AMEND 0001 - SPM2D1-10-R-0011.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICAITON NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicble)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICIATION NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

Offers 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 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 your 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 APPROPIRATION DATA (If required)

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

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

CHECK ONE 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.

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.

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

1 19

0001 Jan 27, 2010

SPM2D1

Defense Supply Center Philadelphia Medical Supplier Operations - FSDB 700 Robbins Avenue Philadelphia, PA 19111-5092 Attn: Robert.Coupe@dla.mil

SPM2D1

SAME AS BLOCK 6

SPM2D1-10-R-0011

Dec 17, 2009

DIGITAL IMAGING NETWORK - PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS (DIN-PACS)

SEE ATTACHED PAGES

Amendment 0001 to SPM2D1-10-R-0011

STANDARD FORM 1449

1. Block 8 – Offer Due date/Local Time: The closing date is hereby extended to:

February 25, 2010 – 3:00 P.M. LOCAL TIME

2. Reference the spreadsheet titled “DINPACS III Contractor Price book Spreadsheet.” This spreadsheet is replaced with the spreadsheet titled “DINPACS III Contractor Price book Spreadsheet – Amendment 0001.” This revised spreadsheet must be used to provide your pricing.

ADDENDUM to 52-212-4:

1. Addenda to 52.212-4(i) Payment: The following is added:

“Contractor must submit a Receiving Report (RR) into the Wide Area Workflow (WAWF) system for inspection by the DSCP Engineer and acceptance by the DSCP Contracting Officer prior to submitting an invoice. If you are not subscribed to the WAWF system and/or need instruction on how to submit a RR for DSCP Medical Capital Equipment, please contact the contracting specialist identified in block 6 of this order.

When submitting the RR, at a minimum, the vendor must include the following:

Administered by DoDAAC: SPM2D1

Issue by DoDAAC: SPM2D1 Inspect by DoDAAC: SPM2D1 Accept by DoDAAC: SPM2D1

Further, regardless of what the delivery order states regarding Inspection and Acceptance points, when the RR is created, the vendor must use “Other” as both the Inspection and Acceptance points.”

2. THE CLAUSES LISTED BELOW ARE INCORPORATED BY REFERENCE WITH THE SAME

FORCE AND EFFECT AS IF THEY WERE GIVEN IN FULL TEXT. UPON REQUEST, THE

CONTRACTING OFFICER WILL MAKE THEIR FULL TEXT AVAILABLE. (Also, the full text of solicitation clauses and provisions may be accessed electronically at the following websites):

FAR, DFARS, DLAD, and DSCP Local Clauses – http://www.dla.mil/j-3/j-336/icps.htm PROCLTRs and FARS Deviations – http://www.dla.mil/j-3/j-3311/dlad/rev5.htm

CLAUSE NUMBER TITLE/DATE

52.246-9019 Material and Inspection Report (April 2008) DLAD 252.246-7000 Material Inspection and Receiving report (Mar 2008) DFARS http://www.dla.mil/j-3/j-336/icps.htm� http://www.dla.mil/j-3/j-3311/dlad/rev5.htm�

STATEMENT OF WORK:

1. DELETE page 45 of the solicitation and REPLACE with new page 45 included in this amendment.

2. DELETE page 48 of the solicitation and REPLACE with new page 48 included in this amendment.

3. DELETE pages 50-51 of the solicitation and REPLACE with new pages 50-51 included in this amendment.

4. DELETE pages 65-66 of the solicitation and REPLACE with new pages 65-66 included in this amendment.

5. DELETE page 80 of the solicitation and REPLACE with new page 80 included in this amendment.

6. DELETE page 81 in its entirety.

7. DELETE pages 100-104 of the solicitation and REPLACE with new pages 100-104 included in this amendment.

8. DELETE pages 109-111 of the solicitation and REPLACE with new pages 109-111included in this amendment.

9. ADD Section 4 - PRESERVATION, PACKAGING, PACKING, LABELING AND MARKING (PPPL&M), pages 4 through 19 of this amendment, to the solicitation

ADDENDUM to 52-212-1:

DELETE pages 124-126 of the solicitation and REPLACE with new pages 124-126 included in this amendment.

PREPROPOSAL CONFERENCE:

Vendor submitted questions and DSCP provided answers included in this amendment are hereby incorporated into the solicitation (see the 16 pages of questions/answers at the end of this amendment).

SECTION 4 - PRESERVATION, PACKAGING, PACKING, LABELING AND MARKING (PPPL&M)

A. General instructions:

1. Unless otherwise specified, all PPPL&M requirements specified herein shall apply to all domestic (CONUS) and overseas (OCONUS) shipments of medical items.

2. Labeling and shipping instructions specified in Section IX shall apply to OCONUS shipments when specifically stated in the call.

3. Sources of referenced documents are provided in paragraph IX.C.

B. Preservation, packaging, and packing:

1. Preservation, packaging, and packing shall be sufficient to preclude damage to containers and/or contents thereof under normal shipping and handling conditions. Exterior (shipping) containers shall conform to the applicable carrier's regulations and shall be substantial commercial containers (export when necessary) of the type, size and kind commonly used for the purpose, so constructed as to insure acceptance and safe delivery by common or other carriers, at the lowest rate, to point of delivery called for in the call. Shipments to OCONUS ordering activities shall be properly packaged and packed for international movement.

2. For non-hazardous items, preservation, packaging, and packing shall be in accordance with ASTM D 3951 (Standard Practice for Commercial Packaging) and as specified herein.

3. For hazardous items, preservation, packaging, and packing shall comply with applicable regulations and as specified herein.

