FBODaily.com | FedBizOpps: PRESOL | B | Laboratory Lipids Analyses for NHANES

FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 01, 2014 FBO #4572
SOLICITATION NOTICE

B -- Laboratory Lipids Analyses for NHANES

Notice Date: 5/30/2014
Notice Type: Combined Synopsis/Solicitation
NAICS: 621511 — Medical Laboratories
Contracting Office: Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
ZIP Code: 30341-4146
Solicitation Number: 2014-N-15808
Archive Date: 7/15/2015
Point of Contact: Juanita A. Waters, Phone: 7704882933, Natasha Y Rowland, Phone: 770-488-2601
E-Mail Address: jvw0@cdc.gov, hee5@cdc.gov
(jvw0@cdc.gov, hee5@cdc.gov)
Small Business Set-Aside: N/A
Description: SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 700) RATING PAGE OF 1 59 2. CONTRACT NO. 3. SOLICITATION NO. 2014-N-15808 4. TYPE OF SOLICITATION SEALED BID (IFB) X NEGOTIATED (RFP) 5. DATE ISSUED 6. REQUISITION/PURCHASE NO. 000HCPCG-2014-67994 7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7) Centers for Disease Control and Prevention (CDC) Procurement and Grants Office (PGO) 2920 Brandywine Road Atlanta, GA 30341-5539 Approved as to Form and Legality: _____________________________ NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder." SOLICITATION 9. Sealed offers in original and 3 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in 2920 Brandywine Road, Atlanta, Georgia 30341 until 2:00p local time June 30,2014 CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation. 10. FOR INFORMATION CALL: A. NAME Juanita A. Waters B. TELEPHONE (NO COLLECT CALLS) AREA CODE NUMBER: EXT: (770) 488-2933 C. E-MAIL ADDRESS 11. TABLE OF CONTENTS (x) DESCRIPTION (x) DESCRIPTION PART I - THE SCHEDULE PART II - CONTRACT CLAUSES X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 27 X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH. X C DESCRIPTION/SPECS./WORK STATEMENT 4 X J LIST OF ATTACHMENTS 38 X D PACKAGING AND MARKING 11 PART IV - REPRESENTATIONS AND INSTRUCTIONS X E INSPECTION AND ACCEPTANCE 11 REPRESENTATIONS, CERTIFICATIONS, AND X F DELIVERIES OR PERFORMANCE 12 X K OTHER STATEMENTS OF OFFERORS 49 X G CONTRACT ADMINISTRATION DATA 14 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 50 X H SPECIAL CONTRACT REQUIREMENTS 18 X M EVALUATION FACTORS FOR AWARD 57 OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period. 12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule. 13. DISCOUNT FOR PROMPT PAYMENT (See Section I, Clause No. 52-232-8) 10 CALENDAR DAYS % 20 CALENDAR DAYS % 30 CALENDAR DAYS % % AMENDMENT NO. DATE AMENDMENT NO. DATE CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER 15B. TELEPHONE NO. AREA CODE NUMBER EXT. 15C. CHECK IF REMITTANCE ADDRESS IS DIFFERENT FROM ABOVE - ENTER SUCH ADDRESS IN SCHEDULE. 17. SIGNATURE 18. OFFER DATE AWARD (To be completed by Government) 19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 21. ACCOUNTING AND APPROPRIATION 10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified) ITEM 24. ADMINISTERED BY (If other than Item 7) CODE 8219 25. PAYMENT WILL BE MADE BY CODE 434 Centers for Disease Control and Prevention (CDC) Procurement and Grants Office (PGO) 2920 Brandywine Road Atlanta, GA 30341-5539 Centers for Disease Control and Prevention (FMO) PO Box 15580 404-718-8100 Atlanta, GA 30333-0080 26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA (Signature of Contracting Officer) 28. AWARD DATE IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice. AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97) PREVIOUS EDITION IS UNUSABLE Prescribed by GSA FAR (48 CFR) 53.214© SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS The purpose of this requirement is for Laboratory Services to measure a Lipids profile (LP) from biologic specimens collected at the National Center for Health Statistics' (NCHS) National Health and Nutrition Examination Survey Centers and develop a laboratory manual comprised of the Tasks outlined in the Performance Work Statement (PWS) in Section C. ITEM SUPPLIES/SERVICES QTY/UNIT UNIT PRICE EXTENDED PRICE 0001 01 0001 02 0001 03 0001-04 0001-05 0002-01 0002-02 0002-03 0002-04 0003-01 0003-02 0003-03 0003-04 0004-01 0004-02 0004-03 0004-04 0005-01 0005-02 0005-03 0005-04 0006-01 0006-02 0006-03 0006-04 0006-05 Year 1 - Total Cholesterol Year 1 - HDL-Cholesterol Year 1 - Triglycerides Year 1 - Apo (B) Draft Laboratory Manual Year 2 - Total cholesterol Year 2 - HDL-cholesterol Year 2 - Triglycerides Year 2 - Apo (B) Year 3 - Total cholesterol Year 3 - HDL-cholesterol Year 3 - Triglycerides Year 3 - Apo (B) Year 4 - Total cholesterol Year 4 - HDL-cholesterol Year 4 - Triglycerides Year 4 - Apo (B) Year 5 - Total cholesterol Year 5 - HDL-cholesterol Year 5 - Triglycerides Year 5 - Apo (B) Year 6 - Total cholesterol Year 6 - HDL-cholesterol Year 6 - Triglycerides Year 6 - Apo (B) Year 6 - Final Laboratory Manual 250/Each 250/Each 250/ Each 250/Each 1/JOB 4600/Each 4600/Each 2400/Each 2400/Each 4600/Each 4600/Each 2400/Each 2400/Each 4600/Each 4600/Each 2400/Each 2400/Each 4600/Each 4600/Each 2400/Each 2400/Each 46/Each 46/Each 24/Each 24 Each 1/Job $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ Lipids Profile (LP) Test from Biologic Specimens collected at the NHANES Examination Centers. (No Funds are obligated on the basic IDIQ contract. Funds will be obligated on each individual Task Order. Lines of Accounting to be Determined when Task Orders are placed.) • The Government guarantees a minimum order of 24 Units each Fiscal Year under this contract unless the contract should be terminated for cause. SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK Performance-Based Performance Work Statement Laboratory Lipids Analyses for NHANES 2014-2019 C.1. General C.1.1 Background The National Health and Nutrition Examination Surveys (NHANES) are a series of cross-sectional surveys conducted by the National Center for Health Statistics (NCHS) designed to provide national statistics on the health and nutritional status of the civilian, non-institutionalized U.S. population through household interviews, standardized physical examinations, and the collection of biologic samples in special mobile examination centers. The surveys oversample the two largest race/ethnic minority groups, non-Hispanic blacks and Mexican-Americans, along with other subgroups of the population. This performance-based performance work statement (PBPWS) seeks to obtain laboratory measurements on biologic specimens for total cholesterol, triglycerides, Apo (B), and HDL-cholesterol among participants 6 years and older. Blood specimens are collected in morning, afternoon and evening sessions. For the morning session the participants are required to fast at least 9 hours. Since triglycerides and Apo (B) must be measured on fasting specimens these tests can only be measured from participants examined in the morning session. Since fasting is not a requirement for total cholesterol and HDL-cholesterol measurements these tests will be measured on all participants in all sessions. Total cholesterol and HDL-cholesterol tests will be performed among participants 6 years and older. Triglycerides and Apo (B) tests will be performed among participants 12 years and older. The goals of this component are to: 1) Monitor the prevalence and trends in major cardiovascular conditions and risk factors in the U.S.; 2) Evaluate prevention and treatment programs targeting cardiovascular disease in the U.S. The main element of the cardiovascular disease laboratory component in NHANES is blood lipid levels. Cardiovascular disease is the leading cause of death in the United States. An estimated 4.8 million Americans have congestive heart failure. Increasing prevalence, hospitalizations, and deaths have made congestive heart failure a major chronic condition in the United States. One serum lipoprotein sub-fraction may emerge as independent risk factors for coronary heart disease-Apolipoprotein B. The test was last measured in NHANES III in 1988-91 and 1991-94, 2005 to present, respectively. The data will be used to: 1) Monitor the status of hypertension prevalence, awareness, treatment and control and the success of the National HBP Education Program; 2) monitor the status of hyperlipidemia and the success of the National Cholesterol Education Program; 3) Estimate the prevalence of congestive heart failure and compare to the baseline data from the NHANES I. C.1.2 Objective and Scope C.1.2.1 Objective: The objective of this firm-fixed price competitive negotiated contract with options is to seek laboratories to measure a Lipids profile (LP) from biologic specimens collected at the NHANES exam center and develop a laboratory manual comprised of the following three (3) tasks. Task 1: A cross comparison of 250 NHANES 2014 serum specimens. There will be a five month overlap between this contract and the existing contractor performing the same work. During this overlap period the same specimens will be measured at both laboratories. The test results from each contract will undergo statistical methods that will determine if the results are comparable. This exercise ensures the continuity of data trends over time. Task 1 will be performed within a five-month time frame upon delivery of serum specimens. Task 2: Lipids profile (LP) testing of 2400 -4600 samples each year from NHANES 2015-2019. Task 2 will be completed within eighteen months after the delivery of specimens. Task 3: Laboratory Manual- - The manual is to be developed in accordance with the instructions found at Paragraph f. of Section 3.2.1.3 and delivered by the date outlined under DELIVERABLES. Any subsequent changes to the manual from NHANES 2014-2019 must be submitted as they occur. C.1.2.2 Scope: This technical approach involves three (3) primary tasks. This technical approach involves three (3) primary tasks for a comparison study in 2014, and a base year with option years. This work will provide laboratory measurements for which the Lipids profile (LP) will include measurements for total cholesterol, triglycerides, Apo (B), and HDL-cholesterol. Specifically this effort will allow the National Centers for Disease Control & Prevention to post the data available via a web site for public use. The lipids profile includes total cholesterol, triglycerides, Apo (B), and HDL-cholesterol. The technical approach for this phase involves the following: C.1.2.3 Work Breakdown Structure C.1.2.4 The technical approach for this phase involves the following three (3) tasks: Task 1 will be a comparison study to provide high-throughput Lipids profile (LP) measurements for 200-250 NHANES 2014 serum samples. The laboratory must be a participant in the CDC LSP and be standardized. The laboratory preferably should use quality control materials for each run that are linked to the CDC Lipid Standardization program. All laboratory data must be comparable throughout the survey with the same laboratory and methods used. The contractor shall perform laboratory analysis for one or more of the following: Cholesterol must be measured enzymatically in serum in a series of coupled reactions that hydrolyze cholesteryl esters and oxidize the 3-OH group of cholesterol. The laboratory must have at least two years of continuous experience in testing these analytes. The volume of samples, required to be processed with results available to NCHS within 3 weeks of receipt of specimens, require a high throughput. The direct HDL method in serum is required. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput. Triglycerides must be measured enzymatically in serum using a series of coupled reactions in which triglycerides are hydrolyzed to produce glycerol. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput. Apolipoprotein (B) must be measured by using a nephelometer method. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput. Test results and quality control results must be supplied in machine-readable format no later than three weeks (3) after receipt of serum specimens. Offerors must have a well-established quality assurance program. Data should be transmitted to NHANES in electronic data files in a format stipulated by NHANES. Task 2 will provide high-throughput Lipids profile (LP) for 2400-4600 samples each year from NHANES 2015-2019. The laboratory must be a participant in the CDC LSP and be standardized. The laboratory preferably should use quality control materials for each run that are linked to the CDC Lipid Standardization program. All laboratory data must be comparable throughout the survey with the same laboratory and methods used. The contractor shall perform laboratory analysis for one or more of the following: Cholesterol must be measured enzymatically in serum in a series of coupled reactions that hydrolyze cholesteryl esters and oxidize the 3-OH group of cholesterol. The laboratory must have at least two years of continuous experience in testing these analytes. The volume of samples, required to be processed with results available to NCHS within 3 weeks of receipt of specimens, require a high throughput. The direct HDL method in serum is required. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput. Triglycerides must be measured enzymatically in serum using a series of coupled reactions in which triglycerides are hydrolyzed to produce glycerol. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput. Apolipoprotein (B) must be measured by using a nephelometer method. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput. The assays must be stable and available as was used for Task 1 to Task 2. Test results and quality control results must be supplied in machine-readable format no later than three weeks (3) after receipt of serum specimens. Offerors must have a well-established quality assurance program. Data should be transmitted to NHANES in electronic data files in a format stipulated by NHANES. Task 3: Laboratory Manual- - The manual is to be developed in accordance with the instructions found at Paragraph f. of Section 3.2.1.3 and delivered by the date outlined under DELIVERABLES. Any subsequent changes to the manual from NHANES 2014-2019 must be submitted as they occur. C.1.2.5 The Contractor will furnish all required staffing, equipment, supplies, services, permits, and licenses necessary to perform the contract. C.2.1 SPECIFIC REQUIREMENTS FOR ALL LABORATORY ANALYSES C.2.2 Performance-based Outputs and Standards. See Paragraph 5 - Performance-based Matrix for specific outputs and standards. C.2.3 Technical Services. C.2.3.1 In preparation for the performance of serum samples obtained from individuals examined in the National Health and Nutrition Examination Surveys NHANES 2014-2019: C.2.3.1.1 Information Technology Requirements. Contractor shall: a. Have in place an automated system for data handling and transmittal for importing sample transmittal information into the system; tracking samples in process; entering analysis results; flagging abnormal or out of range results; and entering quality control data. b. Repeat 2% of the specimens in a random manner. c. Provide detailed auditing information including date, time, and technician identification. d. Generate quarterly reports to NCHS in an electronic version using Microsoft Word. e. Generate an electronic file of the results and quality control data in a government specified format using column delimitated data files generated by software such as Excel. The final format will be negotiated by the contractor and the Project Officer. f. Have in place an automated process for tracking receipt and processing of the samples from time of receipt in the lab to output of the analysis data by the date of receipt, the date and run number of testing, and the technician who completed these tasks. C.2.3.1.2 Record Storage. Contractor shall: Keep historical records/archives of transmissions and results to support resolution of questions or issues regarding particular samples for Task 1 through Task 3. All results must be linked to the sample person's identification number to include: a. Analytic batch and date of analysis. b. Quality control values measured as part of the batch, expected control values, lot number of the controls and the manufacturer and date of expiration of control materials. If control materials are prepared in house, a description of the procedure, data, and the date must be included. c. Standard reference materials used to provide long-term comparability of values. d. Reagents by batch, reagent's expiration dates, and date of change of reagents. Reagents should be identified by lot number and manufacturer. e. All repeated values and reasons for test repeats should be recorded. Repeat tests for abnormal ranges or for specimens that have been compromised in the shipping process will be done at the cost of the Government. All other repeats will be done at the cost of the Contractor. C.2.3.1.3 General Requirements. Contractor shall: a. Keep quality control information relevant to this project. b. Keeps a laboratory log containing a record of the status of all vials upon arrival, date of receipt, deviations from protocol or good laboratory practice, and an account of all vial. Also, a record of all handling, storage, and manipulation of