As the Nation's principal conservation agency, the Department of the Interior has responsibility for most of our nationally owned public lands and natural resources. This includes protecting our fish and wildlife, preserving the environmental and cultural values of our nation's parks and historical places, and providing for the enjoyment of life through outdoor recreation.

The primary goal of the U.S. Fish and Wildlife Service (Service), a Bureau of the Department of the Interior, is the conservation and sound management of sport fishery and wildlife resources for the benefit of present and future generations of Americans. Attainment of this goal requires continual collection, analysis and synthesis of new information on which wise and timely management decisions can be based. As a part of this decision making process, the Service has the responsibility for determining the effects of environmental contaminants on organisms and their habitats. A significant part of this responsibility requires the determination of trace amounts of inorganic compounds in the tissues of fish, wildlife, invertebrates and plants, as well as in water, soil, and sediments.

Studies conducted by the Service cover a wide spectrum of contaminant problems and geographic areas. These include studies involving inorganic compounds derived from agriculture, mining, energy development, industrial, and other activities. Because of the diversity of studies and the unique requirements of individual studies, "batches" of samples submitted for analyses may vary considerably.

The Service is seeking analytical capacity to perform inorganic analyses (primarily metals), in soil or sediment, in animal or plant tissues, and in water. The Service is fully aware that there may be no technically qualified firms available which can accommodate the large annual estimated quantity of samples stated herein (especially when the seasonal nature of the sample submissions is considered). Moreover, it is possible that the number of samples may be significantly higher during some years because of year to year inconsistencies in demand and available funding. Therefore, the Service is prepared to award one or more contracts in order to assure that there will be sufficient analytical capability to meet the estimated annual need.

See Section H.6

Scope of Work

C.2 General Considerations

C.2.1 In accordance with the requirement listed herein, the Contractor shall be responsible for all aspects of this effort and shall furnish all necessary services, materials, labor, and supplies not otherwise indicated to be furnished by the Government.

C.2.2 The contractor must have available, all of the equipment required to perform the analyses as proposed. This will include Inductively Coupled Plasma Emission Spectrometers(ICP) and/or ICP Mass Spec, Atomic Absorption Spectrometers (including graphite furnace and cold vapor instrumentation), as well as the equipment needed to prepare the samples for analyses and the freezer capacity to store the samples before and after the analysis.

C.2.3 Due to the nature of the field sample collection season, most of the samples submitted, under this program, arrive at the laboratory over a very short period of time each year. The laboratory should not plan on even sample submissions over the course of the year. The Service has tended to issue 60% of its analytical delivery orders during the months of June, July and August. The samples tend to arrive within 30 to 50 days of the issuance of the delivery order. Submissions tend to drop to near zero during October, November, and December, and slowly pick up starting in late January. A large freezer capacity is needed to store the samples and offerors should be prepared to perform within the required time-frames.

C.2.4 Extracts/digests of samples submitted for analysis will be retained for one year after the analytical report is accepted. The contractor will be required to store up to one year, all un-analyzed portions of samples (up to 200g) submitted for analysis during the period of performance until disposition is approved by the Service COTR. Method of storage will be by freezing at or below -20 degrees Celsius. Disposition includes either disposal or return to the appropriate Regional Office or Research Center, F.O.B. origin, at the option of the COTR.

C.2.5 On occasion, the contractor will receive samples that will require additional analyses to be performed at another laboratory. In these cases the contractor is required to homogenize the samples and forward, at government expense, the appropriate subsample, to the other laboratories within three weeks after receiving them. Samples are "received" when all of the following criteria have been satisfied.

For a specific batch (catalog), all samples:

1. Even if shipped in different boxes, shall arrive at the laboratory intact (not broken) and properly labeled.
2. Shall have the sample identification number as given in the catalog listed on the delivery order; and
3. Shall match the work described in the delivery order.

