeves in silicone, TPE, elastomeric gel in all sizes and available colors

Will provide mechanical knees with friction, hydraulic control, pneumatic for walking and running activities.

Will provide feet with microprocessor ankles, dynamic response categories, carbon fiber and fiberglass design for all levels of activity.

3. SPECIFIC REQUIREMENTS: The requirements for silicone cosmetic restorations and custom prosthetic interfaces.

Must be able to provide custom silicone cosmetic restorations for upper and lower limb amputees.

Must be able to perform custom color skin matching Must be able to match the pertinent skin and shape characteristics to the sound limb or facsimile Must be able to create custom inner interfaces for both lower and upper extremity prosthetics Must have the ability to incorporate myoelectric components and wiring within the interface Must be able to provide interfaces with variable densities of silicone Must be able to incorporate reinforced regions as specified and determine attachment sites Must have personnel available within 3 working days of request for custom consultation.

Must be capable of providing diagnostic inner liners within 5 working days

4. PROSTHETIC-ORTHOTIC SUPPLIES LIST

Attachment I – Cross Reference Product Matrix includes a sample listing of prosthetic-orthotic supplies;

fabrication supplies and cosmetic restorations supplies required for the prosthetic listed in paragraphs 1, 2 & 3 of this solicitation. Vendors are encouraged to provide a comprehensive price list which includes all offered prosthetic supplies, fabrication, cosmetic and supply items as it relates to this requirement.

Attachment II provides a template for vendor product and price listing.

CROSS REFERENCE PRODUCE MATRIX

GOVERNMENT'S SAMPLE

PROSTHETIC-ORTHOTIC SUPPLIES

LIST

VENDOR OFFERED

PROSTHETIC-ORTHOTIC

SUPPLIES

PROSTHETIC

Category

Discounted

BPA

Price

DESCRIPTION DESCRIPTION

ICEROSS UPPER X 16

CLUTCH ICE LOCK 4H 214

ICEROSS SEAL-IN SOCKS, SIZE 13, ICEROSS

FEMALE PYR TUBE CLAMP TITANIUM

DISTAL CUP DERMO SZ 26

CAR ADAPTER CABLE 12V

GENIUM KNEE W/PYLON

ERGO ARM ELECTRONIC PLUS

PROSTHETIC KNEE SYSTEM

GENIUM X3 3B5-2=ST THREADED

CUSTOM ELBOW SOCKET IN NOT

CON/ATYP

BELOW/ABOVE ELBOW LOCK MECH

BELT WAIST & SOCKS CUSTOM L599

INTL CUSTOM CONG/LATYP INSERT

REPLACEMENT BP SOCKET

3PLY SOFT SOCK REG XTRA SHORT

1SP3RGXS 19

50# BAG MOULDING PLASTER ORDER 9 OR

1/2 IN PROFLEX W/SILICONE 24 X 48

TALC BABY POWDER 51394 40

LYN VALVE BK2 - METRIC

FREESTYLE FOOT ASSEMBLY

STANDARD WRIST ROTATOR (BLACK)

PROPLUS RIGHT

SILICONE SEAL

SHOE HORN

LINER SEAL

FOOT COVER

PROSTHETIC SOCKS

ADULT KNEE IMMOBILIZER

FOOT SHELL

Attachment II - Provides a template for vendor product and price listing.

PROSTHETIC-ORTHOTIC SUPPLIES LIST

Part Number Description Orthopedic Category

List Price Discount Percentage

BPA

Price

The following full text addendums have been revise: See BLUE text

ADDENDUM TO 52.212-1

Volume I – Technical Capability

Factor 1 - Technical Capability - The technical offer shall be addressed in sufficient written detail for the Government to determine if the offeror understands the technical aspects of the Government’s requirement. Statements that the offeror understands, can or will comply with all specifications, or statements paraphrasing the specifications of parts thereof, or phrases such as “standard procedures will be used” or “well-known techniques will be used” will be considered unacceptable. Insufficient explanations may result in your offer receiving an UNACCEPTABLE rating.