specimens, which might affect the quantitative results reported (e.g, freezing, thawing of sera, spilled, contaminated). c. Maintain a quality assurance system by which random or systematic errors may be detected and monitored. d. Have in place a storage facility (-70 degrees C for sera) for specimens upon receipt and for any excess sera specimen remaining in vials after analyzing the samples for at least one year. The government will pay for shipment of samples. e. Accept delivery of specimens on a predetermined schedule supplied by the National Center for Health Statistics (NCHS). f. Prepare a laboratory manual with the Project Officer's approval, which will include detailed information on techniques and materials to be used in the assay and the quality control procedures to be used. Normal ranges for laboratory values will also be included along with published documentation to support the choice of the ranges. The manual must be delivered as a Microsoft Word file. The Project Officer will provide the format of the manual. g. Enrolled in a proficiency testing through independent laboratories such as the College of American Pathologists or a comparable program. Report results to the Project Officer for serum specimens. h. CLIA (Clinical Laboratory Improvement Amendment) -certified or equivalent certification. If CLIA-exempt, provide supporting documentation. i. Transmit critical call or life-threatening results electronically transmitted to the NCHS Data Collection Contractor. j. Apply the Westgard quality control rules for total Lipids Profile. k. Follow the guidelines outlined by the Centers for Disease Control (MMWR 36; 2S, 1987) for the prevention of HIV transmission in health-care settings if they are performing biological testing. l. Provide list of possible comment codes associated with the laboratory results that might be required. m. Repeat a 2% random sample of the specimens tested to monitor the reproducibility of results. n. Notify the Project Officer immediately of any current or foreseeable problems with the data collection and/or preparation. The need for modification in procedures shall be determined by the mutual agreement of the Contractor and the Project Officer. All modifications shall be documented in the laboratory manual as to how and why they were imposed. o. Performance of a method must be judged on both the practicality and reliability of the methods. In evaluating the practicality of a method, speed, cost, technical skill required, dependability and safety must be considered. To judge these factors, provide the following: a. Time needed for analysis of one specimen alone; b. Number of samples which can be analyzed per unit of time under routine conditions; and c. Time in hours' use for preventive maintenance, reagent preparation, calibration, trouble shooting, and total operating time. Indicate acceptable alternative methods or analytical test systems (backup instrumentation) and recommended storage conditions including optimal and maximum storage time for sample retention. C.3.1 The table in Section B summarizes the number of specimens to be tested from the survey for the Base Period and all Optional Periods of Performance. C.4.1 OTHER REQUIREMENTS C.4.1.1 To ensure effective and efficient production of laboratory measurements, the Contractor shall establish and maintain work procedures that facilitate close and continuous coordination with the Contracting Officer, Project Officer, and other program management personnel. C.4.1.2 To function effectively and efficiently as a team member in this environment, the Contractor shall ensure personnel possess a high degree of subject matter knowledge, skills, and abilities to perform the tasks in this contract. C.4.2 Performance-based Matrix For Laboratory Lipids Analyses for NHANES Desired End Result Feature(s) of end result to be surveilled (Indicator). The required performance level for each feature (Standard). Quality Assurance Incentives/Payment-Quality Link The Contractor shall provide QC and test results to Westat Contractor shall submit quarterly status report Contractor shall test data transmission electronically Contractor shall test the report of findings Contractor shall develop and submit laboratory manual Accuracy & timeliness Timeliness Accuracy timeliness Accuracy Accuracy & timeliness Not later than 21 days of testing Not Later Than the 15th day of each quarter Successful imported of file into the NHANES Data Collection data base Successful imported of file into the NHANES Data Collection and generation of a report of findings letter Final manual approved by Program Office Surveillance system will be primarily site inspections and review of lab status reports, and QA/QC Review of the report by the PO All data is QCed for accuracy by the PO. Spot checking of the letters by the PO. Review of manual by PO. 1. Positive incentives: a. Payment of contract labor rate for satisfactory service. b. Contractor performance evaluated using the automated Contractor Performance Assessment Reporting System (CPARS). The evaluation will be considered when future AGENCY contract selections are made. 2. Payment is linked to quality through FAR 52.246-4 Inspection of Services-Fixed-Price. As prescribed in 46.304, insert the following clause: Inspection of Services-Fixed-Price (Aug 1996) (a) Definition. "Services," as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services. (b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires. (c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work. (d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties. (e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may- (1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and (2) Reduce the contract price to reflect the reduced value of the services performed. (f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may- (1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or (2) Terminate the contract for default. (End of clause). ` SECTION D - PACKAGING AND MARKING There are no clauses/provisions included in this section. SECTION E - INSPECTION AND ACCEPTANCE E.1 Inspection and Acceptance (Jul 1999) Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the COR/Project Officer) at the destination of the articles, services or documentation. (End of Clause) E.2 Acceptance: Final acceptance will be based on the completion of each deliverable. (End of Clause) SECTION F - DELIVERIES OR PERFORMANCE F.1 The period of performance will commence on the date of award and continue for a base period of five (5) months, four (4) 12-month Option Periods and an additional Option Period of five ( 5) months. F.2 Deliverables F.2.1 Performance Schedule On average, two shipments of specimens (approximately 50-75 specimens per shipment) will arrive at the laboratory each week. The specimens are not collected during a two (2) week summer vacation (Usually the last week in June and the first week in July. If this should be changed, the vendor will be notified well in advance for rescheduling purposes.) and the last two (2) weeks of December. The shipping schedule and the type of shipment (dry ice, freezer packs, or ambient temperature) will be agreed upon by the Project Officer and the Contractor. August, 2014 Conference call or site visit to discuss requirements of contract. November, 2014 Test data and test QC data transmitted to NHANES data collection contractor. November, 2014 Draft laboratory manual delivered. December, 2014 Test scenarios for early and routine report of findings conducted. February, 2015 First results transmitted to NHANES data collection contractor. The test results for specimens will be transmitted weekly to the NHANES Contractor, Westat, throughout the life of the contract except for two weeks in the summer when specimens are not collected and the last two weeks in December when specimens are not collected. February, 2019 Last results transmitted to NHANES data collection contractor. July 1, 2019 All outstanding results, QC, required reports, and final laboratory manual delivered to NCHS. F.2.2 Delivery Schedule Number of Copies and Delivery Date F.2.2.1 Laboratory Manual The manual will include instructions on the location for the storage of samples, and detailed information on the Techniques and materials used in the assay and quality control procedures. This manual must be reviewed and updated on a periodic basis throughout the study. The document must be submitted in electronic form in Word using the template provided by NCHS in addition to one hard copy of the electronic version. Number of Copies: 1 Hardcopy Delivery Date: Draft Manual/Three months after the start of the contract. Final Manual: July 1, 2019 F.2.2.2 Progress Reports Progress Reports shall include: a)..Summary of the status of all specimens including date of arrival, deviations from protocol, handling, storage, and manipulation of vials, and all laboratory procedures used; b). Description of any major problems such as missing data, out of range values or inconsistent data and what was done to overcome them; c). Internal and external quality control for runs containing NHANES specimens; and d). Instrument calibration and repairs; reagent lots and dates of use. Delivery Date: Quarterly after the start of the data collection. Delivery Method: Electronically by E-mail to the Project Officer F.2.2.3 Laboratory Test Results Submit results and QC files electronically to the NHANES Survey Contractor on a flow basis. Delivery Date: On a flow basis three (3) weeks after the specimens are received. F.3 Place(s) ofPerformance (Jul 1999) The Contractor shall perform all work under this contract at the contractor's facility. (End of Clause) SECTION G - CONTRACT ADMINISTRATION DATA G.1 Contracting Officers Representative (COR) Technical Guidance (Sep 2009) Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract. As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof. In the event that the Contractor feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope. No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract. The Government COR is not authorized to change any of the terms and conditions of this contract. Changes shall be made only by the Contracting Officer by properly written modification(s) to the contract. The Government will provide the Contractor with a copy of the delegation memorandum for the COR. Any changes in COR delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor. (End of Clause) G.2. Contracting Officer's Representative (COR) NCHS COR Brenda Lewis, MT (ASCP), MPH Clinical Laboratory Scientist Planning Branch Division of Health and Nutrition Examination Surveys National Center for Health Statistics Centers for Disease Control and Prevention 3311 Toledo Road, Room 4219 Hyattsville, MD 20782 Telephone: 301-458-4343 G.3. Government Furnished Property - Biologic specimens collected at the NHANES examination centers will be provided to the vendor to measure a lipids profile (LP) in accordance with Section C of the contract.. G.4 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (April 2013) In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor. The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations. The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website. The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor's responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations. [End of Clause] G.5 Contracting Officer (Jul 1999) (a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract. (b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract. (End of Clause) G.6 Contract Communications/Correspondence (Jul 1999) The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract. (End of Clause) G.7 Payment by Electronic Funds Transfer (Dec 2005) (a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer - Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments. (b) In addition to Central Contractor Registration, the contractor shall make the designation by submitting the form titled "ACH Vendor/Miscellaneous Payment Enrollment Form" to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Financial Management Office at (404) 498-4050. (c) In cases where the contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed. (d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address: The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 30333 Or - Fax copy to: 404-638-5342 (End of Clause) G.8 Invoice Submission - Part 1 (Mar 2006) (a) The Contractor shall submit the original contract invoice/voucher to the shown below: The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 3033 (b) Please do not forget to submit a copy of each invoice directly to the Project Officer and Contracting Officer or Contract Administrator concurrently with submission to the Financial Management Office (FMO). It saves time, postage, and speeds up the payment processing by emailing the invoices to the 3 listed email addresses below: Financial Management Office (FMO): Email: FMOAPINV@CDC.GOV, Fax: 404-638-5324 Contracts Specialist: Nina Waters, 770-488-2933 Contracting Officer's Representative (COR): David Lacher, M.D. (301)458-4343 (c) The Contractor is required to submit a copy of each invoice directly to the Project Officer concurrently with submission to the Contracting Officer. (d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904. (e) The Contractor shall include (as a minimum) the following information on each invoice: (1) Contractor's Name & Address (2) Contractor's Tax Identification Number (TIN) (3) Purchase Order/Contract Number and Contract Number, if Appropriate (4) Invoice Number (5) Invoice Date (6) Contract Line Item Number and Description of Item (7) Quantity (8) Unit Price & Extended Amount for each line item (9) Shipping and Payment Terms (10) Total Amount of Invoice (11) Name, title and telephone number of person to be notified in the event of a defective invoice (12) Payment Address, if different from the information in (c) (1). (13) DUNS + 4 Numbers (End of Clause) SECTION H - SPECIAL CONTRACT REQUIREMENTS H.1 Type of Contract The Government anticipates awarding a Firm-Fixed Price/Indefinite Delivery-Indefinite Quantity (IDIQ) Task Order contract to be awarded for this requirement. H.2 Government Rights in Data All data, software and supporting materials acquired under this contract become the property of the U.S. Government. Under no circumstances shall an offeror place a copyright that will in any way limit the Government's use of any of the materials for which the vendor develops, provides and/or receives payment under this contract. The Contractor shall not provide any government documents, information, or licensed material in any form to sources not authorized by NCHS without written approval during the period of performance of this requirement and any time afterwards. Execution of non-disclosure statements will be required. H.3 Review of Data The following persons may review the data: NCHS Project Officer and Contracting Officer Representative; NCDC&P Project Representative, NIH Project Representative, the NHANES Data collection contractor, and outside consultants as requested by the Project Officer or Alternate Project Officer. H.4 Identification and Disposition of Data The Contractor guarantees that it will not tabulate, analyze, release or use the data without prior written approval of the Contracting Office and the Project Officer. The Contractor will release all tabulations and reports solely to the Project Officers or their designee. Copies of quality control data may be maintained in the contracting laboratory. If method development is done as part of this project, the Contractor may keep that data. All biologic specimens must be returned to the Project Officer and may not be used for other purposes unless approved by the Project Officer. H.5 Smoke Free Working Environment (May 2009) In compliance with Department of Health and Human Services (DHHS) regulations, all contractor personnel performing work within CDC/ATSDR facilities shall observe the CDC/ATSDR smoke-free working environment policy at all times. This policy prohibits smoking in all CDC/ATSDR buildings and in front of buildings which are open to the public. This policy is also applicable to contractor personnel who do not work full-time within CDC/ATSDR facilities, but are attending meetings within CDC/ATSDR facilities. (End of Clause) H.6 Privacy Act (Sep 2009) (a) Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl. (b) The COTR is hereby designated as the official who is responsible for monitoring contractor compliance with the Privacy Act. (c) The Contractor shall follow the Privacy Act guidance as outlined in the Privacy Act of 1974 (5 USC 552a) and Section 308(d) of the Public Health Service Act. (End of Clause) H.7 Dissemination of Information (May 2010) No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR. (End of Clause) H.8 Data Subject to Confidentiality Requirements (May 1998) The type(s) of data subject to the Clause at 352.224-70, Confidentiality of Information, which has been incorporated by reference in Section I, are as follows: All Data generated by this procurement, including personally identifying information. Following are the requirements for handling these data: The Contractor is prohibited from publicizing or disseminating information without the prior review and comment of the Project Officer. All data and products developed under this contract shall become and remain the property of the Government. H.9 Issuance of Task/Delivery Orders The Contractor shall be capable of providing the staff necessary to conduct the required work. The timing, magnitude, and scope of each requirement cannot be predicted until the Government determines the specific work to be performed. The Contractor should expect a fluctuating workload throughout the performance period of this contract and will provide the technical, professional, managerial, and clerical support required to complete the task order successfully. The technical monitor, project officer, or designee may accompany the Contractor to each site for the purpose of monitoring the Contractors startup activities and may elect to remain at the site to monitor Contractor activities. Performance hereunder shall be accomplished by task orders issued under this contract in accordance with the following procedure: As the Government identifies specific requirements for work to be performed under this contract, a Task Delivery Order will be issued unilaterally. The Order will detail the requirements and associated funding. The NCHS program official will subsequently provide a predetermined delivery schedule for those requirements. If the Contractor does not accept the Task/Delivery Order and cannot reach agreement on an individual task order basis, it shall be considered a dispute and handled according to the provision of the contract in Section I, FAR 52.233-01 Disputes - Alternate I" (Oct 1995). H.10 Prohibition on the Use of Appropriated Funds for Lobbying Activities (Jul 1999) The contractor is hereby notified of the restrictions on the use of Department of Health and Human Service's funding for lobbying of Federal, State and Local legislative bodies. Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12. In addition, the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress, or any State or Local legislative body itself. The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature. (End of Clause) H.11 Non-Disclosure Agreement for Contractor and Contractor Employees (Mar 2006) (a) The contractor shall prepare and submit a Non-Disclosure Agreement (NDA) to the Contracting Officer prior to access of government information or the commencement of work at CDC. (b) The NDA made part of this clause, exhibit I and II, is required in service contracts where positions and/or functions proposed to be filled by contractor's employees will have access to non-public and procurement-sensitive information. The NDA also requires contractor's employees properly identify themselves as employees of a contractor when communicating or interacting with CDC employees, employees of other governmental entities (when communication or interaction relates to the contractor's work with the CDC), and members of the public. The Federal Acquisition Regulation (FAR) 37.114 (c), states "All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed." (c) The Contractor shall inform employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements. (d) During the contract performance period, the Contractor is responsible to ensure that all additional or replacement contractors' employees sign a NDA and it is submitted to the Contracting Officer prior to commencement of their work with the CDC. (e) Contractor employees in designated positions or functions that have not signed the appropriate NDA shall not have access to any non-public, procurement sensitive information or participate in government meeting where sensitive information may be discussed. (f) The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum include: contract number, employee's name, position, date of hire and NDA requirement. EXHIBIT I Centers for Disease Control and Prevention (CDC) Contractor Non-Disclosure Agreement I. Non-public Information [Name of contractor] understands that in order to fulfill the responsibilities pursuant to [Contract name and number] between the Centers for Disease Control and Prevention and [Name of CDC contractor] dated [date], employees of [contractor] will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. For purposes of this agreement, confidential information means government information that is not or will not be generally available to the public. Privileged information means information which cannot be disclosed without the prior written consent of the CDC. In order to properly safeguard non-public information, [contractor] agrees to ensure that prior to being granted access to government information or the commencement of work for the CDC, whichever is applicable, all employees will sign a Non-Disclosure Agreement (NDA) provided by the CDC prior to beginning work for the CDC. Contractor agrees to submit to the contracting official the original signed copies of NDAs signed by the contractor's employees in accordance with the instructions provided by the contracting official. Failure to provide signed NDAs in accordance with this agreement and instructions provided by the contracting official could delay or prevent the employee from commencing or continuing work at the CDC until such agreement is signed and returned to the contracting official. Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee any non-public information that the employee may obtain in connection with the performance of the employee's responsibilities to the CDC. II. Procurement-Sensitive Information Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual, other than an authorized Government employee, any procurement-sensitive information gained while in connection with fulfilling the employee's responsibilities at the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Statements of Work (SOW), Requests for Contract (RFC), and Requests for Proposal (RFP); Responses to RFPs, including questions from potential offerors; non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data; contract information plans; strategies; source selection information and documentation; offerors' identities; technical and cost data; the identity of government personal involved in the solicitation; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees. Contractor understands and agrees that employee access to any procurement-sensitive information may create a conflict of interest which will preclude contractor from becoming a competitor for any acquisition(s) resulting from this information. Therefore, if an employee participates in any discussions relating to procurement-sensitive information, assists in developing any procurement-sensitive information, or otherwise obtains any procurement-sensitive information during the course of performing duties at the CDC, contractor understands and agrees that contractor are be excluded from competing for any acquisition(s) resulting from this information. III. Identification of Non-Government Employees Contractor understands that its employees are not agents of the Government. Therefore, unless otherwise directed in writing by the CDC, contractor agrees to assist and monitor employee compliance with the following identification procedures: A. At the beginning of interactions with CDC employees, employees of other governmental entities, members of the public, or the media (when such communication or interaction relates to the contractor's work with the CDC), contractors' employees will identify themselves as an employee of a contractor. B. Contractors' employees will include the following disclosures in all written communications, including outgoing electronic mail (e-mail) messages, in connection with contractual duties to the CDC: Employee's name Name of contractor Center or office affiliation Centers for Disease Control and Prevention C. At the beginning of telephone conversations or conference calls, contractors' employees will identify themselves as an employee of a contractor. D. Contractors should not wear any CDC logo on clothing, except for a CDC issued security badge while carrying out work for CDC or on CDC premises. The only other exception is when a CDC management official has granted permission to use the CDC logo. E. Contractors' employees will program CDC voice mail message to identify themselves as an employee of a contractor. I understand that federal laws including, 18 U.S.C. 641 and 18 U.S.C. 2071, provide criminal penalties for, among other things, unlawfully removing, destroying or converting to personal use, or use of another, any public records. Contractor acknowledges that contractor has read and fully understands this agreement. Name of contractor: ___________________________________ Signature of Authorized Representative of Contractor:_________________________________ Date:________________ Copies retained by: contracting official and contractor EXHIBIT II Centers for Disease Control and Prevention (CDC) Contractors' Employee Non-Disclosure Agreement I. Non-Public Information I understand that in order to fulfill my responsibilities as an employee of [Name of CDC contractor], I will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. For purposes of this agreement, confidential information means government information that is not or will not be generally available to the public. Privileged information means information which cannot be disclosed without the prior written consent of the CDC. I [Name of Employee], agree to use non-public information only in performance of my responsibilities to the CDC. I agree further that I will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee, any non-public information that I may obtain in connection with the performance of my responsibilities to the CDC. II. Procurement-Sensitive Information I further agree that unless I have prior written permission from the CDC, I will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee, any procurement-sensitive information gained in connection with the performance of my responsibilities to the CDC. I specifically agree not to disclose any non-public, procurement-sensitive information to employees of my company or any other organization unless so authorized in writing by the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Statements of Work (SOW), Requests for Contract (RFC), and Requests for Proposal (RFP); Responses to RFPs, including questions from potential offerors; non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data; contract information plans; strategies; source selection information and documentation; offerors' identities; technical and cost data; the identity of government personal involved in the acquisition; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees. I understand and agree that my access to any procurement-sensitive information may create a conflict of interest which will preclude me, my current employer, or a future employer from becoming a competitor for any resulting government acquisition derived from this information. Therefore, if I participate in any discussions relating to procurement-sensitive information, assist in developing any procurement-sensitive information, or otherwise obtain any procurement-sensitive information during the course of performing my duties at the CDC, I understand and agree that I, my current employer, and any future employer(s) are excluded from competing for any resulting acquisitions. III. Special Non-Disclosure Clause for Contractors with Access to CDC Grants Management and Procurement-Related Information Technology Systems In addition to complying with the non-disclosure requirements and safeguards stated above, I understand that my authorization to use CDC's grants management and procurement systems is strictly limited to the access and functions necessary for the performance of my responsibilities to the CDC and which have been approved in advance by the CDC. I understand that I am not authorized to enter procurement requests for any requirements pertaining to contracts or subcontracts held by me or my employer. IV. Identification as a Non-Government Employee I understand that as an employee of a government contractor, I represent an independent organization and I am not an agent of the Government. Therefore, I agree that unless I have prior written authorization from the CDC, I will, at the beginning of interactions with CDC employees, employees of other governmental entities, members of the public, or the media (when such communication or interaction relates to the contractor's work with the CDC), identify myself as an employee of a contractor. I further agree to use the following identification procedures in connection with my work at the CDC: A. I will include the following disclosures in all written communications, including outgoing electronic mail (e-mail) messages:Employee's name Name of contractor Center or office Affiliation Centers for Disease Control and Prevention A. I will identify myself as an employee of a contractor at the beginning of telephone conversations or conference calls: B. I will not wear any CDC logo on clothing, except for a CDC issued security badge while carrying out work for CDC or on CDC premises; the only other exception is when a CDC management official has granted permission to use the CDC logo. D. I will program my CDC voice mail message to identify myself as a contractors' employee. I understand that federal laws including, 18 U.S.C. 641 and 18 U.S.C. 2071, provide criminal penalties for, among other things, unlawfully removing, destroying or converting to personal use, or use of another, any public records. I acknowledge that I have read and fully understand this agreement. Name of contractor: ___________________________________ Name of Employee:___________________________ Signature of Employee:_________________________________ Date:________________ Copies retained by: contracting official, contractor, and Employee (End of Clause) H.12 Smoke Free Environment Certification (Sep 2008) The Centers for Disease Control and Prevention (CDC) recognizes that secondhand smoke (SHS) exposure poses serious health risks to nonsmokers. SHS exposure in the workplace has been linked to an increased risk for heart disease and lung cancer among adult nonsmokers. SHS has been designated as a known carcinogen (cancer-causing agent) by the National Toxicology Program of the U.S. Environmental Protection Agency and by the International Agency for Research on Cancer (IARC). The National Institute for Occupational Safety and Health has concluded that SHS is an occupational carcinogen. There is no risk-free level of SHS exposure. Separating smokers from nonsmokers, cleaning the air, and ventilating buildings cannot eliminate this exposure. SHS is an important preventable cause of death from cancer and other illnesses, and many Americans, both adults and children, remain at significant risk from SHS exposure. It is the CDC's intent to protect the health of all CDC employees and reduce cancer and other serious health hazards caused by SHS exposure. Therefore, all meetings and conferences organized and/or sponsored or co-sponsored by the CDC shall be held in a conference venue that provides a smoke-free environment. A smoke-free conference venue is defined as a venue that makes ALL public places in the hotel and in all meeting facilities smoke-free. This includes, but is not limited to, meeting rooms, common areas such as lobbies and hallways, all indoor public spaces, all indoor employee work areas, restaurants (including restaurant bar areas), and lounges. Conferences include symposia, seminars, workshops, and any other organized and formal meeting lasting one or more days, where CDC personnel assemble to exchange information and views or explore or clarify a defined subject, problem, or area of knowledge. CERTIFICATION: Offeror's acceptance of any resulting contract certifies that the meeting/conference venue provided is "smoke-free" and that all CDC personnel attending said meeting/conference will be doing so in a smoke-free environment. (End of Clause) H.13 Government Property (Jan 2000) (a) Government-Furnished Property (GFP). The Government reserves the right to supply the Contractor, as Government-furnished property, any additional supplies, equipment, and materials determined by the Contracting Officer to be necessary and in the best interest of the Government in the performance of this contract provided the property is furnished, or the Contractor is notified of the Government's intent to furnish it, prior to the Contractor's commitment to acquire such items. (b) Contractor-Acquired Property (CAP). Regardless of the place of performance, when the costs of such items will be charged to the contract, the Contractor must receive written consent from the Contracting Officer prior to purchase of any item which requires such consent under FAR 52.244-2 (see Section I, FAR 52.244-2, paragraphs (c), (d) and (e)). (c) If performance of this contract is within and on Government facilities, and the Government-furnished property or contractor-acquired property is for use only within or on the Government