W81K00-16-T-M033 _Solicitation_V3.pdf

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This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in the Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotes are being requested. The solicitation number is W81K00-16-T-M033 and is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-88 and Defense Federal Acquisition Regulation Supplement Publication Notice (DPN) 20160607.

The Regional Health Contracting Office - Central (RHCO-C) intends to award at least one but no more than 4 Blanket Purchase Agreement (BPA) for these services. The requirements are for newborn screenings and related services. The BPA will be established under FAR Part

13.5. The BPA issued as a result of this solicitation will have a single bulk call limit of up to $150,000.00, with a maximum overall BPA limit of $6,500,000.00. BPA calls/orders will be based on patient need and physician preference. The MTF will schedule deliveries against the bulk call as needed based on patient census/need. Quoters are reminded that, in the event they receive a BPA, the issuance of calls/orders is not guaranteed. Funds are not obligated on the BPA, but only on any issued calls/orders.

The anticipated period of performance is 1 October 2016 through 30 September 2021.

The associated North American Industry Classification System (NAICS) code for this procurement is 621511, Testing Laboratories, Medical. The size standard for NAICS 621511 is $32.5M. This procurement is conducted under full and open competition.

Quotes are due by 30 September 2016, at 12:00 PM, Central Standard Time. The point of contact is Mr. Calvin Blue at calvin.L.blue.civ@mail.mil . Quotes and associated documentation shall be submitted via e-mail. Late offers will not be accepted.

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 draft Blanket Purchase Agreement (BPA) is included with this solicitation as Attachment 1. All pertinent clauses are included in this draft BPA, and are not listed here. They are applicable to any BPA that may result from this solicitation. Only provisions are included in this document.

NOTE 3: A price list template is included as Attachment 2. Offerors may submit their own format, but should include as a minimum the headings/categories listed on the template.

PERFORMANCE WORK STATEMENT (PWS)

Newborn Screening Disorders

Brooke Army Medical Center (BAMC)

Department of Pathology mailto:calvin.L.blue.civ@mail.mil

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I. NEWBORN METABOLIC SCREENING: SCOPE OF WORK

Non-Personal Services: Contractor will provide laboratory screening services for a core set of inherited metabolic disorders, supplementary screening tests, and continuous re-evaluation for additional testing based on the recommendations set forth by the

Recommended Universal Screening Panel (RUSP) and the American College of

Medical Genetics. Included in the cost of a single test, the contractor shall provide the following:

Provision of specimen collection materials; to include specimen collection cards, envelopes, labels and pamphlets

Timely transport of collected specimens

Accurate and timely laboratory testing of specimens

Accurate and timely interpretation of test results

Accurate, timely, and comprehensive reporting of results

Data management and technical assistance

Clinical consultation to laboratory and clinical staff within the Military

Health Care System

Participation in quality assurance programs and reporting of quality assurance data

II. SPECIFIC TESTING REQUIREMENTS

Contractor must be inspected and accredited by an appropriate accreditation organization approved by CMS. Contractor shall provide results for the following disorders:

Group Condition Code

Organic Disorder Acid

Disorder

Propionic acidemia PROP

Methylmalonic acidemia

(methylmalonyl-CoA mutase)

MUT

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Methylmalonic acidemia

(cobalamin disorders)

Cbl

A,B

Isovaleric acidemia IVA

3-Methylcrotonyl-CoA carboxylase deficiency

3-MCC

3-Hydroxy-3-methyglutaric aciduria

HMG

Holocarboxylase synthase deficiency

MCD

ß-Ketothiolase deficiency ßKT

Glutaric acidemia type I GA1

Fatty Acid oxidation disorders

Carnitine uptake defect/carnitine transport defect

CUD

Medium-chain acyl-CoA dehydrogenase deficiency

MCAD

Very long-chain acyl-CoA dehydrogenase deficiency

VLCAD

Long-chain L-3 hydroxyacyl-CoA dehydrogenase deficiency

LCHAD

Trifunctional protein deficiency

TFP

Amino Acid disorders Argininosuccinic aciduria ASA

Citrullinemia,type I CIT

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Maple syrup urine disease MSUD