Sub-factor 1A – Specific Requirements – Offerors shall provide a detailed explanation as to how their prosthetic products meet each item listed in paragraph 1, subparagraph (a through e) of the "SALIENT CHARACTERISTICS" and each item listed in paragraph(s) 2 and 3 of the “SPECIFIC REQUIREMENTS” section of this solicitation.

Sub-factor 1B – Prosthetic Supplies Category Identification – Offerors shall identify the category of prosthetic supplies that can be supported by the items provided on their price list.

Offerors must use at least one of the prosthetic categories listed in paragraph 4 of the Statement of Objectives. Offerors may identify more than one prosthetic category and may include other prosthetic categories not listed in paragraph 4, so long as at least one of the listed categories found in paragraphs 1, 2 & 3 is used. The category or categories must be stated on the price list.

Offerors may use the template provided in attachment II or similar format when completing submittals for this sub- factor.

Sub-factor 1C – Cross Reference Product Matrix - Offerors shall complete Attachment II or a similar format, by cross- referencing comparable items offered against the list of items provided in Attachment I. The offeror shall specify the category of prosthetics covered under their cross reference matrix list along with the item’s associated discounted price. A minimum of three items shall be cross referenced.

Volume II - Pricing: Remains Unchanged

Volume III - Administrative: Remains Unchanged

END OF ADDENDUM TO 52.212-1

ADDENDUM TO 52.212-2

Evaluation Process.

The Government anticipates awarding multiple blanket purchasing agreements to responsible vendor(s) whose offer meets or exceeds the minimum technical requirements of the solicitation and provides fair and reasonable pricing. Awards will be made based on the prosthetic categories listed in paragraph 4 of the Statement of Objectives. Offerors must provide a comprehensive price list for prosthetic-orthotic supplies for at least one of the prosthetic categories stated in paragraph 4 of the SOO in order to eligible for award. Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary.

Factor 1 – Technical Capability

Factor 1 - Technical Capability - Technical capability ratings reflect the Government’s confidence in the offeror’s ability, as demonstrated in its written technical proposal, to meet the requirements stated in the solicitation. The Government will make an independent judgment of each sub-factor and of the technical acceptability on offered products. Each subfactor, and the overall factor, will be evaluated using Table 1 below:

Sub-factor 1A – Specific Requirements – Offeror must meet or exceed each requirement listed in paragraph 2 & 3 of the Statement of Objectives in order to be acceptable in this sub- factor. Acceptability will be determined by whether or not the offeror has provided an adequate response or explanation for each requirement listed.

Sub-factor 1B – Prosthetic Supplies Category Identification –Offerors must identify at least one of the prosthetic categories listed in paragraph 4 of the Statement of Objectives when submitting their price list. The category or categories must be stated on the price list in order to be deemed acceptable under this sub- factor.

Sub-factor 1C – Cross Reference Product Matrix - Offerors must provide the completed Attachment I which includes a minimum of three cross referenced items in order to be deemed acceptable for this sub- factor

Technical Evaluation Criteria: Remains Unchanged Factor 2 – Price: Remaing Unchanged

END OF ADDDENDUM TO 52.212-2

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

ADDENDUM TO 52.212-1

Offeror shall submit the following:

(j) Vendors shall submit their offers in three separate volumes. Volume I shall consist of the technical capability submittals. Volume II will consist of the pricing data. Volume III shall consist of the administrative submission.

There shall be no pricing data included in Volume I or III. The combined response for Volume I shall not exceed 20 pages. Proposals shall be submitted on standard 8 ½” by 11” paper, using no small than 10pt. font, front-side only. Each volume shall also have a title page identifying the offeror, the full physical address, e-mail address, phone and facsimile numbers, points of contact (POCs) of the offeror, the solicitation number,and the proposal’s contents. A Statement that the offeror will hold its quote firm for at least 120 days from the due date for receipt of quotes, subject to any changes that may occur as a result of discussions (if applicable). Offeror shall mark and prepare each volume submitted in accordance with these instructions.

(k) The following Factor(s) and sub-factor(s) will be used for evaluation purposes:

Volume I – Technical Capability

Factor 1 - Technical Capability - The technical offer shall be addressed in sufficient written detail for the Government to determine if the offeror understands the technical aspects of the Government’s requirement.

