36C10A18R0175-002.pdf

For VHA Use

PERFORMANCE WORK STATEMENT (PWS)

Sterile Processing Workflow and Inventory

Management System

DEPARTMENT OF VETERANS AFFAIRS

Veterans Integrated Service Network

(VISN) 12

June 24, 2017

VISN 12 SPW ITS PWS For VHA Use Page 2 of 71

Table of Contents 1 Introduction

1.1 Purpose

1.2 Scope of Work

1.3 Related Initiatives

2 Reference Information

2.1 General Information

2.2 General Buying Terms

2.3 General Requirements

2.4 Section 508

2.5 Safety and Environmental

2.6 Enterprise and IT Framework ......................................................... Error! Bookmark not defined.

2.7 Transition and Orientation Support at end of Contract

2.8 CONTRACT Administration

2.9 Locations/Points of Contact

3 Specific tasks and deliverables

3.1 Application

3.2 Hardware/Software

3.3 Technical Requirements

3.4 Marking and Commissioning

4 Project Administration

4.1 Implementation Manager

4.2 Kick-Off Meeting

4.3 Project Management

5 General Requirements

5.1 Solution

5.2 ITS Time Stamp

5.3 Single Sign-on

5.4 Component Delivery

5.5 System Administration

5.6 Pre-Deployment

5.7 Deployment: SPW Application Installation

VISN 12 SPW ITS PWS For VHA Use Page 3 of 71

5.8 Post Deployment Support Services

5.9 Quality and Performance Management

5.10 Performance metrics

5.11 Facility Acceptance Test Plan

5.12 Training

5.13 Component Delivery and Implementation

5.14 Facility Acceptance Report

5.15 Final Hardware Deployment Design Document(s)

6 Appendices

Appendix A: Glossary

Appendix B: Sterile Processing Workflow Business Processes

1 Sterile Processing Workflow Business Processes

1.1 SPW Business Process: Critical Item Processing

1.2 SPW Application Process

1.3 SPW Critical Item Processing Base Configuration

1.4 SPW Business Process: Semi-Critical Item Processing

1.5 SPW Semi-Critical Item Processing Base Configuration

1.6 SPW Business Process: Non-Critical Item Processing

1.7 SPW Business Process: Case Cart and Transportation Tote Processing

For VHA Internal Use

1 Introduction

1.1 Purpose

The VISN 12 Network is responsible for providing health care to Veterans throughout the upper Midwest region. VISN 12 is a health care system that includes 9 Medical Centers, and 40+ Community Based Outpatient Clinics, all working together to provide efficient, accessible health care to Veterans in their areas.

Like all health care facilities, VISN 12 faces numerous clinical and business challenges, including inventorying, monitoring and distributing high-level disinfected (HLD) and sterilized reusable medical equipment (RME). These challenges can be met through the implementation of a Sterile Processing Inventory and Workflow Management Solution. In doing so, VISN 12 plans to improve the efficiency and effectiveness of patient care, with reductions in staff hours spent searching for medical, surgical, and dental devices while maintaining more efficient (i.e. less expensive, utilization tailored) inventory levels.

VISN 12 intends to implement a Sterile Processing Inventory and Workflow Management Solution as a means of achieving the aforementioned benefits.

This contract establishes the requirements for the Contractor provided solutions for the Sterile Processing Inventory and Workflow Management Solution implementation in VISN 12. The Contractor shall provide a fully integrated, seamless, turnkey solution encompassing hardware, software, and incidental services to VISN 12 facilities comprising this contract.

1.2 Scope of Work

Tracking enhances the ability of VA to ensure patient and staff safety by providing reasonable assurance that instruments have been processed in accordance with regulatory guidelines and individual instrument manufacturer’s Instructions for Use (IFU) for reusable medical equipment (RME) and dental/medical-surgical instrumentation.

The Sterile Processing Inventory and Workflow Management Solution shall establish a solid foundation of enterprise-wide compliance with generally accepted recommendations from the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), Association of periOperative Registered Nurses (AORN), The Joint Commission (TJC), International Organization for Standardization (ISO), International Association of Healthcare Central Service Materiel Management (IAHCSMM), Association for the Advancement of Medical Instrumentation (AAMI), and applicable VA Directives and Handbooks.

The Sterile Processing Inventory and Workflow Management Solution workflows shall be based on the CDC Spaulding Classification, which has been used to categorize RME, surgical instruments, and patient care equipment (items) for over 40 years (See Section 3.3.4 for specific items.) This classification is based on the degree of risk for infection involved in the use of these items, which are categorized as Critical, Semi-Critical, and Non-Critical devices. “Items” will be used when referencing surgical / medical / and dental instruments throughout this document.

• Critical items are those that come into contact with sterile tissue and must be sterilized prior to use. This category includes surgical instruments, dental instruments, emergency procedure trays, loaner instruments, and implant sets. The category may include endoscopes that enter a sterile body cavity or items used on a sterile field.

• Semi-Critical items contact mucous membranes or non-intact skin. Examples of Semi-Critical items include, but are not limited to, flexible endoscopes and ultrasound transducers that enter an intact body cavity.

• Non-Critical items are those that come in contact with intact skin only.