Homocystinuria HCY

Classic phenylketonuria PKU

Tyrosinemia,type I TYR I

Endocrine Disorder Primary congenital hypothyroidism

CH

Congenital adrenal hyperplasia

CAH

Hemoglobin Disorders S,S disease (Sickle cell anemia)

Hb SS

S, βeta-thalassemia Hb S/ßTh

Hemoglobin Disorders S,C disease Hb S/C

Other Disorders Biotinidase deficiency BIOT

Cystic fibrosis CF

Classic galactosemia GALT

III. SECONDARY TESTING REQUIREMENTS

Contractor shall provide secondary condition results for the following disorders:

Group Condition Code

Organic Disorder Acid

Disorder

Methylmalonic acidemia with homocystinuria

Cbl C,D

Malonic acidemia MAL

Isobutyrylglycinuria IBG

2-Methylbutyrylglycinuria 2MBG

3-Methylglutaconic aciduria 3MGA

2-Methyl-3-hydroxybutyric 2M3HBA

W81K00-13-T-M093 Page 5 of 37 aciduria

Fatty Acid oxidation disorders

Short-chain acyl-CoA dehydrogenase deficiency

SCAD

Medium/short-chain L-3-hydroxyacl-CoA dehydrogenase deficiency

M/SCHAD

Glutaric acidemia type II GA2

Medium-chain ketoacyl-CoA thiolase deficiency

MCAT

2,4 Dienoyl-CoA reductase deficiency

DE RED

Carnitine palmitoyltransferase type I deficiency

CPT IA

Carnitine palmitoyltransferase type II deficiency

CPT II

Carnitine acylcarnitine translocase deficiency

CACT

Amino Acid disorders Argininemia ARG

Citrullinemia,type II CIT II

Hypermethioninemia MET

Benign hyperphenylalaninemia

H-PHE

Biopterin defect in cofactor biosynthesis

BIOPT

(BS)

Biopterin defect in cofactor regeneration

BIOPT

(REG)

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Amino Acid disorders Tyrosinemia,type II TYR II

Tyrosinemia,type III TYR III

Hemoglobin Disorders Various other hemoglobinopathies

Var Hb

Other Disorders Galactoepimerase deficiency

GALE

Galactokinase deficiency GALK

T-cell related lymphocyte deficiencies

If testing is unavailable, contractor may be working towards obtaining testing capabilities. As new disorders are discovered or new testing procedures develop in the field of newborn screening, the disorder or testing procedure may be added to the contract on a post award basis. In regard to these testing procedures/new disorders, all prices and, terms and conditions will be negotiated on a post-award basis. *Note:

Conditions may be listed by alternate names.

IV. TESTING SERVICES

The military comprehensive panel without G6PD includes the following:

Initial screen

Second Screen

Repeat Screen

Performed as a follow-up to a presumptive positive result (at no additional cost to the government)

Improper sample collection

A technical problem such as patient identification error or degradation of shipment on the initial screen

Disorders confirmed or detected by DNA analysis, as available

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Next day service for samples Monday through Friday (Saturday pickup if available)

V. NEWBORN METABOLIC SCREEN RESULTING

The contractor makes all tests results available within 3 business days and not longer than 5 business days of sample receipt. Test results will be posted on the contractor’s

HIPPA-compliant website within this timeframe and can be accessed 24 hours/7days a week. Reports for normal and abnormal results shall be reported as follows:

Through an electronically secure, HIPPA compliant web based system for access by any MTF worldwide. The system shall identify, as appropriate, specimens drawn early (e.g., less than 24hours of age), unsatisfactory specimens, presumptive positive specimens, specimens collected post transfusion, and missing tests.

Results shall also be received in writing to the submitting MTF via fax or overnight delivery.

Results will be sent in writing to a centralized DoD Newborn Screening registry for tracking newborn demographics and screening results. (This registry may not be established at the time of contract award; the contractor shall add this capability when the registry is established.)