facilities, the control and accountable record keeping for such property shall be retained by the Government (see FAR 52.245-1, Property Records). The Contractor shall remain accountable for loss or damage, but will not be required to submit an annual inventory or place its own bar codes on the items. The Government will provide property labels and other identification for contractor-acquired Government property under this paragraph. (d) If performance of this contract is not within Government facilities, and there is either Government-furnished property or contractor-acquired property being used in performance of the work, the Contractor shall be responsible for the control and accountable record keeping for such property in accordance with FAR Subpart 45.5 as supplemented by HHS Publication (OS) 74.115 entitled "Contractor's Guide for Control of Government Property," a copy of which will be provided upon request. (e) The Chief of Material Management Branch, PGO, Centers for Disease Control and Prevention (CDC), is hereby designated as the Property Administrator for this contract. The Contractor agrees to furnish information regarding the Government property under this contract to the Property Administrator, an authorized representative, or a duly designated successor(s). The Contractor shall identify each item of equipment furnished by the Government to the Contractor or acquired by the Contractor using contract funds, with a suitable decal, tag, or other marking, as prescribed by the Property Administrator, and shall follow the guidance set forth in the "Contractor's Guide for Control of Government Property." (End of Clause) H.14 Laboratory License Requirements (May 1998) The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended). This requirement shall also be included in any subcontract for services under the contract. (End of Clause) H.15 Needle Exchange No funds appropriated in the FY 14 Appropriations Act and obligated to this contract may be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug. (End of Clause) H-16 Rights in Data The Contractor is prohibited from publicizing or disseminating information without the prior written approval of the Project Officer. All data and products developed under this contract shall become and remain the property of the Government. The Contractor guarantees that it will not tabulate, analyze, release or use the data without prior written approval of the Project Officer. The Contractor will release all tabulations and reports solely to the Project Officer or his/her designee. Copies of quality control data may be maintained in the contracting laboratory. If method development is done as part of this project, the Contractor may keep that data. All biologic specimens must be returned to the Project Officer and may not be used for other purposes unless approved by the Project Officer. Section I - Contract Clauses I.1 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acqnet.gov http://farsite.hill.af.mil/(End of Clause) FAR SOURCE TITLE AND DATE FAR 52.202-1 Definitions (Jan 2012) FAR 52.203-3 Gratuities (Apr 1984) FAR 52.203-5 Covenant Against Contingent Fees (Apr 1984) FAR 52.203-6 Restrictions on SubContractor Sales to the Government (Sep 2006) FAR 52.203-7 Anti-Kickback Procedures (Oct 2010) FAR 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Jan 1997) FAR 52.203-10 Price or Fee Adjustment for Illegal or Improper Activity (Jan 1997) FAR 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2007) FAR 52.203-12 Limitation on Payments to Influence Certain Federal Transactions (Oct 2010) FAR 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Righs (Apr 2014) FAR 52.204-4 Printed or Copied Double-Sided on Fiber Content Paper (May 2011) FAR 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) FAR 52.204-13 System for Award Management (Jul 2013) FAR 52.209-6 Protecting the government's Interests When Subcontracting with Contractors Debarred, suspended, or Proposed for Debarment (Aug 2013) FAR 52.215-2 Audit and Records - Negotiation (Oct 2010) FAR 52.215-8 Order of Precedence - Uniform Contract Format (Oct 1997) FAR 52.215-10 Price Reduction for Defective Cost or Pricing Data (Aug 2011) FAR 52.215-12 Subcontractor Cost or Pricing Data (Oct 2010) FAR 52.215-14 Integrity of Unit Prices (Oct 2010) FAR 52.215-15 Pension Adjustments and Asset Reversions (Oct 2010) FAR 52.215-18 Reversion or Adjustment ofPlans for Post Retirement Benefits (PRB) other than Pensions (Jul 2005) FAR 52.215-19 Notification of Ownership Changes (Oct 1997) FAR 52.215-21 Requiements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data - Modifications (Oct 2010) FAR 52.219-8 Utilization of Small Business Concerns (Jul 2013) FAR 52.219-9 Small Business Subcontracting Plan (Jul 2013) FAR 52.222-3 Convict Labor (Jun 2003) FAR 52.222-21 Prohibition of Segregated Facilities (Feb 1999) FAR 52.222.35 Equal Opportunity for Veterans (Sep 2010) FAR 52.222-36 Affirmative Action for Workers with Disabilities ((Oct 2010) FAR 52.222-37 Employment Reports on Veterans (Sep 2010) FAR 52.222.40 Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) FAR 52.222.50 Combating Trafficking in Persons (Feb 2009) FAR 52.222-54 Employment Eligibility Verification (August 2013) FAR 52.223-06 Drug-Free Workplace (May 2001) FAR 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) FAR 52.224-2 Privacy Act (Apr 1984) FAR 52.225-1 Buy American Act-Supplies (Feb 2009) FAR 52.227-1 Authorization and Consent (Dec 2007) FAR 52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement (Dec 2007) FAR 52.229-3 Federal, State and Local Taxes (Feb 2013) FAR 52.232-1 Payments (Apr 1984) FAR 52.232-8 Discounts for Prompt Payment (Feb 2002) FAR 52.232-9 Limitation on Withholding of Payments (Apr 1984) FAR 52.232-11 Extras (Apr 1984) FAR 52.232-17 Interest (Oct 2010) FAR 52.232-23 Assignment of Claims (Jan 1986) FAR 52.232-25 Prompt Payment (Jul 2013) FAR 52.232-33 Payment by Electronic Funds Transfer System for Award Management (Jul 2013) FAR 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.233-1 Disputes (July 2002) FAR 52.233-2 Service of Protest (Sep 2006) FAR 52.233-3 Protest After Award (Aug 1996) FAR 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004) FAR 52.233.71 Litigation and Claims (Jan 2006) FAR 52.242-13 Bankruptcy (Jul 1995) FAR 52.242-15 Stop-Work Order (Aug 1989) FAR 52.243-1 Changes - Fixed-Price, Alternate II (Apr 1984) FAR 52.244-6 Subcontracts for Commercial Items (Dec 2013) FAR 52.246-4 Inspection of Services - Fixed Price (Aug 1996) FAR 52.246-25 Limitation of Liability Services (Feb 1997) FAR 52.249-2 Termination for the Convenience of the Government Fixed Price (Apr 2012) FAR 52.249-8 Default Fixed (Price Supply and Service)(Apr 1984) FAR 52.253-1 Computer Generated Forms (Jan 1991) HHSAR 352.202-1 Definitions (January 2006) HHSAR 352.203-70 Anti-Lobbying (Mar 2012) HHSAR 352.215-70 Late Proposals and Revisions (Jan 2006) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010) HHSAR 352.227-70 Publications and Publicity (Jan 2006) HHSAR 352.223-70 Safety and Health (Jan 2006) HHSAR 352.231-71 Pricing of Adjustments (January 2001) HHSAR 352.239-71 Standard for Encryption Language (Jan 2010) HHSAR 352.239-72 Security Requirements for Federal Information Technology Resources (Jan 2010) HHSAR 352.239-73 Electronic and Information Technology Accessibility (Jan 2010) HHSAR 352.270-1 Accessibility of Meetings, Conferences, and Seminars to Persons with Disabilities ( (Jan 2001) Section I-2 - Clauses Incorporated In Full Text I.1 HHSAR 352.202-1 Definitions (Jan 2006) (a) In accordance with 52.202-1(a)(1), substitute the following as paragraph (a): ‘‘(a) The term ‘‘Secretary'' or ‘‘Head of the Agency'' (also called ‘‘Agency Head'') means the Secretary, Deputy Secretary, or any Assistant Secretary, Administrator or Commissioner of the Department of Health and Human Services; and the term ‘‘his/her duly authorized representative'' means any person, persons, or board authorized to act for the Secretary.'' (b) In accordance with 52.202-1(a)(1), add the following paragraph (h): ‘‘(h) The term ‘‘Project Officer'' means the person who monitors the technical aspects of contract performance. The Project Officer is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. If applicable, the Project Officer is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract.'' (End of Clause) I.2 FAR 52.204-9 Personal Identity Verification of Contractor Personnel (Jan 2006) (a) The Contractor shall comply with agency personal identity verification procedures identified in the contract that implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24, and Federal Information Processing Standards Publication (FIPS PUB) Number 201. (b) The Contractor shall insert this clause in all subcontracts when the subcontractor is required to have physical access to a federally-controlled facility or access to a Federal information system. (End of clause) I.3 52.216-22 INDEFINITE QUANTITY (APR 1984) As prescribed in FAR 16.505(e), insert the following clause in solicitations and contracts when an indefinite-quantity contract is contemplated. (a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract. (b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the 'maximum'. The Government shall order at least the quantity of supplies or services designated in the Schedule as the 'minimum'. (c) Except for any limitations on quantities in the Delivery-Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations. (d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after the completion date for the Base Year and any Option Years exercised. (End of clause) I-4 52.216-18 ORDERING (APR 1984) As prescribed in 16.505(a), insert the following clause in solicitations and contracts when a definite-quantity contract, a requirements contract, or an indefinite-quantity contract is contemplated. (a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders by the individuals or activities designated in the Schedule. Such orders may be issued from Date of Award of Contract through the 12 month Period of Performance(POP) for the Base Period and the same POP for any Option Periods awarded.. (b) All delivery orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order and this contract, the contract shall control. (c) If mailed, a delivery order is considered 'issued' when the Government deposits the order in the mail. Orders may be issued orally or by written telecommunications only if authorized in the Schedule. (End of clause) I.5 52.216-19 DELIVERY-ORDER LIMITATIONS (APR 1984) As prescribed in 16.505(b), insert a clause substantially the same as follows in solicitations and contracts when a definite-quantity contract, a requirements contract, or an indefinite-quantity contract is contemplated: (a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 24 Specimen Tests the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract. (b) Maximum order. The Contractor is not obligated to honor-- (1) Any order for a single item in excess of _24 Specimen Tests; (2) Any order for a combination of items in excess of 4600 Specimen Tests; (3) A series of orders from the same ordering office within __30____ days that together call for quantities exceeding the limitation in subparagraph (1) or (2) above. (c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) above. (d) Notwithstanding paragraphs (b) and (c) above, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 5 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source. (End of clause) I-6 FAR 52.217-6 Option for Increased Quantity (Mar 1989) The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within the Period of Performance of the contract for the Base Year and two Option Years. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree. I.7 FAR 52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 14 days prior to the end of the period of performance. (End of Clause) I.9 FAR 52.239-1 Privacy or Security Safeguards (Aug 1996) (a)The Contractor shall not publish or disclose in any manner, without the Contracting Officer's written consent, the details of any safeguards either designed or developed by the Contractor under this contract or otherwise provided by the Government. (b)To the extent required to carry out a program of inspection to safeguard against threats and hazards to the security, integrity, and confidentiality of Government data, the Contractor shall afford the government access to the contractor's facilities, installation, technical capabilities, operations, documentation, records, and databases. (c)If new or unanticipated threats or hazards are discovered by either the government or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party. (End of Clause) I.10 HHSAR 352.224-70 Privacy Act (Jan 2006) This contract requires the Contractor to perform one or more of the following: (a) design; (b) develop; or (c) operate a federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) [5 U.S.C. 552a(m)(1)] and applicable agency regulations. The term ‘‘system of records'' means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties [5 U.S.C. 552a(i)]. The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance. (End of clause) I.11 HHSAR 352.231-71 Pricing of adjustments (January 2001) As prescribed in 331.102-70, the Contracting Officer shall insert the following clause: When costs are a factor in determination of a contract price adjustment pursuant to the "Changes" clause or any provision of this contract, the applicable cost principles and procedures set forth below shall form the basis for determining such costs: Cost Principles Types of Organizations Subpart 31.2 of the Federal Acquisition Regulation Commercial Subpart 31.3 of the Federal Acquisition Regulation Educational Subpart 31.6 of the Federal Acquisition Regulation State, local, and federally recognized Indian tribal governments 45 CFR Part 74 Appendix E Hospitals (performing research and development contracts only) Subpart 31.7 of the Federal Acquisition Regulation Other nonprofit organizations (End of clause) I.12 FAR 52.237-3 Continuity of Services (Jan 1991) (a) The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption and that, upon contract expiration, a successor, either the Government or another contractor, may continue them. The Contractor agrees to - (1) Furnish phase-in training; and (2) Exercise its best efforts and cooperation to effect an orderly and efficient transition to a successor. (b) The Contractor shall, upon the Contracting Officer's written notice, (1) furnish phase-in, phase-out services for up to 90 days after this contract expires and (2) negotiate in good faith a plan with a successor to determine the nature and extent of phase-in, phase-out services required. The plan shall specify a training program and a date for transferring responsibilities for each division of work described in the plan, and shall be subject to the Contracting Officer's approval. The Contractor shall provide sufficient experienced personnel during the phase-in, phase-out period to ensure that the services called for by this contract are maintained at the required level of proficiency. (c) The Contractor shall allow as many personnel as practicable to remain on the job to help the successor maintain the continuity and consistency of the services required by this contract. The Contractor also shall disclose necessary personnel records and allow the successor to conduct on-site interviews with these employees. If selected employees are agreeable to the change, the Contractor shall release them at a mutually agreeable date and negotiate transfer of their earned fringe benefits to the successor. (d) The Contractor shall be reimbursed for all reasonable phase-in, phase-out costs (i.e., costs incurred within the agreed period after contract expiration that result from phase-in, phase-out operations) and a fee (profit) not to exceed a pro rata portion of the fee (profit) under this contract. (End of Clause) I.13 HHSAR 352.233-71 Litigation and Claims (Jan 2006) a) The Contractor shall provide written notification immediately to the Contracting Officer of any action, including any proceeding before an administrative agency, filed against the Contractor arising out of the performance of this contract, including, but not limited to the performance of any subcontract hereunder; and any claim against the Contractor the cost and expense of which is allowable under the clause entitled ‘‘Allowable Cost and Payment.'' (b) Except as otherwise directed by the Contracting Officer, the Contractor shall furnish immediately to the Contracting Officer copies of all pertinent papers received by the Contractor with respect to such action or claim. To the extent not in conflict with any applicable policy of insurance, the Contractor may, with the Contracting Officer's approval, settle any such action or claim. If required by the Contracting Officer, the Contractor shall effect an assignment and subrogation in favor of the Government of all the Contractor's rights and claims (except those against the Government) arising out of any such action or claim against the Contractor; and authorize representatives of the Government to settle