Statements that the offeror understands, can or will comply with all specifications, or statements paraphrasing the specifications of parts thereof, or phrases such as “standard procedures will be used” or “well-known techniques will be used” will be considered unacceptable. Insufficient explanations may result in your offer receiving an UNACCEPTABLE rating.

Sub-factor 1A – Specific Requirements – Offerors shall provide a detailed explanation as to how their prosthetic products meet each item listed in paragraph 1, subparagraph (a through e) of the "SALIENT CHARACTERISTICS" and each item listed in paragraph(s) 2 and 3 of the “SPECIFIC REQUIREMENTS” section of this solicitation.

Sub-factor 1B – Prosthetic Supplies Category Identification – Offerors shall identify the category of prosthetic prosthetic supplies that can be supported by the items provided on their price list. Offerors must use at least one of the surgical categories listed in paragraph C of the Statement of Objectives. Offerors may identify more than one prosthetic prosthetic category and may include other prosthetic surgical categories not listed in paragraph 4, so long as at least one of the listed categories found in paragraphs 1, 2, & 3 is used. The category or categories must be stated on the price list. Offerors may use the template provided in attachment II or similar format when completing submittals for this sub-factor.

Sub-factor 1C – Cross Reference Product Matrix - Offerors shall complete attachment II or a similar format, by cross- referencing comparable items offered against the list of items provided in Attachment I. The offeror shall specify the category of prosthetic prosthetics covered under their cross reference matrix list along with the item’s associated discounted price. A minimum of three items shall be cross referenced.

Volume II - Pricing

Factor 2 – Price - Offerors shall submit a price list for all offered products/equipment, using Attachment II or a similar format, to include any discounts offered to the Government. Offerors that do not provide Government discounts shall provide an explanation as to why they are not providing a discount. Offeror’s shall certify that their price list establishes prices equal to or lower than pricing found on the schedule holder’s GSA contract. If offeror does not hold a GSA schedule, a certification shall be included that the vendor is offering the lowest pricing available.

Volume III - Administrative

1. Please provide the following items when responding to this solicitation:

2. Potential contractors must be registered in the System for Award Management (SAM) to be eligible for award. The SAM website is http://www.sam.gov. Offers shall be submitted via e-mail to ralph.e.houseman.civ@mail.mil and jamie.m.brunner.civ@mail.mil. Email attachments exceeding 20 MB should be sent separately. Offers are due the date listed in block 8 of the Standard Form 1449. Any offerors submitted after the deadline will be considered untimely and will not be evaluated or considered for an award of a BPA.

• FAR Provision 52.212-3 Offeror Representations and Certifications – Commercial Items

(MAY 2014) Alternate I (MAY 2014). Registration in SAM can be substituted for FAR 52.212-3 Alt I and must be submitted. The SAM website is http://www.sam.gov. The information in SAM must be current and complete before an award can be made. Contractor shall not have any Active Exclusion Record in SAM. All required provisions must be submitted with offer OR completed on SAM.

• FAR Provision 52.209-7, Information Regarding Responsibility Matters (JUL 2013).

3. Also provide the following items:

-DUNS#

-CAGE Code -Delivery Lead Time -Contact Information (Name, Telephone Number, Fax Number, and Email) -Brochures and/or product information containing illustrations of proposed products (no more than 100 pages

END OF ADDENDUM TO 52.212-1

ADDENDUM TO 52.212-2

Paragraph (a) is hereby replaced with the following:

Evaluation Process.

The Government anticipates awarding multiple blanket purchasing agreements to responsible vendor(s) whose offer meets or exceeds the minimum technical requirements of the solicitation and provides fair and reasonable pricing. Awards will be made based on the prosthetic surgical categories listed in paragraph 4 of the Statement of Objectives. Offerors must provide a comprehensive price list for prosthetic-orthotic supplies for at least one of the prosthetic surgical categories stated in paragraph

4 of the SOO in order to eligible for award. Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary.