The test result report shall include:

Quantitative results (and interpretive guidance) for abnormal metabolites

Detailed interpretations of the results (including an overview of the significance, possible differential diagnoses, recommendations for additional biochemical testing and confirmatory studies)

For abnormal results and unsatisfactory specimens the contractor will abide by the following:

Timelines and methods of delivery of presumptive positive/significant abnormal results will follow established protocols per disorder, age of child and degree of illness.

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Abnormal results will be communicated via phone or pager to the

Newborn Screening Coordinator/ordering provider immediately upon testing completion. Abnormal reports shall be faxed to individuals designated to receive abnormal newborn screen results within SAMMC to include the Newborn Screening Coordinator/Ordering provider and the laboratory. Appropriate recommendations for further testing will be made.

The contractor will arrange for designated specialists in metabolic, hematology, pulmonology, endocrinology and immunology to contact the health care provider within 24 hours of laboratory analysis completion to help arrange clinical evaluation and guide medical management.

The contractor must report unsatisfactory specimens by the following three methods: (1) By phone or pager to the Newborn Screening

Coordinator/Ordering provider within 24 hours when the specimen is determined to be unsatisfactory. (2) By phone to the submitting MTF laboratory within 24 hours of when the specimen is determined to be unsatisfactory. (3) By faxing or mailing of a written report to the submitting MTF laboratory within 24 hours of when the specimen is determined to be unsatisfactory.

The contractor shall maintain documentation of all communication with submitting MTF laboratories and physicians regarding screening results

(normal, abnormal, repeat, confirmatory), unsatisfactory specimens, and laboratory errors. All electronic transmissions of data must meet all State and Federal regulations, including the data privacy and security requirements of HIPPA.

The contractor shall report test results to each applicable State

Government Newborn Screening Program, as required by State law.

The contractor shall report test results to the National Newborn

Screening and Genetics Resource Center (NNSGRC), if requested by

NNSGRC.

VI. GENETIC COUNSELING

The contractor shall provide the availability of knowledgeable and licensed newborn screening nurses and other healthcare providers for discussion and interpretation of test results. The contractor’s newborn screening providers will be available 24hours/7 days a week to provide the necessary medical advice and consultation. Contact numbers for follow-up

W81K00-13-T-M093 Page 9 of 37 questions from physicians will be included on any report that contains abnormal test results. Consultative services include, but are not limited to:

Interpretation of screening test results

Recommendations for further evaluation

Recommendation for initial management

Educational support

Patient referral recommendations

VII. STAFF TRAINING/EDUCATION

The contractor will provide the following training/education requirements to laboratory and clinical staff as requested:

Proper sample collection process

Sample shipment preparation and packaging

Logistical coordination for sample processing

Physician education - Physician education as needed when new recommendations are made by the American College of Medical Genetics.

Contractor Manpower Reporting

"ACCOUNTING FOR CONTRACT SERVICES-The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address “https://cmra.army.mil.” The required information includes: (1) Contracting

Office, Contracting Officer, Contracting Officer’s Technical Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data; (5) Estimated direct labor hours

(including sub-contractor); (6) Estimated direct labor dollars paid this reporting period

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(including sub-contractor); (7) Total payments (including sub-contractor); (8)

Predominant Federal Service Code (FSC) reflecting services provided by contractor

(and separate predominant FSC for each sub-contractor if different); (9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity

(the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information); (10) Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest

City, Country, when in an overseas location, using standardized nomenclature provided on website); (11) Presence of deployment or contingency contract language, and, (12)

Number of contractor and sub-contractor employees deployed in theater this reporting period (by country). (13) As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement.

Reporting period will be the period of performance not to exceed 12 months ending

September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The contractor shall notify the Contracting Officer’s Representative

(COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the Contracting Officer."

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

The following minimum Quality Assurance Plan applies. The Government may modify inspection methods in accordance with site specific requirements.

PERFORMANCE OBJECTIVE PERFORMANCE

STANDARD

REF PWS METHOD OF

ASSESSMENT

Scope of Work. Contractor shall provide qualified personnel, services, materials, equipment, supplies and facilities necessary to perform a core set of inherited metabolic disorders and supplementary newborn screening tests as recommended by the ACMG.

