W81K02-12-R-0081_0002.pdf

PACIFIC REGIONAL CONTRACTING OFFICE

MCAA PC P PARNES

160 KRUKOWSKI RD BKDG 160

808-433-2647

TRIPLER AMC HI 96859-5000

0010181229-0002

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item9A 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

1. This amendment is hereby issued to revise salient characteristic #21, System shall be capable of performing the follow ing FDA approved tests. The previously included test for Kappa and lambda free light chains is removed as show n in the Summary of Changes.

2. All other terms and conditions remain unchanged.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 9

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

16C. DATE SIGNED

BY 30-Nov-2012

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 W81K02-12-R-0081

X 9B. DATED (SEE ITEM 11)

13-Nov-2012

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 Item14. The hour and date specified for receipt ofOffer 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 ofthis amendment on each copy of the offer submitted;

or (c) By separate letter or telegramwhich 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. Ifby virtue of this amendment you desire to change an offer already submitted, such change may be made by telegramor letter, provided each telegramor 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.(Ifapplicable)

6. ISSUED BY

3. EFFECTIVE DATE

30-Nov-2012

CODE

PACIFIC REGIONAL CONTRACTING OFFICE

ATTN MCAA PC BLDG 160

160 KRUKOWSKI RD

TRIPLER AMC HI 96859-5000

W81K02 7. ADMINISTERED BY (Ifother than item6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K02

FACILITY CODECODE

EMAIL:TEL:

W81K02-12-R-0081

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

ADDENDUM TO 52.212-1

Delete paragraph (a) (8).

Replace Paragraph 52.212-1(b) with the following:

INSTRUCTIONS FOR PREPARATION OF PROPOSALS:

Offers shall submit signed and dated proposals to the office indicated in Block 9 of the Standard Form (SF) 1449, Solicitation/Contract/order for commercial Items, to arrive no later than the date and time specified in Block 8, SF 1449. The proposal shall have a title page identifying the offeror, the full address, phone/fax number, contacts (POCs) with email addresses, the solicitation number and its contents.

Acceptable Proposal Submission:

Proposals shall be submitted via E-Mail to:

Penelope.a.parnes@us.army.mil

The entire proposal including all VOLUMES (1-5) shall not exceed 10Mb. Please note that the Government cannot receive emails larger than 3Mb. If your proposal is larger than 3Mb, please submit your proposal in separate parts.

Your proposal shall be considered received according to the time and date that the last emailed part is received. The proposals submitted must clearly identify this notice and the name of the contract specialist on the first page or subject line. Submitters bear the burden of ensuring that the proposals reached the designated contracting office on time. Point of contact for this requirement is Penelope Parnes, 808-433-2647.

WARNING: Please do not wait until the last minute to submit your proposals! To avoid submission of late proposals, we recommend the transmission of your proposal file 24 hours prior to the required proposal due date and time.

WRITTEN DOCUMENTATION: Offerors shall submit, in writing, specifications for the item(s) required in the solicitation along with the pricing. (NOTE: offers submitted through AFSI or facsimile are unacceptable):

The offeror shall submit 1 copy of its entire proposal. The submittal of an incomplete proposal may render the proposal unacceptable and will not be considered.

WRITTEN DOCUMENTATION: Offerors shall prepare in five separate volumes as follows (NOTE: offers submitted through AFSI are unacceptable):

VOLUME I - ADMINISTRATIVE

VOLUME II - TECHNICAL (Factor 1) VOLUME III – SUBCONTRACTING PLAN (Factor 2) VOLUME IV – PAST & PRESENT PERFORMANCE (Factor 3) VOLUME V - PRICE (Factor 4)

WRITTEN DOCUMENTATION, shall also include the following:

VOLUME I. ADMINISTRATIVE

a. Request for Proposals – A copy of the Solicitation/Contract/Order for Commercial Items, (SF 1449) with signatures of a corporate officer authorized to negotiate for the company. Include name of the company, phone, fax numbers, and email address (es).

b. Acknowledged and signed copies of amendment(s) if applicable. The number of copies required will be shown on the SF 30.

c. Completed copy of the Representations and Certifications at FAR 52.212-3, (Alternate I), 52.209-7, and DFARS 252.212-7000. If the offeror has completed the Online Representations and Certifications Application (ORCA) at http://orca.bpn.gov, the offeror shall indicate such on the FAR clause. The offeror shall also submit a completed copy of DFARS 252.212-7000, Offeror Representations and Certifications – Commercial Items, and DFARS 252.247-7022, Representation of Extent of Transportation by Sea.

d. The offeror shall provide (with its proposal) points of contact for administration of the contract during offeror’s normal business hours and after normal business hours. The POC for other than normal business hours will be contacted only in the event of emergencies. Accordingly, the named individual(s) should possess sufficient corporate authority to effectively deal with emergency situations and the telephone number provided should be functioning at all times other than normal business hours. If there are different POCs for different conditions, such as weekdays, weekends, holidays, etc., please furnish and explain:

(1) Offeror’s normal business hours/days:

(2) POC(s) during normal business hours: Name & Telephone

(3) POC(s) for other than normal business hours: Name & Telephone

VOLUME II. TECHNICAL (Factor 1)

Technical acceptability will be determined through an evaluation of the offeror’s proposal to determine whether the proposal clearly meets the minimum requirements of the solicitation. Provide, in writing, the specifications for the supply/equipment item required in the solicitation. To meet the Government’s minimum need, all salient characteristics must be met.

1) Platform shall include an automated process capable of tracking reagent use for the purposes of usage prediction and reagent management.

2) System shall provide reagents that are FDA approved for total Vitamin D (25-OH-D) testing.

3) System shall provide reagents that are FDA approved for sex hormone binding globulin (SHBG) testing and total testosterone testing.

4) The analytical system shall not produce more than 25 gallons of water per hour.

5) The middleware shall include an integrated Quality Control (QC) package incorporating the ability to export results into the Bio-Rad QC format.

6) The middleware shall include lab custom programming to communicate with Composite Health Care System (CHCS) Laboratory Information Services (LIS)

7) The total length of the main analyzer shall not exceed 30 feet. The vendor shall configure the complete testing platform to fit within the allocated core lab space in conjunction with corresponding automation and coordinated with the core laboratory plans for the new construction space.

8) Platform shall contain a cost per reportable (CPR) option.

9) Provide fully automated assay linearity for performing linearity studies with no additional soft-ware purchase required of TAMC.

10) Provide a fully automated system to include middleware that is capable of handling sample storage, sample retrieval, centrifugation, de-capping, and re-capping to accommodate the work-flow of the TAMC core laboratory.

11) Provide automated unloading of empty reagent containers; instrument shall be able to hold sample on board for up to 2 hours for add-ons and test re-run.

12) Release of primary sample tube less than 5 minutes for STAT and less than 15 minutes for routine samples, re-testing, or add-on tests.

13) System shall not require “instrument pause” or “stand-by” for loading reagent, calibrators, and controls.

14) Provide a system to eliminate cross-over contamination.

15) Cardiac Reagents shall include high sensitive Troponin approved by the American College of Cardiology and/or the World Health Organization (ACC/WHO) and adhere to a less than 18 minute total testing time.

16) Provide up to a 14-day on board calibration stability for immunoassay testing menu.

17) Provide capability to remotely access the system for troubleshooting, proactive service, and antivirus, firewall, and required software upgrades.

18) Install/initialize equipment and complete correlation studies as specified in the Performance Work Statement (PWS).

19) Provide 24/7 on-island support qualified to maintain equipment in accordance with manufacturer’s specifications with a guaranteed 97% uptime as specified in the PWS.

20) Provide a device, such as an Uninterrupted Power Supply (UPS), to serve as a back-up in case of power instability or power failure

21) System shall be capable of performing the following FDA approved tests:

ANYLYTE

Albumin

Alkaline Phosphatase

Aspartate aminotransferase

Alanine aminotransferase

Blood Urea Nitrogen

Calcium

Chloride

Creatinine

Carbon Dioxide

Glucose (Serum, Urine, and CSF)

Potassium

Sodium

Total Bilirubin and Direct Bilirubin

Total Protein

Cholesterol

Creatine Kinase (CK) and CKMB

Lactate Dehydrogenase

MAGNESIUM

PHOSPHORUS

TRIGLYCERIDES

URIC ACID

Amylase

High Density Lipoportein

Gamma Glutamyltransferase

Iron

Lactate

Lipase

Ammonia

C-Reactive Protein

Alpha 1 Antitrypsin

Anti Streptolysin ASO

C3 Complement

C4 Complement

Haptoglobin

Immunoglobulin A

Immunoglobulin G

Immunoglobulin M

Prealbumin

Rheumatoid factor

Transferrin

Total Iron Binding Capacity (TIBC)

