2011-N-13070 CASC Solicitation.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 80

2. CONTRACT NO.

3. SOLICITATION NO.

2011-N-13070

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE

NO.

7. ISSUED BY CODE 436 8. ADDRESS OFFER TO (If other than Item 7) Ctrs for Disease Control & Prevention (Pgh)

Procurement and Grants Branch - V PO Box 18070, 626 Cochrans Mill Rd Pittsburgh, PA 15236-0070

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 ten (10) handcarried, in the depository located in CDC-NIOSH- PGO, 626 Cochrans Mill Rd, Pittsburgh, PA 15236 until 3:00p local time 05/25/2011 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if

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

Diane J. Meeder

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(412) 386-4412

C. E-MAIL ADDRESS

DMeeder@cdc.gov

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 37

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 8 X J LIST OF ATTACHMENTS 48

X D PACKAGING AND MARKING 16 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 17 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 18 X K OTHER STATEMENTS OF OFFERORS 49

X G CONTRACT ADMINISTRATION DATA 22 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 55

X H SPECIAL CONTRACT REQUIREMENTS 30 X M EVALUATION FACTORS FOR AWARD 73

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 ninety (90) 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 25. PAYMENT WILL BE MADE BY CODE 434 Ctrs for Disease Control & Prevention (Pgh) Procurement and Grants Branch - V PO Box 18070, 626 Cochrans Mill Rd Pittsburgh, PA 15236-0070

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-498-4050 Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print) John Columbia

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©

K

Section B - Supplies Or Services And Prices/Costs

Base Period Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0001 CACS Services - Comprehensive Analytical Chemistry

Support (CACS) as per Performance Work Statement.

Period of Performance August 1, 2011 - July 31, 2012

Option 1 Year 2 Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0002 CACS Services - Comprehensive Analytical Chemistry

Period of Performance August 1, 2012 - July 31, 2013

Option 2 Year 3 Items:

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0003 CACS Services - Comprehensive Analytical Chemistry

Support(CACS) as per Performance Work Statement.

Period of Performance August 1, 2013 - July 31, 2014

Option 3 Year 4 Items:

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0004 CACS Services - Comprehensive Analytical Chemistry

Period of Performance August 1, 2014 - July 31, 2015

Option 4 Year 5 Items:

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0005 CACS Services - Comprehensive Analytical Chemistry

Period of Performance August 1, 2015 - July 31, 2016

Option 5 - Ten (10) Samples Items:

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0006 10 Samples - CACS as per Performance Work Statement.

Option 6 - Ten (10) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0007 10 Samples - CACS as per Performance Work Statement.

Option 7- Ten (10) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0008 10 Samples - CACS as per Performance Work Statement.

Option 8- Ten (10) Samples Items:

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0009 10 Samples - CACS as per Performance Work Statement.

Option 9 -Ten (10) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0010 10 Samples - CACS as per Performance Work Statement.

Option 10- Ten (10) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0011 10 Samples - CACS as per Performance Work Statement.

Option 11- Ten (10) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0012 10 Samples - CACS as per Performance Work Statement.

Option 12- Ten (10) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0013 10 Samples –CACS as per Performance Work Statement.

Option 13 -Ten (10) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0014 10 Samples -CACS as per Performance Work Statement.

Option 14- Ten (10) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0015 10 Samples - CACS as per Performance Work Statement.

Option 15 -Twenty-Five (25) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0016 25 Samples - CACS as per Performance Work Statement.

Option 16 -Twenty-Five (25) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0017 25 Samples - CACS as per Performance Work Statement.

Option 17 -Twenty-Five (25) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

0018 25 Samples -CACS as per Performance Work Statement.

Option 18 -Twenty-Five (25) Samples Items:

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0019 25 Samples - CACS as per Performance Work Statement.

Option 19- Twenty-Five (25) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0020 25 Samples - CACS as per Performance Work Statement.

Option 20 -Twenty-Five (25) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0021 25 Samples - CACS as per Performance Work Statement.

Option 21 -Twenty-Five (25) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0022 25 Samples -CACS as per Performance Work Statement.

Option 22- Twenty-Five (25) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0023 25 Samples- CACS as per Performance Work Statement.

Option 23 -Twenty-Five (25) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0024 25 Samples- CACS as per Performance Work Statement.

Option 24- Twenty-Five (25) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0025 25 Samples- CACS as per Performance Work Statement.

Option 25- One hundred (100) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0026 50 Samples- CACS as per Performance Work Statement.

Option 26 -One hundred (100) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0027 50 Samples- CACS as per Performance Work Statement.

Option 27 -One hundred (100) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0028 50 Samples- CACS as per Performance Work Statement.

Option 28 -One hundred (100) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

0029 50 Samples- CACS as per Performance Work Statement.