The Sterile Processing Inventory and Workflow Management Solution shall record the location, time stamp, and the status of a device/instrument/surgical container (set), etc. as it goes through the Sterile Processing System (SPS) reprocessing workflow. Locations to be scanned include, but may not be limited to Decontamination, Assembly and Preparation, Sterilization, Quality Assurance (QA), and Storage areas.

Within these locations, there will be at least one scan point where work instructions are needed, a work step needs to be recorded, and/or a location update is required. Facility processes, number of stations, physical layout, and the complexity of the workflow in a facility may increase the number of scan points in each area.

The Sterile Processing Inventory and Workflow Management Solution shall capture the movement of VAMC’s Critical and Semi-Critical RME, and Non-Critical RME that have or shall receive an electrochemical or similar supplemental mark. It is assumed that any Non-Critical RME reprocessed by a VAMC Sterile Processing Services (SPS) will have or shall generally receive a linear barcode or 2-dimensional electrochemical mark that can be scanned into the solution.

Some individual items, as well as instrument baskets and packages, cannot be marked electrochemically.

These items shall be affixed with a linear barcode label which allows a handheld scanner to read and identify these items as they are inventoried, assembled, disinfected/sterilized, and prepared for distribution or storage.

Under this contract the Contractor shall provide the Censitrac solution to serve as a VISN-wide Sterile Processing Inventory Tracking and Workflow Management Solution (ITS). The Contractor shall ensure the system is deployed to meet the needs of each unique VA facility based on their current business processes that will be impacted by the new technology. The Contractor shall provide hardware and software components as described in paragraph 3.2.2.

As part of this effort, the Contractor shall conduct site assessments, update facility drawings, develop implementation plans, document system configuration unique to each site, install, configure and test hardware and software, provide pre-testing training to VA staff, provide roles-based training, warranty overview, and facility transition support.

1.3 Related Initiatives

1.3.1 Contractor will collaborate to refresh existing medical technology by evaluating and replacing legacy ITS equipment as appropriate.

1.3.2 Contractor will deploy additional ITS hardware/software to advance VHA-wide strategic initiatives such as VISN-centered technology standardization efforts facilitating increases in health care efficiency.

1.3.3 VA has defined this effort as standardization of Censitrac equipment across facilities within the network. The goal is to simplify towards one manufacturer’s line of products within a Network per type of equipment. Networks are expected to use the same vendor’s equipment across all facilities for each service type of equipment. Each equipment modality should be contained to one manufacturer.

1.3.4 Contractor will contribute toward recurring efficiencies through ITS equipment standardization, primarily across the medical facilities within the Network based upon VA enterprise initiatives.

1.3.5 Contractor will ensure to align team members with respective VA subject matter experts in Nursing, Infection Control, Biomedical Engineering, Information Technology, Facilities Engineering, and Sterile Processing Services.

1.3.6 Contractor will ensure that the solution and its network connectivity is in strict compliance with VA information security initiatives, up to and including FISMA requirements employed by RTLS ITS for the Amazon GovCloud connection to the Censitrac Business Intelligence and Database.

2 Reference Information

2.1 General Information

2.1.1 Category: 70 -- Information Technology (ADP) Equipment (Including Firmware), Software, Supplies and Support Equipment

2.1.2 Sub Category: 7035 -- IT Support Equipment

2.1.3 NAICS: 334118 -- Computer Terminal and Other Computer Peripheral Equipment Manufacturing

2.1.4 Set-Aside Requirement:

2.2 General Buying Terms

2.2.1 Equipment Condition

New equipment ONLY, NO remanufactured or used products. No "GREY" market items.

2.3 General Requirements

2.3.1 Order Type

This effort shall be proposed as a performance based Firm-fixed-price (FFP) CONTRACT.

2.3.2 Performance Period

The period of performance (PoP) for this CONTRACT is 22 months, from July 1, 2018 – May 31, 2020.

2.3.3 Place of Performance / Delivery Information

Efforts under this CONTRACT shall be performed at the VA facilities identified in the section below.

Work may be performed under this CONTRACT at remote locations with prior approval of the Contracting Officer’s Representative (COR).

The VISN 12 VHA facilities to be provided the Sterile Processing Inventory and Workflow Management Solution are:

2.3.3.1 537-12 Jesse Brown VAMC (Chicago, IL)

2.3.3.2 550-12 Illiana VAMC (Danville, IL)

2.3.3.3 578-12 Edward Hines VAMC (Hines, IL)

2.3.3.4 585-12 Oscar G. Johnson VAMC (Iron Mountain, MI)

2.3.3.5 607-12 William S. Middleton VAMC (Madison, WI)

2.3.3.6 695-12 Clement J. Zoblocki VAMC (Milwaukee, WI)

2.3.3.7 695-12 Milo C. Heumpfner CBOC (Green Bay, WI)

2.3.3.8 556-12 Capt. James A. Lovell FHCC (North Chicago, IL)

2.3.3.9 676-12 Tomah VAMC (Tomah, WI)

2.3.4 Travel

The Government anticipates travel under this effort to perform the tasks associated with the effort, as well as to attend program-related meetings or conferences throughout the PoP. Include all estimated travel costs in the FFP line items. These costs will not be directly reimbursed by the Government.

The total estimated number of trips in support of the program related meetings for this effort is three per site.

