36C26121Q0725 Statement of Work - Working.doc

Attachment 1

STATEMENT OF WORK (SOW)

1. Requirements and Background Information The Veterans Affairs Palo Alto Healthcare System (VAPAHS) has requirement for identification marking of every surgical instrumentation on our inventories. Each marking must be of laser marks. VAPAHS is located at 3801 Miranda Ave, Palo Alto Ca 94304 with more than 40,000 surgical instruments. Most of our instrumentations are without barcodes. Barcodes of surgical instruments are needed to monitor each individual instrument for monitoring and tracking instrument for maintenance, repairs or replacement.

2. Scope

· The vendor will provide one (1) CLASS I fiber laser wavelength 1064nm with a max power of 20 watts that complies with 21 CFR 1040.10 and 1040.11 with four (4) R+ Table Top Data Matrix Reader/scanner. (Upon conclusion of project the VA will be the owner of this laser and readers.)

· The vendor shall come to the VA Palo Alto to perform the marking or placing barcodes of our instrumentation on location.

· The vendor shall bring all necessary personnel, equipment, tools, and supplies.

· The vendor shall come to VA Palo Alto and place barcodes on at least 40,000 instruments, performed data entry and commission each barcode to CensiTrac.

· The vendor will provide safety training to all Sterile Processing Service (SPS) personnel on safety of laser use. While on site, the vendor shall provide education to the (SPS) on proper use, handling and care of laser etching equipment, matrix readers and scanners. Barcodes must be compatible with CensiTrac surgical instrument tracking system.

· Vendor will also train hospitals Censis coordinator or appointed staff member on how to clean marks, remove and reapply marks and make necessary changes in real-time when necessary.

· Vendor must demonstrate that surgical trays can be assembled using scans to ensure 100% accuracy of set contents.

· A detailed count sheet must be printable showing (UDI) Unique Device Identification numbers plus confirming that items are in the proper set location.

· Training must be performed by OEM Certified Laser Operator

· Vendor will also provide their own laser to improve efficiency of the project.

3. Specific Tasks equipment requirements

· NUX 20NG Laser etching machine with matrix readers/scanners

· Must be a Class I laser safe to be used within the SPS department

· Capable of applying 2D barcodes to stainless steel, titanium, plastics and anodized aluminum

· Vendor must remove all marks that are not readable, re apply new mark that is scannable into the system.

· Can read barcodes on instrument regardless of instrument contrast, material or position of the code on each instrument.

· Can reads a good geometrical Data Matrix, (manufacturer’s marking).

· Have a minimum requirement 2MP Camera and LED lighting that can read a bar codes as small as .010 x .010mm (4 mils).

· Has a durable body (preferably stainless steels) for cleaning and disinfecting surfaces of the body; and strong enough for the most demanding conditions in a SPS.

· Vendor shall laser etch up to 40,000 of our instruments with a unique 2D Barcode, perform data entry and commission each barcode to CensiTrac;

· As needed, Count sheets will be revised, fixed, and standardized to reflect a more consistent approach, reflective to any noted changes of VA leadership.

· Vendor must Educate and train VA employee in lase 2D etching and application so that the project can be sustainable.

· Vendor Will certify at least two (2) VA technician on Laser Safety Training and Certification through LIA Laser Institute of America

· Must be knowledgeable in Sterile Processing processes with a minimum of 10 years’ experience working with or working in a Sterile Processing Department.

· IAHCSMM or CSPD certification preferred.

4. Performance Monitoring Vendor shall provide report to SPS management at the conclusion of service.

5. Security Requirements:

a. SPS employees shall escort the vendors into the facility on every site visit.

b. Vendors can Call Assistant Chief of SPS for escort to the respective department

b. Vendors will not have access to any medical record.

6. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI) The vendor shall provide all personnel, and tools to perform barcoding and data entry into CensiTrac.

7. Risk Control The vendor shall be provided a coverall or disposable scrubs to wear while accessing SPS to retrieve instruments and trays needing laser etching from preparation area or storage area.

8. Place of Performance The vendor is required to set up a working space within relative proximity to the SPS department and work closely with VA leadership in establishing day to day workloads. Daily communication and updated list of completed sets must be emailed at the end of each workday.

9. HOURS OF WORK

The contractor shall provide this PM between the hours of 7:00 a.m. and 3:30 p.m. Monday through Friday, holidays excluded.

10. GOVERNMENT HOLIDAYS:

Holidays observed by the Federal Government:

New Year's Day

1 January

Martin Luther King's Birthday

Third Monday in January

President's Day

Third Monday in February

Memorial Day

Last Monday in May

Independence Day

4 July

Labor Day

First Monday in September

Columbus Day

Second Monday in October

Veterans Day

11 November

Thanksgiving Day

4th Thursday in November

Christmas Day

25 December If a holiday falls on Sunday, the following Monday shall be observed as the legal holiday. When a holiday falls on a Saturday, the proceeding Friday is observed as a legal holiday By U.S. Government agencies. Also included would be any day specifically declared by the President of the United States of America as a national holiday.

11. SMOKING POLICY

Smoking is not permitted within or around the VA Medical Center, except in designated areas.

12. SERVICE CONTRACTS

Offeror shall provide in the space provided below, the name, location, and telephone number of the office where service calls are to be placed:

DARR Surgical LLC 727 Walden Reserve Park Place Drive

Hinckley, Ohio 44233

Contact: steve@darrlazers.com 330-714-9090

13. BADGES AND PARKING

· All vendor personnel shall be required to wear identification (I. D.) badges during the entire time they are on the VAPA grounds. I. D. badges shall have an identification picture, name of the individual and the represented company depicted on it.

· It is the responsibility of the vendor personnel to park in the appropriate designated parking areas. Parking information shall be available from the VAPA Security Service.

· The VAMC shall not invalidate or make reimbursement for parking violations of the contractor's personnel under any circumstance.