Option 29 -One hundred (100) Samples Items:

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0030 50 Samples- CACS as per Performance Work Statement.

Option 30 -One hundred (100) Samples Items:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED

PRICE

0031 100 Samples-CACS as per Performance Work Statement.

Option 31 -One hundred (100) Samples Items:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED

PRICE

0032 100 Samples-CACS as per Performance Work Statement.

Option 32 -One hundred (100) Samples Items:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED

PRICE

0033 100 Samples-CACS as per Performance Work Statement.

Option 33 -One hundred (100) Samples Items:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED

PRICE

0034 100 Samples- ACS as per Performance Work Statement.

Option 34- One hundred (100) Samples Items:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED

PRICE

0035 100 Samples-CACS as per Performance Work Statement.

Option 35 -Two hundred fifty (250) Samples Items:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED

PRICE

0036 250 Samples-CACS as per Performance Work Statement.

Option 36 -Two hundred fifty (250) Samples Items:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED

PRICE

0037 250 Samples-CACS as per Performance Work Statement.

Option 37- Two hundred fifty (250) Samples Items:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED

PRICE

0038 250 Samples-CACS as per Performance Work Statement.

Option 38 -Two hundred fifty (250) Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0039 250 Samples-CACS as per Performance Work Statement.

Option 39- Five (500) hundred Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

0040 500 Samples-CACS as per Performance Work Statement.

Option 40 -Five (500) hundred Samples Items:

COST

NTE AWARD

FEE

COST PLUS

AWARD FEE

0041 500 Samples-CACS as per Performance Work Statement.

Option 41- Five (500) hundred Samples Items:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS

0042 500 Samples-CACS as per Performance Work Statement.

B.1 Compensation (Award Fee- Performance Based)

a. The total contract amount including allowable costs and award fee shall not exceed $_________________.

b. The Contractor will not be paid a base-fee hereunder, however, the Contractor may earn up to $______________ in fees based upon an evaluation and determination by the Government as to the Contractor's level of performance in accordance with the following conditions and the Performance Based Award Fee Evaluation Plan set forth in Section J.

c. The estimated cost and potential award fee amounts for the base period and option years are as follows:

Estimated Cost Maximum Award Fee

Total Contract $ __________ $ __________

d. The Contractor's performance shall be evaluated approximately six (6) months from the effective date of the contract and semi-annually thereafter.

e. For the purpose of making the Government's determination of periodic award fees earned, the criteria set forth in the Performance Based Award Fee Evaluation Plan shall be utilized to evaluate Contractor performance.

f. Award Fee

(1) The Contractor's performance hereunder shall be evaluated semiannually by the Performance Based Award Fee Evaluation Board composed of individuals appointed by the Chairperson, Award Fee Evaluation Board. The Board will determine whether, and to what extent, the Contractor's performance of the preceding six (6) months warrants payment of a prorated share of the Fee Pool provided for in this clause. The points earned in the evaluation will be converted to a percentage which will be applied to the available award fee pool total to determine the fee earned for a given award fee period. Any unearned award fee will not be rolled over to the subsequent award fee period.

The Award Fee shall be subject to the limitation on the Government's obligation in FAR Clause 52.232-22 Limitation of Funds or FAR Clause 52-232-20, Limitation of Cost, as applicable, included in Section I.

(2) The Contractor will be notified by letter of the award fee payable. Upon receipt of the notification the Contractor may submit a public voucher for payment of the balance of the award fee earned but not yet billed for the period evaluated. Payment of the award fee shall be subject to the withholding provisions as set forth in FAR Clause 52.216-7, Allowable Cost and Payment, included in Section I.

(3) During performance of the contract the Contractor may monthly bill and be paid on a provisional basis two percent (2%) of the maximum award fee funded for that incremental period, and available for payment pursuant to Section B.2. If the maximum award fee actually earned during any given period is less than the provisional award fee paid to the Contractor, the Contractor shall reimburse the Government the difference between the provisional award fee paid and the actual award fee earned. The Government may either withhold the difference on subsequent billings or require the Contractor to repay the difference by check.

(End of clause)

B.2 352.232-71 Estimated Cost - Incrementally Funded Contract (June 2010)

(a) The total estimated cost to the Government for full performance of this contract, including all allowable direct and indirect costs and award fee, is $_______________.

(b) The following represents the schedule* by which the Government expects to allot funds to this contract:

CLIN

Start Date of Period or Increment of

Performance

End Date of Period or Increment of Performance

Estimated Cost

Award Fee ($)

Estimated Cost Plus Award Fee

[Total] [Total] [Total]

* To be inserted after negotiation

(c) Total funds currently available for payment and allotted to this contract are $______________, of which $______________ represents the estimated reimbursable costs and $__________________represents the award fee funded. It is estimated that the amount currently allotted will cover Contractor performance for _____________ of the base year of performance.