2.3.5 Material, Equipment, and Facilities

The Contractor will be provided the following Government Furnished Property (GFP), which includes Government Furnished Material (GFM), Government Furnished Information (GFI), and Government Furnished Equipment (GFE). The GFP includes the following items:

2.3.5.1 Facility Drawings (e.g., CAD Drawings), most recent version available (due to Contractor at the time of the Acquisition Requirements Package submission)

2.3.5.2 Current Facility Level Business Process Flows (due to Contractor 3 weeks prior to facility Site Assessment)

2.3.5.3 Sterile Processing Inventory List (due to Contractor 3 weeks prior to the facility Site Assessment)

2.3.5.4 Infection Control Risk Assessment (ICRA) (due to the Contractor at the time of award)

2.3.6 Shipping

2.3.6.1 Deliverable Schedule

The deliverables table is part of the VISN 12 CONTRACT Schedule of Supplies or Services and Price, and directly aligns with the deliverables identified in this PWS. All deliverables associated with a CONTRACT shall be subject to review and acceptance by the CONTRACT COR.

Note: Days used in the attached table refer to calendar days unless otherwise stated. Deliverables with due dates falling on a weekend or holiday shall be submitted the following Government workday after the weekend or holiday.

2.3.6.2 Shipping Conditions

FOB Destination CONUS (Continental U.S.) Shipping charges shall be included in the purchase cost of the products. Sellers shall deliver the products on the own conveyance to the location listed on the purchase order.

2.3.6.3 Shipping Information

No partial shipments unless otherwise specified at time of order.

2.3.6.4 INSPECTION and ACCEPTANCE / Free on board (FOB) for Shipped Deliverables

Inspection and acceptance shall be at Destination and FOB shall be N/A. Please see “Points of Contact” table below for facility contacts and shipping addresses.

2.3.6.5 Special Shipping Instructions:

Prior to shipping, Contractor shall notify Site POCs, by phone AND followed by email, of all incoming deliveries including line-by-line details for review of requirements. Contractor shall not make any changes to the delivery schedule except as directed by the Site POC upon written request.

Contractors shall coordinate deliveries with Site POCs prior to shipment of hardware to ensure sites have adequate storage space. All shipments, either single or multiple container deliveries, will bear VA Purchase Order number on external shipping labels and associated manifests or packing lists. In the case of multiple container deliveries, a statement readable near VA PO number shall indicate total number of containers for the complete shipment (i.e. “Package 1 of 2”), clearly readable on manifests and external shipping labels.

2.3.6.6 Packing Slips/Labels and Lists shall also include the following:

Note: The Contracting Office will provide the PO# to the contractor. Upon award, the PO# numbers will be listed on the schedule of supplies and services.

IFCAP PO #: ____________ (i.e., 166-E11234 (the IFCAP PO number is located in block #20 of the SF 1449))

Total number of Containers: Package ___ of ___. (i.e., Package 1 of 3)

2.4 Section 508

On August 7, 1998, Section 508 of the Rehabilitation Act of 1973 was amended to require that when Federal departments or agencies develop, procure, maintain, or use Electronic and Information Technology, that they shall ensure it allows Federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. Section 508 required the Architectural and Transportation Barriers Compliance Board (Access Board) to publish standards setting forth a definition of electronic and information technology and the technical and functional criteria for such technology to comply with Section 508. These standards have been developed and published with an effective date of December 21, 2000. Federal departments and agencies shall develop all Electronic and Information Technology requirements to comply with the standards found in 36 CFR 1194.

The Section 508 standards established by the Architectural and Transportation Barriers Compliance Board (Access Board) are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure Electronic and Information Technology (EIT). These standards are found in their entirety at: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards and http://www.section508.gov/content/learn/standards. A printed copy of the standards will be supplied upon request. The Contractor shall comply with the technical standards as marked:

§ 1194.21 Software applications and operating systems § 1194.22 Web-based intranet and internet information and applications § 1194.23 Telecommunications products § 1194.24 Video and multimedia products § 1194.25 Self-contained, closed products § 1194.26 Desktop and portable computers § 1194.31 Functional Performance Criteria § 1194.41 Information, Documentation, and Support

2.5.1 Equivalent Facilitation

Alternatively, offerors may propose products and services that provide equivalent facilitation, pursuant to Section 508, subpart A, §1194.5. Such offerors will be considered to have provided equivalent facilitation when the proposed deliverables result in substantially equivalent or greater access to and use of information for those with disabilities.

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards http://www.section508.gov/content/learn/standards

2.5.2 Compatibility with Assistive Technology

The Section 508 standards do not require the installation of specific accessibility-related software or the attachment of an assistive technology device. Section 508 requires that the EIT be compatible with such software and devices so that EIT can be accessible to and usable by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software.

2.5.3 Acceptance and Acceptance Testing

Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the identified Section 508 standards’ requirements for accessibility and must include final test results demonstrating Section 508 compliance.

Deliverables should meet applicable accessibility requirements and should not adversely affect accessibility features of existing EIT technologies. The Government reserves the right to independently test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon delivery.

Automated test tools and manual techniques are used in the VA Section 508 compliance assessment.

Additional information concerning tools and resources can be found at http://www.section508.va.gov/section508/Resources.asp.

Deliverables:

A. Final Section 508 Compliance Test Results

2.5 Safety and Environmental

Safety and environmental procedures shall be identified in individual contract requirements.

The Contractor shall comply with the Office of Federal Procurement Policy Green Acquisition initiatives, as identified in individual CONTRACTs, in accordance with the policies referenced at http://www.whitehouse.gov/omb/procurement_index_green.