Acetaminophen

Carbamazepine

DIGOXIN

Prostate Specific Antigen (PSA)

Gentamicin

Lithium

Phenytoin

Salicylates

Valproic Acid

Vancomyocin

Alcohol (Urine and Serum)

Amphetamines (Urine)

Benzodiazepines (Urine)

Cocaine (Urine)

Opiates (Urine)

Cannabinoids/THC (Urine)

Homocysteine

Vitamin B12

Ferritin

Folate

Cardiac Troponin T or I N-Terminal Pro-Brain Natriuretic Peptide or BNP

Estradiol

Follicle Stimulating Hormone (FSH)

Luteinizing Hormone (LH)

Progesterone

Prolactin

Testosterone (Total)

Sex Hormone Binding Globulin (SHBG) beta-Human Chorionic Gonadotropin Hepatitis Panel e.g.) Hepatitis B Surface Antigen & Antibody, HCV, HAV, HAV IgM, Hb core total, Hb core IgM

Free T 3

Free T4

Low Density Lipoprotein

Microalbumin

Carcinoembryonic Antigen (CEA)

Ceruloplasmin

HbA1c (Hemoglobin A1c)

Urine and CSF Protein

Thyroid stimulating Hormone (TSH)

Total Vitamin D

VOLUME III. SUBCONTRACTING PLAN (Factor 2)

1. If the offeror is a large business, it must submit either a commercial or an individual subcontracting plan as required under FAR 19.702(a) (1) and must contain separate parts for the base year and each option year. If the offeror is large business and fails to submit a subcontracting plan, it will be ineligible for award. Offerors submitting previously approved commercial subcontracting must provide documentation of approval granted.

2. Each large business shall submit a subcontracting plan, which upon award and approval by the contracting officer will be incorporated into the contract. The offeror shall document clear, detailed, logical, and realistic approaches in its subcontracting plan for establishment, oversight, and quality assurance of subcontracts and the Government’s acquisition and contracting goals pertinent to this solicitation. Current goals are: Not less than 40% of the total contract value for a small business, which included 5% for Small and Disadvantaged Businesses, 5% for Women- Owned Small Businesses, 3% for HUBZone Small Businesses, 3% for Service Disabled Veteran Owned Small Businesses, 3% for Veteran Owned Small Businesses, and 5% for HBCU/MI. The offeror shall list and describe any subcontracts to be used to perform the requirements of the PWS.

a. Identification of the separate percentage goals for using small business, HUBZonesmall business, small disadvantaged business, service disabled veteran-owned small business, veteran-owned small business, woman-owned small business concerns, and HBCU/MI as subcontractors.

b. A statement of the total dollars planned to be subcontracted to small business, HUBZone small business, small disadvantaged business, service-disabled veteran-owned small business, veteran-owned small business, woman-owned small business concerns, and HBCU/MI.

c. A description of the principal types of supplies and services to be subcontracted and an identification of the types planned for subcontracting to small business, HUBZone small business, small disadvantaged business, service-disabled veteran-owned small business, veteran-owned small business, woman-owned small business concerns, and

HBCU/MI.

d. A description of the method used to develop the subcontracting goals.

e. A description of the method used to identify potential sources for solicitation purposes.

f. A statement as to whether or not the offeror included indirect costs in establishing subcontracting goals, and a description of the method used to determine the proportionate share of indirect costs to be incurred with small business, HUBZone small business, small disadvantaged business, service-disabled veteran-owned small business, veteran-owned small business, woman-owned small business concerns, and HBCU/MI.

g. The name of an individual employed by the offeror who will administer the offeror's subcontracting program and a description of the duties of the individual.

h. A description of the efforts the offeror will make to ensure that small business, HUBZone small business, small disadvantaged business, service disabled veteran-owned small business, veteran-owned small business, woman-owned small business concerns, and HBCU/MI have an equitable opportunity to compete for subcontracts.

i. Assurances that the offeror will include the clause at 52.219-8, Utilization of Small Business Concerns (see FAR 19.708(a)) in all subcontracts that offer further subcontracting opportunities and that the offeror will require all subcontractors (except small business concerns) that receive subcontracts in excess of $500,000.00 to adopt a plan that complies with the requirements f the clause at 52.219-9, Small Business Subcontracting Plan. (see FAR .19.708 (b)).