C.2.6 Sample Types

Sample types to be submitted may include animal tissues (whole bodies or organs, fish, wildlife, and invertebrates, eggs), plants, sediment, and water. Additionally, unusual samples will at times be submitted

C.2.7 Sample Homogenization

The Contractor must be capable of homogenizing samples with the following wet weight ranges:

• animal or plant tissues - up to 5 kg
• soil or sediment - up to 5 kg

While most samples will weigh from 30 g to 1 Kg, on occasion samples may even exceed the ranges listed above. If problems occur in homogenizing such samples, advice is available from the COTR. Samples should be homogenized so that replicate analyses meet the criteria listed under Quality Control

C.2.8 Incorporation of Technical Proposal

The Contractor’s technical proposal will be incorporated herein by reference into any contract awarded as a result of this solicitation. In the event of a conflict between the provisions of the technical proposal and any other clause of this contract (including, but not limited to, the statement of work), the conflict shall be resolved in accordance with FAR 52.215-33, Order of Precedence. For this contract, the contractor’s technical proposal will be deemed to be subitem (f) (last in the order of precedence).

The detailed technical content of the proposal is an important factor in the selection of the Contractor for award of this contract. It is agreed therefore, that in the performance of this contract, the Contractor shall not deviate significantly from the approved methodologies without the prior approval of the COTR. If it is necessary for the Contractor to significantly deviate from the approved procedures in order to comply with the requirements of this contract, the contract shall be modified at the discretion of the Government at no increase in cost/price or extension of the delivery schedule.

C.3 Metals Scan (Price Schedules-Section I, CLIN 101A-D, 201A-D, 301A-D etc.)

The contractor is required to analyze the samples in a manner that meets the quality controls standards stated herein. Significant deviations from the contractor’s approved methods will require the prior approval of the COTR.

C.3.1 The METALS SCAN will include quantification of the following metals:

Arsenic, selenium, mercury, aluminum, boron, barium, beryllium, cadmium, chromium, copper, iron, magnesium, manganese, molybdenum, nickel, lead, strontium, vanadium, and zinc

C.3.2 Additional Required Determinations

For each non-water sample, the percent moisture will be determined (all non-water CLIN’s).

Upon request, the contractor is required to analyze soil/sediment samples for Grain size (reported as Percent clay, sand, and silt) and /or Total Organic Carbon. (CLIN’s 102A-B, 202A-B, 302A-B, etc.

C.3.3 Full Data Report

Upon request, the contractor will provide a report, on paper, that includes copies of all of the raw data. The report will include copies of every record related to the analysis that exists at the laboratory. Specifically any existing documents related to receipt of the samples, logs on sample storage and preparation, reports on instrument calibration, instrument printouts, calculation sheets, data summaries, internal QC documents, analyst notes or any other information about the sample in question. The request for a full data report can be made before or after the analysis. (CLIN’s 103, 203, 303, etc.

C.3.4 Rapid Turnaround

Upon request, contractor will provide analysis on a rapid turnaround basis. Rapid turnaround is requires the final report within 22 calendar days of receipt of the samples.

C.3.5 Mandatory Analyses (Price Schedules-Sect.II)

On occasion, additional elements, or a different combination of elements from the metals scan will be requested. The most commonly requested additional elements are calcium, cobalt, potassium, thallium, and uranium. The most commonly requested modified scan is for selenium or mercury alone. Also, it is possible that special detection limits will be needed. Therefore, it is required that the contractor provides the following analytical techniques: Graphite Furnace Atomic Absorption (CLINS 105A-E, 205A-E, 305A-E, etc.), Cold Vapor Mercury Atomic Absorption (CLINS 106A-E, 206A-E, 306A-E, etc.), Inductively Coupled Plasma Emission Spectroscopy (CLINS 107A-E, 207A-E, 307A-E, etc.), and ICP-Mass Spectrometry (CLINS 108A-E, 208A-E, 308A-E, etc.).

C.3.6 Non-Mandatory Analyses (Price Schedules- Section III) ( CLINS 109A, 209A, 309A, etc through…)

On occasion the Service has a need for other inorganic determinations such as phosphorous, nitrogen, nitrate, nitrite, chloride, cyanide, Acid Volatile Sulfides, organo-tins, methyl mercury or other techniques such as neutron activation analysis or Hydride Generation Atomic Absorption. It is not required that an offeror provide these services, but if any offeror desires to do so, they should provide method descriptions and prices. The non-mandatory section is not limited to the listed analytes and procedures. Offeror should add any inorganic analysis they wish to offer the Service.

