36C10X20R0002-008.docx

Sample Representative Task Order

PERFORMANCE WORK STATEMENT (PWS)

STERILE PROCESSING QUALITY MANAGEMENT SYSTEMS

1. Introduction.

Over the past decade, the Office of Inspector General (OIG) has issued significant findings and recommendations for corrective action related to sterile processing of Reusable Medical Equipment (RME). There is still cause for concern regarding the management of Sterile Processing Systems (SPS) and operations, and VHA’s ability to ensure consistent compliance with SPS quality standards across medical facilities. Previous OIG reports have underscored the ongoing need for VHA leaders to respond aggressively to reports of management failures within individual facilities’ SPS and other medical center clinical and business service lines that have a direct impact on patient care. VHA must take appropriate and proactive steps to ensure SPS processes are properly carried out by adequately trained and highly competent professionals whose work and qualifications are consistently and carefully monitored. High performing SPS lies at the very essence of a High Reliability Organization (HRO) in a Healthcare System and is critical to achieving High Reliability at VHA Medical Centers (VAMC).

Ensuring that SPS are functioning properly is of critical importance; and, then inventoried, secured, and maintained in clean conditions. Proper sterile processing and storage of RME is essential to preventing deadly contamination and advance both patient safety and sound fiscal oversight. RME must be reprocessed by staff with the required competencies, according to manufacturers’ instructions and related procedures patient infections, as well as product deterioration. The OIG has reported instances where improper sterile processing has resulted in cancelled surgeries and delays in critical procedures; inefficiency due to repeat processing of RME; and, significantly increased risk of patient harm.

1 a. It is anticipated the work will require tasks classified in the following Functional Categories and Capability Areas:

☒ Functional Category I: Health System Transformation and Innovation ☒ Program and Project Management ☒ Business Requirements Development ☒ Strategic Planning ☒ Program Evaluation ☒ Business Process Reengineering, Improvement and Management ☒ Change Management and Transition ☒ Quality Management ☐ Strategic Communications ☒ Executive Support

☒ Functional Category II: Implementation and Operations Support ☒ Studies and analyses ☐ Data Governance ☒ Performance Measurement ☐ Training Development ☐ Policy Research and Development ☐ Advertising Services

☒ Functional Category III: Healthcare Business Enabling Services (Task Orders aligned with this Functional Category must have an inherent healthcare component or be part of a larger task order spanning Functional Categories I and/or II)

☒ Medical Supply Chain and Healthcare Logistics ☐ Financial Management Modernization ☐ Research and Development Administration Support ☐ Human Resource Support ☐ Acquisition Support ☐ Information, Privacy and Records Management ☐ Revenue Operations ☐ Value Based Healthcare Planning

2. Scope or Purpose.

VHA requires contractor support to design and execute two simultaneous pilot Sterile Processing Quality Management systems at two geographically separated Veteran Integrated Service Networks (VISN), based on recognized international healthcare SPS standards. There are approximately 5 medical centers per VISN that must all pilot the Sterile Processing Quality Management system. To properly establish robust quality management systems, a gap analysis will be conducted at each of the VAMC SPS department(s) within those VISNs to identify any existing deltas to the requirements. Each VAMC within the VISN will undergo a detailed gap analysis where the existing SPS processes, procedures, facilities, software and records are reviewed against the quality management systems requirements. The combined results of the analysis for each VAMC will provide the scope of understanding of the path needed to establish the quality management system. This will require clinical and business competencies of Sterile Processing in healthcare (to include ISO certification) and require staff to be on site during the analysis for VAMC leadership support. Contractors will be required to provide support in Planning, design, organization and management of healthcare executive correspondence and documentation for executives within VHA, VISN and VAMC. Upon completion of the gap analysis and the detailed plan for eliminating the “deltas” is established, the consultant team will assist the VISNs and participating VAMCs to develop a comprehensive project plan for the implementation, monitoring and maintenance of best practices in SPS.

3. Task Statement and Deliverables

Task 1. Healthcare Integration and Project Management Plan (HIPMP) Contractor will deliver a draft strategy focused results driven Healthcare Integration and Project Management Plans that identifies the system of systems approach for SPS in a large and highly complex and integrated healthcare system. The plan will incorporate a Health Systems Quality Control Plan (HSQCP).

Deliverables:

· The Project Management Plan (PMP) portion will be included in the overall Healthcare Integration Plan and delivered within 10 calendar days after award or two (2) calendar days prior to k/o meeting.

1. Health Systems Quality Control Plan (HSQCP) incorporating healthcare quality and safety elements that are identifiable, integrated with all other quality elements, and measurable. Key topics that shall be included:

a. Systems of Systems Model for SPS in a large complex integrated healthcare system

b. Staffing plan

1. Key personnel will have proven and extensive knowledge of sterile processing at VHA Medical facilities and private industry healthcare systems

c. Key tasks and sub-tasks

d. Dependencies for SPS in a large complex integrated healthcare system

e. Risks stratified across all milestones, tasks and sub-tasks

f. Critical path for on time product delivery

g. Essential products to be delivered including resource plan

Task 2. Develop VISN Gap Analysis Protocols The team will update the necessary assessment protocols and materials for conducting a thorough SPS gap analysis of the integrated processes and procedures being utilized in the VISN's SPS departments. This will occur before the first site visit to identify critical information the team must obtain before and during the site visits. The assessment materials are driven by all the internal and external standards and requirements detailed in the ISO 9001:2015 standard.