4. When specified in the call, unitized loads shall be used whenever total quantity for shipment to one destination of one NSN or part number exceeds 250 lbs or 20 cubic feet. Commercial unitization may be supplied.

C. Certification Requirement for Wood Packaging Material (WPM):

1. WPM is defined as wood pallets, skids, load boards, pallet collars, wooden boxes, reels, dunnage, crates, frame and cleats. This definition excludes materials that have undergone a manufacturing process, such as corrugated fiberboard, plywood, particleboard, veneer, and oriented strand board (OSD).

2. All WPM acquired by the Department of Defense (DoD) must meet requirements of International Standards for Phytosanitary Measures (ISPM) 15, “Guidelines for Regulating Wood Packaging Materials in International Trade”. DoD shipments inside and outside of the United States must meet ISPM 15 whenever WPM is used to ship DoD cargo.

3. All WPM shall comply with the official quality control program for heat treatment (HT) or kiln-dried heat treatment (KD HT) in accordance with American Lumber Standard Committee, Incorporated (ALSC) Wood Packaging Material Program and WPM Enforcement Regulations (see http://www.alsc.org/

4. All WPM shall include certification/quality markings in accordance with the ALSC standard.

Markings shall be placed in an unobstructed area that will be readily visible to inspectors. Pallet markings shall be applied to the stringer or block on diagonally opposite sides of the pallet and be contrasting and clearly visible. All containers shall be marked on a side other than the top or bottom, contrasting and clearly visible. All dunnage used in configuring and/or securing the load shall also comply with ISPM 15 and be marked with an ALSC-approved DUNNAGE stamp.

5. Failure to comply with the requirements of this restriction may result in refusal, destruction, or treatment of materials at the point of entry. The Agency reserves the right to recoup from the Contractor any remediation costs incurred by the Government.

6. Additional information regarding DoD’s WPM requirement is available on the DLA Packaging Website:

http://www.dscc.dla.mil/Offices/Packaging/palletization_WPMnotice.html

7. NOTE: DoD does not endorse the methyl bromide fumigation program. Only heat treatment or kiln-dried heat treatment of WPM is authorized.

D. Labeling and marking:

1. Materiel shall be marked in accordance with commercial practice and as stated in the call.

2. For non-hazardous items and all other routine items, labeling and marking shall be in accordance with commercial practice and any applicable regulatory requirements.

3. For all items requiring special handling, i.e., hazardous, perishable, and sensitive/controlled/ perishable material, labeling and marking shall be in accordance with applicable regulatory requirements and as specified herein.

4. In addition to all required labeling and marking as specified herein, all OCONUS shipments moving through military channels shall be labeled and marked as specified in Medical Marking Standard No. 1.

5. The contractor shall provide all necessary documentation with each OCONUS shipment, to speed the processing of materiel through the customs process.

6. Applicable to all Medical items

. The product number is the number assigned to the item by the supplier/manufacturer and may be any number which the supplier/manufacturer uses to identify the product, e.g., National Stock Number (NSN), UPN, NDC, catalog number, etc.

7. Applicable to Medical/Surgical items

. The Government’s long-term goal is to have a Universal Product Number (UPN) assigned by the original manufacturer or private labeler to all medical/surgical products. The UPN can meet one of three acceptable commercial industry standards. Medical product manufacturers can select either the Health Industry Business Communication Council’s (HIBCC) LIC standard, the Uniform Code Council’s (UCC) SSC-14 format, or the Food and Drug Administration’s National Drug Code (NDC). The bar-coded UPN shall be included on all labels, as applicable.

E. Packing list:

1. A properly completed packing list (either DD Form 250 or a suitable commercial alternate), shall accompany each shipment. The packing list shall include the name of the contractor, the DoDAAC of the ordering facility, the order number, date of order, itemized list of shipped items by product number, unit of issue, quantity ordered, quantity shipped, delivered unit price, and the total delivered cost for the order.

The product number used in both the order and confirmation must be duplicated on the packing list. The packing list must be in identical sequence to the order placed by the ordering facility. The delivered unit price will reflect two decimal places (the third decimal place will be rounded down for “4” and below, and will be rounded up for “5” and above).

2. Applicable to Military OCONUS shipments only.

In addition to markings required, each packing list for any shipment which will move through military channels shall also include bar-coded data as follows:

a) Bar codes shall be in accordance with ISP/IEC 16388 (Information Technology– Automatic Identification and Data Capture Techniques – Bar Code Symbology Specification – Code 39).

b) Bar-coded data shall include the document number and suffix, NSN, S9M, unit of issue, quantity, condition code, distribution code and unit price. This data shall be provided on the packing list in 3 separate linear bar codes (code 39 (also known as code 3 of 9)), together with the corresponding Human Readable Interpretation (HRI), as follows:

1st bar code

: Document number and suffix (in absence of document number, the contract or order number)

2nd bar code

: NSN (in absence of NSN, the CAGE and PN)

3rd bar code

: S9M, 2-position unit of issue, 5-position left zero-filled quantity, condition code (shown as "A" unless otherwise specified), 2-position left-zero-filled distribution code and 6-position left zero-filled unit price.

c. Example

3. Bar codes may be printed directly on the packing list or on pressure-sensitive label(s) securely affixed to the packing list.

4. At the supplier's option, bar codes may be supplied on all packing lists for all shipments.

5. In addition, bar codes shall be supplied on the packing list for shipments moving through commercial channels when specifically required by the ordering facility.