(d) The Contracting Officer may issue unilateral modifications to obligate additional funds to the contract and make related changes to paragraphs (b) and/or (c) above.

(e) Until this contract is fully funded, the requirements of the clause at FAR 52.232–22, Limitation of Funds, shall govern. Once the contract is fully funded, the requirements of the clause at FAR 52.232-20, Limitation of Cost, govern.

(End of clause) https://www.acquisition.gov/far/current/html/52_232.html#wp1152962� https://www.acquisition.gov/far/current/html/52_232.html#wp1152929�

Section C - Description/Specification/Work Statement

Performance Work Statement A. Introduction/Background.

NIOSH was established under the provisions of the Occupational Safety and Health Act of 1970 (PL 91-596).

NIOSH has the mandated responsibility for performing research into health and safety hazards found in the workplace. In carrying out this mission, field and research groups within NIOSH are in need of analytical laboratory support. Projects in need of this support are NIOSH Health Hazard Evaluations (HHEs), Industry Wide Studies (IWS), Engineering Control Technology surveys, internal research projects and other related activities.

These investigative projects will be conducted by the Division of Surveillance, Hazard Evaluations, and Field Studies (DSHEFS), Division of Respiratory Disease Studies (DRDS), Division of Safety Research (DSR), Health Effects Laboratory Division (HELD), Office of Mine Safety and Health Research , and Division of Applied Research and Technology (DART). The purpose of this contract is to provide comprehensive analytical laboratory services in support of NIOSH programs.

Definitions.

Quality Assurance (QA) Manual of the Division of Applied Research and Technology, National Institute for Occupational Safety and Health. The purpose of this quality assurance manual is to ensure the integrity of laboratory data reported to the client. The quality assurance program covers all areas of the process, from initial planning to the final review and issuance of reports to our clients.

DART Laboratory Services Standard Operating Procedures (SOPs). The purpose for these SOPs is to provide clear and concise procedures for conducting industrial hygiene chemistry laboratory operations.

Coordination. Coordination means the process of review and assignment of requests for chemical analyses. During this process, a project or sequence number is assigned to the project.

Sequence Number. A sequence number is a unique NIOSH project number for a given research project or segment of a project. A sequence may contain one or more sample sets (sub sequence).

Sample Set. A sample set is a group of samples from a particular project, using the same sampling medium or having the same sample matrix, all having the same analysis request. There may be more than one analyte per sample set.

Subsequence Number: A unique NIOSH number that allows a sequence to be divided into separate sets. These separations may be due to different analytical methods, simultaneous submission of large or numerous groups of samples requiring the same analytical method, or sample submission exceeding the contracted number of samples.

Each subsequence will require a distinct analytical report with its corresponding QA requirements.

Sample Turnaround Time: Turnaround time for a set of samples is defined as the number of calendar days (including holidays) it takes to completely process a set of samples starting the day after the sample set is received in the laboratory and ending the day the analytical report is sent from the laboratory. Sample turnaround time may be suspended by a hold status. Average sample turnaround time is calculated by multiplying the number of samples in a set by the days required to complete the analyses summing over all completed sets in the award fee time period and dividing by the total number of samples analyzed in the time period.

Sample Residence Time: Residence time is defined as the number of calendar days a sample set resides in the laboratory starting with the day after receipt and ending the day the analytical report is sent. Residence time is not suspended by a hold status. Also, residence time is not considered for award fee purposes but is used as a measure of problem areas.

Hold Status: Sample sets that cannot be processed because of one or more problems; e.g. no sample submission paperwork, inadequate specifications for analysis, etc., are subject to a hold status at the discretion of the Contracting Officer’s Technical Representative (COTR) with input from the Contractor. Hold status may also be granted when there are large numbers of samples requiring the same analytical instrumentation. Hold status suspends sample turnaround time but not residence time.

User Check: Blind sample sets prepared and submitted for analysis to evaluate the recovery, precision, and accuracy of a newly developed method or method to be transferred to contract laboratory from NIOSH. This process will also used to evaluate laboratory performance.

B. References.

American Industrial Hygiene Association (AIHA) Laboratory Accreditation Programs, LLC.

[http://www.aihaaccreditedlabs.org/PolicyModules/Pages/default.aspx]

Division of Applied Research and Technology (DART) Laboratory Services Standard Operating Procedures (see Attachment in Section J).

DART Quality Assurance Manual (see Attachment in Section J).

