PERFORMANCE WORK STATEMENT

Surgical Custom Packs

Background:

VA Greater Los Angeles Healthcare System (VAGLAHS) are seeking an IDIQ firm-fixed price contract for the custom surgical packs listed in the scope of work below. These packs are tailored to specific needs of Surgical Healthcare Group – Operating Room for Logistical and Clinical staff to improve patient care, improve utilization, and reduce waste. Orders for supply will be on an as needed basis.

Scope:

Custom surgical packs are tailored to specific needs of Clinical and Logistical staff to improve patient care, improve utilization, and reduce waste. VAGLAHS needs a constant supply of surgical packs with no interruption of source for scheduled procedures in the Operating Room, Interventional Radiology, and Cardiac Catheterization Lab. The Custom Sterile Procedure Pack Program will include pack assembly/manufacture, sterilization, quality assurance, and packaging, contractor electronic communication ordering reporting, and delivery. Due to the complexity and customization of this product, custom surgical packs shall take no more than 24 weeks to produce, sterilize, and deliver for the initial order after the commencement of the forthcoming contract. The Contractor shall provide all labor, materials, transportation, equipment, and supervision, in compliance with federal, state, and local regulations, to provide a Custom Sterile Procedure Pack program for the following VA Medical Facility:

VA Greater Los Angeles Healthcare System 11301 Wilshire Blvd Los Angeles, CA 90073

I. Period of Performance:

Unless otherwise specified, this contract will be for the period of one (1) one-year base period.

II. Products to be Provided:

The forthcoming contract will be an IDIQ firm fixed price requirement contract. The awardee shall deliver Custom Surgical Packs as requested by VAGLAHS in a manner described in section VII of this document. The custom surgical packs will be ordered by the COR or designee in accordance with Section III of this document. The contractor shall make delivery of requested contract items and quantities within the timeframes outlined in Section VII.

The vendor is required to provide the exact components listed for each custom pack for all requests made under the forthcoming contract. See attachment for required items in each kit.

VAGLAHS Packs :

Product Description Estimated Quantities

Intubation Kit 30 Central Line Insertion Kit 30 EP Pack 150 Cysto Pack 180 Cataract Pack 600

Open Heart PPS Pack 90 Major General PPS Pack 350 Plastic ENT PPS Pack 225 Ortho PPS Pack 250 Minor GYN PPS Pack 450 Podiatry PPS Pack 200

Joint Accessory Pack 180 Neuro Spine Pack 150 Cysto Urological Module Pack 200 Vascular Extremity PPS Pack 12 Angio IR Drape Pack 200 Vascular PPS Pack 12 Angio Pack 600 Arthroscopy Pack 10

Oral Surgery Pack 120 Perio Surgery Pack 120 MAC Anesthesia Kit 1 Anesthesia Kit 250

III. Ordering Procedures:

a) The COR or designee shall place orders by email. In case of emergencies, orders may be placed by telephone by the COR or designee.

b) Requests for delivery shall contain at a minimum the following information:

o Date of order o Description and quantity o Place of Delivery o Purchase Order Number

c) The contractor shall confirm receipt of the order and contact the requestor to coordinate delivery within 24 hours.

d) Contractor shall not accept any instructions or perform outside of the parameters of the forthcoming contract unless issued by the Contracting Officer via contract modification.

IV. Production and Supply:

a) The Government shall provide the contractor with estimated monthly usage report by the 5th of every month. The government requires the Contractor to produce the initial quantities of the product and make them available for delivery within forty-five (45) days of contract award, to reasonably assure the Government of an uninterrupted supply of the product. The Government requires the contractor to maintain a 3-month supply on hand and maintain a 95% acceptance rate.

V. Changes Requested by the Government:

a) VAGLAHS may change individual component parts of the tray/pack twice a year, using Attachment C - Pack Change Worksheet (PCW). A completed PCW will be provided to the Contractor by the COR or designee. Individual components of the custom pack may only be changed via a bi-lateral modification of the contract provided by the Network Contracting Office (NCO) 22 Contracting Officer.

b) Any component changes, the Contractor shall be required provide a price estimate for each item to be changed within five (5) business days to the COR or designee.

c) If the change of individual components will result in a change of line-item pricing, the CO will make a price reasonableness determination and may require a price adjustment before modifying the contract.

d) Upon award of the modification, production of the modified packs/kits shall begin within fourteen (14) days. Modified packs shall be delivered no later than forty-five 45 days after the award of the modification.