or defend any such action or claim and to represent the Contractor in, or to take charge of, any action. (c) If the Government undertakes a settlement or defense of an action or claim, the Contractor shall furnish all reasonable assistance in effecting a settlement or asserting a defense. Where an action against the Contractor is not covered by a policy of insurance, the Contractor shall, with the approval of the Contracting Officer, proceed with the defense of the action in good faith. The Government shall not be liable for the expense of defending any action or for any costs resulting from the loss thereof to the extent that the Contractor would have been compensated by insurance which was required by law or regulation or by written direction of the Contracting Officer, but which the Contractor failed to secure through its own fault or negligence. In any event, unless otherwise expressly provided in this contract, the Government shall not reimburse or indemnify the Contractor for any liability loss, cost, or expense, which the Contractor may incur or be subject to by reason of any loss, injury or damage, to the person or to real or personal property of any third parties as may accrue during, or arise from, the performance of this contract. (End of clause) I.14 HHSAR 352.242-71 Tobacco-Free Facilities (Jan 2006) In accordance with Department of Health and Human Services (HHS) policy, the Contractor and its staff are prohibited from using tobacco products of any kind (e.g., cigarettes, cigars, pipes, and smokeless tobacco) while on any HHS property, including use in personal or company vehicles operated by Contractor employees while on an HHS property. This policy also applies to all subcontracts awarded under the contract or order. The term ‘‘HHS properties'' includes all properties owned, controlled and/or leased by HHS when totally occupied by HHS, including all indoor and outdoor areas of such properties. Where HHS only partially occupies such properties, it includes all HHS-occupied interior space. Where HHS leases space in a multi-occupant building or complex, the tobacco-free HHS policy will apply to the maximum area permitted by law and compliance with the provisions of any current lease agreements. The Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understand, and comply with this policy. (End of clause) I.15 HHSAR 352.242-73 Withholding of Contract Payments (Jan 2006) Notwithstanding any other payment provisions of this contract, failure of the Contractor to submit required reports when due or failure to perform or deliver required work, supplies, or services, may result in the withholding of payments under this contract unless such failure arises out of causes beyond the control, and without the fault or negligence of the Contractor as defined by the clause entitled ‘‘Excusable Delays'' or ‘‘Default'', as applicable. The Government shall immediately notify the Contractor of its intention to withhold payment of any invoice or voucher submitted. (End of clause) I.16 HHSAR 352.239-70 Standard for security configuration (January 2010). As prescribed in 339.101(d)(1), the Contracting Officer shall insert the following clause: (a) The Contractor shall configure its computers that contain HHS data with the applicable Federal Desktop Core Configuration (FDCC) (see http://nvd.nist.gov/fdcc/index.cfm) and ensure that its computers have and maintain the latest operating system patch level and anti-virus software level. (Note: FDCC is applicable to all computing systems using Windows XP TM and Windows Vista TM, including desktops and laptops-regardless of function-but not including servers.) (b) The Contractor shall apply approved security configurations to information technology (IT) that is used to process information on behalf of HHS. The following security configuration requirements apply: (NOTE: The Contracting Officer shall specify applicable security configuration requirements in solicitations and contracts based on information provided by the Project Officer, who shall consult with the OPDIV/STAFFDIV Chief Information Security Officer.) (c) The Contractor shall ensure IT applications operated on behalf of HHS are fully functional and operate correctly on systems configured in accordance with the above configuration requirements. The Contractor shall use Security Content Automation Protocol (SCAP)-validated tools with FDCC Scanner capability to ensure its products operate correctly with FDCC configurations and do not alter FDCC settings - see http://scap.nist.gov/validation/. The Contractor shall test applicable product versions with all relevant and current updates and patches installed. The Contractor shall ensure currently supported versions of information technology products meet the latest FDCC major version and subsequent major versions. (d) The Contractor shall ensure IT applications designed for end users run in the standard user context without requiring elevated administrative privileges. (e) The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above. (f) The Contractor shall (1) include Federal Information Processing Standard (FIPS) 201-compliant (see http://csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf), Homeland Security Presidential Directive 12 (HSPD-12) card readers with the purchase of servers, desktops, and laptops; and (2) comply with FAR Subpart 4.13, Personal Identity Verification. (g) The Contractor shall ensure that its subcontractors (at all tiers) which perform work under this contract comply with the requirements contained in this clause. (End of clause) I-17 352.239-71 Standard for encryption language (January 2010) As prescribed in 339.101(d)(2), the Contracting Officer shall insert the following clause: (a) The Contractor shall use Federal Information Processing Standard (FIPS) 140-2-(PDF) compliant encryption (Security Requirements for Cryptographic Module, as amended) to protect all instances of HHS sensitive information during storage and transmission. (Note: The Government has determined that HHS information under this contract is considered "sensitive" in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems, dated February 2004.) (b) The Contractor shall verify that the selected encryption product has been validated under the Cryptographic Module Validation Program (see http://csrc.nist.gov/cryptval/) to confirm compliance with FIPS 140-2 (as amended). The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative. (c) The Contractor shall use the Key Management Key (see FIPS 201, Chapter 4, as amended) on the HHS personal identification verification (PIV) card; or alternatively, the Contractor shall establish and use a key recovery mechanism to ensure the ability for authorized personnel to decrypt and recover all encrypted information (see http://csrc.nist.gov/drivers/documents/ombencryption-guidance.pdf). The Contractor shall notify the Contracting Officer and the Contracting Officer's Technical Representative of personnel authorized to decrypt and recover all encrypted information. (d) The Contractor shall securely generate and manage encryption keys to prevent unauthorized decryption of information in accordance with FIPS 140-2 (as amended). (e) The Contractor shall ensure that this standard is incorporated into the Contractor's property management/control system or establish a separate procedure to account for all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive HHS information. (f) The Contractor shall ensure that its subcontractors (at all tiers) which perform work under this contract comply with the requirements contained in this clause. (End of clause) I-18 352.239-72. - Security Requirements for Federal Information Technology Resources(January 2010) As prescribed in 339.7103, the Contracting Officer shall insert the following clause: (a) Applicability. This clause applies whether the entire contract or order (hereafter "contract"), or portion thereof, includes information technology resources or services in which the Contractor has physical or logical (electronic) access to, or operates a Department of Health and Human Services (HHS) system containing, information that directly supports HHS' mission. The term "information technology (IT)", as used in this clause, includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services) and related resources. This clause does not apply to national security systems as defined in FISMA. (b) Contractor responsibilities. The Contractor is responsible for the following: (1) Protecting federal information and federal information systems in order to ensure their- (i) Integrity, which means guarding against improper information modification or destruction, and includes ensuring information non-repudiation and authenticity; (ii) Confidentiality, which means preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and proprietary information; and. (iii) Availability, which means ensuring timely and reliable access to and use of information. (2) Providing security of any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor, regardless of location, on behalf of HHS. (3) Adopting, and implementing, at a minimum, the policies, procedures, controls, and standards of the HHS Information Security Program to ensure the integrity, confidentiality, and availability of federal information and federal information systems for which the Contractor is responsible under this contract or to which it may otherwise have access under this contract. The HHS Information Security Program is outlined in the HHS Information Security Program Policy, which is available on the HHS Office of the Chief Information Officer's (OCIO) website. (c) Contractor security deliverables. In accordance with the timeframes specified, the Contractor shall prepare and submit the following security documents to the Contracting Officer for review, comment, and acceptance: (1) IT Security Plan (IT-SP) - due within 30 days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies. (i) The Contractor's IT-SP shall comply with applicable federal laws that include, but are not limited to, the Federal Information Security Management Act (FISMA) of 2002 (PDF) (Title III of the E-Government Act of 2002, Public Law 107-347), and the following federal and HHS policies and procedures: (A) Office of Management and Budget (OMB) Circular A-130, Management of Federal Information Resources, Appendix III, Security of Federal Automated Information Resources. (B) National Institute of Standards and Technology (NIST) Special Publication (SP) 800-18 (PDF), Guide for Developing Security Plans for Federal Information Systems, in form and content, and with any pertinent contract Statement of Work/Performance Work Statement (SOW/PWS) requirements. The IT-SP shall identify and document appropriate IT security controls consistent with the sensitivity of the information and the requirements of Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems. The Contractor shall review and update the IT-SP in accordance with NIST SP 800-26, Security Self-Assessment Guide for Information Technology Systems and FIPS 200, on an annual basis. (C) HHS-OCIO Information Systems Security and Privacy Policy. (ii) After resolution of any comments provided by the Government on the draft IT-SP, the Contracting Officer shall accept the IT-SP and incorporate the Contractor's final version into the contract for Contractor implementation and maintenance. On an annual basis, the Contractor shall provide to the Contracting Officer verification that the IT-SP remains valid. (2) IT Risk Assessment (IT-RA) - due within 30 days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy. After resolution of any comments provided by the Government on the draft IT-RA, the Contracting Officer shall accept the IT-RA and incorporate the Contractor's final version into the contract for Contractor implementation and maintenance. The Contractor shall update the IT-RA on an annual basis. (3) FIPS 199 Standards for Security Categorization of Federal Information and Information Systems Assessment (FIPS 199 Assessment) - due within 30 days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard. After resolution of any comments by the Government on the draft FIPS 199 Assessment, the Contracting Officer shall accept the FIPS 199 Assessment and incorporate the Contractor's final version into the contract. (4) IT Security Certification and Accreditation (IT-SC&A) - due within 3 months after contract award. The Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed for applicable information systems - see paragraph (a) of this clause. The Contractor shall perform the IT-SC&A in accordance with the HHS Chief Information Security Officer's Certification and Accreditation Checklist; NIST SP 800-37, Guide for the Security Certification and Accreditation of Federal Information Systems; and NIST SP 800-53, Recommended Security Controls for Federal Information Systems. An authorized senior management official shall sign the draft IT-SC&A and provide it to the Contracting Officer for review, comment, and acceptance. (i) After resolution of any comments provided by the Government on the draft IT-SC&A, the Contracting Officer shall accept the IT-SC&A and incorporate the Contractor's final version into the contract as a compliance requirement. (ii) The Contractor shall also perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid. Evidence of a valid system accreditation includes written results of (A) annual testing of the system contingency plan and (B) the performance of security control testing and evaluation. (d) Personal identity verification. The Contractor shall identify its employees with access to systems operated by the Contractor for HHS or connected to HHS systems and networks. The Contracting Officer's Technical Representative (COTR) shall identify, for those identified employees, position sensitivity levels that are commensurate with the responsibilities and risks associated with their assigned positions. The Contractor shall comply with the HSPD-12 requirements contained in "HHS-Controlled Facilities and Information Systems Security" requirements specified in the SOW/PWS of this contract. (e) Contractor and subcontractor employee training. The Contractor shall ensure that its employees, and those of its subcontractors, performing under this contract complete HHS-furnished initial and refresher security and privacy education and awareness training before being granted access to systems operated by the Contractor on behalf of HHS or access to HHS systems and networks. The Contractor shall provide documentation to the COTR evidencing that Contractor employees have completed the required training. (f) Government access for IT inspection. The Contractor shall afford the Government access to the Contractor's and subcontractors' facilities, installations, operations, documentation, databases, and personnel used in performance of this contract to the extent required to carry out a program of IT inspection (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the integrity, confidentiality, and availability, of HHS data or to the protection of information systems operated on behalf of HHS. (g) Subcontracts. The Contractor shall incorporate the substance of this clause in all subcontracts that require protection of federal information and federal information systems as described in paragraph (a) of this clause, including those subcontracts that- (1) Have physical or electronic access to HHS' computer systems, networks, or IT infrastructure; or (2) Use information systems to generate, store, process, or exchange data with HHS or on behalf of HHS, regardless of whether the data resides on a HHS or the Contractor's information system. (h) Contractor employment notice. The Contractor shall immediately notify the Contracting Officer when an employee either begins or terminates employment (or is no longer assigned to the HHS project under this contract), if that employee has, or had, access to HHS information systems or data. (i) Document information. The Contractor shall contact the Contracting Officer for any documents, information, or forms necessary to comply with the requirements of this clause. (j) Contractor responsibilities upon physical completion of the contract. The Contractor shall return all HHS information and IT resources provided to the Contractor during contract performance and certify that all HHS information has been purged from Contractor-owned systems used in contract performance. (k) Failure to comply. Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause shall be grounds for the Contracting Officer to terminate this contract. (End of clause) Section J - List Of Attachments Quality Assurance Surveillance Plan (QASP) follows: Quality Assurance Surveillance Plan (QASP) 1.0 Introduction 2.0 Method of Surveillance 3.0 Roles and Responsibilities 4.0 Surveillance 5.0 Standards 6.0 Procedures 7.0 Contract Performance Evaluation Tab 1 Performance - Based Matrix Tab 2 Contractor Performance Report Tab 3 Nonconforming Deliverables Quality Assurance Surveillance Plan (QASP) 1.0 Introduction 1.1 Since this is a Performance-Based Contract, the Government must effectively validate in a timely manner the performance of the Contractor in meeting the services required. This QASP provides a systematic surveillance method for the services, and describes the methodology by which the Contractor's performance will be monitored. 