Documentation in accordance with regulations, established guidelines

I COR Review

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Specific Testing requirements.

Testing performed must be able to provide results for the following disorders (see PWS)

Comply initially and as required

100% of the time.

II COR Maintain Log

Newborn Screen Resulting.

Contractor must make all tests results available within 3 business days and not longer than 5 business days after it receives the specimen.

Comply initially and as required

100% of the time.

V COR Maintain Log

Genetic Counseling.

Contractor will provide the availability of Board certified medical consultants; available

24 hours / 7days a week to provide the Newborn Screening

Nurses necessary medical advice and consultation.

Comply initially and as required

100% of the time.

VI COR maintain log.

52.212-1 Instructions to Offerors – Commercial Items APR 2014

ADDENDUM TO 52.212-1

Quoter shall submit the following:

1. Technical Capability. Explain in detail how the offeror will meet each of the requirements of the Performance Work Statement. Offerors shall demonstrate that the newborn screening services proposed complies with the technical requirements of the Performance Work Statement (PWS) via submission of a written capability statement, product literature, or other materials, with their offer.

Factor 1 Technical – Offerors shall provide a detailed narrative as to how they plan to meet each section of the Performance Work Statement. This factor consists of the following subfactors;

Subfactor 1A – Performance Work Statement Compliance – Offeror shall provide a detailed narrative stating as to how they plan to meet each of the sections and

W81K00-13-T-M093 Page 12 of 37 elements contained therein. Each response must indicate which section and element of the PWS it is addressing. Technical submission for this subfactor shall not exceed 75 pages.

Subfactor 1B – Quality Control Plan – Offeror shall provide a quality control plan that at a minimum meets the performance objectives and standards stated in the PWS. Quality Control Plans shall not exceed 20 pages.

NOTE: Offerors must be rated as acceptable in each technical subfactor in order to be considered for award.

Factor 2 –Price – Offerors shall provide test list that contains pricing per test that is inclusive of all 53 tests contained in the PWS. Offerors shall also provide a discount % and the discounted BPA price for each test offered on their price list. A sample format is provided in attachment 2.

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.

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

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.

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

4. Also provide the following items:

-DUNS#

-CAGE Code

-Delivery Time

-Contact Information (Name, Telephone Number, Fax Number, and Email)

-Any Shipping Cost

-Brochures and/or product information (no more than 20 pages) http://www.sam.gov/

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5. 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.

CLAUSES INCORPORATED BY REFERENCE

52.225-25 Prohibition on Contracting with Entities Engaging in Sanctioned Activities Relating to Iran — Representation and Certification

NOV

CLAUSES INCORPORATED BY FULL TEXT

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (JULY 2013)

(a) Definitions. As used in this provision--

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange

Commission Administrative Proceedings, Civilian Board of Contract Appeals

Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

Federal contracts and grants with total value greater than $10,000,000 means--

(1) The total value of all current, active contracts and grants, including all priced options;

and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror ( ) has ( ) does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee

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Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a

Federal contract or grant, been the subject of a proceeding, at the Federal or

State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) Administrative proceeding, a finding of fault and liability that results in--

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c) (1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c) (1) (i) through (c) (1) (iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management database via https://www.acquisition.gov (see 52.204- 7).

(End of provision)

52.233-2 SERVICE OF PROTEST (SEP 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from Ms. Michelle Bartkowski, 3851 Roger Brooke Drive, Brooke Army Medical Center, Fort Sam Houston TX 78234-6200.

https://www.acquisition.gov/

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(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address (es):

http://www.acquisition.gov/far http://farsite.hill.af.mil

52.252-5 AUTHORIZED DEVIATIONS IN PROVISIONS (APR 1984)

(a) The use in this solicitation of any Federal Acquisition Regulation (48 CFR Chapter 1) provision with an authorized deviation is indicated by the addition of “(DEVIATION)” after the date of the provision.

(b) The use in this solicitation of any DOD FAR Supplement (48 CFR Chapter 2) provision with an authorized deviation is indicated by the addition of “(DEVIATION)” after the name of the regulation.

