SOW Histology 23-250.pdf

STATEMENT OF WORK

National Oceanic and Atmospheric Administration (NOAA)

NOAA FISHERIES

Panama City Lab

Histological Processing of Reproductive Tissue Samples

NF-FN7110-23-01614

I. Background/Overview:

NMFS SEFSC Panama City Lab is in need of a non-personal services contract to have fish reproductive tissue samples processed on glass slides with stained tissue sections for histological review. The data obtained through reproductive histology slide readings aid stock assessors in ensuring the sustainability of fish populations. The primary stain that would be needed is hematoxylin and eosin (H&E). However, there may also be a need to use either a Mallory’s Trichrome stain or periodic acid-Schiff’s hematoxylin with metanil yellow counterstain for some species. Needs will vary by species due to reproductive strategy variations (i.e. hermaphrodites). These stained slides will be used to microscopically determine reproductive status and conditions of fish specimens to meet stock assessment needs.

The Panama City Lab is additionally performing some comparison studies, which may require specialty stains and/or fixatives. These include samples stored in ExcellPlus fixative, and testing of Mallory’s Trichrome stain and periodic acid-Schiff’s hematoxylin with metanil yellow counterstain. Vendor shall accept some shipments with specific guidelines provided on comparison needs.

An essential requirement for this contract is that the vendor shall accept pre-labeled slides that show the identification number and inventory barcode to meet Panama City Lab protocols.

Vendor shall also accept samples that have been stored long-term in neutrally buffered formalin.

Accommodations can be made to ship samples in 70% ethanol solution upon request by the vendor.

II. Scope of Work

The work shall be performed under a contract with firm-fixed-unit prices provided on a per-sample basis for the various types of analyses. The contractor shall provide support on multiple projects for all priced contract line item numbers (CLINS) as set forth in the award. The work is intended to support stock assessments, including those conducted by Southeast Data Analysis Review (SEDAR) on multiple fish species. Base year requirement is for a total of 1,000 slides.

Option years shall require a minimum of 1000 slides and a maximum of 2750 total slides per year.

III. Tasks

1.0 Light Microscopy sample processing

1.1 Routine tissue processing for light microscopy on glass slides with histological staining.

1.1.1 The vendor shall process reproductive tissue from fish species.

1.2 Shall embed tissue in either paraffin wax or non-electron microscopy (EM) plastics.

1.2.1 The vendor shall accept tissues in cassettes for embedding.

1.2.2 The vendor shall accept trimmed tissues for embedding.

1.2.3 The vendor shall trim fixed tissue to suitable size and orientation for embedding.

1.3 Shall conduct microtomy of the tissue (i.e., sectioning embedded blocks of tissue).

The vendor shall be able to produce routine tissue sections of 5 micrometers that are artifact free and be able to accommodate microtomy at other tissue thicknesses (0.5- 50 micrometers) as requested in the delivery order.

1.4 Shall conduct slide preparation, defined by placement of section onto specified type of glass slide (e.g., SuperFrost or SuperFrost Plus) or coated slides (e.g., poly-L lysine, Probe On, Plus Slides, etc.). Special slide requirements will be specified in the delivery order.

1.4.1 The vendor shall offer slide preparations that contain one section per block of any particular collection of tissue blocks (e.g., a given case) to assist pathology review by allowing easy comparison across samples. This will be specified in the Delivery Order.

1.4.2 The vendor shall offer slide preparations that place up to 5 sections cut from a given block on one slide. This will be specified in the delivery order.

1.5 Shall conduct standard histological staining procedures of tissue sections mounted on glass slides with hematoxylin and eosin (H&E). In addition to routine sample preparation, H&E sections shall also be prepared as a quality control measure for each sample to determine the quality of the fixation and processing of a given sample.

The vendor shall produce H&E sections with even staining, all cytoplasmic and nuclear structures visible within the limitations of light microscopy and no torn or wrinkled sections from both paraffin and plastic embedded tissues, where indicated.