1.2 The principal focus of the surveillance system is the Contractor's performance of the indicators identified in the Performance-Based Matrix at Paragraph C.4.2 of the Performance-Based Performance Work Statement (PBPWS). Therefore, the QASP surveillance standards are identical to those in Paragraph C.11. See Tab 1 for a copy of the Performance-Based Matrix. 1.3 The task order will be surveilled with this Quality Assurance Surveillance Plan (QASP). 1.4 The plan will use the Contractors Performance Assessment Reporting System (CPARS) to electronically process interim and final contractor performance assessments at www.cpars.gov. At a minimum, interim contractor performance assessments will be conducted every 12 months until the end of the contract. CPARS allows the Contracting Officer's Representative or Contracting Officer, to report Contractor and subcontractor performance on a national, easily accessible database. It requires the Contracting Officer to review the database prior to approving the use of a Contractor to insure that the Contractor or subcontractor has done a good job in the past. As a result, it is anticipated that CPARS should help motivate the Contractor, wishing future work in the Federal sector, on the current contract toward superior performance. 1.5 For the purpose of this plan, AGENCY considers the FAR Clause 52.246-4 Inspection of Services - Fixed Price to meet the FAR Part 37.601 criteria for establishing a procedure for reduction of price or fee of a contract. 1.6 This QASP: 1.6.1 Identifies the services and products that will be measured. 1.6.2 Establishes the specific standards of performance for each required output. 1.6.3 Establishes the responsibilities for performing the measurement. 1.6.4 Defines the Government role in overseeing the performance. 1.6.5 Provides for feedback to the Contractor regarding quality, quantity, and timeliness of the service outputs. 1.6.6 Establishes timeframes for communicating performance improvements. 2.0 Methods of Surveillance: 2.1 The Performance-Based Matrix at Tab 1 lists the services to be monitored and the standards to be applied. 2.2 This QASP is based on the premise the government desires to maintain a quality standard for acquisition support services. 2.3 The Contractor, and not the government, is responsible for management and quality control actions to meet the terms of the contract. The role of the government is quality assurance to ensure contract standards are achieved. 2.4 In this contract the Contractor quality control program is the basis for service quality. The Contractor is required to only deliver acquisition support services that conform to the requirements of the contract. 3.0 Roles and Responsibilities: 3.1 The Contractor's primary responsibility is to ensure all requirements are met at the required quality level. The Government shall ensure this responsibility has been met before payment is made to the Contractor. The primary Government team members are the COR and the Contracting Officer (CO). 3.2. The CO has the overall responsibility for overseeing the Contractor's performance. The CO is responsible for monitoring Contractor performance in the areas of contract compliance, contract management, and the resolution of all issues relative to the language of the contract. 3.3 The COR is responsible for directly monitoring, assessing, recording, and reporting on the technical performance of the Contractor. The COR will have primary responsibility for signing off on all invoices and documenting the inspection and evaluation of the Contractor's performance. 3.4 The COR will work with staff and the Contractor to ensure good communication and resolve any problems not requiring the CO's authority. 4.0 Surveillance: The COR will evaluate the performance objectives through periodic inspections quarterly. See Tab 2 for a sample of a Contractor's Performance Report. 4.1 The following information will be included: 4.1.1 Contract paragraph number referencing the requirement. 4.1.2 A Short description of the requirement being surveilled. 4.1.3 Date, time, and location of surveillance. 4.1.4 Results of surveillance. 4.1.5 Signature of individual accomplishing the surveillance. 4.2 All performance must be documented, whether acceptable or unacceptable. When unacceptable performance is documented, the COR shall take the following actions: 4.2.1 If government actions caused the unacceptable performance, take steps to prevent it in the future. 4.2.2 If the Contractor's performance is unacceptable, inform the Contractor's on site representative of the unacceptable performance and the reasons why it is unacceptable. 4.2.3 If the contractor wants to dispute the results of the surveillance, refer them to the CO for resolution. 4.3 Performance should not be determined unacceptable until all possible contributing factors have been considered. 4.4 For required tasks not shown on the Performance-Based Matrix, the government still retains the right to inspect any item included in the contract. These services will be inspected periodically and the results provided to the CO. 5.0 Standards: All standards in the Performance-Based Matrix must be met. All deliverable dates and other contractual completion dates must also be met. If any of the standards are not met, the Government shall receive consideration from the Contractor for breach of contract. 5.1 Late performance is un-excusable unless the Contractor can justify all of the following: 5.1.1 The delay was not the Contractor's fault. 5.1.2 The delay was not foreseeable. 5.1.3 It was beyond the Contractor's control to avoid the delay. 5.2 All work shall be performed in accordance with the PBPWS. The COR shall not consider the services complete until all deficiencies have been corrected. 5.3 The COTR shall determine whether the failure was a minor non-conformance or a substantive non-conformance. (See Tab 3 for decision matrix on Nonconforming Deliverables.) 6.0 Procedures: The Government will inspect performance requirements to ensure contractor compliance and record results of inspection, noting the date and time of inspection. Unacceptable performance and complaints shall be referred to the CO for investigation and validation. The CO will investigate and validate the unacceptable performance and/or customer input. The Contractor shall be given a reasonable amount of time after notification to correct the unacceptable performance and report to the CO that the deficiency has been corrected. If deficiencies are not corrected, the COR will notify the CO and recommend a course of action. 7.0 Contract Performance Evaluation 7.1 FAR 42.15 - Contractor Performance Information establishes the Government responsibility for recording and maintaining contractor performance information. This requirement does not apply to procedures used in determining incentive awards or other incentive systems, although the two systems should be mutually supporting. 7.2 FAR 42.1501 - Past performance information is relevant information for future source selection purposes, regarding a contractor's actions under previously awarded contracts. It includes, for example, the contractor's record of conforming to contract requirements and to standards of good workmanship; the contractor's record of forecasting and controlling costs; the contractor's adherence to contract schedules, including the administrative aspects of performance; the contractor's history of reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the contractor's business-like concern for the interest of the customers. 7.3 The general procedures to be used are addressed in the following FAR section. 42.1503 Procedures: (a) Agency procedures for the past performance evaluation system shall generally provide for input to the evaluations from the technical office, contracting office and, where appropriate, end users of the product or service. (b) Agency evaluations of contractor performance prepared under this subpart shall be provided to the contractor as soon as practicable after completion of the evaluation. Contractors shall be given a minimum of 30 days to submit comments, rebutting statements, or additional information. Agencies shall provide for review at a level above the CO to consider disagreements between the parties regarding the evaluation. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, contractor response, and review comments, if any, shall be retained as part of the evaluation. These evaluations may be used to support future award decisions, and should therefore be marked "Source Selection Information". 7.4 The Contractor Performance Report form at Tab 2 will be completed at least annually and more frequently if necessary to motivate or reward the contractor. Tab 1: Performance-based Matrix to QASP/Laboratory Lipids Analyses for NHANES Performance-based Matrix For Laboratory Lipids Analyses for NHANES Desired End Result Feature(s) of end result to be surveilled (Indicator). The required performance level for each feature (Standard). Quality Assurance Incentives/Payment-Quality Link The Contractor shall provide QC and test results to Westat Contractor shall submit quarterly status report Contractor shall test data transmission electronically Contractor shall test the report of findings Contractor shall develop and submit laboratory manual Accuracy & timeliness Timeliness Accuracy timeliness Accuracy Accuracy & timeliness Not later than 21 days of testing Not Later Than the 15th day of each quarter Successful imported of file into the NHANES Data Collection data base Successful imported of file into the NHANES Data Collection and generation of a report of findings letter Final manual approved by Program Office Surveillance system will be primarily site inspections and review of lab status reports, and QA/QC Review of the report by the PO All data is QCed for accuracy by the PO. Spot checking of the letters by the PO. Review of manual by PO. 1. Positive incentives: a. Payment of contract labor rate for satisfactory service. b. Contractor performance evaluated using the automated Contractor Performance Assessment Reporting System (CPARS). The evaluation will be considered when future AGENCY contract selections are made 2. Payment is linked to quality through FAR 52.246-4 Inspection of Services - Fixed Price Price (Aug. 1996) (a) Definition: "Services," as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services. (b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires. (c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work. (d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties. (e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may - (1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and (2) Reduce the contract price to reflect the reduced value of the services performed. (f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may - (1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or (2) Terminate the contract for default. (End of Clause) Tab 2: Contractor Performance Report CONTRACTORS PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS) RATINGS Block 18a - Quality of Product or Service. Assess the Contractor's conformance to contract requirements, specifications and standards of good workmanship (e.g. commonly accepted technical, professional, environmental, or safety and health standards). MANDATORY. • For example: Are reports/data accurate? Does the product or service provided meet the specifications of the contract? Does the Contractor's work measure up to commonly accepted technical or professional standards? Assess the degree of Government technical direction required to solve problems that arise during performance. • For Operations Support: Assess how successfully the Contractor meets program quality objectives such as ability to produce, reliability, maintainability and ability to inspect. The Assessing Official must be flexible in how Contractor success is measured; e.g. using data from field reliability and maintainability and failure reports, user comments and acceptance rates, and scrap and rework rates. These quantitative indicators may be useful later, for example, in source selection evaluations, in demonstrating continuous improvement, quality and reliability leadership that reflects progress in total quality management. Assess the Contractor's control of the overall production process to include material control, shop planning and control, and status. Block 18b - Schedule. Assess the timeliness of the Contractor against the completion of the contract, task orders, milestones, delivery schedules, and administrative requirements (e.g. efforts that contribute to or effect the schedule variance). MANDATORY. • This assessment of the Contractor's adherence to the required delivery schedule should include the Contractor's efforts during the assessment period that contributes to or effect the schedule variance. This element applies to contract closeout activities as well as contract performance. Instances of adverse actions such as the assessment of liquidated damages, or issuance of Cure Notices, Show Cause Notices, and Delinquency Notices are indicators of problems which may have resulted in variance to the contract schedule and should therefore be noted in the evaluation. Block 18c - Cost Control (Not required for Firm Fixed Price or Firm Fixed Price with Economic Price Adjustment). Assess the Contractor's effectiveness in forecasting, managing, and controlling contract cost. MANDATORY. • For example, does the Contractor keep within the total estimated cost (what is the relationship of the negotiated costs and budgeted costs to actuals)? Did the Contractor do anything innovative that resulted in cost savings? Were billings current, accurate and complete? Are the Contractor's budgetary internal controls adequate? Block 18d - Business Relations. Assess the integration and coordination of all activity needed to execute the contract, specifically the timeliness, completeness and quality of problem identification, corrective action plans, proposal submittals, the contractor's history of reasonable and cooperative behavior (to include timely identification of issues in controversy), customer satisfaction, timely award and management of subcontracts. MANDATORY Include, as applicable, information on the following: • Is the contractor oriented toward the customer? • Is interaction between the contractor and the government satisfactory or does it need improvement? • Include the adequacy of the contractor's accounting, billing, and estimating systems and the contractor's management of Government Property (GFP) if a substantial amount of GFP has been provided to the contractor under the contract. • Address the timeliness of awards to subcontractors and management of subcontractors, including subcontract costs. Consider efforts taken to ensure early identification of subcontract problems and the timely application of corporate resources to preclude subcontract problems from impacting overall prime contractor performance. • Assess the prime contractor's effort devoted to managing subcontracts and whether subcontractors were an integral part of the contractor's team. Block 18e - Management of Key Personnel (For Services and Information Technology Business Sectors only - Not Applicable to Operations Support).. Assess the Contractor's performance in selecting, retaining, supporting, and replacing, when necessary, key personnel. MANDATORY. • For example, how well did the Contractor match the qualifications of the key position, as described in the contract, with the person who filled the key position? Did the Contractor support key personnel so they were able to work effectively? If a key person did not perform well, what action was taken by the Contractor to correct this? If a replacement of a key person was necessary, did the replacement meet or exceed the qualifications of the position as described in the contract schedule? Block 18f - Utilization of Small Business. FAR Subpart 19.7 and 15 U.S.C. 637 contains statutory requirements for complying with the Small Business Subcontracting Program. Assess whether the contractor provided maximum practicable opportunity for Small Business (including Alaska Native Corporations (ANCs) and Indian Tribes) (including Small Disadvantaged Businesses (which also includes ANCs and Indian Tribes), Women Owned Small Businesses, HUBZone, Veteran Owned, Service Disabled Veteran Owned Small Business, Historically Black Colleges and Minority Institutions and ANCs and Indian Tribes that are not Small Disadvantaged Businesses or Small Businesses) to participate in contract performance consistent with efficient performance of the contract. Assess compliance with all terms and conditions in the contract relating to Small Business participation (including FAR 52.219-8, Utilization of Small Businesses and FAR 52.219-9, Small Business Subcontracting Plan (when required). Assess any small business participation goals which are stated separately in the