C.4 Quality Control

C.4.1 Offerors must supply a copy of a quality assurance plan which describes the steps they take to assure a valid analysis. The operation of the laboratory must be in conformance with applicable portions of the Good Laboratory Practices regulations as stated in 40 CFR,part 160. Specifically:

SUBPART B Organization & Personnel

• 160.29 a,b,d,e
• 160.31 a,b,d,e,f
• 160.33 b,c,f
• 160.35 a,b.6

SUBPART C Facilities

• 160.41
• 160.51

SUBPART D Equipment

• 160.61
• 160.63 a,b,c

SUBPART E Testing Facilities Operation

• 160.81 a(SOPs must exist and deviations must be documented),b.3,b.5,b.11,c
• 160.83

SUBPART G Protocol for and Conduct of a Study

• 160.130 e

SUBPART J Records and Reports

• 160.185 a.6 (see reporting requirements)

Additionally, the plan must address the following topics and meet any minimums listed (for the purposes of this program, all samples are treated as one of four matrices, animal tissue, plant tissue, soil/sediment, or water):

C.4.2 Assuring a Valid Sample.

1. Sample validation upon receipt: condition, identification, and integrity.
2. Storage requirements: time and conditions before and after analysis.
3. Maintaining the Chain of Custody of the samples.
4. Actions required if problems arise in A, B, or C above must be clearly defined in Standard Operating Procedures. Especially if a storage system failure occurs

C.4.3 Assuring a Valid Measurement Process.

1. Only validated methods should be used. Validation includes, at a minimum:
   
   1. Calculation of the Method Detection Limit for each analyte in each matrix.
   2. Documentation that minimum acceptable precision has been achieved.
   3. Documentation that minimum acceptable accuracy has been achieved.
   4. Standard Operating Procedures must be up-to-date, and followed.
   5. A state of control must be demonstrated through control charts covering both precision and accuracy
      
2. Instrument Calibration.
   
   1. Standards must be "in-date" as defined in a Standard Operating Procedure.
   2. Standard curves must be run for each analyte.
   3. Standard curves must be established with at least three points, in addition to zero.
   4. Linearity must be established with a regression coefficient of Linearity must be established with a regression coefficient of >
   5. Mid-range calibration standards must be analyzed after every tenth sample and the last injection of any run must be a standard.
      
3. Samples must be quantified within the demonstrated linear range for the analytical run.
4. Limit of detection measurements must be made at least annually. This limit is considered the minimum limit of detection. It is recognized that on an infrequent basis, it may be necessary to adjust detection limits upward to account for interferences in the samples.
5. Control charts demonstrating a state of control in both precision and accuracy will be established and maintained for each matrix.

C.4.4 Assuring Precision.

Samples will be analyzed in duplicate at a rate of 5%, with at least one duplicate per matrix per analytical run. This requirement is waived when there is insufficient sample to perform a duplicate analysis

C.4.5 Assuring Accuracy.

1. At a rate of 5 %, with at least one spike per matrix per analytical run, a sample will be fortified with a known quantity of analyte and analyzed as part of the run. The spike level should be between 10 and 50 times the limit of detection, or the expected analyte concentration, whichever is higher. If there is insufficient sample to analyze a spike of the submitted samples, the laboratory can spike a similar material from another source.
2. At a rate of 5%, with at least one per analytical run, a procedural blank will be analyzed.
3. At a rate of 5%, with at least one per matrix per analytical run, a Standard Reference Material will be analyzed. All SRMs provided by the National Institute of Standards and Technology are acceptable. Prior approval of the COTR is required for use of other SRMs for use in this program.

C.4.6 Reports.

1. Electronic. The Fish and Wildlife Service has a data base for contaminant analyses. Section J details the specifications the data format and method of transfer that will be used. The contractor may be required to modify report format at no-additional costs, as further development of the system takes place.
2. Routine Paper. Paper reports may from time to time be necessary. These reports must include the following:
   
   1. A Description of the samples, their condition on receipt, and storage prior to analysis.
   2. A brief summary of the analytical procedures.
   3. Analytical results, reported as ppm dry weight, or as % in the case of moisture, TOC, or grain size determinations. Water sample are reported on a wet weight basis.
   4. Quality Assurance Report including:
      
      1. Results of procedural blank analyses.
      2. Results of duplicate analyses, including a computation of the average, and the relative percent difference.
      3. Results of spiked sample analyses, including the percent recovery, and the amount in the original sample.
      4. Estimate of the limit of detection, on a sample by sample basis.(This can be included in the results section).
      5. Discussion of any problems with the analyses.
3. Full Data Report
   
   1. All of the items under Routine Paper Report
   2. Copies of all of the Raw Data Used to Generate the Report

C.4.7 Limits of Detection

For the purposes of this contract, the Limit of Detection is the "Method Limit of Detection" as described by the Environmental Protection Agency in 40 CFR Part 136, Appendix B. In summary, the limit of detection is defined as the Student's t for 99% confidence times the standard deviation of seven replicate measurements of the same low level sample.