F. Destination address label. A destination address label shall be supplied on each exterior (shipping) container.

1. Commercial label:

a) In addition to all commercial labeling and marking, a commercially-prepared shipping label shall be supplied on all CONUS/OCONUS shipments moving through commercial channels. The contractor-generated may be completed as specified in Medical Marking Standard No. 1.

b) As a minimum, unless otherwise specified in the call, the label shall include the Transportation Control Number (TCN), the requisition number, or the contract/order number, the contractor's name and address and the destination address. When specified in the call, additional information as shown below may be required on the label:

TCN: (In the absence of a TCN, the requisition number or contract or order number)

FROM: CONTRACTOR'S NAME AND ADDRESS

TO: DESTINATION ADDRESS

PROJECT CODE: (when specified in the contract or order)

RDD: (when specified in the contract or order)

WT***CU*** (weight and cube of the exterior shipping container or, for unitized shipments, weight and cube of the unitized load)

BX * OF ** (box number and total number of boxes in shipment; for loads, substitute “PALLET * OF **” and indicate pallet number and total number of pallets in shipment)

2. Military shipping label (MSL)

a) Commercial CONUS/OCONUS shipments

. Normally, a bar-coded MSL will not be required on CONUS/OCONUS supplier shipments moving through commercial channels directly to the customer, unless otherwise required by the customer and specified in the call. However, at the supplier's option, a bar-coded MSL may be supplied on all commercial CONUS/OCONUS shipments.

b) Military OCONUS shipments

. A properly completed bar-coded MSL shall be required on all OCONUS shipments moving through military channels.

c) Requirements

. Detailed requirements regarding the MSL are as follows:

(1) The MSL shall be in addition to all commercial and military markings as specified herein and in the call. The MSL shall be securely affixed to each exterior (shipping) container or unitized load. The MSL supersedes DD Form 1387, which is no longer acceptable for use.

(2) Complete technical requirements for the MSL are contained in MIL-STD-129P, paragraphs. 4.2 through 4.2.3, as applicable. In addition to in-the-clear data elements, 2 types of bar codes, linear (code 39 (also known as code 3 of 9)) and two-dimensional (2D), are required on the MSL, as follows:

a. In-the-clear data elements

. Each MSL shall include the following in-the-clear data elements, unless otherwise indicated:

Transportation Control Number (TCN)

Contractor/vendor name and address

Ship to address

Mark for address, when applicable

Date shipped, weight, cube

Additional information as specified in the contract or order

b. Code 39 linear bar codes

. Three separate code 39 linear bar codes shall be supplied on each MSL. Each bar code shall have a minimum height of one-half inch, shall be accompanied by the HRI, and shall include the following:

1st bar code

: TCN (in the absence of a TCN, the call number)

2nd bar code: Piece number -Do not left zero-fill

3rd bar code

: DoDAAC for the ultimate consignee/mark for consignee

c. 2D bar code

. The 2D bar code shall include the Document (Requisition) Number; the National Stock Number (NSN) (in absence of the NSN, the CAGE and Part Number), S9M, 2-position unit of issue, 5-position left zero-filled quantity, condition code (shown as "A" unless otherwise specified), and 6-position left zero-filled unit price.

(3) A sample of a completed MSL is provided for information:

G. Radio Frequency Identification (RFID):

1. The RFID requirement will be phased in over several years. RFID tagging will not be required on supplier shipments of specific Class VIII (Medical Materiel) items until the applicable DFARS clause has been finalized. RFID tagging shall be in addition to all commercial and military markings, and shall be required on cases (for Medical this equates to the exterior (shipping) container) and on unitized loads. Phase 1 did not apply to Medical shipments.

2. Phase 2, which became effective for acquisitions issued on/after 19 July 2006, applies to specific supplier shipments of Medical items, as follows:

a) Medical Equipment and Medical/Surgical items only

(1) Depot stock shipments stock to the Defense Distribution Depots located in Susquehanna, PA, San Joaquin, CA, Hill AFB, UT, and Tobyhanna, PA.

. RFID tagging shall be required for all supplier shipments of Medical Equipment and Medical/Surgical items for depot

(2) Direct supplier shipments

. RFID tagging will not normally be required for supplier shipments of Medical Equipment and Medical/Surgical items which are delivered directly to the CONUS/OCONUS customer through commercial channels.

(3) OCONUS supplier shipments diverted/redirected through select Air Mobility Command Terminals

. RFID tagging shall be required for all OCONUS supplier shipments of Medical Equipment and Medical/Surgical items which are diverted/redirected through any of the following air terminals:

Charleston AFB - Charleston, SC Naval Air Station - Norfolk, VA Travis AFB - Fairfield, CA

b) Federal Supply Classes (FSCs) 6505, 6508, 6509 and 6550

. To keep in step with the Food and Drug Administration's (FDA) current initiatives, RFID tagging for supplier shipments of most items in FSCs 6505 (Drugs and Biologicals (Human Use)), 6508 (Medicated Cosmetics and Toiletries), 6509 (Drugs and Biologicals (Veterinary Use)), and 6550 (In Vitro Diagnostic Substances, Reagents, Test Kits and Sets) will be further delayed (specific date to be announced).

c) Phase 3, (specific effective date to be announced), will apply to all supplier shipments of identified Medical items to all identified locations

. When required, RFID tagging shall be supplied on cases (i.e., exterior (shipping) container) and on unitized loads.

3. Detailed information regarding RFID is available at www.dodrfid.org

H. Unique identification (UID):

1. Effective January 1, 2007, UID may be required for certain Medical items if the acquisition cost is more than $5,000, the item is DoD serially managed, mission essential, or a controlled inventory piece of equipment/reparable, the item is a consumable which requires permanent identification, or the item is a component of an end item and UID is required. The requirement for the UID will be determined by the ordering facility, and will be specified in the call, when applicable.