contract. Assess achievement on each individual goal stated within the contract or subcontracting plan including good faith effort if the goal was not achieved. It may be necessary to seek input from the Small Business specialist, ACO or PCO in regards to the contractor's compliance with these criteria. For DoD in cases where the contractor has a comprehensive subcontracting plan, request DCMA Comprehensive Subcontracting Plan Manager to provide input including any program specific performance information. For contracts subject to a commercial subcontracting plan, the Utilization of Small Business factor should be rated "satisfactory" as long as an approved plan remains in place, unless liquidated damages have been assessed by the contracting officer who approved the commercial plan (see FAR 19.705-7(h)). In such case, the Utilization of Small Business area must be rated "unsatisfactory". This area must be rated for all contracts and task orders that contain a small business subcontracting goal. Ratings for the Utilization of Small Business evaluation area will be in accordance with the definitions described below. Ratings for the other CPAR evaluation areas will be in accordance with the ratings described in Block 18 Evaluation Areas. In accordance FAR 19.705-2(e) a contract may have no more than one subcontracting plan. Evaluations of the Utilization of Small Business are required for contracts and orders placed against basic ordering agreement (BOA) and blanket purchase agreement (BPA) if a subcontracting plan is required. Evaluations of Utilization of Small Business for single-agency task orders and delivery orders (to include FSS) are not required and shall not be accomplished unless the contracting officer determines that such evaluations would produce more useful past performance information for source selection officials than that contained in the overall contract evaluation. Execution of any subcontracting plan may be addressed in block 20. • Exceptional. Exceeded all negotiated subcontracting goals or exceeded at least one goal and met all of the other negotiated subcontracting goals for the current period. Had exceptional success with initiatives to assist, promote, and utilize small business (SB), small disadvantaged business (SDB), women-owned small business (WOSB), HUBZone small business, veteran-owned small business (VOSB) and service disabled veteran owned small business (SDVOSB). Complied with FAR 52.219-8, Utilization of Small Business Concerns. Exceeded any other small business participation requirements incorporated in the contract, including the use of small businesses in mission critical aspects of the program. Went above and beyond the required elements of the subcontracting plan and other small business requirements of the contract. Completed and submitted Individual Subcontract Reports and/or Summary Subcontract Reports in an accurate and timely manner. Note: To justify an Exceptional rating, identify multiple significant events and state how they were a benefit to small business utilization. A singular benefit, however, could be of such magnitude that it constitutes an Exceptional rating. Ensure that small businesses are given meaningful, innovative work directly related to the project, rather than peripheral work, such as cleaning offices, supplies, landscaping, etc. Also, there should have been no significant weaknesses identified. • Very Good. Met all of the negotiated subcontracting goals in the traditional socio-economic categories (SB, SDB and WOSB) and met at least one of the other socio-economic goals (HUBZone, VOSB, SDVOSB) for the current period. Had significant success with initiatives to assist, promote and utilize SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB. Complied with FAR 52.219-8, Utilization of Small Business Concerns. Met or exceeded any other small business participation requirements incorporated in the contract, including the use of small businesses in mission critical aspects of the program. Endeavored to go above and beyond the required elements of the subcontracting plan. Completed and submitted Individual Subcontract Reports and/or Summary Subcontract Reports in an accurate and timely manner. Note: To justify a Very Good rating, identify a significant event and state how they were a benefit to small business utilization. Ensure that small businesses are given meaningful, innovative work directly related to the project, rather than peripheral work, such as cleaning offices, supplies, landscaping, etc. There should be no significant weaknesses identified. • Satisfactory. Demonstrated a good faith effort to meet all of the negotiated subcontracting goals in the various socio-economic categories for the current period. Complied with FAR 52.219-8, Utilization of Small Business Concerns. Met any other small business participation requirements included in the contract. Fulfilled the requirements of the subcontracting plan included in the contract. Completed and submitted Individual Subcontract Reports and/or Summary Subcontract Reports in an accurate and timely manner. Note: To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor has addressed or taken corrective action. There should have been no significant weaknesses identified. A fundamental principle of assigning ratings is that contractors will not be assessed a rating lower than Satisfactory solely for not performing beyond the requirements of the contract. • Marginal. Deficient in meeting key subcontracting plan elements. Deficient in complying with FAR 52.219-8, Utilization of Small Business Concerns, and any other small business participation requirements in the contract. Did not submit Individual Subcontract Reports and/or Summary Subcontract Reports in an accurate or timely manner. Failed to satisfy one or more requirements of a corrective action plan currently in place; however, does show an interest in bringing performance to a satisfactory level and has demonstrated a commitment to apply the necessary resources to do so. Required a corrective action plan. Note: To justify Marginal performance, identify a significant event that the contractor had trouble overcoming and how it impacted small business utilization. A Marginal rating should be supported by referencing the actions taken by the government that notified the contractor of the contractual deficiency. • Unsatisfactory. Noncompliant with FAR 52.219-8 and 52.219-9 and any other small business participation requirements in the contract. Did not submit Individual Subcontract Reports and/or Summary Subcontract Reports in an accurate or timely manner. Showed little interest in bringing performance to a satisfactory level or is generally uncooperative. Required a corrective action plan. Note: To justify an Unsatisfactory rating, identify multiple significant events that the contractor had trouble overcoming and state how it impacted small business utilization. A singular problem, however, could be of such serious magnitude that it alone constitutes an Unsatisfactory rating. An Unsatisfactory rating should be supported by referencing the actions taken by the government to notify the contractor of the deficiencies. When an Unsatisfactory rating is justified, the contracting officer must consider whether the contractor made a good faith effort to comply with the requirements of the subcontracting plan required by FAR 52.219-9 and follow the procedures outlined in FAR 52.219-16, Liquidated Damages-Subcontracting Plan. NOTE 1: Plus or minus signs may be used to indicate an improving (+) or worsening (-) trend insufficient to change assessment status. NOTE 2: For subcontracting plans under the DoD Comprehensive Small Business Subcontracting Plan (Test Program), DFARS 252.219-7004, the ratings entered in CPARS shall mirror those assigned by the Defense Contract Management Agency who is responsible for monitoring such plans. NOTE 3: Generally, zero percent is not a goal unless the Contracting Officer determined when negotiating the subcontracting plan that no subcontracting opportunities exist in a particular socio-economic category. In such cases, the contractor shall be considered to have met the goal for any socio-economic category where the goal negotiated in the plan was zero. Block 18g - Other Areas. Specify additional evaluation areas that are unique to the contract, or that cannot be captured elsewhere on the form. More than one type of entry may be included, but should be separately labeled. If extra space is needed, use Block 20. If the contract contains an award fee provision, enter "award fee" in the "Other Areas" block (18g). The Assessing Official should translate the award fee earned to adjective ratings, which could prove more useful for using past performance to assess future performance risk in upcoming source selections. If award fee information is included in the CPAR, use block 20 to provide a description for each award fee. Include the scope of the award fee by describing the extent to which it covers the total range of contract performance activities, or is restricted to certain elements of the contract. If any other type of contract incentive is included in the contract (excluding contract shareline incentives on fixed price or cost-type contracts), it should be reported in a manner similar to the procedures described above for award fee. Use Block 18g in those instances where the Assessing Official believes strongly, either positively or negatively, regarding an aspect of the Contractor's performance, but cannot fit that aspect into any of the other blocks on the form. Tab 3: Nonconforming Deliverables -( Firm Fixed Price) NONCONFORMING DELIVERABLES MINOR NONCONFORMANCE If Then Consideration Consideration would be less than the cost of modifying the contract Accept as is (once) None Note performance in report. Consideration would be greater than the cost of modifying the contract Accept as is (once) Consideration comparable to the value of the loss sustained by the Government Note performance in report. MAJOR NONCONFORMANCE If Then Consideration The contractor agrees to correct the deliverable (or re-perform the service) within the delivery schedule Withhold acceptance until receipt of the corrected deliverable Cost to re-inspect or retest. Delete profit from rate per hour for corrected work. Note performance in report. The contractor agrees to correct the deliverable (or re-perform the service) but needs an extension of the delivery date Withhold acceptance until receipt of the corrected deliverable Cost to re-inspect or retest Delete profit from rate per hour for corrected work. Note performance in report. Acceptance: • Would not affect safety or performance, and • Is justified on the basis of economy or urgency Accept as is None Note performance in report. The contractor refuses to make repair or provide appropriate consideration. Either:• Correct the product or service through other means (contract or in-house), or• Terminate for default and re-procure. Contractor to pay all costs for the correction or re-procurement. Note performance in report. SECTION K - Representations, Certifications, and Other Statements of Offerors or Respondents. These will be reviewed in SAMs. SECTION L. Instructions, Conditions, and Notices to Offerors FAR SOURCE TITLE AND DATE 52.204-6 Data Universal Numbering System (DUNS) umber (Oct 2003) 52.214-34 Submission of Offers in the English Language (Apr 1991) 52.214-35 Submission of Offers in U.S. Currency (Apr 1991) (A) prescribed in 16.105, complete and insert the following provision: Type of Contract (Apr 1984) - The Government contemplates award of a Firm Fixed Price/Indefinate Delivery/Indefinite Quantity Contract resulting from this solicitation. The Business proposal received from vendors will contain the Unit Price and the Extended Price for all Line Items. The objective of this firm-fixed price competitive negotiated contract with options is to seek laboratory(s) to measure a Lipids profile (LP) from biologic specimens collected at the NHANES exam center (MEC) and develop a laboratory manual comprised of three tasks described in Section C. (B) To judge these factors, provide the following: (a) Time needed for analysis of one specimen alone; (b) Number of samples which can be analyzed per unit of time under routine conditions; and (c) Time in hours' use for preventive maintenance, reagent preparation, calibration, trouble shooting, and total operating hours. Indicate in your technical proposal acceptable alternative methods or analytical test systems (backup instrumentation) and recommended storage conditions including optimal and maximum storage time for sample retention. (C) The period of performance shall be for a Base Year of 6 months with three (12) month Option Periods and a final six (6) month Option Period. FAR 52.215-1 Instructions to Offerors-Competitive Acquisition (Jan 2004);Alternate I (Oct. 1997). As prescribed in 15.209(a), insert the following provision: (a) Definitions. As used in this provision- "Discussions" are negotiations that occur after establishment of the competitive range that may, at the Contracting Officer's discretion, result in the offeror being allowed to revise its proposal. "In writing," "writing," or "written" means any worded or numbered expression that can be read, reproduced, and later communicated, and includes electronically transmitted and stored information. "Proposal modification" is a change made to a proposal before the solicitation's closing date and time, or made in response to an amendment, or made to correct a mistake at any time before award. "Proposal revision" is a change to a proposal made after the solicitation closing date, at the request of or as allowed by a Contracting Officer as the result of negotiations. "Time," if stated as a number of days, is calculated using calendar days, unless otherwise specified, and will include Saturdays, Sundays, and legal holidays. However, if the last day falls on a Saturday, Sunday, or legal holiday, then the period shall include the next working day. (b) Amendments to solicitations. If this solicitation is amended, all terms and conditions that are not amended remain unchanged. Offerors shall acknowledge receipt of any amendment to this solicitation by the date and time specified in the amendment(s). (c) Submission, modification, revision, and withdrawal of proposals. (1) Unless other methods (e.g., electronic commerce or facsimile) are permitted in the solicitation, proposals and modifications to proposals shall be submitted in paper media in sealed envelopes or packages (i) addressed to the office specified in the solicitation, and (ii) showing the time and date specified for receipt, the solicitation number, and the name and address of the offeror. Offerors using commercial carriers should ensure that the proposal is marked on the outermost wrapper with the information in paragraphs (c)(1)(i) and (c)(1)(ii) of this provision. (2) The first page of the proposal must show- (i) The solicitation number; (ii) The name, address, and telephone and facsimile numbers of the offeror (and electronic address if available); (iii) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and agreement to furnish any or all items upon which prices are offered at the price set opposite each item; (iv) Names, titles, and telephone and facsimile numbers (and electronic addresses if available) of persons authorized to negotiate on the offeror's behalf with the Government in connection with this solicitation; and (v) Name, title, and signature of person authorized to sign the proposal. Proposals signed by an agent shall be accompanied by evidence of that agent's authority, unless that evidence has been previously furnished to the issuing office. (3) Submission, modification, revision, and withdrawal of proposals. (i) Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that proposal or revision is due. (ii)(A) Any proposal, modification, or revision received at the Government office designated in the solicitation after the exact time specified for receipt of offers is "late" and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and- (1) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of proposals; or (2) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or (3) It is the only proposal received. (B) However, a late modification of an otherwise successful proposal that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted. (iii) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the proposal wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel. (iv) If an emergency or unanticipated event interrupts normal Government processes so that proposals cannot be received at the office designated for receipt of proposals by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation, the time specified for receipt of proposals will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume. (v) Proposals may be withdrawn by written notice received at any time before award. Oral proposals in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile proposals, proposals may be withdrawn via facsimile received at any time before award, subject to the conditions specified in the provision at 52.215-5, Facsimile