2.5.1 Security and Privacy Requirements

It has been determined that protected health information may be disclosed or accessed and a signed Business Associate Agreement (BAA) shall be required. The Contractor shall adhere to the requirements set forth within the BAA, referenced in Section D of the contract, and shall comply with VA Directive 6066.

2.5.1 POSITION/TASK RISK DESIGNATION LEVEL(S)

Position Sensitivity

Background Investigation (in accordance with Department of Veterans Affairs 0710 Handbook, “Personnel Suitability and Security Program,” Appendix A)

Low / Tier 1 Tier 1 / National Agency Check with Written Inquiries (NACI) A Tier 1/NACI is conducted by OPM and covers a 5-year period. It consists of a review of records http://www.whitehouse.gov/omb/procurement_index_green

Position Sensitivity

Background Investigation (in accordance with Department of Veterans Affairs 0710 Handbook, “Personnel Suitability and Security Program,” Appendix A) contained in the OPM Security Investigations Index (SII) and the DOD Defense Central Investigations Index (DCII), Federal Bureau of Investigation (FBI) name check, FBI fingerprint check, and written inquiries to previous employers and references listed on the application for employment. In VA it is used for Non-sensitive or Low Risk positions.

Moderate / Tier 2

Tier 2 / Moderate Background Investigation (MBI) A Tier 2/MBI is conducted by OPM and covers a 5-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and a FBI fingerprint check], a credit report covering a period of 5 years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, law enforcement check;

and a verification of the educational degree.

High / Tier 4 Tier 4 / Background Investigation (BI) A Tier 4/BI is conducted by OPM and covers a 10-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and a FBI fingerprint check report], a credit report covering a period of 10 years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, spouse, neighbors, supervisor, co-workers; court records, law enforcement check, and a verification of the educational degree.

The position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the PWS are:

Position Sensitivity and Background Investigation Requirements by Task

Task Number Tier1 / Low / NACI Tier 2 / Moderate /

MBI

Tier 4 / High / BI

The Tasks identified above and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the Background Investigation requirements for Contractor individuals, based upon the tasks the particular Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required Background Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal.

2.5.2 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor Responsibilities:

a. The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain the appropriate Background Investigation, and are able to read, write, speak and understand the English language.

b. The Contractor shall bear the expense of obtaining background investigations.

c. Within 3 business days after award, the Contractor shall provide a roster of Contractor and

Subcontractor employees to the COR to begin their background investigations in accordance with the ProPath template. The Contractor Staff Roster shall contain the Contractor’s Full Name, Date of Birth, Place of Birth, individual background investigation level requirement (based upon Section 6.2 Tasks), etc. The Contractor shall submit full Social Security Numbers either within the Contractor Staff Roster or under separate cover to the COR. The Contractor Staff Roster shall be updated and provided to VA within 1 day of any changes in employee status, training certification completion status, Background Investigation level status, additions/removal of employees, etc. throughout the Period of Performance. The Contractor Staff Roster shall remain a historical document indicating all past information and the Contractor shall indicate in the Comment field, employees no longer supporting this contract. The preferred method to send the Contractor Staff Roster or Social Security Number is by encrypted e-mail. If unable to send encrypted e-mail, other methods which comply with FIPS 140-2 are to encrypt the file, use a secure fax, or use a traceable mail service.

d. The Contractor should coordinate the location of the nearest VA fingerprinting office through the COR. Only electronic fingerprints are authorized.

e. The Contractor personnel shall submit all required information related to their background investigations (completion of the investigation documents (SF85, SF85P, or SF 86) utilizing the Office of Personnel Management’s (OPM) Electronic Questionnaire for Investigations Processing (e-QIP) after receiving an email notification from the Security and Investigation Center (SIC).

f. The Contractor employee shall certify and release the e-QIP document, print and sign the signature pages, and send them encrypted to the COR for electronic submission to the SIC.

These documents shall be submitted to the COR within 3 business days of receipt of the e- QIP notification email. (Note: OPM is moving towards a “click to sign” process. If click to sign is used, the Contractor employee should notify the COR within 3 business days that documents were signed via eQIP).

g. The Contractor shall be responsible for the actions of all personnel provided to work for VA under this contract. In the event that damages arise from work performed by Contractor provided personnel, under the auspices of this contract, the Contractor shall be responsible for all resources necessary to remedy the incident.

h. A Contractor may be granted unescorted access to VA facilities and/or access to VA Information Technology resources (network and/or protected data) with a favorably adjudicated Special Agreement Check (SAC), training delineated in VA Handbook 6500.6 (Appendix C, Section 9), and, the signed “Contractor Rules of Behavior.” However, the Contractor will be responsible for the actions of the Contractor personnel they provide to perform work for VA. The investigative history for Contractor personnel working under this contract must be maintained in the database of the Office of Personnel Management

(OPM).

i. The Contractor, when notified of an unfavorably adjudicated background investigation on a Contractor employee as determined by the Government, shall withdraw the employee from consideration in working under the contract.

j. Failure to comply with the Contractor personnel security investigative requirements may result in loss of physical and/or logical access to VA facilities and systems by Contractor and Subcontractor employees and/or termination of the contract for default.

k. Identity Credential Holders must follow all HSPD-12 policies and procedures as well as use and protect their assigned identity credentials in accordance with VA policies and procedures, displaying their badges at all times, and returning the identity credentials upon termination of their relationship with VA.