Assurances that the offeror will:

Cooperate in any studies or surveys as may be required. Submit periodic reports so that the Government can determine the extent of the compliance by the offeror with the subcontracting plan.

Submit Standard Form (SF) 294 (Subcontracting Report for Individual Contracts) and SF 295 (Summary Subcontract Report) following the instructions on the forms or as provided in agency regulations.

Ensure that its subcontractors agree to submit SF 294 and SF 295.

j. A description of the types of records that will be maintained concerning procedures adopted to comply with the requirements and goals in the plan, including establishing source lists, and a description of the offeror's efforts to locate small business, HUBZone small business, small disadvantaged business, service disabled veteran-owned small business, veteran-owned small business, woman-owned small business concerns, and HBCU/MI and to award subcontracts to them.

Subcontracting plans submitted by any large business concern will be evaluated in accordance with the requirements under FAR Subpart 19.704. If a large business concern fails to submit a subcontracting plan with its proposal, it will be ineligible for award. The subcontracting plan will be evaluated for establishment, oversight, and quality assurance of subcontracts and goals pertinent to this solicitation.

VOLUME IV. PAST & PRESENT PERFORMANCE (Factor 3)

a. Submit evidence of past performance through the attached Past Performance Surveys (see Attachment 1) for at least three contracts you currently have or have completed within the past three years from the solicitation issue date under which you performed similar services (with respect to complexity and dollar value) for other federal agencies. If you have not performed any similar contracts, you may furnish any other past performance information which you believe demonstrates ability to perform the services required by this solicitation.

b. Offerors shall ensure their customers submit the attached Past Performance Surveys directly to the Pacific Regional Contracting Office, ATTN: Penelope Parnes via e-mail or fax by the closing date of the solicitation. The Government will not be responsible for tracking incorrect references and phone numbers.

c. To expedite the evaluation process, offerors are requested to send their private sector references a letter authorizing the reference to provide information to the Government. The Government may begin surveying references immediately after the solicitation closing date; therefore, it is crucial that offerors immediately authorize their references to release information to the Government.

d. The Government may also consider any additional information from its own files, databases such as the Past Performance Information Retrieval System (PPIRS), or from any other source it deems appropriate. The Government may survey references to verify the information provided.

e. The Government will not be responsible for tracking incorrect references and phone numbers, or those surveys not submitted by the due date. Offerors are reminded that, while the Government may elect to consider data obtained from other sources, the burden of providing thorough and complete past and present performance information rests with the offeror.

VOLUME V. PRICE (Factor 4)

a. Schedule Pricing for Requirements. The offeror shall submit proposed pricing for all Line Item Numbers identified in the Request for Proposal, unless otherwise noted. The offeror shall submit pricing for the base period and each option period if applicable.

(End of 52.212-1 paragraph b replacement)

m. Protests received at a level higher than the contracting officer will be referred to the contracting officer.

Protestor may request a review by the contracting officer or an independent review at a level higher than the contracting officer. Requests for appeals or independent review will be addressed to the contracting officer for referral to the review authority. Questions on this process will be referred to the cognizant contracting officer identified in the solicitation.

n. SITE VISIT. A site visit has been scheduled on 29 November 2012 at 0900, Tripler Army Medical Center, Jarrett White Road, Honolulu, Hawaii. All interested parties are to meet outside the Oceanside Lobby. All interested offerors must notify Penelope Parnes (808) 433-2367 or e-mail Penelope.a.parnes@us.army.mil at least 2 (two) business days before the scheduled site visit. Due to space limitations, offerors shall be limited to no more than two

(2) representatives per firm. Site visit is a representation of various types of services to be performed but not all inclusive. In the interest of orderly procedures and impartiality to all offerors, the site will be accessible at the specified time only. Prospective offerors are hereby notified that additional inspection opportunities will not be permitted.

o. The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

(End of Addendum 52.212-1)

(End of Summary of Changes)