1.6 The vendor shall provide cover slipping of each stained section with a glass coverslip.

1.7 The vendor shall provide a unique identification label for each slide which is clearly visible, readable, and permanent.

1.7.1 Pre-labeled (e.g. barcoded) slides may be provided, and if so, vendor shall maintain standards to ensure correct sample assignment. In the case of pre-labeled slides, matching labels (barcodes) will be present on tissue cassettes.

2.0 Special histological stains

2.1 For established special stains, the vendor shall use industry-standard protocols for the use of special stains with appropriate adaptations for the particular taxa of marine organism being analyzed.

2.2 The vendor shall provide positive control slides as requested. Pre-printed slides designated as control slides will be provided.

2.3 The vendor shall provide a wide variety of the traditional dye stains for comparison studies, including:

2.3.1 Schiff’s Mallory Trichrome

2.3.2 Periodic acid-Schiff stain with metanil yellow counterstain

3.0 Special fixative handling

3.1 Vendor shall handle fixatives other than formalin, including:

3.1.1 ExcellPlus

4.0 Adherence to established quality control standards

4.1 Vendor shall deliver standard sized (3” x 1”) glass histopathology slides with good to excellent staining of tissues using standard operating procedures for paraffin or non- EM plastic embedded tissue as determined by H&E stained quality control slides.

Good to excellent staining is determined by uniformity of staining on section, intensity of stain, and distinction of cellular features (i.e., nucleus, cytoplasm).

4.1.1 Delivery of unstained or specially stained glass slides shall be in accordance with specific thicknesses, slide types, and treatments outlined in the specific delivery order.

4.2 Vendor shall ensure that any batch of slides meets or exceeds success rate of 85% for staining and section integrity (i.e., devoid of tears, folds, knife marks).

4.2.1 Slides that are of poor quality (as determined by the Vendor or government POC) due to processing, embedding, staining, or coverslipping will be redone at no additional cost to the government.

4.2.2 Slides that are of poor quality (as determined by the Vendor or government POC) due to tissue quality or other factors relating to the condition of the specimen or handling prior to submission to the processing laboratory will be redone at an additional cost to the government.

5.0 Sample processing timeline

5.1 Vendor shall ensure that slide processing will be conducted in a manner that supports a 2-4 weeks turnaround time for traditional samples, based on number of cases or tissues received, with larger number of blocks necessitating a longer period for processing.

5.1.1 The duration for any specific sample will be determined in consultation with the contracting official (or their designee) and specified in the delivery order.

5.1.2 Turnaround time for new techniques or non-traditional tissues may be up to 3 months and duration determined by consultation with contracting official (or designee) and specified in the delivery order.

6.0 Sample return and shipping

6.1 Vendor shall return tissues and blocks to the government POC at the completion of the delivery order, unless the entire block of tissue has been exhausted and in such case the contracting officer shall be notified.

6.2 The vendor shall establish shipping procedures for return shipments.

6.2.1 The slides shall be packaged in such a way as to prevent breakage, insured and shipped by an express carrier (e.g., FedEx, Priority Mail, UPS).

IV. Period of Performance

The period of performance shall include one base period (12 month base starting upon date of award) and four (4) 12 month option periods.

V. Place of Performance

All work will be performed at the Contractor’s site. The Government will not furnish office space or equipment for Contractor staff.

VI. Deliverable Schedule

All glass slides and tissue blocks produced shall be delivered to the government’s designated scientific lead or POC in accordance with the instructions provided in each delivery.

All Deliverables will be delivered to Project Lead, NMFS Panama City Lab, 3500 Delwood Beach Road, Panama City, FL 32408 upon completion.

