STATEMENT OF WORK REUSABLE STERILE GOWNS-STATEMENT OF WORK (SOW) A.1. Contractor shall make daily deliveries, Monday through Friday, excluding federal holidays, between the hours of 6:00 and 7:00 AM to the North Texas Veterans Healthcare System, at 4500 S. Lancaster Road Dallas, TX. and at 2201 SE Loop 820 Ft. Worth, TX. Delivery sites shall be identified after contract award and are subject to change. A.2. The Contracting Officer's Technical Representative from SPS shall call in replenishment order by 2:00 PM, one day before the garments are required at the medical center. A.3. Each gown shall be individually wrapped and contain a sterile huck radopaque towel. Gowns and towels shall be dark green. The towels shall be hucka-back type and made of 100% cotton. A.4. The contractor shall deliver clean gowns and towels to Radiology, SPS, FWOPC and the Cardiac Cath. Laboratory, as well as retrieve their soiled gowns and towels. Radiology, SPS, FWOPC, and the Cardiac Cath. Lab shall be invoiced separately. A.5. Service performed under this contract is a complete off-site reprocessing service. A.6. Service shall include/consist of: 1. Daily pick up and delivery 2. A dedicated reusable inventory specific to each medical center department 3. A validated decontamination, wash and drying process 4. Each gown shall be inspected after each washing on a light table to insure that there are no penetrations, rips, tears or frayed areas. 5. The Contractor shall have the capability to test, repair log and track each item. The tracking system must provide data regarding garment variability as required by JCAHO. 6. The service shall include packaging and sterilization capabilities. The configuration of packs shall meet the VA hospital's specifications. Each pack shall contain one gown folded in the standard walk-in donning, as well as one hand towel in the envelope wrap sealed in a peel-a part pouch. The sterilization cycle must be validated for all products. The sterilization efficacy must be validated by a daily spore test and mechanical evidence of sterilization for each load (i.e., strip chart, chemical indicator). The towel wrap material shall be of the same material and color as the liquid proof part of liquid proof gown. The products included in this service shall be: STERILE STAND GOWNS, STERILE LIQUID PROOF GOWNS AND BULK STERILE RADOPAQUE TOWELS. The BULK STERILE TOWELS shall not be mixed by color: they shall be packed separately (4 blue towels to a package and 4 white towels to a package). In addition, soiled item hamper bags shall be provided at no charge to the North Texas Veterans Healthcare System in quantities of 100 per case to be delivered on an "as needed basis". A.7. The facility used to process these products shall be registered with the FDA, operated in compliance with GMP and follow written Standard Operating Procedures (SOPs). A.8. BILLING: All services shall be billed on a per use basis and billed monthly in arrears. In addition, for the convenience of the Government, the billing shall breakdown the price for the four (4) services A.9. A retrieval system, as determined by the Government, shall be provided, at no charge to the North Texas Veterans Healthcare System, to aid in the segregation and removal of soiled products. The system shall include: (a.) Impervious hamper bags, which incorporate sealed seams and are clearly labeled as to its "Bio-hazardous" contents. The labeling shall include the word "Bio-Hazardous" as well as the "Bio-Hazardous" symbol. Impervious hamper bags shall be delivered upon request and at no cost to the North Texas Veterans Healthcare System. (b.) Hamper stands shall be provided for the above hamper