NIOSH [1995]. Guidelines for Air Sampling and Analytical Method Development and Evaluation. By Kennedy ER, Fischbach TJ, Song R, Eller PM, Shulman SA. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 95–117. [http://www.cdc.gov/niosh/docs/95-117/pdfs/95-117.pdf]

NIOSH [1994]. NIOSH Manual of Analytical Methods (NMAM™). 4th ed. Eller PM, Cassinelli ME, O’Connor PF, Schlecht PC, eds. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 94−113; 1st Supplement, Publication No. 96−135; 2nd Supplement, Publication No. 98−119; 3rd Supplement, Publication No.

2003−154. [http://www.cdc.gov/niosh/nmam/]

NIOSH. NIOSH Manual of Analytical Methods (NMAM™). 5th ed., O’Connor PF, Schlecht PC, eds. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Electronic only. [http://www.cdc.gov/niosh/docs/2003-154/new.html]

NIOSH Cincinnati Operations – Health and Safety Manual http://cinoams.cdc.gov/oamssite/HealthandSafetyManual.html

HHS 508 Policy http://www.hhs.gov/od/508policy/index.html

C. Scope and Requirements.

Independently, and not as an agent of the Government, the Contractor shall furnish the necessary facility, personnel, laboratory instrumentation, and all items and supplies necessary and shall exert its best effort to provide comprehensive analytical laboratory services in support of NIOSH industrial hygiene and research programs.

Specifically, the Contractor shall:

1. Sample Type and Quantity:

Perform analyses on approximately 800 samples per month. These samples will usually require multi-component analyses, typically two [2] to six [6] analytes/sample ( analytical requests have averaged about three [3] analyses per sample). The Contractor is expected to have the capability to handle sample loads of 150% of those expected per http://www.aihaaccreditedlabs.org/PolicyModules/Pages/default.aspx� http://www.cdc.gov/niosh/docs/95-117/pdfs/95-117.pdf� http://www.cdc.gov/niosh/nmam/� http://www.cdc.gov/niosh/docs/2003-154/new.html� http://cinoams.cdc.gov/oamssite/HealthandSafetyManual.html� http://www.hhs.gov/od/508policy/index.html� month (1200), without placing the samples in a hold status. When the sample load exceeds 150% of the projected sample load, or when less than 150% but deemed by the COTR to be of a particularly difficult nature, the COTR, at her or his discretion, may assign a hold status. These projected totals include field samples plus duplicate analyses, and internally generated quality control samples. Samples will include industrial hygiene samples, such as filters, impinger solutions, solid sorbent tubes (analyses required for both front and backup sections); environmental samples, such as water, waste water or soils, wipe samples, air samples, bulk mixtures for pesticides, samples requiring dust or fiber counting, and bulk process materials Measurements on the above samples will require both quantitative and qualitative analyses according to the methods contained in the NIOSH Manual of Analytical Methods (NMAM), 4th and 5th editions, and other established sources. In any instance where the analytical feasibility of requested measurements may be in question, a decision as to whether or not the measurement will be attempted will be made jointly by the Contractor's Project Director, NIOSH's CASC COTR, the Laboratory Coordinator, and the sample submitter.

2. Perform routine analyses on NIOSH samples:

The Contractor’s primary references for analytical methods will be the NMAM, (4th ed. and 5th Ed.). Secondary sources include the Occupational Safety and Health Administration analytical methods, AIHA analytical guides, American Society of Testing and Materials (ASTM), International Organization for Standardization (ISO), Environmental Protection Agency manuals and methods, industrial hygiene technical literature, and finally, internally developed Contractor methods. NIOSH will supply new validated NMAM methods to the Contractor as they become available, and the new draft NMAM methods and Chemical Exposure and Monitoring Branch (CEMB) procedures when needed. The Contractor will also follow DART Standard Operating Procedures unless otherwise directed by the COTR. Sample analyses following protocols that involve standard laboratory techniques shall be considered routine for the purposes of calculating turnaround time, even if these protocols are not taken from published methods.

3. Specialty Measurements.

The Contractor will be expected to evaluate properly and have supporting QA for minor modifications from an established method such as applying an air method for wipe analysis of a given chemical. Also, when unexpected problems occur with an analytical method, the Contractor will validate modifications, such as variations in digestion or extraction techniques, use of alternate chromatography columns to achieve better separation and elimination of interferences, and necessary measures to optimize analytical techniques in the presence of interferents. Procedures initially defined as “specialty measurements” shall be considered routine for the purposes of calculating turnaround time if this procedure has been undertaken repeatedly and has effectively become routine.

On some occasions, the Contractor will be requested to perform a "User Check" of a newly developed NIOSH analytical method. This check will be accomplished in two parts: (1) a paper review of the method in which the Contractor will critique the method for its applicability for use in an industrial hygiene laboratory and (2) an analysis of an audit set of QA samples provided by DART QA Manager. During the User Check, the Contractor's QA officer will develop appropriate QA procedures to be followed upon the implementation of the method in the Contractor's laboratory (DART SOP-540).