Deliverable:

A. Contractor Staff Roster

2.6 Transition and Orientation Support at end of Contract

The Contractor shall perform transition and orientation services (e.g., develop Phase-In/Phase-Out Transition Plan) to insure continuity of services as specified in the individual CONTRACT upon completion of contract. Transition and orientation support may include transitioning to Government or Contractor personnel.

2.7 CONTRACT Administration

2.7.1 Contracting Officer’s Representative (COR)

The COR designated for this CONTRACT will provide the Contractor access to all available GFI, facilities, material, equipment, and services required to complete this CONTRACT. In addition to the COR, there will be a facility-specific VHA point of contact (POC) assigned for each facility installation. The Contractor shall coordinate on-site activities with the designated site-specific facility POC.

2.7.2 Deliverable Review

The Contractor shall submit all deliverables within a timeframe that allows for proper review and acceptance in accordance with the due date(s) identified in the Schedule B of this order. The Contractor shall provide the CONTRACT COR the final updates and revisions within 5 business days after receiving the COR’s comments.

2.8 Locations/Points of Contact

Role Name Telephone # Email

V12 Project Champion Barry O’Brien 906-774-3300x32124 barry.obrien@va.gov

COR Mike Frydach 414-384-2000x49494 michael.frydach@va.gov Contracting Officer TBD Contracting Specialist TBD mailto:barry.obrien@va.gov mailto:michael.frydach@va.gov

Role Name Telephone # Email Budget POC TBD

Station POC’s

537- Jewel Givens 550- Eric Powell 556- Sam Thorell 578- Sherry Lewis 585- Barry O’Brien 607- Rhonda Reals 676- Kelley Lecy 695- Gwynne Roberts

312-569-8375 217-554-5491 224-610-4178 708-202-4734 906-774-3300x32124 608-256-1901x11270 608-372-3971x61783 414-384-2000x44071

3 Specific tasks and deliverables The Contractor shall perform the following requirements:

3.1 Application

The Contractor shall provide the Censitrac Sterile Processing Inventory Tracking and Workflow Management Solution (ITS) to VISN 12 to satisfy the functional and business requirements detailed by the figure below and in Section 5.0.

The Government will support a pre-CONTRACT award Vendor site visit, at the Vendor’s cost, should one be requested.

3.2 Hardware/Software

3.2.1 Salient ITS Characteristics to be provided by contractor

3.2.1.1 Inventory Control Provides:

Pictures of individual instruments 3.2.1.1.1

Pictures of correctly assembled trays. 3.2.1.1.2

Individually marked instruments will be visible and traceable throughout the 3.2.1.1.3 facility

System shall display readiness status of any queried item/tray/RME 3.2.1.1.4

Electronically create and manage count sheets. 3.2.1.1.5

3.2.1.2 Workflow Efficiency & Patient Safety provide:

Permanent 2-D marking to identify each surgical instrument. 3.2.1.2.1

Electronically capture pass/fail status, cycle type, sterilizer alarms, information 3.2.1.2.2 and results for process monitoring devices (Biologic Indicator (BI), Chemical Indicator (CI), etc.).

Reason and surgical case ID captured for Immediate Use Steam Sterilization 3.2.1.2.3 (IUSS) loads.

Visual and audible error alerts for any incomplete tray assembly or any 3.2.1.2.4 sterilization method mismatched with load contents.

Target patient notification (via surgical case ID) when instrument recalls are 3.2.1.2.5 required for sterilization load failures

Manufacturers’ and customer-generated instructions/Standard Operating 3.2.1.2.6 Procedures (SOPs) for every RME/endoscope in inventory needs to automatically appear on screen when specific RME/endoscope ID is manually entered or scanned

3.2.1.3 Administration Tools for Benchmarking & Continuous Improvement provide:

Extensive standard and custom management reporting i.e., Summaries and 3.2.1.3.1 details for inventory, maintenance, utilization, location, etc.

Ability to export data to Excel for integration with other Information and further 3.2.1.3.2 analysis.

3.2.2 Solution Hardware, Software, and Services

VA requires Contractor to provide for the following solution hardware, software, and related services.

Surgical Instrument Tracking and Management System (ITS) includes the following Censis Technologies, Inc. part numbers:

3.2.2.1 Medical Grade Touch Screen (CT0141) Hardware 22" All in one medical grade touch screen PC. This is a brand name or equal request; see Section 3.2.1 for baseline salient system characteristics. PCs will possess not less than 4 GB RAM to accommodate VA standard Gold Image.

3.2.2.2 Non-Medical Grade Touch Screen Workstation (CT0143) Hardware 24" All in one non-medical grade touch screen PC. This is a brand name or equal request;

see Section 3.2.1 for baseline salient system characteristics. PCs will posess not less than 4 GB RAM to accommodate VA standard Gold Image.

3.2.2.3 Waterproof Keyboard (CT0104): Hardware Waterproof Keyboard with Integrated Touchpad Mouse. This is a brand name or equal request; see Section

3.2.1 for salient characteristics.

3.2.2.4 Instrument Scanner-Tethered (CT0058A): Hardware Instrument Scanner tethered. This is a brand name or equal request; see Section 3.2.1 for salient characteristics.

