P09 SOW R2 Laser Marking Commissioning Data Optimization.docx

STATEMENT OF WORK

Onsite Surgical Instrument Laser Marking, Commissioning, and Data Optimization

I. GENERAL REQUIREMENTS:

a. Introduction:

VA New York Harbor Healthcare System’s Sterile Processing Service (SPS) at the Manhattan Campus, has a requirement to have an estimated 25,000 pieces of Reusable Medical Devices (RMD)/instruments laser marked, commissioned, and data optimized into a CensiTrac system currently in use at the facility. This requirement includes standardizing Contractor names and catalog numbers (removing incorrect or duplicate data) and identifying acceptable substitutes for instruments in the database.

Place(s) of Performance:

VA New York Harbor Healthcare System Manhattan Campus 423 East 23rd Street New York, NY 10010

b. Background:

The Manhattan Campus SPS has been using the CensiTrac electronic tracking and data management system for RMD that utilizes laser marking capabilities to mark instruments with a unique identifier that allows the facility to track instruments utilizing a database created and maintained by Censis Technologies with access by VA employees. Using CensiTrac guides SPS staff through proper sterilization procedures, allows for faster instrument tray turnaround times, which increases operating room (OR) efficiency and ensures surgeons have the right instruments when they need them. This requirement is for laser marking of additional dental and medical-surgical instruments utilizing unique identifiers that are able to be read and tracked by the CensiTrac tracking system, as part of the National Real Time Location System (RTLS). The CensiTrac tracking system is currently in place at the Manhattan Campus SPS and the facility desires the remaining RMD items marked with the same system for continuity of instrument tracking and marking using a continuous numbering series in the existing database for Manhattan SPS.

c. Requirement Descriptions:

1. Laser Marking: Each VA-owned instrument will be laser marked with a scannable mark that uniquely identifies the instrument. Details about the instrument are entered into the existing database which allows the instruments to be tracked through the reprocessing process. Laser marks are to be permanent or semi-permanent and in the same format as the instruments already in the tracking system.

2. Commissioning is a process that involves the marking of instruments, data entry into CensiTrac where the unique identifier marking is scanned and linked to the corresponding manufacturer and product information. The Contractor certified trained laser technician will scan the instrument after marking to ensure it scans correctly and easily into the system. The work will be done on a Contractor-provided workstation that permits access to the instrument database. The Contractor will not be granted access to the VA computer system as the Contractor must provide their method for scanning the newly marked instruments into CensiTrac. After commissioning, the instrument is ready for use and tracking.

3. Data Optimization is cleaning up the database and improving the quality of the data such as removing errors, inconsistencies and duplicates to ensure data reliability and accuracy. Data optimization occurs after all the required instruments are marked.

d. Performance Period and Delivery Date:

1. Period of performance: Laser marking and data commissioning must be completed within 120 business days (6 months) from date of award. Data optimization must be completed within 10-12 weeks after marking is completed.

2. Laser Marking: Work to be performed on site at the Manhattan Campus SPS during the business hours of: 7:30 am – 4:00 pm Monday – Friday (excluding Federal Holidays).

The following are Federal Holidays observed by the facility and the Contractor shall not expect access to the VA Facility of VA employees on these dates unless notified otherwise by the VAMC POC. Preventive maintenance or other services are not to be scheduled on these dates:

And any other day specifically declared by the President of the United States to be a national holiday.

3. Data Optimization: the Contractor will perform all the work remotely offsite. Status calls between the client and Contractor will track project progress.

II. WORK REQUIREMENTS:

a. Contractor must provide a certified trained laser technician and all laser equipment and supplies to apply semi-permanent or permanent scannable Laser Markings as determined by the COR on RMD instruments currently used by the Manhattan Campus of VA NYHHS (maximum of 25,000 pieces). Instruments marked must include RMD in OR trays and clinical RMD instruments from the Manhattan Campus.

b. Certified trained laser technicians must provide training certification on the laser unit they are using.

c. Three hundred (300) instruments will be provided for marking each day, with the goal of marking 250 instruments each day. Once marked, the instruments are to be returned to the service the same day for reprocessing and use for clinic and OR procedures.

d. Markings must be able to be read, tracked, and have a sequential numbering series to follow current instruments already in the CensiTrac system.

e. Marking process must be completed on site, at the Manhattan Campus SPS, Ground Floor, only.

f. All labor must be performed by the contractor’s authorized personnel.

g. Instruments must be clearly marked and well-spaced on their flat surfaces, on shafts or near handles, dependent on the shape and design of instrument.

h. Contractor must enter data into the CensiTrac database for all dental and medical/surgical single and loose RMD instruments, and OR and clinical tray count sheets prior to use after uploading is complete.

i. All markings must be commissioned by the Contractor onto sustained CensiTrac Sterile Processing Services (SPS) Instrument Tracking Systems (ITS) at the VA medical facility. All newly marked instruments shall be tested for functionality by Contractor and SPS Staff/Mgmt.

j. Contractor must standardize Contractor names and catalog numbers, removing any incorrect or duplicated data from the instrument database. Original information is maintained. The Contractor will perform an analysis of the instrument database/catalog to identify acceptable substitutes for instruments/items on count sheets.

k. Contractor must provide a written report via email at the end of each workday, capturing daily marking work for SPS Staff/Mgmt review. SPS POC and Contractor project lead will meet weekly to review progress.

l. Contractor must be available during normal business hours for customer support on marking issues.

III. ADDITIONAL REQUIREMENTS:

a. Contractor must provide instructions and a listing of approved and compatible chemistries to SPS staff for cleaning and disinfecting any RMD marked instruments.

b. Contractor must provide SPS staff training on how to scan at the instrument level.

c. Any defective markings must be resolved within 72 hours.

d. Privacy Training for contractor without access to VA Sensitive Information:

All contractor employees and subcontractors participating under this contract are required to complete the VA's Privacy training requirement - “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or the Use of VA Sensitive Information” Contractors must provide certifications of completion to the COR during each year of the contract. Training expires 365 days after the training is taken. This requirement is in addition to any other training that may be required of the contractor and subcontractor(s). The COR for the contract is responsible for ensuring the contractor takes the training and to follow up with the annual requirements.