Deliverables:

· Short-term and Long-term Plans/Goal for SPS in VA

1. Consultation, facilitation and support for development

· Gap Analysis Protocol

1. Implementation of proven systematic method for evaluation

2. Application of a healthcare system engineering approach Task 3. Gap Analysis Conduct gap analysis to review the integrated systems processes and procedures being utilized by each of the VAMC's SPS departments for compliance to healthcare industry standards. The purpose of the gap analysis is to identify the actions needed to expand the scope of existing Quality Management system to include each of these healthcare facilities. At the end of the site visits to each VAMC, the contractor shall provide a summary report to the VISN Director, Chief Medical Officer (CMO) and Quality Management Officer (QMO) identifying the observed gaps, opportunities for improvement, reduced variability, integration points, and observed strengths and healthcare industry best practices. Upon delivery of the report(s), the contractor shall provide a further briefing to key VAMC staff, if requested, where findings and systematic recommendations can be discussed.

Deliverables:

· Gap Analysis VAMC and VISN Level

1. VAMC Summary Report and Recommendations

2. VISN Summary Report and Recommendation

3. Program Evaluation Summary Document and Recommendations

Task 4. Comprehensive Project Plan The Contractor will develop a comprehensive project plan with (with integrated master schedule) to closely monitor and manage all the required tasks to close the identified deltas. The plan shall be updated continually throughout the lifecycle of the task to track what has been accomplished as well as what remains to be complete.

Deliverables:

· Master Schedule for program implementation will outline Contractor’s approach, timeline, resources and tools used in execution of this TO

· Final PMP

Task 5. Reporting The Contractor shall participate in bi-weekly meetings in support of the tasks within this PWS. In conjunction with the meeting, the Contractor shall provide a report and brief bi-weekly. On a quarterly basis, Contractor shall submit a summary report that rolls up all activities from the quarter.

· Program Status Reporting

· Bi-weekly TO Meetings

· Bi-weekly TO Status Reports

· Quarterly Summary Reports

Task 6. Implementation (Optional Task) The Contractor will execute the project management plan, once approved and authorized by the Government, and implement the systems of systems approach for SPS at five VAMCs. The Contractor will monitor and measure success of implementation in accordance with the PMP. The Contractor will be responsible for facilitation of on-site change management activities in support of implementation. The Contractor will provide a status update on implementation to the Government PM weekly.

· Standard Operating Procedure for RME SPS

· Recommendations and support for the development and implementation

· Weekly update brief to include:

· Weekly activities

· Update on implementation metrics

· Current status of measures of success

· Change management plan

· Successful implementation of systems of systems approach to SPS at 5 VAMCs

4. Delivery Schedule. [Complete the table below based on deliverables defined above]

Staffing Plan Program Approach

HSQCP

VAMC Reports VISN Report Summary Report As agreed to by contractor and COR within the 1-year PoP

Bi-weekly TO Team Meeting Progress Report

Quarterly Progress Report and Action Plan 26 Base 26 Option

26 Base 26 Option 4 Base 4 Option Periodic on day agreed to between contractor and COR

5. Period of Performance. The Period of Performance will be a base of 1 year after date of award with 2 additional 1 year option periods.

6. Type of Contract. This will be a hybrid Firm Fixed Price (FFP) and Labor Hour (LH) task order.

7. Place of Performance. Contractor must be able to support central Program Offices located in Washington DC as well as various VAMC s throughout the continental United States. Contractor will be notified of all locations and duty stations prior to solicitation.

8. Travel. It is anticipated that travel will be required for the initial evaluation and to monitor the implementation of projects at multiple VAMCs through the Continental United States. A travel schedule will be identified during the PM planning phase. Travel may be required with short notice to the contractor. Contractor must be able to accommodate dynamic and changing requirements that may entail travel to various VHA and VAMC facilities.

9. Government-Furnished Information, Equipment, and Facilities. Government-Furnished Information, Equipment and Facilities is not required at this time.

10. Security Requirements. [If applicable, specify. VA 6500.6 Checklist, Appendix A (Attachment D below) must be completed and signed by COR and ISO. Include any special security requirements beyond what is included in the base contract here.]

11. Key Personnel. Key Personnel will have proven and extensive knowledge of Sterile Processing at VHA Medical facilities and Private Industry Healthcare Systems.

a. SPS Program Manager: The contractor shall designate a Program Manager who has 10 years of experience in healthcare areas relevant to the tasks defined in this PWS. The Program Manager is defined as a person with a master’s degree and experience relevant to the task order requirement. Such experience shall include planning, initiating, managing, executing and closing out programs in support of an integrated Health Care System. The Program Manager shall assist VA in the execution of targeted program goals. Additionally, contractor personnel shall possess a Project Management Professional (PMP) certification or similar in quality with a minimum of six years’ experience supporting a large corporation or government agency.

b. Supply Change SME: The contractor shall designate a Supply Chain SME to lead teams on a variety of Supply Chain Optimization projects. This requires the skills of a highly collaborative and professional leader with expertise in all functions of Supply Chain. Proven experience in business development in one or more supply chain functions and lead project delivery teams for national industry. SME will have experience in the improvement of the practice’s services, methodologies, tools, templates, and ensure delivery of high-quality projects. Advisory and client relationship management skills, including strong oral communication skills, distinctive problem solving skills, and ability to architect solutions with clients real-time Expertise in business process improvement methodologies and transformation (e.g., Lean Six Sigma, Business Process Reengineering) and end-to-end supply chain management (e.g., demand forecasting, logistics sourcing) Experience with technology solutions from leading vendors (e.g. SAP, Oracle, JDA Software, Microsoft and others) Deep understanding of supply chain management principles, process improvement, and business process re-engineering methodologies Strong practice building skills, including the capacity to identify and attract leading talent, delegate effectively, and inspire a team Strong customer presence - excellent communication (written and oral), presentation, and interpersonal skills. Strong leadership and project management skills.

c. Bio Med Engineer SME: The contractor shall designate an Environment of Care (EOC)/Safety SME to provide expertise in infrastructure and capital management relevant to maintaining and modernizing the existing infrastructure. Tasks may include assessing VA facility engineering and safety programs, conducting root cause analysis on a myriad of topics, and providing expert consultation into capital asset, EOC, and Safety related policy and other issues. The EOC/Safety SME will have proven experience in VA, large government or a large integrated healthcare system leading safety and capital asset programs and with a deep understanding of capital asset infrastructure, facility condition assessments, assessing safety risks and adequacy of the environment of care. 20 years of experience and a master’s degree.

d. Infectious Disease/Regulatory/Sterile Processing SME/Health Systems Analyst The contractor shall designate Health Systems (HS) experts to support VHA in the analysis, design, development, and implementation of appropriate business processes within the organization. The HS expert shall assist VHA with the analysis of current and future state concepts for the VHA; development of new business processes; diagnosis of current problems, and redesign, reconstruction, and monitoring processes to make sure they are effective. The HS expert shall assist VHA with the continuous analysis per policy or organizational changes. The Senior Health Systems SME shall have proven and extensive experience in a large-scale Government Integrated Healthcare System with substantive programs focused on Veterans health care (e.g Patient Centered Medical Home; Mental Health; Prosthetics; Tele Health; Mental Health (including Residential Rehabilitation and PTSD); Women’s Health; Specialty Care; Veterans Homelessness, and Geriatrics and Extended Care). In addition, the HS must have extensive experience in/with VHA and VHA Medical Center Operations; working knowledge of the Veterans Service Integrated Network (VISN); experience with/knowledge of clinical and business processes within the VHA.

12. Task Order Quality Assurance Surveillance Plan (QASP). [Complete table below based on requirements and edit the surrounding paragraphs as appropriate. It is the responsibility of the TO COR to ensure review and contractor compliance with these standards.]

The Government shall evaluate the contractor's performance in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the government must do to ensure the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rates.

Standard Surveillance Method Outcome

[Insert]

[Example: Delivery of Services]

[Example: Quality of Deliverables] [Insert]

[Example: Services shall be provided in accordance with the Deliverable Schedule 100% of the time]

[Example: The services shall meet the requirements as outlined in Section X of the IDIQ Contract]

[Example: Deliverables shall be free of grammatical and typographical errors 95% of the time] [Insert]

[Example: 100% inspection. The TO COR will review each Deliverable for quality/timeliness according to criteria established in this TO.] [Insert additional specifics as applicable. May include performance incentives or disincentives.]

Poor performance may result in issuance of a Contractor Discrepancy Report (CDR), as outlined in Section 5.2 of the IDIQ contract. The contractor’s performance on this TO will be reported to the Contractor Performance Assessment Reporting System (CPARS) on an annual basis. The CO and COR will make use of information from CDRs, as well as any additional knowledge and information available to them with respect to the contractor’s performance, to complete the CPARS.

The Government will not pay for services that do not conform or do not meet performance standards, or have not been properly rendered.

The contractor will be given an opportunity to correct non-conforming services at no cost to the Government if the services are non-conforming or the contract requirement is unacceptable.

The Contractor’s performance on this task order will be reported on an annual basis to the Contractor Performance Assessment Reporting System (CPARS). Poor performance may result in issuance of a Contractor Discrepancy Report (CDR), as outlined in Section 5.2 of the IDIQ contract. The CO and COR will make use of information from CDRs, as well as any additional knowledge and information available to them with respect to the contractor’s performance, to complete the CPARS. The Government will not pay for services that do not conform or do not meet performance standards or have not been properly rendered. The contractor will be given an opportunity to correct non-conforming services at no cost to the Government if the services are non-conforming or the contract requirement is unacceptable.