Attachment D.12 - Sample Pack Evaluation Checklist Amended.pdf
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- Solicitation number
- 36C77625R0017
About this file
This document is a Custom Pack Sample Review Checklist for Solicitation 36C77625R0017, which provides a detailed evaluation criteria for submitted sample custom sterile surgical procedure packs. The checklist includes 16 specific requirements that must be met for each of the three required sample packs, with a pass/fail rating system. To receive an "Acceptable" Rating for Factor 2 – Technical (d) and be eligible for award, all three sample packs must pass every requirement.
Key evaluation criteria include: containing individual lot numbers, having comprehensive packing slips, being free of debris, using TAA-compliant components, meeting packaging specifications (such as rigid plastic trays, ETO sterilization indicators, sealed dust covers), and specific technical requirements for gowns and towels. Critical technical specifications cover aspects like latex-free materials, gown design (non-abrasive, non-toxic, allowing freedom of movement), and cloth towel flammability standards. The checklist is directly linked to specific sections of the Statement of Work (SOW), providing a structured method for evaluating the technical compliance of custom surgical procedure pack samples.
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Custom Pack Sample - Review Checklist (Amended) Solicitation 36C77625R0017
Custom Pack Sample Description:
Rating Evaluation for the submitted Sample Custom Packs Each submitted Sample Pack (3 required) will be rated using a Pass or Fail in accordance with the criteria shown below. ALL three (3) submitted Sample Packs must PASS these requirements in order to receive an “Acceptable” Rating for Factor 2 – Technical (d) to be eligible for award.
Custom Pack Requirements
Sample Pack contains individual Lot Number. (SOW 6.1) Pass □ Fail □
Sample pack contains a packing slip. (SOW 6.1) Pass □ Fail □
Packing slip includes: manufacturer, manufacturer item number, description of the component, quantity of component, Country of Origin (COO), and lot number. (SOW 6.1) Pass □ Fail □
Sample pack is free of debris and excessive particulates. (SOW 6.1.14) Pass □ Fail □
Sample Pack has correct components, type, and quantities as shown in the pack's Bill of Material (Attachment D.11 – Three Sample Packs – Bills of Material). Pass □ Fail □
Sample pack components are TAA compliant. (SOW 6.2.1.1) Pass □ Fail □
Sample pack components are removed from outer packaging unless otherwise required by the customer or the component manufacturer. (SOW 6.2.1.3) Pass □ Fail □
Sample pack uses rigid plastic or biodegradable trays. (SOW 6.2.1.4) Pass □ Fail □
Sample pack has Ethylene Oxide (ETO) tape/indicator or other indicator demonstrating that packs were sterilized, and the method used shall be affixed to outer wrap and tray where applicable. (SOW 6.2.1.4)
Pass □ Fail □
Sample pack provided in an approved packaging material with a plastic dust cover. (SOW 6.2.1.4) Pass □ Fail □
Sample pack has a sealed plastic dust cover with tamper evident seal and allows for ease of aseptic presentation. (SOW 6.2.1.4) Pass □ Fail □
Sample pack is latex free and is labeled "latex free" or clearly labeled on the outside covering if they contain latex products. All products containing latex must also be clearly labeled individually as containing latex. (SOW 6.2.1.5)
Pass □ Fail □
Sample pack gown(s) are non-abrasive, free of toxic ingredients, non-fast dyes, and noxious odors. Gown materials are non-glare and of a color that minimizes distortion from reflected light. (SOW 6.2.2.2 & 6.2.2.3)
Pass □ Fail □
Sample pack gown(s) allows for freedom of movement. (SOW 6.2.2.4) Pass □ Fail □
Sample pack gown(s) have stockinet/stockinette cuffs, raglan sleeves and welded or stitched seams. (SOW 6.2.2.5) Pass □ Fail □
Sample pack cloth towels are lint-free and meet or exceed the current requirements of the National Fire Protection Regulations for flammability in Part 1610 of the Code of Federal Regulations - Standard for the Flammability of Clothing Textiles. (SOW 6.2.3) Pass □ Fail □
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