RFP 75D301-21-R-71818 CACS 4-27-21.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 92

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-21-R-71818

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE

NO.

000HCCCK-2021-53326

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7) Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS) 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 one(1) 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 until 2:00p local time May 27, 2021

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 55

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

X C DESCRIPTION/SPECS./WORK STATEMENT 7 X J LIST OF ATTACHMENTS 62

X D PACKAGING AND MARKING 38 PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 39 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 40 K OTHER STATEMENTS OF OFFERORS 63

X G CONTRACT ADMINISTRATION DATA 45 L INSTRS., CONDS., AND NOTICES TO OFFERORS 70

X H SPECIAL CONTRACT REQUIREMENTS 52 M EVALUATION FACTORS FOR AWARD 87

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 25. PAYMENT WILL BE MADE BY CODE 434

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©

K

Section B - Supplies Or Services and Prices/Costs

Base Period:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS AWARD

FEE

0001 Comprehensive Analytical Chemistry Support (CACS) as per Performance Work Statement.

Period of Performance: August 1, 2021 - July 31, 2022 Custodial Account #: 00252

Base period additional Samples:

ITEM SUPPLIES / SERVICES ESTIMATED

COST

NTE AWARD

FEE

COST PLUS AWARD

FEE

0001-1 Additional samples as per CACS Performance Work Statement.

This Optional Line Item can be exercised more than once throughout the Period of Performance:

August 1, 2021 - July 31, 2022, up to a maximum of 13,525 samples.

Per Sample:

Est. Cost NTE AF CPAF

Option Yr 1 Items:

COST

NTE AWARD

FEE

COST PLUS AWARD

FEE

0002 CACS Services Comprehensive Analytical Chemistry Support (CACS) as per Performance Work Statement.

Period of Performance: August 1, 2022 - July 31, 2023

Option Yr 1 additional Samples:

COST

NTE AWARD

FEE

COST PLUS AWARD

FEE

0002-1 Additional samples as per CACS Performance Work Statement.

This Optional Line Item can be exercised more than once throughout the Period of Performance:

August 1, 2022 - July 31, 2023, up to a maximum of 13,525 samples.

Per Sample:

Option Yr 2 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, 2023 - July 31, 2024

Option Yr 2 additional Samples:

COST

NTE AWARD

FEE

COST PLUS AWARD

FEE

0003-1 Additional samples as per CACS Performance Work Statement.

This Optional Line Item can be exercised more than once throughout the Period of Performance:

August 1, 2023 - July 31, 2024, up to a maximum of 13,525 samples.

Per Sample:

Option Yr 3 Items:

COST

NTE AWARD

FEE

COST PLUS AWARD

FEE

0004 CACS Services - Comprehensive Analytical Chemistry Support (CACS) as per Performance Work Statement.

Period of Performance: August 1, 2024 - July 31, 2025

Option Yr 3 additional Samples:

COST

NTE AWARD

FEE

COST PLUS AWARD

FEE

0004-1 Additional samples as per CACS Performance Work Statement.

This Optional Line Item can be exercised more than once throughout the Period of Performance:

August 1, 2024 - July 31, 2025, up to a maximum of 13,525 samples.

Per Sample:

Option Yr 4 Items:

COST

NTE AWARD

FEE

COST PLUS AWARD

FEE

0005 CACS Services

Comprehensive Analytical Chemistry Support (CACS) as per Performance Work Statement.

Period of Performance: August 1, 2025 - July 31, 2026

Option Yr 4 additional Samples:

COST

NTE AWARD

FEE

COST PLUS AWARD

FEE

0005-1 Additional samples as per CACS Performance Work Statement.

This Optional Line Item can be exercised more than once throughout the Period of Performance:

August 1, 2025 - July 31, 2026, up to a maximum of 13,525 samples.

Per Sample:

B.1 Option for Increased Quantity – Separately Priced Line Items

The Government may require the delivery of the numbered line items 0001-1, 0002-1, 0003-1, 0004-1, and 0005-1, identified in the Schedule as optional items, up to a maximum of 13,525 samples, at the stated price per sample in the CLIN. This option may be exercised more than once, but the total quantity ordered hereunder shall not exceed the 13,525 samples in the line item. The period of performance for the option for increased quantity will be as indicated under the CLIN that is exercised. These optional line items are in addition to the surge capacity identified in the PWS.