The User Check mechanism will also be used in situations where the Contractor is not familiar with the method of choice. This will be known as a Method Check. In such a situation, a field sample set will be placed on hold until the results are acceptable to both the COTR and Q. A. Manager. (DART SOP-540).

4. Assigned Method Development Projects:

The Contractor must be prepared to support projects not specifically described above, such as methods development for analytes not having established analytical methods. When such a project is assigned to the Contractor, the COTR may appoint a senior researcher in the Branch to serve as a Methods Development Manager (MDM) and if assigned, the COTR will advise the contractor in writing, which NIOSH Senior Researcher will be appointed MDM for a specific project. The contractor shall: (a) coordinate with the MDM and COTR such that the project continues in a timely manner, (b) from time to time conduct literature reviews and develop the project protocol, and (c) have direct communication with the MDM by both email and telephone. The contractor shall work closely with the MDM and COTR to ensure timely progress of the work and that all tasks requested meet the criteria of the contract. These special projects can be expected to be approximately 30% of the total contract effort. The Contractor shall also prepare special reports or review reports on any work performed under this contract (DART SOP 320, 323).

5. Other Analysis.

If the Contractor subcontracts analyses not available because of a lack of in-house instrumentation or expertise, performs analyses using in-house capabilities not specifically noted in the contract, and initiates new analytical techniques at the government’s expense, the Contractor will work with the DART QA Manager and CASC COTR to ensure these analyses conform to DART’s policies and standards. NIOSH reserves the right to approve or disapprove of the Contractor’s selected Subcontractor for analytical work on this contract.

6. Quality Control:

The DART QA Manager shall enforce all aspects of the Contractor's quality control manual including modifications made by NIOSH. This manual (with modifications) is hereby incorporated into and made a part of this contract and henceforth, referred to as the contract quality control manual. In the event of a conflict between the Contractor's quality control manual and any other terms or conditions of this contract, the terms or conditions stated in this contract will take precedence.

The Contractor will be required to internally generate and analyze quality control samples at the target of 10% (within a range of 8-12%) of field samples to be distributed over all sample sets (multiple QA’s over multiple subsequences). The Contractor will also be required to perform replicate analyses of field samples at the rate of 5% of the total field samples received by the Contractor.

The Contractor must also provide evidence of having analytical systems in control including:

Confirmation of continuing AIHA accreditation: Copies of AIHA Proficiency Analytical Testing (PAT) program results must be forwarded to the DART QA Manager. If an outlier is experienced, sample analysis using the deficient analytical technique will be suspended until a complete investigation and report of corrective actions are approved by the DART QA Manager.

Confirmation of proficiency for analytical techniques: Copies of results for additional proficiency testing (such as Workplace Analytical Scheme for Proficiency or internal proficiency testing) must be forwarded to the DART QA Manager. If the laboratory receives a low rating for 2 consecutive rounds, sample analysis using the deficient analytical technique will be suspended until a complete investigation and report of corrective actions are approved by the DART QA Manager.

Quality Control Report: A quality control report must accompany each analytical report. The form of this report will be determined by the DART QA Manager.

Quality Control Charts: Quality control charts must be maintained of all blind sample recovery for analytes processed (DART SOP-506).

Maintenance Documentation: Maintenance of instruments and calibration system must be documented (DART

SOP-502).

Initiate Problem/Corrective Action Reports: Reports must log initial problem and corrective action taken (DART

SOP-510).

Analyst training records: Maintenance of analyst training records must be documented (DART SOP 550).

7. Sampling Equipment and Supplies:

The Contractor will prepare and dispense to NIOSH personnel field sampling media and supplies, such as impinger solutions, pre-weighed or pre-treated filters in cassettes and other reagents and absorbing media that may be required for proper sample collection (DART SOP-103).

Approximately 1,000 pre-weighed or preconditioned filters loaded in various cassettes will be required per year under this contract. Instructions for the preparation of sample media are contained in NMAM. When no method is available, the COTR will provide instructions as necessary.

8. Sample Tracking:

The Contractor will document procedures of sample receipt, logging, and handling. The Contractor will have and maintain a computerized logging system (Laboratory Information System (LIMS) for managing samples submitted to the laboratory consistent with the guidelines for the AIHA Laboratory Accreditation Policies.

Upon issuance of the contract, the Contractor will be given information on the data format required for the NIOSH LIMS. The Contractor will be responsible for maintaining a competent computer support staff to implement and provide support for the daily electronic transfer of files between the NIOSH LIMS and the Contractor’s LIMS.

