SPECIAL NOTICE
H -- LABORATORY ACCREDITATION
- Notice Date
- 1/5/2009
- Notice Type
- Special Notice
- 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-09-1051754
- Response Due
- 1/12/2009
- Archive Date
- 1/27/2009
- Point of Contact
- Kimberly m Davis, Phone: 301-827-7179, Patricia M Pemberton,, Phone: 301-827-1022
- E-Mail Address
-
kimberly.davis@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration intends to award a firm fixed price purchase order to the American Association for Laboratory Accreditation. This is NOT a request for competitive quotes. The Purchase Order will be made on a sole source basis in accordance with FAR Part 13 – Simplified Acquisition Procedures and 13.501 (A) – Sole source acquisitions for the following services to be performed at American Association for Laboratory Accreditation. Statement of Work: Assessment The objective of an assessment is to establish whether or not a laboratory complies with the accrediting body’s requirements for accreditation and can competently perform the types of tests or calibrations for which accreditation is sought. Accreditation is required to demonstrate compliance with additional criteria of AOAC Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals. Pre-Site Visit Once the application information is completed and the appropriate fees are paid, one or more assessors are assigned to conduct an assessment at the laboratory’s site. Assessors are selected on the basis of their testing or calibration expertise so as to be better able to provide guidance to the laboratories. Assessments may last from one to several days depending on the extent of the desired scope and the size of laboratory. Assessors are given an assessor guide and checklists to follow in performing an assessment. These documents are intended to ensure that assessments are conducted as uniformly and completely as possible among the assessors and from laboratory to laboratory. Before the assessment is conducted, the assessor team requests copies of quality documentation and representative technical SOPs in order to prepare for the assessment. The quality manual and related documentation must be reviewed by the assessor team before the assessment can begin. This review is done ideally before the assessment is scheduled. Upon review of submitted documentation, the assessor(s) will provide the document review results to the laboratory in writing, and may ask the laboratory to implement corrective action to fill any documentation gaps required by ISO/IEC 17025 before scheduling the assessment. Prior to scheduling the full assessment, the assessor reviews the draft scope(s) to determine the tests to possibly witness and checks on the availability of the technical personnel who perform the tests. An assessment agenda is provided by the assessor. On-Site Assessment The full assessment involves: • An entry briefing with laboratory management; • Interviews with technical staff; • Demonstration of selected tests or calibrations including, as applicable, tests or calibrations at representative field locations; • Examination of equipment and calibration records; • Audit of the management system to verify that it is fully operational and that it conforms to all sections of ISO/IEC 17025 and the AOAC requirements, including documentation; • Evaluation of your laboratory’s compliance with the accrediting body’s requirements documents; • A written report of assessor findings; and • An exit briefing including the specific written identification of any deficiencies. During the assessment, assessors may observe deficiencies. A deficiency is any nonconformity to accreditation requirements including: • a laboratory’s inability to perform a test, type of test, or calibration for which it seeks accreditation; • 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; or • a laboratory does not conform to any additional requirements of A2LA or specific fields of testing or programs necessary to meet particular needs. At the conclusion of an assessment, the assessor prepares a report of findings, identifying deficiencies which, in the assessor's judgment, the laboratory must resolve in order to be accredited. The assessor holds an exit briefing with top management of the laboratory, going over the findings and presenting the list of deficiencies (deficiency report). Laboratory’s Response to Deficiencies The laboratory is requested to respond, in writing, detailing either its corrective action or why it does not believe that a deficiency exists. 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. Annual Review Accreditation is granted for two years. For subsequent annual reviews occurring after the renewal of accreditation each laboratory must pay annual fees and submit updating information on its organization, facilities, key personnel and results of any proficiency testing. Objective evidence of completion of the internal audit and management review is also required. If the renewal laboratory does not promptly provide complete annual review documentation, significant changes to the facility or organization have occurred, or proficiency testing results have been consistently poor, a one-day surveillance visit and payment of the associated assessor fees is required. American Association for Laboratory Accreditation has worked extensively in these areas and thus possesses an understanding of the procedures, problems and timeliness aspect to these projects. Having the same Laboratory continue to do this will ensure that critical work is not interrupted and is completed in a manner that furthers the mission of FDA. The proposed source is for commercial services for which the Government intends to solicit and negotiate with only one source. This action is proposed on a sole source basis because it is a follow-on contract where the University has developed procedures that help expedite critical requests and there being a substantial duplication of cost to the government. Any Interested party should submit a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met, no later than January 12, 2009. A determination by the Government not to compete the proposed contract based on responses from this notice is solely within the discretion of the Government. Responses to this notice must be sent via email to Kimberly.davis@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=d9b422c99544d5d4a6d4b53056233bc1&tab=core&_cview=1)
- Place of Performance
- Address: Various Laboratories, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01726628-W 20090107/090105214857-d9b422c99544d5d4a6d4b53056233bc1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |