Attachment A - Statement of Work.pdf

STATEMENT OF WORK

Comprehensive Water Management Program (WMP) VA Pittsburgh Healthcare System (VAPHS)

Sterile Processing Service University Drive C

Pittsburgh, PA 15240

1.0 INTRODUCTION

Background: The VA Pittsburgh Healthcare System (VAPHS) Sterile Processing Services requires the expertise of a contracted company to develop a Comprehensive Water Management Program (WMP.)

Performance period: The work will take place at the VAPHS Campus located in Pittsburgh, PA. Generally, work hours are limited to Monday through Friday 7:00 AM to 4:00 PM with prior coordination with the program point of contact (POC) and Sterile Processing Service Chief from VAPHS.

SPS requires the start of Water Management Program Services within 30 days of contract award.

Delivery Location VA Pittsburgh Healthcare System (VAPHS), Sterile Processing Service | University Drive C, Pittsburgh, PA 15240 | Sterile Processing Chief (412-360-6615)

Stakeholder Team

Team Includes: Sterile Processing Chief VA Pittsburgh Healthcare System Sterile Processing Service staff

Biomed: vhapthbiomedicalengineering@va.gov FMS vhapthfmsmgrs-supvrs@med.va.gov Infection Prevention: vhapthinfectionpreventiondepartment@va.gov POC: Executive Assistant, PCS 412-360-6077

2.0 TASKS AND DELIVERABLES

The contractor shall develop a Comprehensive Water Management Program for our sterile processing system in order to ensure the critical and utility water is consistent with guidance provided by the VA’s National Program Office for Sterile Processing (NPOSP), AAMI ST108:2023 Water for the Reprocessing of Medical Devices, Association of perioperative Registered Nurses (AORN) Guideline for Cleaning and Care of Surgical Instruments and is required by VHA Directive 1116(1.)

The contractor scope includes the following main SPS process improvement services with the development of this Water Management Program Development for Sterile Processing:

2.1 Facilitate the formation of the Water Management Team (WMT). The WMT will oversee the development of the WMP.

2.2 Perform an onsite or remote survey of the SPS Water System(s) in the facility to include interviewing personnel familiar with the SPS Water Systems.

mailto:vhapthbiomedicalengineering@va.gov mailto:vhapthfmsmgrs-supvrs@med.va.gov mailto:vhapthinfectionpreventiondepartment@va.gov

3.0 CONTRACTOR RESPONSIBILITIES

3.1 The contractor shall establish a Program Team (Water Management Team) to identify persons responsible for SPS WMP development, implementation, and operation.

3.2 The contractor shall develop program goals associated with this requirement to be implemented at the VA Pittsburgh Healthcare System. The goals established shall include water safety and quality goals for SPS.

3.3 The contractor shall describe the VAPHS Water Systems and describe the critical water, utility water, and steam systems within SPS and develop water-system process flow diagrams.

3.4 The contractor shall analyze Building Water Systems. Analysis should be a systematic analysis of hazardous conditions in the SPS water systems.

3.5 The contractor must determine all Control Locations in the system where control measures are required.

3.6 The contractor must establish control measures. For each control measure at each control location established; the contractor must determine the limits including but not limited to a maximum value, a minimum value, or a range of values within which a chemical or physical parameter must be monitored and maintained to reduce hazardous conditions to an acceptable level.

3.7 The contractor must set up a Program Team (Water Management Team) and identify personnel responsible for SPS WMP development, implementation, and operation.

3.8 The contractor shall develop program goals and establish water safety and quality goals for SPS.

3.9 The contractor must describe Water Systems and describe the critical water, utility water, and steam systems within SPS and develop water-system process flow diagrams.

3.10 The contractor shall analyze building water systems and conduct a systematic analysis of hazardous conditions in the SPS water systems.

3.11 The contractor must determine control locations within VAPHS and determine and report the locations in the system where control measures are required.

3.12 For the control limits for each control measure at each control location established; the contractor must determine the limits including but not limited to a maximum value, a minimum value, or a range of values within which a chemical or physical parameter must be monitored and maintained to reduce hazardous conditions to an acceptable level.

3.13 The contractor must report and establish the preferred monitoring procedures for monitoring to determine if control measures are operating within established control limits.

3.14 The contractor must document and report corrective actions to establish the corrective actions to be taken when monitoring indicates that the control parameters are outside of the established control limits.

3.15 The contractor must develop a verification strategy and establish procedures to confirm that all the program elements are being implemented as designed at a frequency established by the WMT.

3.16 The contractor will develop a validation strategy, establish validation criteria, and frequency to confirm that the program effectively controls the hazardous conditions throughout the SPS water systems.

3.17 The contractor must develop documentation and communication procedures for all activities of the WMP and maintain records appropriate to these principles and their application.

3.18 The contractor will build a work plan for a 90-day development timeline. Sterile

Processing Water Management Program Facilitation must take place for 1 year.

3.19 The contractor must provide the following additional Water Management Program facilitation services:

3.19.1 All meetings and site visits must be coordinated with the SPS Chief.

3.19.2 The contractor must also facilitate quarterly meetings for the Water Management

Team on-site or remotely and must be collaborated with.

3.19.3 Maintain, assist, and advise in the operation of the WMP and generate required documentation.

3.19.4 Recommend and implement changes to the WMP as directed by the Water

Management Team to achieve the desired performance in alignment with AAMI ST-108.

3.19.5 Provide, operate, and continue to customize the WMP using the web-based data management software.

3.19.6 Provide remote support on water management questions as needed.

3.19.7 Verify that the WMP is being implemented as designed on a quarterly basis through monitoring and documentation of system performance and WMP records and record in the web-based data management software.

3.19.8 Validate that the WMP adequately controls the hazardous conditions in the building water system through the review of water system validation testing.

4. SECURITY

Appendix A

• The contractor Personnel Security Requirements.

• The contractor may not have access to the VA network or any VA sensitive information under this contract.

• The contractor owned computer equipment including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical equipment must be scanned by Biomed or OIT.

ISSO/PO Comments: The POC and SPS Chief is responsible for ensuring that all Contractors comply with physical security policies. A compliant ID badge must be worn by Contractors at all times while on VA premises. Contractor may not have access to the VA network or VA sensitive information. The following language from VA Handbook 6500.6 is required in this contract:

Appendix C: Paragraphs #3a, b, d, e, h

All Contractors must receive Privacy training annually using one of the following methods:

• Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct

Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/SecureAuth35/).

Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The POC must ensure that all contractors are validated in the PIH domain.

• Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA

Computer Systems or Direct Access to or Use to VA Sensitive Information”. Signed training documents must be submitted to the POC. Training must be completed prior to the performance of the contract and annually thereafter. Proof of training completion must be verified and tracked by the POC.

5.0 RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS

• Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

• Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

• Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

https://www.tms.va.gov/SecureAuth35/

• Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

• Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

• The Government Agency owns the rights to all data/records produced as part of this contract.

• The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

• Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

• No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

• Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

6.0 TRAINING

6.1 Contractor shall provide training to the designated VA Pittsburgh Healthcare System Water

Management Program Team on the WMP processes and best practices for SPS water systems.

6.2 There will be no additional charge if there is a need for the contractor to perform on site training.

7.0 SYMPLR REQUIREMENT FOR ON-SITE APPOINTMENTS

Symplr credentialing is required for any contracted staff that will be coming on-site at the VA Pittsburgh

Healthcare System. The contractor would be responsible for ensuring that they utilize the Symplr System as described below in to remain in compliance with VAPHS policies and standards.

Contractor access to the VA Pittsburgh Healthcare System and sister locations are by appointment only and requires credentialing through our vendor credentialing partner Symplr.