252.203-7005 REPRESENTATION RELATING TO COMPENSATION OF FORMER

DOD OFFICIALS (NOV

2011)

(a) Definition. Covered DoD official is defined in the clause at 252.203-7000, Requirements Relating to Compensation of Former DoD Officials.

(b) By submission of this offer, the offeror represents, to the best of its knowledge and belief, that all covered DoD officials employed by or otherwise receiving compensation from the offeror, and who are expected to undertake activities on behalf of the offeror for http://www.acquisition.gov/far http://farsite.hill.af.mil/

W81K00-13-T-M093 Page 16 of 37 any resulting contract, are presently in compliance with all post-employment restrictions covered by 18 U.S.C. 207, 41 U.S.C. 2101-2107, and 5 CFR parts 2637 and 2641, including Federal Acquisition Regulation 3.104-2.

(End of provision)

252.209-7001 DISCLOSURE OF OWNERSHIP OR CONTROL BY THE

GOVERNMENT OF A TERRORIST COUNTRY (JAN 2009)

(a) Definitions. As used in this provision—

(1) “Government of a terrorist country” includes the state and the government of a terrorist country, as well as any political subdivision, agency, or instrumentality thereof.

(2) “Terrorist country” means a country determined by the Secretary of State, under section 6(j) (1) (A) of the Export Administration Act of 1979 (50 U.S.C. App. 2405(j)

(i) (A)), to be a country the government of which has repeatedly provided support for acts of international terrorism. As of the date of this provision, terrorist countries subject to this provision include: Cuba, Iran, Sudan, and Syria.

(3) “Significant interest” means—

(i) Ownership of or beneficial interest in 5 percent or more of the firm’s or subsidiary’s securities. Beneficial interest includes holding 5 percent or more of any class of the firm’s securities in “nominee shares,” “street names,” or some other method of holding securities that does not disclose the beneficial owner;

(ii) Holding a management position in the firm, such as a director or officer;

(iii) Ability to control or influence the election, appointment, or tenure of directors or officers in the firm;

(iv) Ownership of 10 percent or more of the assets of a firm such as equipment, buildings, real estate, or other tangible assets of the firm; or

(v) Holding 50 percent or more of the indebtedness of a firm.

(b) Prohibition on award. In accordance with 10 U.S.C. 2327, no contract may be awarded to a firm or a subsidiary of a firm if the government of a terrorist country has a significant interest in the firm or subsidiary or, in the case of a subsidiary, the firm that owns the subsidiary, unless a waiver is granted by the Secretary of Defense.

(c) Disclosure. If the government of a terrorist country has a significant interest in the Offeror or a subsidiary of the Offeror, the Offeror shall disclose such interest in an attachment to its offer. If the Offeror is a subsidiary, it shall also disclose any significant

W81K00-13-T-M093 Page 17 of 37 interest the government of a terrorist country has in any firm that owns or controls the subsidiary. The disclosure shall include—

(1) Identification of each government holding a significant interest; and

(2) A description of the significant interest held by each government.

252.209-7994 REPRESENTATION BY CORPORATIONS REGARDING AN UNPAID

DELINQUENT TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL

LAW—FISCAL YEAR 2014 APPROPRIATIONS (DEVIATION 2014-O0004)

(OCTOBER 2013)

(a) In accordance with section 101(a) of Division A of the Continuing Appropriations

Act, 2014 (Pub. L. 113-46), none of the funds made available by that Act for DoD

(including Military Construction funds) may be used to enter into a contract with any corporation that—

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless the agency has considered suspension or debarment of the corporation and made a determination that this further action is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless the agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that—

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability,

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

END OF ADDENDUM 52.212-1

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52.212-2 Evaluation - Commercial Items JAN 1999

ADDENDUM TO 52.212-2

Replace paragraph (a) with the following:

(a) Award will be made to the offeror whose proposal conforms to the requirements of the solicitation; and its price is determined to be fair and reasonable by the contracting officer.