2. Requirements regarding UID will be incorporated into this document when they are finalized.

Detailed information regarding UID is available at http://www.acq.osd.mil/dpap/pdi/uid/index.html

I. Materiel requiring special handling:

1. Materiel requiring special handling must be properly identified in order to alert the receiving activity that the materiel requires special handling and storage. In addition to labeling and marking requirements specified herein, the supplier shall annotate the packing list accompanying each shipment with the following notation: “REQUIRES SPECIAL HANDLING AND/OR STORAGE”, together with the applicable special handling and/or storage statement(s). Examples of special handling and storage statements include the following: “STORE BETWEEN 2 o

– 8 o

C (36 o

-46 o

F)”; “KEEP FROZEN”, “FLAMMABLE”,

etc. In addition, the exterior (shipping) container shall be marked with the applicable storage statements.

For Medical items subject to damage by freezing, marking on each shipping container shall include the statement "DO NOT PERMIT TO FREEZE"; in addition, “ARROW” and “FRAGILE” markings, as appropriate, shall be applied to each shipping container. Similar commercial storage statements are acceptable on the packing list, the exterior (shipping) container, and the unitized load.

2. Perishable Medical Materiel

a) Packaging, packing, labeling and marking of perishable medical materiel shall be in accordance with all applicable regulatory requirements and commercial practice.

b) Perishable medical materiel requiring chill or freeze temperatures shall be properly packaged and packed to insure that the required temperature shall be maintained during shipment.

Required packaging shall be determined by the type of materiel being shipped, the climatic conditions under which the shipment will be made, and the destination's ambient temperature. Prior to preparing perishable medical materiel for shipment, contact the DSCP Contracting Officer for guidance.

3. Protected cargo

a) To assure that all sensitive, controlled, or pilferable items, as defined by Federal, State, and Local regulations, can be properly identified by the customer’s receiving point, the shipper shall annotate the following statement on its packing list for those orders containing Controlled Substances:

“CONTROLLED SUBSTANCE REQUIRES * STORAGE.” *SHIPPER will enter the words “VAULT” or “LIMITED

ACCESS.”

In accordance with Federal regulations, these items are identified by a distinctive Controlled Substance Schedule Symbol. This symbol appears only on the immediate container or carton. “VAULT” is to be used for items bearing Symbol C-II; “LIMITED ACCESS” is to be used for items bearing Symbol C-III, C-IV or C-V.

b) Use of the word “narcotics” on shipping containers or packing lists is prohibited.

c. All sensitive/controlled/pilferable items, regardless of whether the item is classified s Schedule II, III, IV or V, shall be shipped via traceable means. Signature service shall be used for all shipments of these items.

d. Hazardous protected cargo

. The requirements specified in paragraph J shall apply to any shipment of a sensitive, controlled, or perishable item which is also identified as hazardous material.

4. Transportation Special Handling/Protective Services. Certain shipments of nonhazardous medical materiel may require special handing/protective services when being transported by military-controlled aircraft. When applicable, a properly completed DD Form 1387-2 (Special Handling Data/Certification) label shall be affixed to the exterior (shipping) container. The contractor shall complete the form as illustrated below, and shall firmly affix the completed form adjacent to the Military Shipping Label. All required information shall be supplied in appropriate locations identified by asterisks (*). Signature block shall be completed by the person preparing the shipment. Copies of this form may be obtained by contacting DSCP-FSFB (Packaging) via email at DSCP.Packaging@dla.mil

. NOTE: DD Form 13872 is no longer authorized for certifying hazardous items for shipment via military aircraft per AFMAN 24‐204(I)/TM 38‐250/NAVSUP

PUB 505/ MCO 4030.19/DLAI 4145.3.

This is to certify that the above named materials are properly classified, described, packaged, marked and labeled, and are in proper condition for transportation according to the applicable regulations of the Dept of Transportation. THIS IS A MILITARY SHIPMENT! (Complete applicable blocks below)

J. Hazardous material (HAZMAT):

1. HAZMAT includes any materiel defined as hazardous under 49 CFR 171.8 (Code of Federal Regulations (CFR) Title 49) and the latest version of FED-STD-313.

2. Material Safety Data Sheets (MSDSs)

a) MSDSs shall meet the requirements of 29 CFR 1910-1200 (g) and FED-STD-313. Nothing contained in this DBPA shall relieve the Contractor from complying with applicable Federal, State, and local laws, codes, ordinances and regulations (including the obtaining of licenses and permits) in connection with hazardous materiel. Neither the requirements of this DBPA, nor any act or failure to act by the Government shall relieve the Contractor of any responsibility or liability for the safety of Government, Contractor, or Subcontractor personnel or property.

b) The contractor shall furnish applicable MSDSs as specified herein. If at any time during the contract there is a change in the composition of any item or a revision to FED-STD-313, which renders incomplete or inaccurate the data previously submitted, the contractor shall promptly notify the DSCP Contracting Officer. The DSCP Contracting Officer may at his/her option, require the contractor to resubmit the revised MSDSs to each ordering facility as well as DSCP-FSFB (Packaging). MSDSs shall be provided to the customer as follows:

(1) Applicable to CONUS shipments ONLY

. In compliance with 29 CFR 1910.1200(g), an MSDS shall be provided with the first order from the CONUS customer, whenever an applicable MSDS undergoes a major revision, or every 3 years. In addition, an MSDS shall be provided in response to the customer's request.