Proposals. Proposals may be withdrawn in person by an offeror or an authorized representative, if the identity of the person requesting withdrawal is established and the person signs a receipt for the proposal before award. (4) Unless otherwise specified in the solicitation, the offeror may propose to provide any item or combination of items. (5) Offerors shall submit proposals in response to this solicitation in English, unless otherwise permitted by the solicitation, and in U.S. dollars, unless the provision at FAR 52.225-17, Evaluation of Foreign Currency Offers, is included in the solicitation. (6) Offerors may submit modifications to their proposals at any time before the solicitation closing date and time, and may submit modifications in response to an amendment, or to correct a mistake at any time before award. (7) Offerors may submit revised proposals only if requested or allowed by the Contracting Officer. (8) Proposals may be withdrawn at any time before award. Withdrawals are effective upon receipt of notice by the Contracting Officer. (d) Offer expiration date. Proposals in response to this solicitation will be valid for the number of days specified on the solicitation cover sheet (unless a different period is proposed by the offeror). (e) Restriction on disclosure and use of data. Offerors that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall- (1) Mark the title page with the following legend: This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed-in whole or in part-for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of-or in connection with-the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government's right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained in sheets [insert numbers or other identification of sheets]; and (2) Mark each sheet of data it wishes to restrict with the following legend: Use or disclosure of data contained on this sheet is subject to the restriction on the title page of this proposal. (f) Contract award. (1) The Government intends to award a contract or contracts resulting from this solicitation to the responsible offeror(s) whose proposal(s) represents the best value after evaluation in accordance with the factors and subfactors in the solicitation. (2) The Government may reject any or all proposals if such action is in the Government's interest. (3) The Government may waive informalities and minor irregularities in proposals received. (4) The Government intends to evaluate proposals and award a contract without discussions with offerors (except clarifications as described in FAR 15.306(a)). Therefore, the offeror's initial proposal should contain the offeror's best terms from a cost or price and technical standpoint. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary. If the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals. (5) The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit cost or prices offered, unless the offeror specifies otherwise in the proposal. (6) The Government reserves the right to make multiple awards if, after considering the additional administrative costs, it is in the Government's best interest to do so. (7) Exchanges with offerors after receipt of a proposal do not constitute a rejection or counteroffer by the Government. (8) The Government may determine that a proposal is unacceptable if the prices proposed are materially unbalanced between line items or subline items. Unbalanced pricing exists when, despite an acceptable total evaluated price, the price of one or more contract line items is significantly overstated or understated as indicated by the application of cost or price analysis techniques. A proposal may be rejected if the Contracting Officer determines that the lack of balance poses an unacceptable risk to the Government. (9) If a cost realism analysis is performed, cost realism may be considered by the source selection authority in evaluating performance or schedule risk. (10) A written award or acceptance of proposal mailed or otherwise furnished to the successful offeror within the time specified in the proposal shall result in a binding contract without further action by either party. (11) If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable: (i) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer. (ii) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror. (iii) The overall ranking of all offerors, when any ranking was developed by the agency during source selection. (iv) A summary of the rationale for award. (v) For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror. (vi) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency. (End of provision) Alternate I (Oct 1997). As prescribed in 15.209(a)(1), substitute the following paragraph (f)(4) for paragraph (f)(4) of the basic provision: (f)(4) The Government intends to evaluate proposals and award a contract after conducting discussions with offerors whose proposals have been determined to be within the competitive range. If the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the ContractingOfficer may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals. Therefore, the offeror's initial proposal should contain the offeror's best terms from a price and technical standpoint. L.2 Inquiries (May 1998) Inquiries concerning the solicitation document should be submitted in writing to the issuing office. Any additions, deletions, or changes to the solicitation will be made by an amendment. OFFERS ARE INSTRUCTED SPECIFICALLY TO CONTACT ONLY THE SOLITICATION CONTRACTING OFFICE IN CONNECTION WITH ANY ASPECT OF THIS REQUIREMENT PRIOR TO CONTRACT AWARD. PROPOSALS AND ALL CORRESPONDENCE RELATING TO THE SOLICITATION DOCUMENT SHALL BE SUBMITTED TO THE CONTRACTING OFFICE. Questions and Inquiries should be received at the Contracting Office not later than 10 calendar days or (Date) after issuance of the solicitation and must be submitted via e-mail to jvw0@cdc.gov or hee5@cdc.gov. (End of provision) L.2 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 CDC/PGO, 2920 Brandywine Road, Atlanta, GA. 30341. [Contracting Officer designate the official or location where a protest may be served on the Contracting Officer.] (b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. (End of provision) L.3 In accordance with FAR Part 19.708, paragraph (b)(ii) and Clause 52.219-9 Small Business Subcontracting Plan (JAN 2011), (c), the offeror, if a Large Business, is hereby requested to submit the necessary subcontracting plan with the initial proposal. L.4 General Instructions (Negotiated)(Jan 2000) (a)Offerors are invited to submit a proposal in response to this solicitation. All proposals will become part of the official file. (b)The following instructions establish the acceptable minimum requirements for the format and content of proposals. (c)Your proposal must be prepared in separate parts as instructed herein. Each part shall be separate and complete in itself so that evaluation of one may be accomplished independently of evaluation of the other(s). The technical proposal (if required) must not contain reference to cost; however, resource information, such as data concerning labor hours and categories, material, subcontract, et., must be contained in the technical proposal so you're your understanding of the Performance Work Statement can be evaluated. The technical proposal (if required) must disclose your technical approach in sufficient detail to provide a clear and concise presentation that addresses, but is not limited to, the requirements of the technical proposal instructions. (d) The proposal must be signed by an official authorized to bind your organization. You must submit 1 electronic copy of your proposal to CDC/PGO via email to jvw0@cdc.gov and hee5@cdc.gov. Subject: (Company Name) Proposal to RFP:# 2014-N-15808: (e) Offerors are requested to submit proposals, to the maximum extent possible, on high grade white paper which can be recycled, if submitting via surface mail. You must submit 4 hard copies of your proposal (Technical and Business) to CDC/PGO point of contact at the address below: Attn: Nina Waters 2920 Brandywine Road, MS K-69 Atlanta, Georgia 30341 Solicitation No. 2014-N-15808 Proposals must be submitted by the Closing Date on Page 1 of the RFP 2014-N -15808. The electronic files must be compatible with MS office 2003 and Adobe 8.0. (f)Facsimile proposals are not authorized unless this solicitation incorporates FAR 52.215-5, Facsimile Proposals, in Section L. (g)The Government will evaluate proposals in accordance with the evaluation criteria set forth in Section M, Evaluation Factors for Award. (End of Provision) L.5 Technical Proposal Instructions Technical Proposal. The technical proposal should be in enough detail to reflect a clear understanding of the nature of the work being undertaken and should address each of the Technical Evaluation Criteria in Section M. Your proposal must be prepared in three separate parts as instructed herein. (Volume I, Technical Proposal, Volume II, Business Proposal (Cost), and Volume III, Past Performance Information.) Each part shall be separate and complete in itself so that evaluation of one may be accomplished independently of evaluation of the other(s). The technical proposal must not contain reference to cost; however, resource information, such as data concerning labor hours and categories, material, subcontracts, etc., must be contained in the technical proposal so that your understanding of the Statement of Work can be evaluated. The technical proposal (if required) must disclose your approach in sufficient detail to provide a clear and concise presentation that addresses, but is not limited to, the requirements of the technical proposal instructions. L.6 Length of Technical Proposal The technical proposal should succinctly address the PWS at Section C and the evaluation criteria at Section M.5. THE TECHNICAL PROPOSAL MUST NOT EXCEED 30 SINGLE-SPACED, SINGLE-SIDED, STANDARD 8 1/2 X 11 INCH PAGES OF 12 CHARACTERS PER INCH TYPE, EXCLUDING APPENDICES AND RESUMES OF KEY PERSONNEL. THE TECHNICAL PROPOSAL SHOULD "STAND ALONE" WITH THE APPENDICES USED ONLY FOR CLARIFYING OR BACK UP INFORMATION. (End of Provision) L.7 Business Proposal Instructions a. The Business Proposal shall be separate from the Technical Proposal and shall be comprised of the following elements: The offeror must submit a cost proposal in response to Section B that is based on the offeror's technical proposal directly associated with the PWS. The intent is to award a single contract for the Line Items shown in Section B of this contract. This Business Proposal must be signed by an individual within the organization with the authority to be responsible for the Proposal. (b)Other Administrative Data Your proposal must stipulate that it is predicated upon all the terms and conditions of this RFP. In addition, it must contain a statement to the effect that it is firm for a period of at least 60 days from the date of receipt of the Government; List name and telephone number of person to contact regarding your proposed accounting system; Your proposal must list any current commitments with the Government relating to the work or services and indicate whether these commitments will or will not interfere with the completion of work and services as contemplated under this proposal. Your proposal must identify any former HHS employee to be utilized on this project by providing the individual's name when employed by HHS, where employed, and the capacity in which employed; Your proposal must indicate whether you have the necessary financial capacity, working capital, and other resources to perform the contract without assistance from any outside source. (If not, indicate the amount required and the anticipated source.). (End of Clause) Section M - Evaluation Factors for Award FAR SOURCE TITLE AND DATE M.1 FAR 52.217-5 Evaluation of Options (Jul 1990) M.1 Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s). (End of Provision) M.2 Past Performance Evaluation (Adjectival Rating System) (Jan 2000) Past performance information will be evaluated in the following manner: (a) Each offeror shall be evaluated on its past performance under current and prior contracts performed within the last five years. By past performance, the Government means the offeror's record of conforming to specifications and to standards of good workmanship; the offeror's record of forecasting and controlling costs; field data collection; survey participant response rate; the offeror's adherence to contract schedules and terms, including the administrative aspects of performance; the offeror's reputation for reporting and project management; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer and the degree of quality of deliverables and performance. (b) The Government will focus on information that demonstrates quality of performance for health data collection services for this very complicated NHANES program. Vendors must demonstrate experience in their proposed technical approach. (End of Provision) M.3 Relationship between Cost or Price and Technical Strength (May 1998) Offerors are hereby informed that both cost and the result of the contractor's technical proposal shall be considered when selecting the successful offeror. However, technical content and capability will be weighted more heavily than cost or price. Award shall be made to that responsible offeror submitting the proposal (Technical and Business) determined to be the most advantageous and the best value to the Government as evaluated under the criteria described in this Section. The Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. (End of Provision) M.4 Evaluation of Offers The Government will perform a qualitative technical review of proposals. The technical proposal will be scored against the evaluation criteria described below. Each factor shall be weighted as shown. The total number of possible points is 100. M.4.a Technical Approach: 40 points Contractors are to provide a discussion of their technical approach for providing the services required. The proposed approach to comply with each of the requirements specified in the Statement of Work, methods to be used, and scheduling of time and resources. The offeror should specify laboratory equipment, methods and materials for the analysis, and the amount of specimens (serum, plasma, urine, whole blood, etc.) required to perform the test and for repeat tests if unusual values are observed. The definition of unusual or out-of-range values will be agreed upon by the Contractor and the Project Officers but should be discussed in the proposal. The Offeror must describe methodology by which all laboratory personnel are made cognizant of the proper laboratory methods and techniques to be used in the study. The Offeror should propose systems for receiving and storing samples, assay calibrations, performing assays, quality control including verification of calibration with available reference materials, and participation in available external proficiency testing programs, and recording and reporting results. The methods to assess day-to-day variability should also be stated. The offerors should participate in external proficiency testing if available. Minimum requirements for reporting results are stated in the scope of work, but these requirements may be waived for offerors who propose alternative methods of accomplishing the project objectives. This criterion will be evaluated according to the soundness, practicality, and feasibility of the offeror's technical approach for providing the services required. M.4.b Staffing, Management, and Facility: 30 points Contractors are to provide (1) a staffing plan that demonstrates their understanding of the requirements for this contract; and (2) a management plan that describes their approach for managing the work. Include a description of the project organization including for individuals and staff that will be working on this requirement and curriculum vitae detailing relevant training and experience. This should demonstrate the experience, expertise, and qualifications to perform the duties described in the scope of work. The functions for these individuals, therefore, must be described and related to each individual's qualifications. An overall management schedule of critical events also shall be presented indicating how the work will be completed in a timely manner to meet the requirements of the contract. This criterion will be evaluated according to the soundness, practicality, and feasibility of the offeror's staffing and management plans for this requirement. M.4.c. Past Experience: 30 points Contractors are to describe their past, relevant experience in providing support to a Government agency in the peer review process of extramural research applications within the past five (5) years. TOTAL 100 Points
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2014-N-15808/listing.html)
Place of Performance: Address: TBD, TBD, United States
Record: SN03381500-W 20140601/140531022121-8be8dc6508a06ccce1f4ed8093839e95 (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 |

Loren Data's SAM Daily™

B -- Laboratory Lipids Analyses for NHANES