Factor 1 – Technical Capability

Factor 1 - Technical Capability - Technical capability ratings reflect the Government’s confidence in the offeror’s ability, as demonstrated in its written technical proposal, to meet the requirements stated in the solicitation. The Government will make an independent judgment of each sub-factor and of the technical acceptability on offered products. Each subfactor, and the overall factor, will be evaluated using Table 1 below:

Sub-factor 1A – Specific Requirements – Offeror must meet or exceed each requirement listed in paragraph 2 & 3 of the Statement of Objectives in order to be acceptable in this sub- factor.

Acceptability will be determined by whether or not the offeror has provided an adequate response or explanation for each requirement listed..

Sub-factor 1B – Prosthetic Supplies Category Identification –Offerors must identify at least one of the prosthetic categories listed in paragraph 4 of the Statement of Objectives when submitting their price list. The category or categories must be stated on the price list in order to be deemed acceptable under this sub- factor.

Sub-factor 1C – Cross Reference Product Matrix - Offerors must provide the completed Attachment I which includes a minimum of three cross referenced items in order to be deemed acceptable for this sub- factor

Technical Evaluation Criteria:

Offerors must be deemed acceptable in each sub-factor in order to receive an acceptable rating for “Factor 1 – Technical Capability”. Each sub-factor will be assigned an adjectival rating. An unacceptable rating in any technical sub-factor will render the offeror’s entire “Technical Capability” unacceptable and therefore ineligible for award. If found Technically Unacceptable, the government will not evaluate Price.

The following adjectival ratings will be used in evaluating the offeror’s written technical capability:

Table 1 - Rating Description Acceptable - Quote clearly meets the minimum technical capability, sub-factors and requirements of the

RFQ.

Unacceptable - Quote does not clearly meet the minimum technical capability, sub-factors and requirements of the RFQ.

Factor 2 – Price - Offeror must certify that their price list establishes prices equal to or lower than pricing found on the schedule holder’s GSA contract. If offeror does not hold a GSA schedule, a certification must be included that the vendor is offering the lowest pricing available for all offered products. Failure to certify that the vendor is offering the lowest pricing available and/or previously negotiated with another federal agency, will make the offeror ineligible for award

Each technically acceptable offeror’s price lists will be reviewed to determine the reasonableness of offered prosthetic implants and supplies by using one or more of the following price analysis methods;

(l) Comparing the items listed in the Cross Reference Product Matrix.

(m) Evaluate offered pricing against the Independent Government Cost Estimate (IGCE).

Offeror’s pricing must be determined to be fair and reasonable in order to be eligible for an award.

Options: N/A.

END OF ADDDENDUM TO 52.212-2

HIPAA, IRAPT, LEIE

Non-Defense Health Agency (Non-DHA) Health Insurance Portability and Accountability Act (HIPAA) Business Associate Agreement (BAA) (7 July 2014)

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 BAA between the signatory parties for purposes of the HIPAA and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

(a) Catchall Definition. Except as provided otherwise in this BAA, the following terms used in this BAA shall have the same meaning as those terms in the DoD HIPAA Rules: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

—Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

—Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of Business Associate signatory 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 [insert name of MHS component signatory to this BAA].

—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

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

(o) 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.

(p) 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.

(q) 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.

(r) 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.

(s) 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.

(t) 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

(b) 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.

(c) 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.

(d) 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.

(e) 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.

(f) 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.

(g) 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.

(d) 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 Business Associate shall contact the Covered Entity for guidance when the incident is not an HHS Breach.

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 Covered Entity and to the US Computer Emergency Readiness Team (US CERT) -the 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.

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 -Covered Entity and the applicable Service-Level Privacy Office, if requested by either. Business Associate questions about US-CERT reporting shall be directed to the Covered Entity or Service- Level Privacy Office, not the US-CERT office.

The additional US Army and the US Army Medical Command (MEDCOM) reporting requirements are addressed in the PII Breach Reporting and Notification Policy. The latest version of this policy can be obtained from the Covered Entity or the MEDCOM Privacy Act/Freedom of Information Act (FOIA) Office at:

usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil . 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.

When a Breach Report 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 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 Report. 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.

In the event the Business Associate is uncertain on how to apply the above requirements, the Business Associate shall consult with the Covered Entity (or the Service-Level Privacy Office, which will consult with the DHA 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.