bags in each operating room and any other area where reusable items are used. There shall be a total of thirty (34) hamper stands. These stands shall be repaired and replaced as needed. (c.) A fully contained, closed, lockable cart system shall be employed for the retrieval of hamper bags. The system shall be clearly labeled as to its "Bio-Hazardous" contents. A total of eight (9) lockable carts shall be delivered to the Dallas VA Medical Center for the Cardiac Lab, SPS, Radiology, FWOPC and the Operating Room(s). Sterile carts must be convertible to soiled carts and possess the capability to house full hamper loads. A.10. The service shall include the support of a Nurse Consultant to aid in product in-servicing and optimizing pack configuration. The Nurse Consultant shall be available to the hospital by telephone "as needed" basis to address and resolve problems. The response time after each call shall be one (1) hour. A.11 The North Texas Veterans Healthcare System shall make no capital investment. All products provided are the property of the contractor, who shall be responsible for their maintenance and replacement. A.12. The Contractor shall be responsible for identifying and returning hospital owned property inadvertently mixed with the Contractor's laundry. A.13. The Contractor shall monitor the barrier quality of the linen products to insure that products exhibiting unacceptable properties are culled. Also, in addition to tracking the number of uses of an individual product, physical testing of all products must take place at predetermined intervals to insure product acceptability. This in-process testing must be correlated with the actual barrier properties of the linen. A.14. Contractor must produce before contract award a written contingency plan that deals with equipment failure before contract award. B. PROCESSING SPECIFIC REQUIREMENTS B.1. A Quality Assurance System must be documented and in place to insure that the quality and barrier properties of products are not compromised. The system shall include: full inspection of each item between every use; light table inspection of linen items to detect holes; barrier testing of products at levels to insure barrier properties are acceptable; and testing and inspection results shall be available on demand by the North Texas Veterans Healthcare System. B.2. Implement a system to record the number of uses for each product that possess' essential barrier properties. At the minimum this will include gowns. B.3. The Contractor shall use "state of the art" equipment to wash, dry and sterilize all products. B.4. The trucks used to deliver the product(s) shall be compartmentalized to make certain that clean products are not mixed with soiled products. In addition, between deliveries/pick-ups the truck must under go decontamination. B.5. The facility shall be in compliance with Good Marketing Practices (GMP) as required by the FDA. In addition, facility operation procedures must be maintained and made available to the North Texas Veterans Healthcare System. B.6. The sterilization process shall be validated with a minimum SAL of 10-6. A biological indicator shall operate concurrently with each load. B.7. The processing facility shall repair, and test after repairing, all products requiring restoration. In addition, the contractor shall maintain a log of all products restored to use, which shall be made available to the North Texas Veterans Healthcare System. B.8. All processes used to wash, dry, decontaminate and sterilize products must be validated and recorded. B.9. The Contractor shall be responsible for all product repairs. C. PRODUCT SPECIFIC REQUIREMENTS C.1. Gowns: At a minimum, two