(Section 6, DART QA Manual).

From time to time, additional data formats or changes in the data format may be required due to changes in the NIOSH LIMS and report formatting. The contractor shall be responsible for making changes in the data format as requested by NIOSH.

9. Sample Storage:

The contractor must maintain adequate and safe storage areas for samples and maintain a proper sample log in procedure. Samples are to be logged and processed upon receipt at the laboratory. Storage of bulk samples, inorganic digests, and chemically stable samples will be held for a minimum period of 5 weeks following the analysis unless otherwise stated by the CASC PO. Organic extracts and desorption solutions will be held for a minimum of two weeks following analysis unless otherwise stated by the CASC PO. The contract laboratory will be responsible for proper and safe disposal of all samples (DART SOP-207).

10. Sample Turnaround Time:

The Contractor will be expected to report the results of each sample set within an average sample turnaround time of 20 calendar days. The official sample turnaround time will be determined from the NIOSH LIMS. If there is a disagreement between the time calculated from the LIMS and the Contractor's calculation, the LIMS value will take precedence. It is also expected that a large majority of the samples will be reported out with a residence time of less than 30 calendar days.

Situations in a research project may arise that are designated emergencies or that would severely hamper progress if the results of an analysis were not received in a timely manner. Upon NIOSH designating the samples as priority, these analyses will proceed as quickly as possible while maintaining adequate quality control. Hold codes may be issued by the CASC PO to adjust the turnaround time when deemed necessary or if sample volume exceeds the contractor’s maximum number of samples. (DART SOP-500)

11. Communication.

Communication between the COTR and the Contractor is necessary to allow the contract to proceed. The contractor is expected to use electronic mail, telephone, and the Internet for day to day contract information exchanges.

Additionally, the Contractor will make available key members of the staff (Contract Project Officer, Contract QA Manager, Contract analysts) to review and clarify questions arising after sample analysis, provide input into sample analysis strategy, and review written material.

12. Sample Set Cost Accounting:

For each sample set (Subsequence) the contractor will send by email an estimate of the cost for the analysis to the CASC COTR and also include this amount in the data transmitted to the NIOSH LIMS. It is emphasized that this is an estimate and not the exact cost. After completion of the sample set, the contractor shall submit the final actual cost of the sample set into the NIOSH LIMS.

The contractor shall also provide monthly reports of cost information. The costs shall be broken out by sample set, project, and NIOSH Division. Running total costs by Fiscal Year shall also be provided.

13. Section 508 Compliance.

In 1998, Congress amended the Rehabilitation Act of 1973 to require Federal agencies to make their electronic and information technology (EIT) accessible to people with disabilities. The Contractor will work with the DART 508 Compliance Officer to fulfill these requirements and follow all reporting requirements.

D. Deliverables.

NIOSH is committed to becoming Section 508 compliant. Reporting formats may change as the most efficient procedures evolve.

1. Reports of Chemical Analysis:

Laboratory reports will be due upon completion of all work required on each sample set. The reports from each sample set (Subsequence) will be reported to the CASC COTR through the LIMS. The reports for each subsequence will consist of a client report, a QA report, and a data table. The current format for the client and QA report is a full text pdf that has been generated from a word processing application. A pdf that has been generated by scanning a hard copy of the report is not an acceptable format. The data table will be in tabular form with proper headings in a Standard Delimited ASCII format.

The client report will consist of a cover memo that documents the analytical chemistry methodology used in the analyses, a data table, and the sample submittal form. The data table should be in tabular form and the sample submittal form accompanying the field samples should be attached. The cover memo should summarize the method used with appropriate references and note complete details of all significant modifications to the method, including any information about particulars such as color of samples, problems with digestion or extraction, sample dilutions, or any deviation from normal that may benefit the client. In addition, the limit of detection (LOD) and limit of quantitation (LOQ), precision for the method, and range of the method should be included. If requested by the COTR, uncertainty measurements and values must be included in the report as required in ISO 17025. Definitions of these parameters are contained in the DART Quality Assurance Manual, which will be provided to the Contractor.

(DART SOP-305 and 508)

A QA report for each sample set consists of all the elements of the client report plus a QA report. The QA report will discuss the replicate analyses, internal QA analyses, and LOD/LOQ calculations. The format of this QA report will be specified by the DART Quality Assurance Manager. An example of a typical report is shown in Attachment V (DART QA Manual, Section 13). (DART SOP-504)

All laboratory reports and all associated information regarding work performed under this Contract must be held in the strictest confidence. All requests for information regarding reports or analyses performed under this Contract must come from the COTR. Request for information, data, and results of analyses by sources outside of NIOSH, particularly those that involve litigation will be directed to the COTR, who will then request clearance from the CDC legal counsel through the Contract Officer.