(2) Applicable to ALL OCONUS shipments. The contractor shall furnish the OCONUS customer with all applicable MSDSs with each shipment of HAZMAT.

c) A copy of each MSDS, annotated with either the National Stock Number, if applicable, or commercial part number, and item name, shall be provided to DSCP, ATTN: DSCP-FSFB (Packaging). MSDSs will also be provided to the DSCP Contracting Officer, upon request.

3. Hazard Warning Labels (HWLs)

. The contractor shall also obtain and maintain a file of all applicable Hazardous Warning Labels (HWLs). Each MSDS provided to DSCPFSFB (Packaging) and to the DSCP Contracting Officer shall be accompanied by the HWL, when applicable.

4. Packaging, labeling and marking of HAZMAT

a) Packaging of HAZMAT shall comply with all applicable regulations, i.e., 49 CFR, International Civil Aviation Organization (ICAO) Technical Instructions (excluding para. 1.4 of Chapters 1 and 3), and International Air Transport Association (IATA) Dangerous Good Regulations, and International Maritime Dangerous Goods Code (IMDG). The contractor shall insure that all hazardous materiel is packaged, labeled and marked correctly. HAZMAT labeling shall be in accordance with one of the following:

• Federal Insecticide, Fungicide, and Rodenticide Act

• Federal Food, Drug, and Cosmetics Act and regulations promulgated there under

• Consumer Product Safety Act

• Federal Hazardous Substances Act

• Federal Alcohol Administration Actor, if the materiel is not subject to one of the above acts, Hazard Communication Standard 29 CFR 1910-1200 et seq.

b) When required by the ordering facility, HAZMAT shall also be marked as specified in

Medical Marking Standard No. 1.

5. Packaging and marking of HAZMAT for shipment via military air

. In addition, packaging and marking of HAZMAT destined for shipment through a military aerial port via military aircraft shall comply with AFMAN 24-204(I)/TM 38-250/NAVSUP PUB 505/ MCO 4030.19/DLAI 4145.3. Such shipments are identified with Ship To Addresses to the Container Consolidation Points at: Defense Distribution Depot, Susquehanna, PA (DoDAAC: W25N14, RIC: SDQ, SPLC: 209405270) or Defense Distribution Depot, San Joaquin, CA (DoDAAC: W62N2A, SPLC: 875702270); to the Norfolk, VA Container Freight Station (DoDAAC:

N45631, POE: IMJ, RIC: None found); or to the USAF Aerial Ports of Embarkation at Norfolk, VA (DODAAC:

N45627, RIC: None found), Dover Air Force Base, DE (DoDAAC: FB4497, RIC: DJN), Charleston Air Force Base, SC (DoDAAC: FB4418, RIC: DKY) or Travis Air Force Base, CA (DoDAAC: FB4427, RIC: DZK). Each shipment shall be accompanied by a properly completed standard commercial “Shipper’s Declaration for Dangerous Goods.”

6. Shipper’s Declaration for Dangerous Goods (required for ALL commercial/military air shipments)

a) This is a standard commercial form with a red border which is available from commercial vendors specializing in HAZMAT transportation supplies. The form must meet the format, size and color specifications outlined in IATA Dangerous Goods Regulations. Each commercial and military air shipment of hazardous items shall be accompanied by a completed Shipper’s Declaration for Dangerous Goods prepared in accordance with each modal requirement for each segment of the shipment.

b) Applicable to shipments moving to/from/through the United States, Europe, the Middle East and Asia

. Emergency point of contact information shall be included on the Shipper's Declaration in the section headed "Additional Handling Information". The complete telephone number shall be listed; the number shall include the international access code, the country code and the city code, so that a call may be made from any international location. The number must be monitored at all times by a point of contact who is knowledgeable about the hazards and characteristics of the HAZMAT, has comprehensive emergency response and accident mitigation information for the HAZMAT or has immediate access to a knowledgeable person.

7. Special shipping instructions

. Orders placed for HAZMAT should normally include special shipping instructions. If the contractor does not receive special shipping instructions in an order, the contractor shall contact the ordering activity. If special shipping instructions apply to the order, the ordering activity shall promptly furnish them to the contractor.

8. When shipping hazardous cargo to a transshipment point, the contractor shall contact New Cumberland at (717) 770-6969 or Tracy at (209) 832-9634 for assistance.

IX.

LABELING AND SHIPPING INSTRUCTIONS FOR OCONUS SHIPMENTS

A. General instructions. In addition to all requirements specified in section VIII, additional packaging requirements and labeling and shipping instructions shall apply for OCONUS supplier shipments redirected/diverted through defense consolidation points, water ports or military air terminals. These shipments will be identified with one of the following SHIP TO Addresses to the Container Consolidation Points at: Defense Distribution Depot, Susquehanna, PA (DoDAAC: W25N14, RIC: SDQ, SPLC: 209405270) or

Defense Distribution Depot, San Joaquin, CA (DoDAAC: W62N2A, SPLC: 875702270); to the Norfolk, VA Container Freight Station (DoDAAC: N45631, POE: IMJ, RIC: None found); or to the USAF Aerial Ports of Embarkation at Norfolk, VA (DoDAAC: N45627, RIC: None found), Dover Air Force Base, DE (DoDAAC:

FB4497, RIC: DJN), Charleston Air Force Base, SC (DoDAAC: FB4418, RIC: DKY) or Travis Air Force Base, CA (DoDAAC: FB4427, RIC: DZK).

B. Preservation, packaging, packing, labeling and marking requirements

. The following requirements shall also apply to all supplier shipments moving through any defense consolidation point or military air terminal:

1. Certification Requirement for Wood Packaging Material (WPM)

. Complete requirements for certification of WPM are specified in paragraph C of section VIII.