The following is a list of the analytes to be determined under the Metals Scan and the minimum acceptable limit of detection in tissues, soils/sediments, and water for that scan. The minimum acceptable limit assumes an adequate weight of sample was submitted for analysis.

Minimum Acceptable Method Detection Limits

Offerors should list the Limits of Detection routinely obtained in their laboratory for all elements for which analyses are routinely performed.

C.4.8 Precision and Accuracy Acceptance Criteria

The principal measure of accuracy used to assess the quality of data submitted will be the recovery of spiked analyte. The average recovery of analyte from spiked tissue and water should be between 80 and 120 %.

Additionally, when charted the spike recoveries must indicate that the procedure is in a state of control. Approximately 95 % of the points should be within 2 standard deviations of the mean. In computing the averages, only valid spikes will be used. In a valid spike, the amount of analyte added is at least as much as was present in the sample originally. It is understood that some analytes in some matrices, especially soil and sediment given the strong acid digestion, may not meet this criterion. In the proposal, the offerer should list those analytes and matrices for which the proposed method will not meet this requirement.

Separate charts are to be maintained for each matrix, for each analyte.

Standard Reference Materials also serve as a measure of the accuracy of the analysis. The assessment of the reference material analyses will based on the range in the certification as well as the precision of the analysis.

The principal measure of precision will be the average relative percent difference (RPD) between duplicates. It is understood that an acceptable RPD will change depending on the proximity of the analyte concentration to the limit of detection. Data reported under this contract will be evaluated according to the table below based on the average analyte concentration of the duplicate pair.

Additionally, when charted the RPDs must indicate that the procedure is in a state of control. Approximately 95 % of the points should be within 2 standard deviations of the mean.

The numbers above, result in an estimate of the 95 % confidence interval for the method of + 30 % for concentrations between 2-10 limits of detection, and + 15 % for concentrations > 10 limits of detection.

Separate charts are to be maintained for each matrix, for each analyte. Separate charts can be maintained for each concentration group, or alternatively a Range Ratio chart can be maintained.

• Average moisture RPDs should be less than 5 %.
• Average Total Organic Carbon RPDs should be less than 10 %.
• Average grain size RPDs should be less than 20%.

In computing Relative Percent difference, if the concentration of analyte is less than the limit of detection, take half the limit of detection for use in the calculation.

In addition to the quality control performed in conjunction with the actual analyses, the Service will on a periodic basis send proficiency check samples to the laboratory. These samples may or may not be labeled as such. The offeror will be paid for performing these analyses. Any group of samples analyzed by the offeror is subject to call back to the Service for reanalysis in one of its own laboratories. The service will, on occasion, request copies of all raw data for the purpose of conducting a data audit. It is a requirement that the offeror take whatever steps are necessary to correct any deficiencies uncovered.

Contractor shall provide copies of control charts to the COTR, on request.

C.4.9 Corrective Actions

It is required that whenever a quality control sample does not meet the standards listed above, that the procedures be reviewed by the contractor in an attempt to ascertain the cause of the error. If errors are found, the analyses should be repeated from the point of the error. If no errors can be found and the quality control failure appears to indicate that most of the scan is questionable, the analyses should be repeated. If it appears the quality control failure impacted a small number of the analytes within the scan, the Fish and Wildlife Service Quality Assurance Officer should be contacted for a decision. Any corrective action must be applied to all samples analyzed concurrently with the sample which initiated the action.

It can not be stated strongly enough that simply flagging quality control errors is NOT a sufficient action.

C.5 Access to Methods Used

Much of the data provided under the contract will be submitted as part of a scientific publication. It is required that successful offerors provide the Service with either a literature citation that completely describes the methods used or provides the Service with an electronic copy of the Procedures used which will published by the Service on the World Wide Web.