levels of protection shall be required in the gown offering. a. Liquid Protection - This product shall be constructed with 100% (GORTEX) polyester micro-fiber material. In addition, the product shall contain a durable liquid repellant treatment that lasts the life of the product. Cotton and poly-cotton panels and components are unacceptable. b. General Gown Requirements - Both liquid and liquid proof shall be available. All styles of gowns in a full range of sizes from Medium to XX Large, X Large and Large shall be made available. Snaps, not ties, shall be used to close necks. Ties shall be used for waist closures. The micro-fiber used in the construction of the gown shall be antistatic. Gowns shall be folded for standard "walk in" donning and gowns shall be made available as singled put ups. C.2. Towels: The Contractor shall furnish sterile huckable Radiopaque towels approximately 14" X 24". (a) Fan-folded, four(4) per package in an envelope wrap and sealed in a peel-a-part pouch (b) The towels shall be colored green or blue with the option to order white. (c) Bulk towels fan folded (Non Sterile) (d) Bulk towels flat (Non Sterile) D. PERSONNEL D.1. The contractor shall use customary commercial practices for medical linen as established by the Joint Commission of Accreditation of Healthcare Organizations (JCAHO) and the National Association of Institutional Linen Management (NAILM). E. HOURS OF OPERATION E.1. (8:00 AM to 4:30 PM) E.2. Recognized Holidays: The following is a list of Federal Holidays that may affect the contractor's ability to access the Government facilities. New Years Day Martin Luther King's Birthday Presidents Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas Schedule a Base plus 3 year option Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 1079A-STD GOWN, MED W/PAPER TWL 105 Towel, Paper Surgical Hand 1 4 ply scrim, overall size: 17" x 20", folded size: 5" x 8.5", M fold, 1079A-STD GOWN, MED W/PAPER TWL 124 Wrap, Disposable 24x24 1 Sterilization wrap, Cellulose sheet reinforced with synthetic binders, 24" x 24" 1079A-STD GOWN, MED W/PAPER TWL 510 Pass Off Card, Open Slit 1 Die cut card with slits to hold gown tie, tag stock, printed, 6.75" x 2.5" 1079A-STD GOWN, MED W/PAPER TWL 800 Label, Sterile ID 1 Product ID label, tag stock, printed, sterile, 3.5" x 6" 1079A-STD GOWN, MED W/PAPER TWL 1015 Maintenance Cover 10 x 15 1 Plastic sealable bag, with easy open tear feature, 10" x 15" 1079A-STD GOWN, MED W/PAPER TWL 7002 GreenGown Standard Medium L2 1 Level 2 surgical gown, reusable, fabric: level - 99% polyester, 1% carbon - size: medium Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 1080B-STD GOWN, LG W/PAPER TWL 105 Towel, Paper Surgical Hand 1 4 ply scrim, overall size: 17" x 20", folded size: 5" x 8.5", M fold, 1080B-STD GOWN, LG W/PAPER TWL 124 Wrap, Disposable 24x24 1 Sterilization wrap, Cellulose sheet reinforced with synthetic binders, 24" x 24" 1080B-STD GOWN, LG W/PAPER TWL 510 Pass Off Card, Open Slit 1 Die cut card with slits to hold gown tie, tag stock, printed, 6.75" x 2.5" 1080B-STD GOWN, LG W/PAPER TWL 800 Label, Sterile ID 1 Product ID label, tag stock, printed, sterile, 3.5" x 6" 1080B-STD GOWN, LG W/PAPER TWL 1015 Maintenance Cover 10 x 15 1 Plastic sealable bag, with easy open tear feature, 10" x 15" 1080B-STD GOWN, LG W/PAPER TWL 7003 GreenGown Standard Large L2 1 Level 2 surgical gown, reusable, fabric: level - 99% polyester, 1% carbon - size: large Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 1081B-STD GOWN, XLG W/PAPER TWL 105 Towel, Paper Surgical Hand 1 Towel, 4 ply scrim, disposable, overall size: 17" x 20", folded size: 5" x 8.5", M fold, 1081B-STD GOWN, XLG