B.2 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.3 Estimated Cost - Incrementally Funded Contract

(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

0001 August 1, 2021 Jan. 31, 2022 0001 Feb. 1, 2022 July 31, 2022 0002 August 1, 2022 Jan. 31, 2023 0002 Feb. 1, 2023 July 31, 2023 0003 August 1, 2023 Jan. 31, 2024 0003 Feb. 1, 2024 July 31, 2024 0004 August 1, 2024 Jan. 31, 2025 0004 Feb. 1, 2025 July 31, 2025 0005 August 1, 2025 Jan. 31, 2026 0005 Feb. 1, 2026 July 31, 2026 [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 “The services contemplated under this contract/order are considered to be an Other Function as defined by the Office of Federal Procurement Policy in OFPP letter 11-01 and by HHS in Acquisition Policy Memorandum 2012-01.”

Title: Comprehensive Analytical Chemistry Services Contract

(CASC)

Performance Work Statement

SECTION 1 – 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 and those associated with the mining industry (Federal Mine Safety and Health Act of 1977, PL 91- 173, amended PL 95-164). In carrying out this mission, field and research groups within NIOSH are in need of analytical laboratory support and method development. Projects in need of this support are NIOSH Health Hazard Evaluations (HHEs), industry-wide studies, engineering control technology surveys, internal research projects and other related activities. These investigative projects will be conducted by the Division of Field Studies and Engineering (DFSE), Respiratory Health Division (RHD), Division of Safety Research (DSR), Health Effects Laboratory Division (HELD), Western States Division (WSD), Division of Science Integration (DSI), and the mining program (PMRD and SMRD). The need for this contract, as in the past, is based on the fact that the number of requests for laboratory analyses and methods development exceeds the current internal capacity.

The proposed Contract is part of a continuing effort to provide laboratory analyses and method development for NIOSH studies and research. For the past 45 years, NIOSH has contracted laboratory analyses in order to better utilize in-house staff to solve the more difficult industrial hygiene sampling and analytical problems.

SUBSECTION A – DEFINITIONS

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.

HELD/CBMB 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.

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 Representative (COR) 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.

Laboratory Information Management System (LIMS): The LIMS is a software system used to manage analytical requests and reports. The LIMS is used to send analytical requests from NIOSH to the contract laboratory and is used to retrieve analytical reports from the contractor to NIOSH.

Method Development: Studies with an objective to develop an analytical method. Method development is not considered routine analysis.

Non-routine Analyses: Those analyses defined as special measurements or method development.

Quality Assurance (QA) Manual of the Chemical and Biological Monitoring Branch, Health Effects Laboratory Division, 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.

Routine Analyses: Sample analyses that follow established protocols involving standard laboratory techniques.

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.

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.

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 (subsequence).

Special Measurements: Sample analyses that deviate from or do not follow established methods. This may be modifying sample work up procedures to accommodate different matrices or an expanded list of analytes, for example. The majority of special measurement analyses shall become routine after successful completion of a reasonable number of samples under the non-routine conditions, typically 2-3 sample sets.

Subsequence Number: A unique NIOSH number that allows a sequence to be divided into separate sample 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.

User Check: The laboratory conducts a read-through review of the proposed method and provides a written report of this review. The lab must then demonstrate successful analysis of internally prepared calibration curve and analyte spikes. Following that, blind sample sets will be prepared and submitted for analysis to evaluate the recovery, precision, and accuracy of a newly developed method or method to be transferred to the contract laboratory from NIOSH.

SECTION 2 – PURPOSE

The purpose of this contract is to provide comprehensive analytical laboratory services in support of NIOSH’s mandated responsibility to conduct research and assess worker’s exposure to harmful conditions in the workplace. The contract will provide analyses of samples collected at field surveys and within laboratories to aid in exposure assessment and measuring the efficacy of engineering controls. This contract will be available for use by all Divisions in NIOSH, and projects currently in need of this support include NIOSH Health Hazard Evaluations (HHEs), industrywide studies, engineering control surveys, internal laboratory research projects and other related activities. This acquisition will provide NIOSH’s primary contract for analytical chemistry laboratory services.

It is proposed that the period of performance for this contract be a base period of one year with options for four additional one-year option periods. The place of performance is expected to be the contractor’s location.

Operating constraints could include cost (unplanned reductions in NIOSH budget) or capability/performance constraints (such as the inability of the contractor to find a suitable subcontractor when analysis cannot be accomplished by the primary contractor).