3.2.2.5 Bar Code Scanner (CT0147): This is a brand name or equal request; see Section

3.2.1 for salient characteristics.

3.2.2.6 FIPS Compliant Wireless Scanner (CT0128): Hardware FIPS Compliant wireless scanner. This is a brand name or equal request; see Section 3.2.1 for salient characteristics.

3.2.2.7 Label Printer With Network Card (CT0024): Hardware Label printer with network card. This is a brand name or equal request; see Section 3.2.1 for salient characteristics.

3.2.2.8 Laser Jet Printer (CT0071): Hardware Laser Jet Printer Open Market Item. This is a brand name or equal request; see Section 3.2.1 for salient characteristics.

3.2.2.9 Document Scanner (CT0098): Hardware Document Scanner Open Market Item.

This is a brand name or equal request; see Section 3.2.1 for salient characteristics.

3.2.2.10 Electrochemical Marking Kit (CT0088): Hardware Electrochemical Marking Kit.

This is a brand name or equal request; see Section 3.2.1 for salient characteristics

3.2.2.11 Electrochemical Marking Stencils (CT0087a): Supplies Electrochemical Marking Stencils Standard (per 1,000). This is a brand name or equal request; see Section 3.2.1 for salient characteristics.

3.2.2.12 Electrochemical Marking Stencils (CT0087b): Supplies Electrochemical Marking Stencils Small (per 1,000). This is a brand name or equal request; see Section

3.2.1 for salient characteristics.

3.2.2.13 Implementation Consumables Package (ICONS): Implementation Consumables Package (tray, location/labels, printer ribbons). This is a brand name or equal request; see Section 3.2.1 for salient characteristics.

3.2.2.14 Instrument Management Implementation Fee (IMT 301): Implementation Instrument Management Implementation Fee. This is a brand name or equal request; see Section 3.2.1 for salient characteristics.

Loading of Available Images, this includes both 3.2.2.14.1

3.2.2.14.1.1 Images provided to Censis since 2014.

3.2.2.14.1.2 Images from previous VA sites that have undergone upgrade and standardization efforts resulting in full compliance with current data (nomenclature) standards.

Sterilization Methods 3.2.2.14.2

Consumables 3.2.2.14.3

3.2.2.14.3.1 Packaging Materials

3.2.2.14.3.2 Biological/Chemical Indicators/Integrators

Count Sheets Created with Marked Instruments associated to Trays 3.2.2.14.4

3.2.2.14.4.1 Pre-load of existing electronic count sheets

Item Tray Placement 3.2.2.14.5

NOTE: ALL system configuration and data entry activities MUST be delivered in full compliance with the existing VA Data Standards, to include the VA Medical-Surgical and Dental Instrument Nomenclature Guidance standards.

3.2.2.15 Tier 3 InstrumentTrac (SUT301): Subscription, Tier 3 InstrumentTrac. This is a brand name request; see Section 3.2.1 for salient characteristics.

3.2.2.16 Tier 3 Subscription Renewal (SRE202) Year 2. This is a brand name request; see Section 3.2.1 for salient characteristics.

3.3 Technical Requirements

3.3.1 Requirement of the Solution

Workflow data is collected for barcoded or 2D marked items whenever items return to SPS through the SPS decontamination area, throughout the SPS assembly and sterilization processes, to storage, and/or point-of-use location. Case carts are scanned into decontamination, emptied, sent through automatic cart washers, and then to cart storage or to the assembly and preparation area. Items are manually washed in decontamination area sinks. After the decontamination processes are complete, items arrive via pass-through windows or washer disinfectors into the SPS assembly and preparation area. At the assembly and preparation workstation, the SPS Technician uses a tethered handheld scanner to scan a barcode on an instrument tray/basket and an electronic count sheet displays on the monitor which lists all items needed for a specific surgical set. Items are assembled into instrument sets by using a tethered scanner to read the 2D electrochemical data matrix mark (on those items capable of being marked).

Wrapped item(s)/sets and peel pouch(es) hold surgical items that are not included in an instrument tray.

Barcodes are printed in the assembly and preparation area and attached to the wrapped item(s) sets or peel pouch(es) to identify their contents.

Assembled trays, wrapped items, and peel packs are placed on a sterilizer loading cart and scanned to build a load for the sterilizer. The load is assigned to a sterilizer by scanning the sterilizer to record information about the contents, such as sterilization cycle duration and temperature. After sterilization is complete, the instrument trays and items are scanned using a mobile handheld scanner to a clean case cart, distribution/storage area, or point of service location such as the Operating Room (OR), dental clinic, or emergency room.

Case cart content identification occurs when the tray or individual peel pack are scanned to the case cart. This association provides information of what instruments are in a tray(s) within a case cart.

3.3.2 System Interfaces

Sterilizer interfaces, where applicable (not all sterilizers can be integrated with Censitrac, and others require an OEM service event to complete the interface), are provided as part of the annual license agreement, and will allow the ITS solution to store data about the sterilizer. Typically, the data includes the sterilizer cycle time, cycle temperature, and a time stamp related to sterilizer cycles which is stored for the purpose of electronic documentation.

Table 1: Sterilizers

Sterilizers with Instrument Tracking System Interface Compatible Version(s)

Belimed Determined by manufacturer

Getinge Determined by manufacturer

Advanced Sterilization Products (ASP) Currently STERRAD NX and STERRAD 100NX

STERIS Determined by manufacturer

NOTE: Other products may be included as COTS developments since onset of this project/document.