Deliverable Description Quantity/Media Completion Due Date

1 Documentation of quality control evaluation measures and quality assurance for review

Electronic documents 7 days from contract award

2 Histopathology glass slides produced from samples provided in each shipment

Varies by shipment, not to exceed 500 each shipment

30 days from receipt of shipment

Government POC review of provided slides, including return of poor quality slides and associated cassettes for reprocessing (as applicable)

As applicable 30 days from receipt of return shipment

Reprocessing of samples as required by Government (as applicable)

Varies by shipment 30 days from receipt of shipment

3 Tissues and blocks remaining after slide preparation from each shipment

Varies by shipment, not to exceed 500 each shipment

30 days from receipt of shipment

VII. Government-Furnished Resources

The Government will not furnish any resources to the Contractor in support of this contract.

VIII. Security Requirements

This contract does not have any security requirements.

IX. Applicable Standards

Not applicable.

X. Special Requirements

a. Equipment

The vendor shall possess the equipment necessary to meet the requirements stated above.

At a minimum, the equipment must include a tissue processor, embedding station, rotary microtome, water bath for paraffin sections, and slide warmer. Reagents on site must include hematoxylin, eosin, PAS, trichrome mix and metanil yellow. Other general supplies include paraffin wax, coverslips, mounting medium, and replacement microtome blades.

b. Confidentiality and Data Privacy

This contract may require that services contractors have access to Privacy Information.

Service contractors are responsible for maintaining confidentiality of all subjects and materials and may be required to sign and adhere to a Non-disclosure Agreement (NDA).

c. Intellectual Property Rights

All deliverables are the property of the U.S. Government. All documents, analyses, files (digital or other), reports, notes and photos are to be used only by Contractor personnel assigned to this purchase order. Documents, files and other data are to be stored exclusively on Government owned equipment and at no point should be saved or archived on personal drives or devices. Copies are not to be disseminated to anyone outside of the NMFS or to any other contractor personnel without explicit release from the Government.

d. IT Security

The contractor will not require access to Federal Buildings, DOC Systems and does not include an IT component.

e. Section 508 Compliance

Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by P.L. 105-220 under Title IV (Rehabilitation Act Amendments of 1998), all Electronic and Information Technology (EIT) developed, procured, maintained and/or used under this contract shall be in compliance with the “Electronic and Information Technology Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR Part 1194. The complete text of Section 508 Standards can be accessed at http://www.access-board.gov/ or at http://www.section508.gov.

http://www.access-board.gov/ http://www.section508.gov/

XI. Inclusion of Clause 52.217-8

Inclusion of FAR clause 52.217-8, Option to Extend Services, is for use by the Government as outlined at FAR 37.111, Extension of Services. If an option is included, it will be exercised as needed at any time during the life of the contract using the rates applicable at the time of exercise. Evaluation of options will not obligate the Government to exercise the option(s).

XII. Required Knowledge and Experience:

The vendor shall have at least one staff member that possesses an American Society for Clinical Pathology (ASCP) Histotechnician (HT) or Histotechnologist (HTL) Certification, or at least one staff member that has successfully completed a National Accreditation Agency for Clinical Laboratory Sciences (NAACLS) accredited Histotechnician or Histotechnology program.

XIII. Inclusion of CAR 1352.237-75 Key personnel Key Personnel (APR 2010)

(a) The contractor shall assign to this contract the following key personnel:

At least one staff member that possesses an American Society for Clinical Pathology (ASCP) Histotechnician (HT) or Histotechnologist (HTL) Certification, or at least one staff member that has successfully completed a National Accreditation Agency for Clinical Laboratory Sciences (NAACLS) accredited Histotechnician or Histotechnology program

(b) The contractor shall obtain the consent of the Contracting Officer prior to making key personnel substitutions. Replacements for key personnel must possess qualifications equal to or exceeding the qualifications of the personnel being replaced, unless an exception is approved by the Contracting Officer.

(c) Requests for changes in key personnel shall be submitted to the Contracting Officer at least 15 working days prior to making any permanent substitutions. The request should contain a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. The Contracting Officer will notify the contractor within 10 working days after receipt of all required information of the decision on substitutions. The contract will be modified to reflect any approved changes.