SECTION 3 – SCOPE OF WORK

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.

The Government and the Contractor will practice open communication regarding all sample analyses throughout the process. The Contractor shall perform analyses on samples as they are received unless otherwise directed by the Laboratory Coordinator. Samples will usually require the analysis of multiple analytes/sample. Samples will include industrial hygiene samples, such as filters, impinger solutions, and solid sorbent tubes; non-personal/area samples, such as wipe samples, area air samples, bulk mixtures or bulk process materials, samples requiring dust or fiber counting, and, to a lesser degree, environmental samples such as water, waste water or soils; limited biological samples such as freeze-dried tissue, human blood and urine; and established microbial techniques.

The Contractor shall perform routine analyses on NIOSH samples that will require both quantitative and qualitative analyses. The Contractor’s primary references for analytical methods will be the NIOSH Manual of Analytical Methods (NMAM), (4th ed. and 5th ed.). Secondary sources include the Occupational Safety and Health Administration analytical methods, AIHA analytical guides, ASTM International, International Organization for Standardization (ISO), Environmental Protection Agency manuals and methods, industrial hygiene technical literature, and finally, internally developed Contractor methods.

The Contractor will also perform method development and related activities. The Contractor must be prepared to support methods development projects for analytes not having established analytical methods. The Contractor will also be expected to evaluate properly and have supporting QA for minor modifications from an established method and validate modifications appropriately. On some occasions, the Contractor will be requested to perform a "User Check" of a newly developed NIOSH analytical method or a “Method Check” on unfamiliar procedures.

At the request of the COR and in coordination with the Contracting Officer, the Contractor will subcontract analyses not available because of a lack of in-house instrumentation or expertise, perform analyses using in-house capabilities not specifically noted in the contract, and initiate new analytical techniques at the government’s expense, as necessary and through a contract modification as necessary.

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 such as thermal desorption tubes that may be required for proper sample collection.

Quality control is a critical aspect of this contract. The Contractor is expected to comply with the Contractor's quality control manual including modifications made by NIOSH. The Contractor will be required to internally generate and analyze quality control samples as set forth in the requirements of this Contract. The Contractor must also provide evidence of having analytical systems in control including confirmation of continuing AIHA accreditation, confirmation of proficiency for analytical techniques, quality control reports, quality control charts, maintenance documentation, Problem/Corrective Action Reports and analyst training records.

The Contractor will document procedures of sample receipt, logging, and handling through use of a computerized logging system (Laboratory Information Management System (LIMS)) for managing samples submitted to the laboratory consistent with the guidelines for the AIHA Laboratory Accreditation Policies. The Contractor’s IT systems in which Federal contract information resides in or transits through must meet government data security requirements.

The primary deliverable is an analytical report, accompanied by an associated quality control report and data file for each sample set. The Contractor will be expected to report the results of each sample set within an average sample turnaround time of 20 calendar days. Periodic contract summary reports and Quality Control reports are also required.

Upon contract award, NIOSH and the awarded Contractor will hold an initial meeting (“kick-off meeting”) to conduct introductions and discuss contract expectations.

SPECIAL CONSIDERATIONS

HHSAR Provision, 352.239-73: Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

(End of provision) http://www.hhs.gov/web/508 http://hhs.gov/web/508 http://508.hhs.gov/ http://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

SECTION 4 – TASKS TO BE PERFORMED

1. Sample Type and Quantity:

Perform analyses on approximately 800 samples per month. These samples will usually require multi-component analyses, up to approximately thirty-six [36] analytes, with an average of about six [6] analyses per sample. The Contractor is expected to have the capability to handle sample loads of 150% of those expected per month (1200), without placing the samples in a hold status. This surge capacity may be needed during emergency situations such as during natural or man-made disasters or high priority public health issues. When the sample load exceeds 150% of the projected sample load, or when less than 150% but deemed by the COR to be of a particularly difficult nature, the COR, at their 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, and solid sorbent tubes; non-personal/area samples, such as wipe samples, area air samples, bulk mixtures or bulk process materials, samples requiring dust or fiber counting, and, to a lesser degree, environmental samples such as water, waste water or soils; limited biological samples such as freeze-dried tissue, human blood and urine; and established microbial techniques. 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 Comprehensive Analytical chemistry Services Contract (CASC) COR, 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, ASTM International, International Organization for Standardization (ISO), Environmental Protection Agency manuals and methods, industrial hygiene technical literature, and finally, internally developed Contractor methods. NIOSH will alert the Contractor of new validated NMAM methods as they become available and provide new draft NMAM methods and Chemical and Biological Monitoring Branch (CBMB) procedures when needed. The Contractor will also follow relevant HELD/CBMB Standard Operating Procedures unless the Contractor has acceptably equivalent SOPs or are otherwise directed by the COR.