2. Labeling and marking

. In addition to all required labeling and marking as specified herein, the following shall apply:

a) The TCN and the MARK FOR address (correct DoDAAC and the name of the Medical Ordering Facility) shall be shown on the inner package, the packing list, the exterior (shipping) container, and the MSL.

b) The TCN is necessary to identify, control and trace a shipment from origin to ultimate consignee. An example is FM5604-6326-0008XXX for a complete order that is being sent in one shipment to an overseas Air Force medical ordering activity. Without a TCN, a shipment may end up as frustrated cargo, especially at a transshipment point. The "MARK FOR" entry is required to identify the ultimate destination.

All TCN and MARK FOR information will be provided in the call.

c) In lieu of a contractor-generated commercial address label, a bar-coded MSL shall be supplied on all contractor shipments moving through any defense consolidation point or military air terminal. The bar-coded MSL shall be securely affixed to the exterior (shipping) container or unitized load and shall be completed as specified in paragraph F.2 of section VIII.

d) When required, a passive RFID tag shall be supplied on each shipment, as specified in paragraph G of section VIII.

e) The contractor shall provide all necessary documentation to speed the movement of materiel through the customs process.

C. Transshipment points

. The “SHIP TO” address is the transshipment point.

1. For shipments going to Germany, England and Italy, the transshipment points are as follows:

Routine Medical Shipments NORMAL CARGO OVER 70-LBS

SHIP TO:

DEFENSE DISTRIBUTION DEPOT SUSQUEHANNA SITE EAST

BLDG 2001 (MISSION DRIVE)

CCP DOORS 135-168

NEW CUMBERLAND, PA 17070-5000

TCN:

MARK FOR: (Fill in the DoDAAC and the name of the medical ordering facility)

Hazardous Medical Shipments

DEFENSE DISTRIBUTION DEPOT SUSQUEHANNA SITE EAST

BLDG 87 (MISSION DRIVE)

NEW CUMBERLAND, PA 17070-5000

SHIP TO: DEFENSE DISTRIBUTION DEPOT SUSQUEHANNA SITE EAST

Refrigerated Medical Shipments

U AVENUE BLDG. 89, DOOR 10

NEW CUMBERLAND, PA 17070-5000 TCN:

Controlled Substances (Medical)

DEFENSE DISTRIBUTION DEPOT SUSQUEHANNA SITE EAST

U AVENUE, BLDG. 89, DOOR 6

NEW CUMBERLAND, PA 17070-5000

2. For shipments to Guam, Okinawa, Korea, Japan, Hawaii and Alaska, the transshipment points are as follows:

Routine Medical Shipments

DEFENSE DISTRIBUTION DEPOT SAN JOAQUIN

WAREHOUSE 30

25600 S. CHRISMAN ROAD

TRACY, CA 95304-5000

Hazardous Medical Shipments

DEFENSE DISTRIBUTION DEPOT SAN JOAQUIN

WAREHOUSE 28

25600 S. CHRISMAN ROAD

TRACY, CA 95305-5000

Refrigerated Medical Shipments

DEFENSE DISTRIBUTION DEPOT SAN JOAQUIN WEST COAST

MEDEX, WAREHOUSE 17-5

25600 S. CHRISMAN ROAD

TRACY, CA 95304-5000

Controlled Substances (Medical)

DEFENSE DISTRIBUTION DEPOT SAN JOAQUIN

WAREHOUSE 19-3

25600 S. CHRISMAN ROAD

TRACY, CA 95304-5000

D. Shipments moving through military air terminals

1. All ECAT suppliers who ship to overseas medical facilities by military air

. The following shipping instructions shall also apply to all shipments moving through military air terminals:

must

2. Shippers must obtain permission to ship controlled substances by military air. If approved, Signature Tally Service is required. Approval can be obtained when calling for an air clearance as shown below.

call for an air clearance.

3. It is mandatory that all shipments to Air Mobility Command (AMC) air channels obtain shipment clearance from the Service Air Clearance Authority 24 hours prior to arrival. To obtain clearance, the shipper must contact Enterprise Transportation (ET) at (800) 456-5507, fax (717) 770-2701, email delivery@dla.mil

a) DoDAAC (ET will provide a Transportation Control Number (TCN)).

and provide the following information:

b) Date of shipment, mode and number of days enroute.

c) Number and type of containers, weight and cube.

d) Special handling instructions (e.g., perishable, hazardous, etc.).

4. The shipper will also be asked to complete a request form and fax it to ET. See page 22 for a sample of the ET request form.

5. Once ET has received the shipping information from the contractor, ET will email or fax the contractor a Transportation Control Movement Document (TCMD). The TCMD shall be affixed to the outside of the exterior (shipping) container or, as an alternate, shall be inserted into a pouch which is securely affixed to the box.

6. When the air clearance has been obtained, ET will provide the contractor with the applicable AMC channel address.

ET REQUEST FORM

IX.

QUESTIONS/ASSISTANCE:

A. Questions on shipping/labeling should be addressed to: Air Force Ms. Charlotte Christian (301) 619-4164; Army Major Monte Kapec (808) 4333503 (Korean Area); Navy

Ms. Nataki McCowin (301) 295-1325 or Robert L. Keck (301) 319-8796.

B. Questions on packaging/marking and requests for copies of DD Form 13872 should be addressed to:

Defense Supply Center Philadelphia: Miss Loretta F. Connors, DSCP-FSFB (Packaging), Voice (215)737-4189, Fax (215)737-8139 or 8150, or Email Loretta.Connors@dla.mil

C. Sources of referenced documents:

1. ASTM D 3951 is available for purchase from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959 (www.astm.org).

2. ISP/IEC 16388 is available for purchase from The American National Standards Institute, 25 West 43rd Street, New York, NY 10036, (http://www.ansi.org/ or http://www.iso.ch).