(End of clause)

XIV. Evaluation Factors:

The Government will issue an order resulting from this request for quotation to the responsible offeror whose quotation results in the best value to the Government, considering both price and non-price factors. The following factors will be used to evaluate quotations:

Technical Evaluation Factors:

Factor 1--TECHNICAL APPROACH. The proposal will be evaluated on how the offeror intends to organize, staff and manage the contract and the means that will be used to accomplish the contract requirements. The degree to which the proposal demonstrates an understanding of the requirements will be evaluated, as well as the offeror's planned management of consultants and subcontractors, if applicable. Also, as part of the evaluation criteria for selection of vendors, the quality assurance standards for the vendor’s laboratory must be submitted with a proposal and will be evaluated.

Factor 2--EXPERIENCE. The offeror's background, experience, and qualifications will be assessed to determine the likelihood that that offeror can successfully perform the contract requirements and the degree of the risk of non-performance.

Factor 3--KEY PERSONNEL. The education, experience, and accomplishments of key personnel will be evaluated to determine the degree to which they possess the qualifications to perform their proposed duties under the contract.

Factor 4--PAST PERFORMANCE. The offeror's past performance on related contracts will be evaluated to determine, as appropriate, successful performance of contract requirements, quality and timeliness of delivery of goods and services, effective management of subcontractors, cost management, level of communication between the contracting parties, proactive management and customer satisfaction.

● Offeror shall provide at least three (3) past performance references. Provide name, address, phone number, and name of the project.

If a quoter has no relevant past performance, the quoter must affirmatively state that it possesses no relevant past performance history. Offerors who fail to either provide past performance information or affirmatively state that they have none, may be considered as non-compliant to the solicitation.

Factor 5 - COST/PRICE. The proposed prices/costs will be evaluated. The cost evaluation will determine whether the proposed costs are realistic, complete, and reasonable in relation to the solicitation requirements. Proposed costs must be entirely compatible with the technical approach.

XV. Project Lead:

Provided at time of award

XVI. Contractor's invoice.

Prior to October 1, 2023, the Contractor shall prepare and submit proper invoices to MB.Invoices@noaa.gov. However, beginning October 1, 2023 the Contractor must submit payment requests electronically through the U.S. Department of the Treasury's Invoice Processing Platform (the IPP) System in accordance with Clause 1330-52.232-72 NOAA Transition to the Invoice Processing Platform

Electronic Invoicing System (Feb 2023) and Attachment 2. If the invoice does not comply with these requirements, the designated billing office will return it within 7 business days after receipt with the reasons why it is not a proper invoice. Invoices can be submitted monthly in arrears or less frequent but shall be based on services provided and acceptance provided by the government. Any invoices submitted prior to this will be returned to the vendor as unacceptable.

The Government will take into account untimely notification when computing any interest penalty owed the Contractor. Terms are Net 30. Please do not seek payment information until the 30 days have passed from acceptance. NOAA does make every attempt to make prompt payments.

(i) Name and address of the Contractor.

(ii) Invoice date and invoice number. (The Contractor should date invoices as close as possible to the date of the mailing or transmission.)

(iii) Contract number or other authorization for supplies delivered or services performed (including order number and line item number).

(iv) Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed.

(v) Shipping and payment terms (e.g., shipment number and date of shipment, discount for prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on Government bills of lading

(vi) Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice.

(vii) Any other information or documentation required by the contract (e.g., evidence of shipment, Bill of Lading (BOL) invoice showing exact charges if freight exceeds $100. The government will only pay exact costs for freight when the charge exceeds $100, must be supported by airway or BOL invoice)

(viii) Upon completion of the services under this purchase order, the Vendor shall submit their final invoice. The final invoice must include the words “FINAL INVOICE.” Upon receipt of the final invoice and Government acceptance of the invoice and deliverables, the Government will process the final invoice for payment and commence closeout procedures.