W/PAPER TWL 124 Wrap, Disposable 24x24 1 Sterilization wrap, Cellulose sheet reinforced with synthetic binders, 24" x 24" 1081B-STD GOWN, XLG W/PAPER TWL 510 Pass Off Card, Open Slit 1 Die cut card with slits to hold gown tie, tag stock, printed, 6.75" x 2.5" 1081B-STD GOWN, XLG W/PAPER TWL 800 Label, Sterile ID 1 Product ID label, tag stock, printed, sterile, 3.5" x 6" 1081B-STD GOWN, XLG W/PAPER TWL 1015 Maintenance Cover 10 x 15 1 Plastic sealable bag, with easy open tear feature, 10" x 15" 1081B-STD GOWN, XLG W/PAPER TWL 7004 GreenGown Standard XL L2 1 Level 2 surgical gown, reusable, fabric: level - 99% polyester, 1% carbon - size: XL Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 1085-STD GOWN,XXLG W/PAPER TWL 105 Towel, Paper Surgical Hand 1 4 ply scrim, overall size: 17" x 20", folded size: 5" x 8.5", M fold, 1085-STD GOWN,XXLG W/PAPER TWL 124 Wrap, Disposable 24x24 1 Sterilization wrap, Cellulose sheet reinforced with synthetic binders, 24" x 24" 1085-STD GOWN,XXLG W/PAPER TWL 510 Pass Off Card, Open Slit 1 Die cut card with slits to hold gown tie, tag stock, printed, 6.75" x 2.5" 1085-STD GOWN,XXLG W/PAPER TWL 800 Label, Sterile ID 1 Product ID label, tag stock, printed, sterile, 3.5" x 6" 1085-STD GOWN,XXLG W/PAPER TWL 1015 Maintenance Cover 10 x 15 1 Plastic sealable bag, with easy open tear feature, 10" x 15" 1085-STD GOWN,XXLG W/PAPER TWL 7005 GreenGown Standard XXL L2 1 Level 2 surgical gown, reusable, fabric: level - 99% polyester, 1% carbon - size: XXL Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 122208-4 TOWEL PK DISP BLUE XR (FF) 124 Wrap, Disposable 24x24 1 Sterilization wrap, Cellulose sheet reinforced with synthetic binders, 24" x 24" 122208-4 TOWEL PK DISP BLUE XR (FF) 800 Label, Sterile ID 1 Product ID label, tag stock, printed, sterile, 3.5" x 6" 122208-4 TOWEL PK DISP BLUE XR (FF) 813 Maintenance Cover 8 x 13 1 Plastic sealable bag, with easy open tear feature, 8" x 13" 122208-4 TOWEL PK DISP BLUE XR (FF) 2055 TOWEL,DISP BLUE X-RAY DET 4 Towel, OR, disposable, 17" x 26" prewashed, blue, x-ray detectable Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 122210-25 NON-STERILE X-RAY TOWELS FF 810 Label, Non Sterile ID 1 Product ID label, tag stock, printed, non- sterile, 3.5" x 6" 122210-25 NON-STERILE X-RAY TOWELS FF 2055 TOWEL,DISP BLUE X-RAY DET 25 OR Towel, 100% cotton,disposable, blue, x-ray detectable, 17" x 26" 122210-25 NON-STERILE X-RAY TOWELS FF 1824NS Maintenance Cover 18 x 24 (NS) 1 Plastic sealable bag, with easy open tear feature, 16" x 22" Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 122549-4 TOWEL PK X-RAY DET. WHITE 117 Towel,White,X-Ray Detectable 4 OR towel,100% cotton, disposable, white, 24" x 17", 122549-4 TOWEL PK X-RAY DET. WHITE 124 Wrap, Disposable 24x24 1 Sterilization wrap, Cellulose sheet reinforced with synthetic binders, 24" x 24" 122549-4 TOWEL PK X-RAY DET. WHITE 800 Label, Sterile ID 1 Product ID label, tag stock, printed, sterile, 3.5" x 6" 122549-4 TOWEL PK X-RAY DET. WHITE 1622 Maintenance Cover 16 x 22 1 Plastic sealable bag, with easy open tear feature, 16" x 22" Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 622000-L4 PREMIUM GOWN MED W/PAP TWL 105 Towel, Paper Surgical Hand 1 4 ply scrim, overall size: 17" x 20", folded size: 5" x 8.5", M fold, 622000-L4 PREMIUM GOWN MED W/PAP TWL 124 Wrap, Disposable 24x24 1 Sterilization wrap, Cellulose sheet reinforced with synthetic binders, 24" x 24" 622000-L4 PREMIUM GOWN MED W/PAP TWL 1015 Maintenance Cover 10 x 15 1 Plastic sealable bag, with easy open tear feature, 10" x 15" 622000-L4 PREMIUM GOWN MED W/PAP TWL 7802 GreenGown Premium L4 M 1 Level 4 surgical gown, reusable, level 3 fabric in all