3. MIL-STD-129P is available from Document Automation and Production Service (DAPS), Bldg 4D, 700 Robbins Avenue, Philadelphia, PA 19111-5094 (http://assist.daps.dla.mil/quicksearch/

4. Medical Marking Standard No. 1 is available from Defense Supply Center Philadelphia, ATTN:

DSCP-FSFB (Packaging), Bldg 6A South, 700 Robbins Avenue, Philadelphia, PA 19111-5092, email:

DSCP.Packaging@dla.mil. Medical Marking Standard No. 1 is also available on the DLA Packaging Webpage at http://www.dscc.dla.mil/downloads/packaging/mms1.pdf

D. Forms

1. Submit a request for the following forms to DSCP -FSFB (Packaging) via email

. Supplies of referenced forms are available as follows:

DSCP.Packaging@dla.mil

DD Form 1387-2 Special Handling Data/Certification (red border)

; include the form number, quantity required, and complete mailing address, together with the name and telephone number of your POC:

DD Form 1502 Frozen Medical Materiel Shipment – Perishable – Keep Frozen

(green pressure-sensitive label)

DD Form 1502-1 Chilled Medical Materiel Shipment – Perishable – Keep Chilled (orange pressure-sensitive label)

DD Form 1502-2 Limited Unrefrigerated Medical Shipment (red pressure-sensitive label)

DSCP Form 2770 Notice for Frozen Shipments DSCP Form 2770-1 – Notice for Chilled Medical Material Shipments

DSCP Form 2770-2 Notice for Limited Unrefrigerated Medical Shipments

2. Supplies of the Shipper's Declaration for Dangerous Goods are available from commercial vendors who specialize in hazardous material transportation supplies. This is a red-bordered form and must meet the format, size and color specifications outlined in IATA Dangerous Goods Regulation, Section 8 – Documentation.

http://www.astm.org/� http://www.iso.ch/�

SOLICITATION NUMBER SPM2D1-10-R-0011 45 of 147

STATEMENT OF WORK - CONTINUED

TAB D. System Functionality

Instructions for TAB D: Please provide your “Compliance Status” and “Describe” the following in Excel Spreadsheet named: “Section 3 – Statement of Work and Functional Requirements” and in Worksheet named “TAB D”.

D.1. A mechanism shall be provided to permit a system administrator to age patient records out of the database (for example, to remove records after twenty-seven years or after the age of majority of the patient).

D.2. The database shall support, as a minimum, ad hoc queries using search criteria based on the values, or range of values, of Table 1 data items, combined using logical operators, and with the ability to sort results. The purpose of this requirement is to assure that worklist query and administrative report queries can be constructed to support a range of needs.

D.2.1. The database must support a direct DICOM Query/Retrieve.

Table 1: DICOM Attribute Name/Tag

DICOM Attribute Name (Searchable Item)

DICOM Tag

Patient’s Name (0010, 0010) Patient ID (0010,0020) Accession Number (0008,0050) Requesting Service (0032, 1033) Requested Procedure Code Sequence (0032, 1064) Study Time (0008,0030) Study Date (0008,0020) Study ID (0020,0010) Study Description (0008,1030) Study Status ID (0032,000A) Study Priority ID (0032,000C) Interpretation Status ID (4008, 0212) Modality (0008, 0060) Body Part (0018, 0015) Interpretation Diagnosis Code Sequence

(4008, 0117)

Institutional Department Name (0008,1040) Patient’s Institution Residence (0038,0400) Placer Order Number (0040,2016)

SOLICITATION NUMBER SPM2D1-10-R-0011 48 of 147

TAB D Continued:

D.7.4. All monitors must comply with ISO 13406-2:201, Ergonomic Requirements for work with

Visual Display based on Flat Panels. Part 2: Ergonomic Requirements for Flat Panel Displays (ISO 2001) standards.

D.7.5. Configuration D.7.5.1. Workstation monitors shall display no fewer than 1024 shades of gray (10 bit depth).

D.7.5.2. Maximum monitor brightness shall be greater than or equal to 500 candela per meter squared (cd/m2) for primary monitors, 400 cd/m2 for secondary monitors and 600 cd/m2 for mammography monitors.

D.7.5.3. The monitor shall equal to or less than 15% brightness uniformity degradation from the center to the periphery.

D.7.5.4. The monitor shall have less than 3% nonlinearity from center to periphery.

D.7.5.5. The monitor shall have less than 2% geometric distrotion for primary monitors and 5% geometric distrotion for secondary monitors from center to periphery.

D.7.5.6. The spot size shall vary less than 20% from the center to any corner of a rectangle 1/2" inside the perimeter of the monitor.

D.7.5.7. The number of defective pixels per million shall not exceed the perameters defined in

ISO 13406-2.

D.7.5.8. Vendor shall provide a description and specifications for the proposed Primary

D.7.5.9. Vendor shall provide a description and specifications for the proposed monitors including; Spatial Resolution and Diagonal Screen Dimensions for each of the following:

- Grayscale Flat Panel Monitors

- Color Flat Panel Monitors

Secondary

D.7.6. Monitor Calibration monitors including; Spatial Resolution and Diagonal Screen Dimensions for each of the following:

- - Grayscale Flat Panel Monitors

- Color Flat Panel Monitors

D.7.6.1. Brightness and contrast adjustment range of the monitors shall support matching of the monitor grayscale displays on a workstation to less than 10%.

D.7.6.2. The three-month drift of monitor brightness and contrast shall be less than 5%.