3.3.3 Location Types

Location types allow for creating business rules that apply to a specific grouping of locations. The table below shows the established VA data standards for SPS-related locations. The current data standard hierarchy format for entering locations is entered as facility, building, floor, and optional configurable locations: wing, zone, sub-zone, room, and sub-room. Additional “custom” locations are available upon approval by the Government.

Table 2: SPS Location Types

ID Name Description

1 General Equipment Storage

Any walled storage location not labeled/designated as clean or dirty storage, for example General Equipment Storage in clinical areas (ITS Monitored Location).

ID Name Description

2 Patient Care Any area where patient care may occur (most often triggers Patient Care Use status, also supports Cross-Contamination use case) (ITS Monitored Location).

3 Dirty Storage Any area in a clinical department that is considered dirty (most often triggers Dirty status) (ITS Monitored Location).

4 Clean Storage Any area in a clinical department that is considered clean (most often triggers Clean status, also supports Cross-Contamination use case) (ITS Monitored Location). This includes scope storage that may not be in SPS area.

5 Cleaning-Space Any area that is a predefined area for cleaning equipment (e.g., SPS, central supply, etc.) (most often triggers Cleaning in Progress status) (ITS Monitored Location).

6 Decontamination Area within SPS where items are cleaned. The decontamination area is utilized for removing bulk contaminants/bioburden from SPS instruments/items (Most often triggers Decontamination status) (ITS monitored and/or ITS Scanned Location).

7 High Level Disinfection

Area within SPS and/or Gastroenterology (GI) Lab where Semi-Critical devices are scanned for reprocessing (ITS Scanned Location)

8 Cart Washer Area within SPS where case carts are cleaned (most often triggers Cart Washing status) (ITS Monitored Location).

9 Preparation Area within SPS where tracked items are prepared for sterilization/reprocessing. The preparation area is utilized for sorting and holding decontaminated instruments/items before they are placed into their respective trays/packages (most often triggers Preparation status) (ITS Scanned Location) (optional tracking location).

10 Packaging Area within SPS utilized for placing decontaminated instruments/items into trays or packages before sterilization (most often triggers Packaging status) (ITS Scanned Location).

11 Sterilizer A sterilizer in SPS that tracked items are scanned into prior to sterilization.

The area within SPS where sterilizing equipment is located, and equipment that has been packaged is loaded (Most often triggers Sterilization status) (ITS Scanned Location).

12 Quarantine Area within SPS where quarantine storage is performed to ensure that sterilization processes have been completed and mechanical and biological indicators are evaluated for results (Most often triggers Quarantine status) (ITS Scanned Location) (optional tracking location).

ID Name Description

13 Storage A physical room that is denoted as storage for holding instruments, trays, or case carts ready for use. It is the area within SPS where instruments, trays, and other equipment that has completed the SPS sterilization process are stored, inventoried, and tracked prior to distribution to clinical areas for use (most often triggers SPS Storage status) (ITS Monitored and/or ITS Scanned Location).

14 Service Any area that is a predefined area for maintaining or repairing equipment (most often triggers In Maintenance Repair Area status for repair, also supports Cross-Contamination use case) (ITS Monitored and/or ITS Scanned Location).

15 Exit Any area that is considered a building exit (most often triggers Exited status) (ITS Monitored Location).

16 Area.* [multiple] The creation of location types that are designated as an ‘Area’ will allow for equipment that are assigned to an area to trigger notifications when equipment leaves or returns to this area and for equipment to appear on the Out of Area report. (ITS Monitored Location).

17 Long-Term Storage (Warehouse)

Any long-term storage area, like a warehouse or other storage area that are not in a clinical department where ‘clean’ equipment is stored. Equipment leaving this area that follows a predefined cleaning cycle would be considered ‘dirty.’ (Most often triggers In Storage status, also supports Cross-Contamination use case). Equipment must be cleaned prior to entering and after leaving this area. (ITS Monitored Location).

18 Assembly Area of the SPS where tracked items are packaged and scanned into a tray.

19 On Case Cart Equipment is located within a mobile cart for transport to patient care areas (surgical suites). Item is considered to be clean and ready to use on a patient.

20 Sterilization – Not for Use

Item removed from the sterilizer, but has not yet passed QA checks. (i.e., In Quarantine)

21 Sterilization – Ready for Use

Item is located within the Quarantine area of SPS location, but has passed its QA checks.

3.3.4 SPS Equipment Types

Equipment types allow for easy searching for a specific type of equipment and for creating use cases (business rules) for a specific type of equipment. The following list outlines examples of equipment types based upon CDC’s Spaulding Classification model that are commissioned into the Censitrac software when the system is installed.

• Critical Surgical Items:

o Scissors o Forceps o Needle Holders o Retractors o Scalpels o Instrument Trays

• Semi-Critical Items:

o Flexible Endoscopes o Transesophageal Endoscope (TEE) probes o Ultrasound transducers

• Non-Critical Items o Infusion Pumps o Case Carts o Transportation Totes

3.3.5 Reports and Queries

Solution will contain a Business Analytics and Reporting Management Suite that allows the generation of standard and customized reports within a variety of categories. Sorting and filtering options are available and users have the ability to save reports to Favorites.