Notwithstanding the above, the Contractor, at the discretion of the COTR, may be requested to make direct contact with the NIOSH requester for verbal reports or information. The primary contact will be the appropriate field group laboratory coordinator.

2. Additional Reporting Requirements:

In addition to the analytical reports and those required by the General Provisions, the Contractor will prepare and submit the following reports to the Government.

a. Monthly Progress Report:

Reports summarizing the monthly contract activities are due 10 days after the end of each contract month. One (1) copy should be delivered via e-mail to the COTR and attached in Adobe Acrobat format. These reports will include:

(1) Summary of Services provided, including various numbers and types of analyses performed, numbers and type of field sampling media dispensed.

(2) Summary of quality control activities, including the rate of replicate analyses and internally generated or reference sample analysis and other relevant quality control activities.

(3) Laboratory Reports that report calculated turnaround time on a monthly and cumulative basis over the fee evaluation period and over the current contract year.

(4) Average Residence Reports that give time of samples in calendar days on a monthly and cumulative basis over the fee evaluation period and over the current contract year.

(5) Major Accomplishment Summary that describes the period. Sample and analysis totals, average sample turnaround time, residence time, and reported sets should be included.

(6) Problem Areas and Recommendations for solution of problems identified during the report period. In the case of problems, brief but concise narratives must be provided that state the nature of the problem, attempts by the Contractor to remedy the situation, and suggestions for resolving the problem.

(7) Summary of Activities planned for the following period.

(8) Special Items of Interest and Activities in the laboratory, including equipment purchases or service and personnel activities and changes.

(9) Funds Projected and Expended presented in graphical and tabular fashion. The costs shall also be provided by sample set, project, and NIOSH Division. Cumulative running total costs by Fiscal Year shall also be provided by project, NIOSH Division, and total cost.

(10) Direct Labor Hours Projected and Expended presented in graphical and tabular fashion.

(11) Sample Set Disposition showing a graphical and tabular presentation of the number of sets canceled, placed on hold, and never placed on hold.

b. Quality Assurance 6-Months Report.

Reports summarizing the quality assurance activities for each 6-month contract period are due 30-days after the end of each 6-month contract period. One (1) copy should be sent to the DART Quality Assurance Manager and one (1) copy should be sent to the COTR via e-mail attached in Adobe Acrobat7 format. These reports shall include:

(1) Maintenance Documentation of the instruments and calibration program.

(2) Laboratory Performance Summary of Proficiency Analytical Testing (PAT) or any proficiency testing programs.

(3) Quality Control Program Report of any changes or problems in the analytical methodology.

c. Analytical Methods Developed Report

Reports summarizing the results for each completed method development are due 60-days after the efforts completion. One (1) copy should be sent to the DART NMAM Editor and one (1) copy should be sent to the COTR via e-mail in NMAM format. These reports shall include:

(1) Method in NMAM approved format.

(2) Back-up Data Report.

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

FAR SOURCE TITLE AND DATE

52.246-5 Inspection of Services - Cost-Reimbursement (Apr 1984)

52.242-15 (Alt 1)

Stop Work Order (Aug 1989) Alt 1 (Apr 1984)

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 COTR) at the destination of the articles, services or documentation.

(End of Clause)

Section F - Deliveries Or Performance F.1 Period of Performance (Jul 1999)

The period of performance shall be a base period of one (1) year , with four options for one (1) year each, and thirty-seven (37) options, at various quantities, for additional samples.

(End of Clause)

F.2 Deliverable(s) Schedule (Jul 1999)

The Contractor shall deliver, within the time frames specified below and in accordance with F.3.

Item # Description Quantity Delivery Date Deliver To

Chemical Analysis Reports Three (3)

On or before seven (7) days after completion of all work on each sample set.

Contracting Officer’s Technical

Representative (COTR)

Monthly Progress Reports Two (2)

On or before Ten (10) days after the end of each contract month.

COTR and Contracting Officer

(CO)

Quality Assurance 6- Months Report Two (2)

On or before Thirty (30) days after the end of each six

(6) month contract period.

COTR, DART Quality

Assurance Manager 4 Analytical Methods

Development Report Two(2) On or before Sixty (60) days after completion of the work COTR, NMAM Editor

(End of Clause)

F.3 Deliverable Documentation (Jul 1999 revised)

(a) Documentation

The following is a list of required documentation to be delivered to the Government as a part of contract performance.

(1) Chemical Analysis Report

(i) Quantity: Three (3) copies.

(ii) Due Date: Laboratory reports will be due on or before seven (7) days after completion of all work required on each sample set.

