SOLICITATION NOTICE
H -- Laboratory Accreditation - Attachment A-Price Structure
- Notice Date
- 12/22/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 813920
— Professional Organizations
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-10-1067252
- Archive Date
- 2/2/2010
- Point of Contact
- Ariana Nijaradze, Phone: 3018277161
- E-Mail Address
-
ariana.nijaradze@fda.hhs.gov
(ariana.nijaradze@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is the price structure. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-10-1067252 and is issued as a request for quotation (RFQ). The incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-38. The NAICS code for this solicitation is 813920. The Government anticipates a fixed price contract with One Base Year and Four Option Years. Please attachment A for the price structure. I. Description of Services for FDA Laboratory accreditations. Third party assessments of FDA’s twelve field laboratories to maintain accreditation status in compliance with the ISO 17025 and the AOAC Food and Pharmaceutical Program. FDA has 12 field laboratories that are currently accredited to ISO 17025 and the AOAC specific requirements for food and pharmaceutical testing. The on-site assessments occur every two years. The assessment schedule alternates with seven laboratories in one year and then the other five laboratories the next year; the schedule repeats itself for the following years. Example: 7 labs are assessed in 2010; then the other 5 labs in 2011; 7 labs are assessed in 2012; then the other 5 labs in 2013; and 7 labs in 2014. The following disciplines or fields have been identified: Chemical, Biological, and Mechanical. Four of the twelve field laboratories have only one discipline (Chemical); a one field laboratory has all three fields; seven laboratories have two fields (Chemical and Biological). I.1. Technical Requirements The contractor shall conduct third-party assessments on the identified schedule (see B.3) for twelve laboratories for compliance to ISO 17025 and the AOAC Food and Pharmaceutical Program. The accrediting body is nationally and internationally recognized and has established recognition MOUs with other national and international organizations and accrediting bodies. The following are the assessment requirements: I.2. Pre-Onsite Requirements Upon receipt of award, the vendor shall arrange for one or more assessors to conduct an assessment at the laboratory’s site prior to the expiration date of the Accreditation Certificate for that specific laboratory. See the attached pricing structure for the laboratory accreditation renewal dates. Prior to the assessment beginning, the FDA Laboratories will provide the assessor team all quality documentation requested, as well as the laboratory’s representative technical SOPs. The quality manual and related documentation must be reviewed by the assessor team before the assessment can begin. This review shall be done before the assessor(s) come on-site for the scheduled assessment. Upon review of submitted documentation, the assessor(s) shall provide the document review results to the laboratory in writing before the scheduled onsite assessment, and may ask the laboratory to implement corrective action to fill any documentation gaps required by ISO/IEC 17025 before the scheduled assessment. Prior to scheduling the full assessment, the assessor(s) shall review the draft scope(s) to determine the tests they shall witness and checks on the availability of the technical personnel who perform the tests. An assessment agenda shall be provided by the assessor at least a week before the scheduled date of the assessment. I.3. On-Site Assessment Assessments may last from one to four days depending on the extent of the desired scope, number of disciplines, and the size of laboratory. The contractor shall provide the assessors with an assessor guide and checklists to follow when performing an assessment. All of the guidelines shall be consistent among the assessors in the various laboratories. An entry briefing with laboratory management is conducted by the assessor(s). At the entry briefing, the assessor(s) review the assessment agenda and if any changes are necessary due to scheduling conflicts. This briefing lasts approximately 30 minutes. Interviews with technical staff are conducted from the staff matrix document submitted from the laboratory as part of the document review. Interviews consist of the sample analysis process for a specific technology and/or method. Assessment can also include a demonstration of selected tests or calibrations by the appropriate technical staff. The assessor(s) shall examine the equipment and calibration records. The assessor(s) audit the management system to verify that it is fully operational and that it conforms to all sections of ISO/IEC 17025, the accrediting body’s requirements, and the AOAC requirements, including documentation. A written report of the assessor(s) findings is presented at the close of the assessment. An exit briefing with staff is conducted to go over the findings which are identified as deficiencies in the written report. A deficiency is any nonconformity to accreditation requirements, including: (1) A laboratory’s inability to perform a test, type of test, or calibration for which it seeks accreditation. (2) A laboratory’s management system does not conform to a clause or section of ISO/IEC 17025, is not adequately documented, or is not completely implemented in accordance with that documentation. (3) A laboratory does not conform to any additional requirements of the accrediting body or specific fields of testing or programs, such as AOAC, necessary to meet particular needs. I.4. Laboratory’s Response to Deficiencies The FDA laboratory is requested to respond, in writing, detailing either its corrective action or why it does not believe that a deficiency exists. This response is due 30 days from the close of the assessment. The corrective action response must include the laboratory’s root cause analysis