non-critical zones, level 4 liquidproof fabric in all critical zones, polyester cuffs, includes pass-off card (#510) - size: medium Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 623000-L4 PREMIUM GOWN LG W/PAP TWL 105 Towel, Paper Surgical Hand 1 4 ply scrim, overall size: 17" x 20", folded size: 5" x 8.5", M fold, 623000-L4 PREMIUM GOWN LG W/PAP TWL 124 Wrap, Disposable 24x24 1 Sterilization wrap, Cellulose sheet reinforced with synthetic binders, 24" x 24" 623000-L4 PREMIUM GOWN LG W/PAP TWL 1015 Maintenance Cover 10 x 15 1 Plastic sealable bag, with easy open tear feature, 10" x 15" 623000-L4 PREMIUM GOWN LG W/PAP TWL 7803 GreenGown Premium L4 L 1 Level 4 surgical gown, reusable, level 3 fabric in all non-critical zones, level 4 liquidproof fabric in all critical zones, polyester cuffs, includes pass-off card (#510) - size: large Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 624000-L4 PREMIUM GOWN XLG W/PAP TWL 105 Towel, Paper Surgical Hand 1 4 ply scrim, overall size: 17" x 20", folded size: 5" x 8.5", M fold, 624000-L4 PREMIUM GOWN XLG W/PAP TWL 124 Wrap, Disposable 24x24 1 Sterilization wrap, Cellulose sheet reinforced with synthetic binders, 24" x 24" 624000-L4 PREMIUM GOWN XLG W/PAP TWL 1015 Maintenance Cover 10 x 15 1 Plastic sealable bag, with easy open tear feature, 10" x 15" 624000-L4 PREMIUM GOWN XLG W/PAP TWL 7804 GreenGown Premium L4 XL 1 Level 4 surgical gown, reusable, level 3 fabric in all non-critical zones, level 4 liquidproof fabric in all critical zones, polyester cuffs, includes pass-off card (#510) - size: XL Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 625000-L4 PREMIUM GOWN XXLG W/PAP TWL 105 Towel, Paper Surgical Hand 1 4 ply scrim, overall size: 17" x 20", folded size: 5" x 8.5", M fold, 625000-L4 PREMIUM GOWN XXLG W/PAP TWL 124 Wrap, Disposable 24x24 1 Sterilization wrap, Cellulose sheet reinforced with synthetic binders, 24" x 24" 625000-L4 PREMIUM GOWN XXLG W/PAP TWL 1015 Maintenance Cover 10 x 15 1 Plastic sealable bag, with easy open tear feature, 10" x 15" 625000-L4 PREMIUM GOWN XXLG W/PAP TWL 7805 GreenGown Premium L4 XXL 1 Level 4 surgical gown, reusable, level 3 fabric in all non-critical zones, level 4 liquidproof fabric in all critical zones, polyester cuffs, includes pass-off card (#510) - size: XXL Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 642000-L4 PREMIUM GOWNS XLG 20 PK N/S 7804 GreenGown Premium L4 XL 20 Level 4 surgical gown, reusable, level 3 fabric in all non-critical zones, level 4 liquidproof fabric in all critical zones, polyester cuffs, includes pass-off card (#510) - size: XL 642000-L4 PREMIUM GOWNS XLG 20 PK N/S 867NS ClearTote Bag22x16x40,1.3MILNS 1 Bag, clear 22"x 16" x 40", 1.3 ml Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 665100-5/PK L4 PREMIUM GOWNS MED NS 7802 GreenGown Premium L4 M 5 Level 4 surgical gown, reusable, level 3 fabric in all non-critical zones, level 4 liquidproof fabric in all critical zones, polyester cuffs, includes pass-off card (#510) - size: medium 665100-5/PK L4 PREMIUM GOWNS MED NS 1622NS Maintenance Cover 16 x 22 (NS) 1 Plastic sealable bag, with easy open tear feature, 16" x 22" Product & Description Component Number Component Description Qty Per Pack Salient Characteristics 665200-5 L4 PREMIUM GOWNS, LG N/S 7803 GreenGown Premium L4 L 5 Level 4 surgical gown, reusable, level 3 fabric in all non-critical zones, level 4 liquidproof fabric in all critical zones, polyester cuffs, includes pass-off card (#510) - size: large 665200-5 L4 PREMIUM GOWNS, LG N/S 1622NS Maintenance Cover 16 x 22 (NS) 1 Plastic sealable bag, with easy open tear feature, 16" x 22"

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