VI. Substitutions / Run-Withouts (RWO)

a) Temporary substitutions of custom pack components may be made without a change in pricing, only when given prior authorization in writing by the COR or designee. The COR or designee, at their discretion may request a sample of any proposed substitution.

b) If for any reason the Contractor is unable to deliver the agreed upon packs, the Contractor will provide 30-day notice, in writing, to the COR. The communication must include the Kit Item Number, specify the item(s) that are unavailable, and the number of kits that will be affected.

c) The contractor shall provide the COR with a list of any available, equal substitutions, for review and approval.

d) Substitution of items will not impact the delivery timeframes previously specified in paragraph VII.

e) Each pack list must clearly identify and highlight the missing/substituted item(s) to be easily identified on each pack by clinical staff.

f) In the case of run-with outs a (% or $ TBD) discount shall be applied to missing OR Custom Pack Items and a (% or $ TBD) discount will be applied to Non-OR Custom Pack Missing Items. These are marked on each surgical pack, *Non-C and C* to the applicable invoice after receipt of the RWO kit.

VII. Delivery Requirements:

a) All components for Custom Packs shall be delivered to the following locations:

VA Greater Los Angeles, Warehouse Building 249, Los Angeles, CA 90073

b) Pack deliveries shall be made one business day after receipt of the order if placed before

1:00 pm PST. Orders placed after 1:00pm shall be delivered within two (2) calendar days.

c) The contractor shall furnish quarterly inventory reports by the fifth (5th) business day of October, January, April, and July to the COR for the duration of the forthcoming contract.

VIII. Packaging:

a) Items must be packaged in a manner adequate to prevent deterioration and damage during shipping, handling, and storage.

b) Each pack shall have an outward facing label specifying the pack name, the manufactured date, the sterilization date of the pack, the expiration date of any dated products, and if the pack includes any items containing latex. A label, located inside each pack, shall also contain an itemized list of all components, as well as any missing items that were approved to be left out by the COR. The pack contents list must contain item and quantity. All custom sterile procedure packs shall have a minimal shelf life of twelve (12) months at the time of delivery to the Government. Delivery of short-dated products may be approved on a case-by-case basis by the COR.

c) Package content quality is the responsibility of the contractor, including items affixed to the outside of the pack (piggyback) and distributed as a part of the pack. Any pack determined to be defective (e.g., contains expired components, sterility has been compromised, etc.), through no fault of the Government, shall be returned to the Contractor at the Contractor’s expense. Full credit or replacement shall be made to the Government.

IX. Hours of Coverage:

a) All deliveries shall be scheduled during normal work hours - Monday through Friday from 7:00 am to 3:00 pm, Pacific Standard Time (PST), excluding Federal Holidays.

After-hours deliveries to include weekends and federal holidays must be approved by the COR and will be at no additional cost to the government.

X. Overtime and National Federal Holiday:

a) In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following National holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”:

• New Year’s Day: January 1

• Martin Luther King’s Birthday: Third Monday in January

• President’s Day: Third Monday in February

• Memorial Day: Last Monday in May

• Juneteenth Independence Day: June 18

• Independence Day: July 4

• Labor Day: First Monday in September

• Columbus Day: Second Monday in October

• Veterans Day: November 11

• Thanksgiving Day: Fourth Thursday in November

• Christmas Eve: December 24*

• Christmas Day: December 25

• The Day After Christmas: December 26* *Tentative

b) Any overtime or holiday pay that may be entitled to the Contractor’s employees shall be the sole responsibility of the Contractor and shall not be billed to nor reimbursed by the Government.

c) When one of the holidays fall on a Sunday, the following Monday will be observed as a National Federal Holiday. When one of the holidays falls on a Saturday, the preceding Friday will be observed as a National Federal Holiday. Also included, would be any other day specifically declared by the President of the United States of America to be a National Holiday.

XI. Invoices:

a) The Contractor shall submit one invoice, monthly, for items delivered during the month, under active delivery orders. https://authentication.tungsten-network.com/login. All invoices shall include, at minimum, the following information:

a. Contract number

b. Delivery order number

c. Item nomenclatures

d. Quantities

e. Unit price

f. Total invoice amount

g. And note any substitutions or run-without components and identify substitution or run-without kits.

h. In the event of substitutions or run-with outs, the invoice shall state both the regular invoice amount, discount percentage, and discounted invoice amount.

XII. Parking policy: It is the responsibility of contractor personnel to park only in designated parking areas. Parking information is available from the VA Police. The VA shall not invalidate or make reimbursement for parking violations of contractor's personnel under any circumstances.

XIII. Smoking policy: Contractor personnel may smoke only in designated areas. Smoking is allowed in all outside areas that are 25 feet away from entrances to buildings unless indicated otherwise. Enclosed patios connected to facility buildings are considered part of the building and as such are non-smoking areas.

XIV. The contractor shall perform necessary background checks on any employees who will be entering any VA facility in the performance of their duties under this contract.

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