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.

Routine and special measurement analyses can be expected to be approximately 70% of the total contract effort.

3. Perform Method Development:

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 analyte. 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. As determined by the COR, procedures initially defined as “method development” 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 three 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, (2) a successful analysis of internally prepared spikes and blind spikes with an appropriate calibration curve(s) and limit of detection, and (3) an analysis of an audit set of QA samples provided by CBMB 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 (HELD SOP CBM-00389).

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 COR and QA Manager. (HELD SOP CBM- 00389).

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 CBMB Branch Chief, after consultation with the COR, may appoint a subject matter expert (SME) in the Branch to serve as a Methods Development Manager (MDM). The Contractor shall:

(a) coordinate with the MDM and COR such that the project continues in a timely manner, (b) 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 COR to ensure timely progress of the work and that all tasks requested meet the criteria of the contract. Method development projects can be expected to be approximately 30% of the total contract effort. The Contractor shall also prepare special reports or review reports.

4. Other Analysis.

At the request of the COR and in coordination with the Contracting Officer, the Contractor will subcontract analyses not available because of a lack of in-house instrumentation or expertise, perform analyses using in-house capabilities not specifically noted in the contract, and initiate new analytical techniques at the government’s expense, as necessary and through a contract modification as necessary. The Contractor will work with the CBMB QA Manager and CASC PO to ensure these analyses conform to NIOSH’s policies and standards. Any subcontractor selected by the Contractor to perform analytical analyses for this contract must be approved by NIOSH.

5. Quality Control:

The CBMB QA Manager shall enforce all aspects of the Contractor's quality control manual including modifications made by NIOSH. This manual (with modifications) will be 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 QC’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, with a minimum of one [1] replicate per sample set.

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

Confirmation of continuing AIHA accreditation: Documentation of continued accreditation must be provided to the CBMB QA Coordinator. Documentation of noted deficiencies and changes in policies or procedures as a result of a site assessment may also be requested.

Confirmation of proficiency for analytical techniques: Copies of AIHA Proficiency Analytical Testing (PAT) program results must be forwarded to the CBMB QA Manager. If an outlier is experienced, a complete investigation and report of corrective actions must be reported and approved by the CBMB QA Manager.

Copies of results for additional proficiency testing (such as LGC Air Proficiency Testing or internal proficiency testing) must also be forwarded to the CBMB QA Manager. If the laboratory fails or 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 CBMB QA Manager and the laboratory passes the next round.

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

Quality Control Charts: Quality control charts must be maintained for quality control sample recovery for analytes processed (SOP CBM-00383).

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

CBM-00380).

Initiate Problem/Corrective Action Reports: Reports must log initial problem and corrective action taken. (See SOP CBM-00386 for additional information.)

Analyst training records: Maintenance of analyst training records must be documented. (See SOP CBM- 00390 for more information.)

6. 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, thermal desorption tubes, and other reagents and absorbing media that may be required for proper sample collection (SOP CBM-00362).

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 COR will provide instructions as necessary.

7. Sample Tracking:

The Contractor will document procedures of sample receipt, logging, and handling. The Contractor will have and maintain a computerized logging system 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 not be given access to NIOSH LIMS but will be given information on the data format required for exporting from the vendor’s logging system. 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 Contractor’s LIMS and the NIOSH LIMS. (Section 6, CBMB 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.

8. 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 samples will be held for a minimum period of 6 weeks following delivery of the report unless otherwise stated by the CASC PO. Organic extracts and desorption solutions will have their punctured septum replaced for storage. The contract laboratory will be responsible for proper and safe disposal of all samples (SOP CBM-00368).

9. 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 (SOP CBM- 00377).

10. Communication.

Communication between the COR and the Contractor is necessary to allow the contract to proceed. The contractor is expected to use email, telephone, and the internet for day-to-day contract information exchanges.

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

11. Sample Set Cost Accounting:

At the request of the CASC PO, the contractor will provide by email an estimate of the cost for the analysis. 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.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

The Government will furnish an atmosphere vapor generation system (AVGS). The Contractor must have available space and an adequate ventilation option (i.e. fume hood or equivalent) for AVGS exhaust. List of parts (serial numbers) provided below.