The standard reports within each category are as listed in the following table.

Table 3: Reporting Requirements

Category/Report Name Description

Dashboard Configurable set of charts to monitor metrics on demand

Case Tracking

Case List List of surgical cases by date.

Cross Reference List of surgical cases that have reused items since they were in the selected case.

Cross Reference Detail Detailed list of instruments reused since being used in selected surgical case.

Instrument Detail Instrument details by case ID.

Charts

Average Container Assembly Time

Actual and standard assembly time averages for containers.

Container Completion Rate Percent of containers assembled completely and percent of containers assembled with all Critical items included.

Containers by Process Step Current tally or percent of containers in each step of processing, such as Decontamination, Assembly, Sterilization, etc.

Processing Flow Times Average container processing times by process type.

Processing Priorities Current tally or percent of containers by priority level based on OR schedule interface (if present).

Throughput Volume by time period of sets assembled, sterilizer loads, case carts assembled, sets washed, items sterilized, location scans, peel packs.

User Logon Count Number of unique users that logged on per time period.

Category/Report Name Description

Container Reports

Assembly History Detail Assembly history by container.

Average Assembly Times Average assembly times by container for selected time period.

Completion Rates Summary of container completions.

Cost Total instrument costs by container, with ability to drill down to detailed instrument costs.

Cost and Product Detail Container pick list detail with extended cost.

General Information General information fields for each container name.

Hourly Assembly Trends Assembly trends by container, date, and hour.

Hourly Assembly Trends Summary

Assembly trends summary by date and hour.

Inventory List of containers with current location, status, case cart, and last updated information.

Inventory by Location Tally of containers by current location type, with ability to drill down to specific location details.

Loaner Activity Loaner tallies by surgical case date with drill down to case details and history.

Location History Location history by container.

Processing Flow Times Average container processing times by process type, including maximum and minimum times spent in each of the reprocessing steps.

Utilization Rate Utilization rates compared with the number of actual sets.

Employee Reports

Assembly History Container assembly history by technician.

Efficiency Hours earned over hours worked.

General Information User logon IDs, names, and access levels.

Hourly Assembly Trends Sets assembled by technician, by date, by hour.

My Productivity My (user’s) individual processing activity, by activity type.

Productivity Processing activity by technician and activity type.

Equipment Reports

Cost Equipment costs by equipment type.

Inventory Detailed equipment inventory report.

Inventory by Location Equipment sorted by current location.

Location History Location history for each equipment item.

Maintenance Due Equipment maintenance due by date.

Maintenance History Maintenance history by request date and supplier.

Open Maintenance List of equipment currently in maintenance cycle.

Category/Report Name Description

General Reports

Implementation Status Overview of Censitrac system utilization.

Inventory by Location Containers, case carts, loose instruments and equipment sorted by current location.

Inventory Throughput Inventory throughput by location type for containers, case carts, and equipment.

Out-of-Sequence Warnings Out of sequence warnings issued by date.

Quality Feedback Feedback tallies by event type with ability to drill down to event details.

Queue Time Snapshot Elapsed time in current locations for containers, case carts, and equipment.

User Last Logon List each user with the date and time of that user’s most recent logon.

User Logon Audit List logon attempts from the Censitrac security log.

Instrument Reports

Inactive Instruments List of instruments not scanned since specified date.

Inactive Instruments Identification

Move all instruments not scanned during a specified period to Missing.

Inventory by Location Loose instruments sorted by location.

Inventory Summary Summary of the instrument inventory by supplier and catalog number.

Items Missing History Instruments that were missing from previous assemblies.

Items Missing from Assembly Instruments that are currently missing from sets.

Maintenance Due List of all instruments or containers with maintenance due based on usage parameters.

Maintenance History Maintenance history by request date and supplier.

Maintenance in Progress List of instruments currently in maintenance cycle.

Product Catalog Browse and audit your instrument catalog.

Substitutions by Container Instrument substitutions by service and container.

Utilization and Shortages Monthly statistics by container of percent instruments utilized, missing, and unmarked for assembled containers.

PAR Inventory Levels

Inventory Levels Actual and required quantities of instruments and containers by location.

Sterilization Reports

Container Level Containers sterilized by sterilizer, date, and time.

Container Level by Load Containers sterilized by load number, sterilizer, date, and time.

Indicator Results Summary Summary of load indicator results by sterilizer and date.

Instrument Level Instruments sterilized by sterilizer, date, and time, including instruments in containers and peel packs.

Category/Report Name Description

Instrument Level by Load Instruments sterilized by load number, sterilizer, date, and time, including instruments in containers and peel packs.

Sterilizer Load Summary Tally of loads and contents by sterilizer and time period.

Sterilizer Loads List of sterilizer loads by sterilizer and date.

Sterilizer Status Summary of current status of each sterilizer

AER Reports Endoscope Reprocessing Reports

Immediate Use Steam Sterilization Rate

Report should be structured to run monthly with goal of less than 5% based upon surgical cases.

3.3.6 Technical package should include a signed written statement stating all, not partial, items required can be supplied by them as required by FAR 52.212-2(a).

3.3.7 Evaluation Factors are located in FAR 52.212-2 and will be used to evaluate offers based on the written information submitted.

3.4 Marking and Commissioning

3.4.1 Purpose

Censitrac is a Dental and Medical-Surgical instrument and reusable medical equipment…