The following factors will be used to evaluate offers:

Factor 1 Technical – Factor 1 Technical – Offerors shall provide a detailed narrative as to how they plan to meet each section of the Performance Work Statement. This factor consists of the following subfactors;

Subfactor 1A – Performance Work Statement Compliance – Offeror shall provide a detailed narrative stating as to how they plan to meet each of the sections and elements contained therein. Each response must indicate which section and element of the PWS it is addressing. Technical submission for this subfactor shall not exceed 75 pages.

Subfactor 1B – Quality Control Plan – Offeror shall provide a quality control plan that at a minimum meets the performance objectives and standards stated in the PWS. Quality Control Plans shall not exceed 20 pages.

NOTE: Offerors must be rated as acceptable in each technical subfactor in order to be considered for award.

Factor 2 –Price – Offerors shall provide test list that contains pricing per test that is inclusive of all 53 tests contained in the PWS. Offerors shall also provide a discount % and the discounted BPA price for each test offered on their price list. A sample format is provided in attachment 2.

1. Technical Capability. The following adjectival ratings will be used in evaluating the offeror’s technical quote:

Acceptable – To receive this rating, the offerors product/service shall meet each requirement outlined in the Performance Work Statement (PWS) and requirements set forth in the solicitation.

Unacceptable – An unacceptable rating will be assessed on any offeror that presents items/services that demonstrate any of the following:

a. Failure to meet each of the requirements set forth in the PWS and solicitation.

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2. Price. Pricing will be reviewed to determine reasonableness based on one or any combination of the following; competition, market research and independent government estimate.

3. Paragraph (b), Options, is deleted, as it is not applicable to this solicitation

END OF ADDDENDUM TO 52.212-2

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL

ITEMS (NOV 2011) ALTERNATE I (APR 2011)

An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically at http://orca.bpn.gov . If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (o) of this provision.

(a) Definitions. As used in this provision--

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Forced or indentured child labor” means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Inverted domestic corporation,” as used in this section, means a foreign incorporated entity which is treated as an inverted domestic corporation under 6 U.S.C. 395(b), i.e., a corporation that used to be incorporated in the United States, or used to be a partnership in the United States, but now is incorporated in a foreign country, or is a subsidiary whose parent corporation is incorporated in a foreign country, that meets the criteria specified in 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c). An inverted domestic corporation as herein defined does not meet the definition of an inverted domestic corporation as defined by the Internal Revenue Coe at 26 U.S.C. 7874.

http://orca.bpn.gov/

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“Manufactured end product” means any end product in Federal Supply Classes (FSC) 1000-9999, except—

(1) FSC 5510, Lumber and Related Basic Wood Materials;

(2) Federal Supply Group (FSG) 87, Agricultural Supplies;

(3) FSG 88, Live Animals;

(4) FSG 89, Food and Related Consumables;

(5) FSC 9410, Crude Grades of Plant Materials;

(6) FSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) FSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) FSC 9610, Ores;

(9) FSC 9620, Minerals, Natural and Synthetic; and

(10) FSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

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(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran;

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b) (3)).

“Service-disabled veteran-owned small business concern”—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

“Subsidiary” means an entity in which more than 50 percent of the entity is owned—

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(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

“Veteran-owned small business concern” means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans(as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

“Women-owned business concern” means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of the its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

“Women-owned small business concern” means a small business concern --

(1) That is at least 51 percent owned by one or more women or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

“Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127),” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

(b)

(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b) (2) of this provision do not automatically change the representations and certifications posted on the Online Representations and Certifications Application (ORCA) website.

(2) The offeror has completed the annual representations and certifications electronically via the ORCA website at http://orca.bpn.gov .After reviewing the ORCA database information, the offeror verifies by submission of this offer that the representation and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, http://orca.bpn.gov/

W81K00-13-T-M093 Page 23 of 37 and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs _. [Offeror to identify the applicable paragraphs at (c) through (o) of this provision that the offeror has completed for the purposes of this solicitation only, if any. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on ORCA.]

(c) Offerors must complete the following representations when the resulting contract is to be performed in the United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it [_] is, [_] is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [_] is, [_] is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it [_] is, [_] is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror provision.] The offeror represents, for general statistical purposes, that it [_] is, [_] is not, a small disadvantaged business concern as defined in 13 CFR 124.1002.