Darwin Environmental Chamber KB030-AA-DA-GD (9171834) Dell Computer Optiplex 7060 (HDWTDX2) Miller Nelson HCS-501 (10041) Gasmet IR DX4015 (132654) Cole Parmer Syringe Pump 200 (211239) Cole Parmer Syringe Pump 200 back up (210975) HOBO Onset Data Logger U14-002 (20191706) TSI Flow Meter 4043 (40431745002) Mesa Labs Air Pump Defender 510-L (160792) Mesa Labs Air Pump Defender 510-L back up (172164) Humidity / Temperature Sensor S-THB-M002 (20614789) Miller-Nelson SV-2000 (10032)

NIOSH may also have the following government furnished property available for use. However, it is preferred the Contractor supply these instruments:

Gas chromatograph (GC/FID) system (Agilent 8890) Thermal desorption-gas chromatography-mass spectrometry (TD-GC-MS) system (Markes TD- 100xr, Agilent

8890 GC/5977B MS)

Portable GC-MS (Inficon HAPSITE® ER) with thermal desorption attachment Closed Vessel Microwave Digestion System (CEM Mars 6) Micronizing Mill (McCrone XRD-Mill)

SECTION 6 – PERIOD OF PERFORMANCE

Base period of one (1) year with four (4), one (1) year option periods.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

Items Description Quantity or No.

of Copies Delivery Date Deliver To

Laboratory Report Report for each sample set will include a QA report (pdf), a client report (pdf) and a data file (.csv). These reports include method details, analytical data and quality control data.

One of each type per sample set (electronic)

On or before seven

(7) calendar days upon completion of the sample set analysis.

Laboratory Coordinator and

CBMB QA

Manager (through

LIMS)

Monthly Progress Report

Report (pdf) summarizing the monthly contract activities and cost- related information.

One copy (electronic)

On or before ten

(10) calendar days after the end of each contract month.

COR, CO

Quality Assurance Six Month Report

Report (pdf) summarizing the quality assurance activities for each 6- month contract period.

One copy (electronic)

On or before thirty

(30) calendar days after the end of each six-month contract period.

CBMB QA

Manager; CASC Project Officer

Analytical method development Report

Analytical method in NMAM format and Back Up Data Report; both in Microsoft Word

One copy (electronic)

On or before sixty

(60) days after completion of the method development

COR; NMAM

Editor

Award Fee Presentation

PowerPoint summarizing laboratory activities and metrics, quality control, and business operations.

One copy (electronic)

On or before forty-five (45) days after completion of the six-month performance period.

COR; CO

(a) Required Reports/Documentation and Content

(1) Laboratory Reports

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 PO through the LIMS. The reports for each subsequence will consist of a client report, a QA report, and a data file. 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 file 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 observational 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 Project Officer, uncertainty measurements and values must be included in the report as required in ISO 17025. Definitions of these parameters are contained in the CBMB Quality Assurance Manual, which will be provided to the Contractor.

(SOP CBM-00371)

A QA report for each sample set consists of all the elements of the client report plus a QA section. The QA report will discuss the replicate analyses, internal QA analyses, and LOD/LOQ calculations (SOP CBM- 00382). The format of this QA report will be specified by the CBMB Quality Assurance Manager. An example of a typical report as described in the CBMB QA Manual, Section 13.

The data file will be in tabular form with proper headings in a Standard Delimited ASCII format. It is required for all sample sets and must be properly populated for all sample sets with quantitative data.

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 Project Officer. Request for information, data, and results of analyses by sources outside of NIOSH, particularly those that involve litigation will be directed to the Project Officer, who will then request clearance from the CDC legal counsel through the Contract Officer.

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

(2) Monthly Progress Report:

Monthly progress reports summarizing the monthly contract activities are required. The format is full text pdf that has been generated from a word processing application. The reports will be provided to the CASC PO.

These reports will include:

(i) Technical Information

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

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

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

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

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

(f) 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.

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

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

(ii) Business/Financial Information

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

(b) 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.

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

(3) Quality Assurance 6-Month Report.

Reports summarizing the quality assurance activities for each 6-month contract period are required. The format is full text pdf that has been generated from a word processing application. These reports shall include:

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

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

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

(d) Select Control Charts

(4) Analytical methods developed or substantially…