and a copy of any objective evidence (e.g., calibration certificates, lab procedures, paid invoices, packaging slips and/or training records) to indicate that the corrective actions have been implemented/completed. It is entirely possible that the laboratory will disagree with the findings that one or more items are deficiencies. In that case, the laboratory is requested to explain in its response why it disagrees with the assessor(s). Accreditation shall be granted for two years. An Accreditation Certificate of successful completion is issued by the accrediting body within 60 days of the laboratory’s response unless there is an unresolved issue. II. Deliverables (1) Document review results. This review is done before the assessor is scheduled to come on site. (2) The assessment agenda. This agenda is due at least one week before the scheduled assessment date. (3) The deficiency report for the on-site findings. This is due at the close of the assessment. If no deficiencies are observed, the deficiency report shall state that none were observed. (4) The Certificate of Accreditation containing the Scope of Accreditation. III. Security The accrediting body shall have a policy of confidentially and require that all assessors sign one which is kept on file by the accrediting body and updated before the on-site assessment of an FDA laboratory. Assessors shall be escorted during the assessment by assigned FDA personnel. IV. Evaluation Factors Award will be made to the party whose quote offers the best value to the Government, technical, price, and evaluation factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," 2) Relevant Experience and 3) Price. Technical Capability and Relevant Experience when combined is significantly more important than price. The offeror shall provide a detailed description of the relevant qualifications, experience and expertise in no more than 25 pages. V. Government Point of Contact: Ariana Nijaradze, Contract Specialist 5630 Fishers Lane, Room 2137 Rockville, MD 20857 Ph: 301.827-7161 Fax: 301.827.7151 Email: Ariana.Nijaradze@fda.hhs.gov VI. Submission: Questions are due not later than COB January 11, 2010. All questions shall be addressed at one time beginning on January 12, 2010. FDA intends to make an award soon after the response date of this notice and all proposals and modifications shall be submitted via email and be received by 4:30 PM (1630) EST on 18 January 2009 to the attention of Ariana Nijaradze, Ariana.Nijaradze@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. VII. Provisions and Clauses: The following provisions and clauses are hereby incorporated by reference: 52.212-1, Instructions to Offerors – Commercial Items (JUN 2008) 52.212-4, Contract Terms and Conditions – Commercial Items (MAR 2009) 52.217-8 Option to Extend Services (NOV 1999) 52.217-9 Option to Extend the Term of the Contract (MAR 2000) 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders – Commercial Items (Applicable clauses are listed below) (DEC2009) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: _x_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402). _x_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Dec 2008) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). _x_ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (MAR 2009) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) ___ (8)(i) 52.219-6, Notice of Total Small Business Set-Aside (June 2003) (15 U.S.C. 644). ___ (10) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)). _x_ (19) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _x_ (20) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Feb 2008) (E.O. 13126). _x_ (39) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: N/A (d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause— (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Dec 2008) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). (ii) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) [Reserved] (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). (vi) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793). (vii) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201). (viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). (xii) 52.222-54, Employment Eligibility Verification (JAN 2009). (xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of clause) Alternate I (Feb 2000). As prescribed in 12.301(b)(4), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or (d) of this clause” in the redesignated paragraph (d) to read “paragraphs (a), (b), and (c) of this clause.” Alternate II (May 2009). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows: (d)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to— (i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and (ii) Interview any officer or employee regarding such transactions. (e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than— (i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and (ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause— (A) 52.203-13, Contractor Code of Business Ethics and Conduct (Dec 2008) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). (B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (May 2009) (Section 1553 of Pub. L. 111-5). (C) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (D) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (E) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). (F) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793). (G) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201). (H) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (I) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). (J) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (K) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Feb 2009) (41 U.S.C. 351, et seq.). (L) 52.222-54, Employment Eligibility Verification (Jan 2009). (M) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (N) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.
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