(5) Women-owned small business concern. [Complete only if the offeror provision.] The offeror represents that it [_] is, [_] is not a women-owned small business concern.

Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror prepresents that—

(i) It [_] is, [_] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no

W81K00-13-T-M093 Page 24 of 37 change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It [_] is, [_] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate in reference to the WOSB concern or concerns that are participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern or concerns that are participating in the joint venture: _.] Each WOSB concern participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(7) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that—

(i) It [_] is, [_] is not an EDWOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It [_] is, [_] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate in reference to the EDWOSB concern or concerns that are participating in the joint venture. The offeror shall enter the name or names of the EDWOSB concern or concerns that are participating in the joint venture: . Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

(8) Women-owned business concern (other than small business concern).

[Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.]. The offeror represents that it [_] is, a women-owned business concern.

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:

(10) [Complete only if the solicitation contains the clause at FAR 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns, or FAR 52.219-25, Small Disadvantaged Business Participation

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Program—Disadvantaged Status and Reporting, and the offeror desires a benefit based on its disadvantaged status.]

(i) General. The offeror represents that either—

(A) It [_] is, [_] is not certified by the Small Business Administration as a small disadvantaged business concern and identified, on the date of this representation, as a certified small disadvantaged business concern in the CCR Dynamic Small Business Search database maintained by the Small Business Administration , and that no material change in disadvantaged ownership and control has occurred since its certification, and, where the concern is owned by one or more individuals claiming disadvantaged status, the net worth of each individual upon whom the certification is based does not exceed $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); or

(B) It [_] has, [_] has not submitted a completed application to the Small Business Administration or a Private Certifier to be certified as a small disadvantaged business concern in accordance with 13 CFR 124, Subpart B, and a decision on that application is pending, and that no material change in disadvantaged ownership and control has occurred since its application was submitted.

(ii) Joint Ventures under the Price Evaluation Adjustment for Small Disadvantaged Business Concerns. The offeror represents, as part of its offer, that it is a joint venture that complies with the requirements in 13 CFR 124.1002(f) and that the representation in paragraph (c)(10)(i) of this provision is accurate for the small disadvantaged business concern that is participating in the joint venture. [The offeror shall enter the name of the small disadvantaged business concern that is participating in the joint venture: .]

(11) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that--

(i) It [_] is, [_] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR part 126; and

(ii) It [_] is, [_] is not a HUBZone joint venture that complies with the requirements of 13 CFR part 126, and the representation in paragraph

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(c)(11)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: .] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

(12) (Complete if the offeror has represented itself as disadvantaged in paragraph (c)(4) or (c)(10) of this provision.)

[The offeror shall check the category in which its ownership falls]:

Black American.

Hispanic American.

Native American (American Indians, Eskimos, Aleuts, or Native Hawaiians).

Asian-Pacific American (persons with origins from Burma, Thailand, Malaysia, Indonesia, Singapore, Brunei, Japan, China, Taiwan, Laos, Cambodia (Kampuchea), Vietnam, Korea, The Philippines, U.S. Trust Territory or the Pacific Islands (Republic of Palau), Republic of the Marshall Islands, Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, Guam, Samoa, Macao, Hong Kong, Fiji, Tonga, Kiribati, Tuvalu, or Nauru).

Subcontinent Asian (Asian-Indian) American (persons with origins from India, Pakistan, Bangladesh, Sri Lanka, Bhutan, the Maldives Islands, or Nepal).

Individual/concern, other than one of the preceding.

(d) Representations required to implement provisions of Executive Order 11246 --

(1) Previous contracts and compliance. The offeror represents that --

(i) It [_] has, [_] has not, participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and

(ii) It [_] has, [_] has not, filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that --

(i) It [_] has developed and has on file, [_] has not developed and does not have on file, at each establishment, affirmative action programs required

W81K00-13-T-M093 Page 27 of 37 by rules and regulations of the Secretary of Labor (41 CFR parts 60-1 and 60-2), or

(ii) has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C.

1352). (Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for…