Symplr is a cost to each vendor, vendor representative or vendor contractor requiring entry to:

VA Pittsburgh Healthcare System, University Drive C. Pittsburgh PA 15240

Each person entering campuses must obtain the required credentialing as advertised on the Symplr site. The link to the Symplr site is as follows: https://www.symplr.com

Vendor, vendor representatives or vendor contractors must login to the Symplr site:

• Create an account on the Symplr Site

• Select the plan pertaining to the contract requirements for the on-site visit at:

o VA Pittsburgh Healthcare System, University Drive C. Pittsburgh PA 15240

• Each person, vendor, vendor representative, vendor contractor must pay for plan to begin the required credentialing on Symplr.

• Vendor, contractors, or vendor representatives must be in a green light status on Symplr to be permitted to proceed with on-site appointments. In the event a vendor is red lighted, a replacement vendor must be substituted and in a green light status or the appointment will be cancelled.

• All vendors are required to check in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (Heinz) and obtain a day badge which will include date, time, and location of approved appointment. Company badge with photo ID is also always required to be worn while onsite.

• Vendors are only permitted to visit the location identified on their badge and must exit the facility promptly, checking out via their smart phone once appointment has ended.

• Contractor shall have VA approved form of identification (Symplr Badge, Photo ID.)

Plan Costs to Vendor is as advertised on the Symplr Website for options listed below starting at $299 but may increase based on Symplr:

1. Clinical Vendors (entering patient care areas/direct patient involvement)

2. Service (Non-Clinical) Vendors

All vendors are required to check in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (Heinz) and obtain a day badge which will include date, time, and location of approved appointment. Company badge with photo ID is also always required to be worn while onsite.

Vendors are only permitted to visit the location identified on their badge and must exit the facility promptly, checking out via their smart phone once appointment has ended.

a. All contractor employees and sub-contractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with The contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.

https://www.symplr.com/

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training.

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document– e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing The contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

8.0 INFLUENZA VACCINATION

VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical, and administrative, paid, and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS.

• Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

• It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

• Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination.

• Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

• The contractor is required to submit annual certification in the form of a memorandum to the

Designated Program Representative that all contract staff performing services at VA facilities are in compliance with VHA Directive 1192.

9.0 TUBERCULOSIS PREVENTION

1. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the

DESIGNATED PROGRAM REPRESENTATIVE and Contracting Officer. Tests shall be current within the past year.

2. Tuberculosis Testing: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

3. Rubella Testing: Contractor shall provide proof of immunization for all contract personnel for measles, mumps, rubella, or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the DESIGNATED

PROGRAM REPRESENTATIVE.

10.0 MANDATORY TRAINING FOR VA CONTRACTOR PERSONNEL

In order to be granted access to VA resources, you must first complete all of your assigned mandatory training.

Required courses are accessed via the VA Talent Management System (TMS).

To access the TMS, you must first create a TMS user profile. Once you have crea ted a user profile, you will see the list of mandatory training and the date(s) by which it must be completed.

In order to access the TMS you must use one of the following browsers:

• Internet Explorer (7.0 to 11.0)

• Mozilla Firefox (3.6.x.x and above)

• Safari on Mac (6.0 and above)

• Google Chrome (23.0.x.x and above)

To ensure that the training courses operate correctly, your system must also have the following software installed and enabled:

• Flash player version 10.0.0 and above

• Adobe Reader 9.0 and above

You will be required to provide specific information about yourself as well as information related to the work you will be doing under this contract. Your contract Project Manager should have provided you with the following information:

1. The VA Location being supported.

2. The VA Contracting Officer’s Representative (COR) First Name, Last Name, Email Address, and Telephone Number.

3. The Name of the Contract.

4. The Contract Number.

5. The Vendor Project Manager

6. If you must complete HIPPA training.

The above information is required in order to create your profile. Make sure that you have it before starting the TMS User Profile creation process.

Step-by-step instructions for creating your TMS profile and then launching and completing the required training are attached as an attached file to this Statement of Work.