D.7.6.3. All monitors will be calibrated in conformance to the performance requirements of the

NEMA Standard on Gray-Scale Display Function.

D.7.6.4. The vendor shall supply a QC procedure and all required images and calibration equipment to assure that the test and calibration requirements in this Section are met.

D.7.6.5. The monitors viewing angel shall be greater than 140o horizontal and 140o

D.7.6.6. The angular performance of the monitor shall not reduce the luminance ratio by more than 30% within the operating ranges of the viewing angles.

vertical.

D.7.6.7. The contrast response for any viewing angle shall not be greater than three times the expected limits on axis. (30% for diagnostic displays and 60% for clinical displays)

D.7.6.8. With their “Notice of Readiness to Inspect”, prior to the start of acceptance testing, Vendors will submit their calibration procedures, calibration data, and any associated log files to the Government or the Government’s representative.

SOLICITATION NUMBER SPM2D1-10-R-0011 50 of 147

TAB F. System Reliability (see Appendix 6) Instructions for TAB F: Please provide your “Compliance Status” and “Describe” the following in

Excel Spreadsheet named: “Section 3 – Statement of Work and Functional Requirements” and in Worksheet named “TAB F”.

F.1. The Vendor will comply with the Government’s system reliability requirements per Appendix 6, Section 2 of the Solicitation.

F.2. The system shall be designed with reasonable redundancy so that no single point of failure can cause a major breakdown of radiology service.

F.3. The system shall protect against the loss of acquired images and data.

F.4. If a failure interrupts or disables image acquisition, the system shall provide a means to enter the missed images from the imaging equipment at a later time.

F.5. Where appropriate to guarantee against loss of image or exam information during acquisition or storage in the PACS in the event of a power failure, the vendor shall supply an Uninteruptable Power Supply (UPS) with sufficient capacity to support the necessary equipment during the operation. This requirement is not intended to require UPS at all locations, only at those locations where a power failure would cause a loss of patient images or information. This requirement is also not intended to require that the system continue to operate for additional acquisitions during the power outage.

F.6. The system shall maintain a total system uptime of 99% monthly, and individual component uptimes of at least 90% monthly, calculated monthly during the fist 6 months, and quarterly thereafter. Percentages will be calculated based on the Principal Period of Maintenance (see Appendix 6, Section 2.4 for calculation).Component and system downtimes will include scheduled and unscheduled outages. Vendors shall document their current experience with their product that would demonstrate to the Government that this requirement can be met. (see Appendix 6 for definitions of uptime and downtime.)

SOLICITATION NUMBER SPM2D1-10-R-0011 51 of 147

TAB G. System Maintenance Instructions for TAB G: Please provide your “Compliance Status” and “Describe” the following in Excel Spreadsheet named: “Section 3 – Statement of Work and Functional Requirements” and in Worksheet named “TAB G”.

G.1. The Vendor will comply with the Government’s system maintenance requirements specified in Appendix 6 .

G.2. Vendor shall offer maintenance service in accordance with the “maintenance scope of work options” specified in Appendix 6, paragraph 3.13.

G.3. Vendors are encouraged to offer their normal, commercial maintenance service plans (based on their standard commercial maintenance service terms and conditions) in addition

G.4. The offered maintenance plans shall specify the level of operations support, including all on-site field engineers, part-time and/or off-site personnel, as well as the hours of coverage.

to the Government specified service options above.

G.5. Maintenance and support response time shall be 4 hours or less during the 0800-1700 time period and 4 hours or less during the remainder of the day. Maintenance may be conducted remotely or onsite, or a combination of the two. Response time is measured from the time the vendor is notified of a need for maintenance or support, until maintenance is started from a remote location or support personnel arrive on-site and begin actively working on the problem.

If remote maintenance and support is begun and the problem remains unresolved after the initial 4 hour timeperiod, vendor personnel shall immediately be dispatched to the site and arrive within 4 hours or less.

TAB H. Repair Parts Strategy Instructions for TAB H: Please provide your “Compliance Status” and “Describe” the following in Excel Spreadsheet named: “Section 3 – Statement of Work and Functional Requirements” and in Worksheet named “TAB H”.

H.1. The vendor shall provide a guarantee that the Government will be able to purchase all required spare parts from the vendor for seven years from the date of final system acceptance.

H.2. If the Government elects not to upgrade existing systems to new versions (either hardware or software), the vendor shall guarantee that they will continue to provide support for hardware, software and spare parts FOR THE INSTALLED SYSTEM for a minimum of three years after release of the upgrade.

SOLICITATION NUMBER SPM2D1-10-R-0011 65 of 147

Appendix 2 - DICOM Support Continued

2. Non-DICOM Modalities

A For existing modalities that cannot be retrofit to support DICOM the vendor shall offer an acquisition gateway that accepts information from the modality and acts as a DICOM Storage SCU of the appropriate SOP class.

B The vendor shall provide a mechanism to assure that correct patient and exam identification information is included in all images transmitted to the system.

C An acquisition gateway shall include a DICOM Storage Commitment Push Model SCU.

D An acquisition gateway shall include a DICOM Study Component Management SCU.

3. General Interface Requirements A The interface between a modality and the system shall not decrease the patient throughput of the modality.

B The system shall accept the full, original image dataset transmitted from the modality.

C Vendors are expected to support the Integrating the Healthcare Enterprise (IHE) initiatives as it evolves.

SOLICITATION NUMBER SPM2D1-10-R-0011 66 of 147

Appendix 3: Contract Data Requirements List (CDRL) The Contractor shall provide on a site specific basis one or more of the following documentation items (DD Forms 1664 items AA through AJ).