(2) Monthly Progress Report (combines content of a Monthly Technical Letter Report and Monthly Financial Letter Report into a single report)

(i) Quantity: Two (2) copies.

(ii) Due Date: On or before ten (10) days after the end of each month.

(3) Quality Assurance 6-Months Report.

(ii) Due Date: On or before thirty (30) days after the end of each six-month contract period.

(4) Analytical methods developed or substantially modified for use under this Contract.

(ii) Due Date: On or before sixty (60) days after completion of the work.

(b) Report Content

(1) Chemical Analysis Report

Three (3) reports will be sent electronically to the COTR. One (1) report will contain the cover memo, the data table, and the QA report in Adobe Acrobat format. One (1) report will contain the cover memo, the data table, without the QA report in Adobe Acrobat pdf format. One (1) copy will contain the data table in a Standard Delimited ASCII format.

Report must be 508 compliant. Formats may change as the most efficient procedures evolve.

The reports from each sample set (Subsequence) will be reported to the CASC COTR through the LIMS. The reports for each subsequence will consist of a client report, a QA report, and a data table. The current format for the client and QA report is a full text pdf that has been generated from a word processing application. A pdf that has been generated by scanning a hard copy of the report is not an acceptable format. The data table will be in tabular form with proper headings in a Standard Delimited ASCII format.

The client report will consist of a cover memo that documents the analytical chemistry methodology used in the analyses, a data table, and the sample submittal form. The data table should be in tabular form and the sample submittal form accompanying the field samples should be attached. The cover memo should summarize the method used with appropriate references and note complete details of all significant modifications to the method, including any information about particulars such as color of samples, problems with digestion or extraction, sample dilutions, or any deviation from normal that may benefit the client. In addition, the limit of detection (LOD) and limit of quantitation (LOQ), precision for the method, and range of the method should be included. If requested by the COTR, uncertainty measurements and values must be included in the report as required in ISO 17025. Definitions of these parameters are contained in the DART Quality Assurance Manual, which will be provided to the Contractor. (DART SOP-305 and 508)

A QA report for each sample set consists of all the elements of the client report plus a QA report. The QA report will discuss the replicate analyses, internal QA analyses, and LOD/LOQ calculations. The format of this QA report will be specified by the DART Quality Assurance Manager. An example of a typical report is shown in Attachment V (DART QA Manual, Section 13). (DART SOP-504)

All laboratory reports and all associated information regarding work performed under this Contract must be held in the strictest confidence. All requests from NIOSH investigators for information regarding reports or analyses performed under this Contract will be directed to the COTR. Request for information, data, and results of analyses by sources outside of NIOSH, particularly those that involve litigation will be directed to the COTR, who will then request clearance from the CDC legal counsel through the Contract Officer.

Notwithstanding the above, the Contractor, at the discretion of the COTR, may be requested to make direct contact with the NIOSH requester for verbal reports or information. The primary contact will be the appropriate field group laboratory coordinator.

(2) Monthly Progress Report

Two (2) copies will be delivered, one (1) via e-mail to the Contracting Office and one (1) via e-mail to the COTR by attachment in Adobe Acrobat format.

Report must be 508 compliant. Formats may change as the most efficient procedures evolve.

(i) Monthly Report, Technical Portion. The Contractor shall prepare and submit monthly technical progress reports in narrative form which shall contain technical results of the work accomplished during the reporting period. This report shall be in sufficient detail to disclose all work started and results achieved during the reporting period, an indication of any current problems which may impede performance, the proposed corrective action, and the work forecast for the next period. This document shall report progress and planning so as to correspond with the work schedule contained in the Bureau approved program plan.

It shall distinctively include:

• A Summary of Services

, including various numbers and types of analyses performed numbers and type of field sampling media dispensed.

• A Summary of Quality Control Activities

, including the rate of replicate analyses and internally generated or reference sample analysis and other relevant quality control activities.

• Laboratory Reports that report calculated turnaround time on a monthly and cumulative basis over the fee evaluation period and over the current contract year.

• Average Residence Reports that give time of samples in calendar days on a monthly and cumulative basis over the fee evaluation period and over the current contract year.

• A Major Accomplishment Summary that describes the period. Sample and analysis totals, average sample turnaround time, residence time, and reported sets should be included.

• Problem Areas and Recommendations for solution of problems identified during the report period. In the case of problems, brief but concise narratives must be provided that state the nature of the problem, attempts by the Contractor to remedy the situation, and suggestions for resolving the problem.

• A Summary of Activities planned for the following period.

• Sample Set Disposition showing a graphical and tabular presentation of the number of sets canceled, placed on hold, and never placed on hold.

(i) Monthly Business / Financial Portion. The Contractor shall prepare and submit monthly financial reports which will summarize in tabular form the expenditures for the…