QSS - ISO 35001 Implementation Pilot Yr. 2 Project Plan.pdf

Center for Surveillance, Epidemiology and Laboratory Services (CSELS) Division of Laboratory Systems (DLS)

CDC-RFA-OE20 -2001: Enhancing Public Health Laboratory Capabilities and Increasing Capacity

New Focus Area Project Plan Template

SECTION 1: GENERAL INFORMATION

1.

Name of Applicant:

Association of Public Health Laboratories (APHL) 2.

Focus Area:

Quality and Safety Systems

3.

Requested Funding Amount: (Whole Numbers Only)

$25,000 4.

Funding Source (e.g., BA, COVID, PPHF, OPIOID):

BA

5.

Name of Project:

ISO 35001 Implementation in Public Health Laboratories

6.

Name of Technical Monitor(s):

William (Bill) Arndt 7.

Technical Monitor(s) Email Address:

opu9@cdc.gov

8.

Technical Monitor(s) Phone Number:

404-498-0657

9.

Name of Focus Area Coordinator (FAC):

Victor R. De Jesus

10.

Email Address of FAC:

foa5@cdc.gov

11.

Phone Number of FAC:

770-488-7963

SECTION 2: PROJECT SUMMARY

2.1 – Project Description

Project Status: Select whether your project/activity is an entirely new project or an extension of an existing project:

☒New CIO Project/Activity

☐ CIO Existing Project/Activity (Expansion/Change of Scope)

Project Description: Provide a description of the project including a justification for the project’s bona fide need in the space below:

Background: ISO 35001:2019 Biorisk management for laboratories and other related organizations defines a process and provides tools to identify, access, control and monitor risks associated with hazardous biological materials. ISO 35001 is based on a biorisk management system approach and defines the framework components to be integrated into a laboratory’s overall governance, strategy and planning, management, reporting processes, policies, objectives, values and culture to mitigate biosafety and biosecurity risks.

Purpose: This project is designed to develop a strategy, provide guidance, and support the implementation and use of a biorisk management system in accordance with ISO 3500:2019 in public health laboratories. The goal of this biorisk management system is to establish, document, implement, communicate, maintain and continually improve processes and operations to reduce the biological risks inherent in laboratory activities.

Significance: The biorisk management system is built on the concept of continual improvement (Plan, Do, Check Act model); the identification and correction of system deficiencies will result in improved performance and control of biorisks. In addition, a biorisk management system can assist an organization to fulfill its legal requirements; and can be applied to any organization, large or small, domestic or international, that works with, stores, transports, and/or disposes of hazardous biological materials.

Expected Results: Implementation of ISO 35001 in public health laboratories will enable these organizations to improve their internal processes to reduce incidents, accidents, infections and illnesses that may result from laboratory operations. In turn, public health laboratories can then assist clinical laboratories in their jurisdictions to implement a biorisk management system in order to improve laboratory quality and safety, and reduce harm to laboratory professionals.

Activities: Describe activities to be carried out in this project as well as their associated deliverables:

QSSB will work with the Association for Public Health Laboratories (APHL) to prepare, assist and support public health laboratories in successfully implementing ISO 35001. Furthermore, QSSB will also work with our partners to identify and pilot the implementation strategy at two (2) public health laboratories. Following this pilot test, the implementation strategy will be revised if needed, and then implemented within the pilot laboratories to support biosafety best practices and to ensure the safety of the laboratory staff responsible for conducting diagnostic testing, surveillance, and clinical research.

2.2 – Project Strategy and Outcomes Project Strategies: Select one or more strategies that the project will contribute towards:

☒S1. Science, Management and Operations

☐S2. Policy, Partnership and Communication

☒S3. Training and Capacity Building

☒S4. Laboratory Quality, Safety and Informatics for Public Health Testing Services, Surveillance and Response

For this Project: Select the outcomes that the project will contribute towards Please check and select responses for all applicable boxes below.

POs and IOs Proposed for this Project

PO-1. Improved collaboration and communication across public health laboratories and other stakeholders.

PO-2. Improved awareness and understanding of public health laboratory capabilities and needs among public health laboratories and other stakeholders.

PO-4. Improved awareness of new tools and resources for public health laboratories and other stakeholders.

PO-5. Increase in needs met due to improved awareness and understanding of public health laboratory training and professional development needs and opportunities among training and workforce development stakeholders.

PO-6. Improved access to and participation in training and workforce development resources and opportunities among current and potential laboratory professionals.

PO-7. Enhanced knowledge, skills, and abilities among current and potential public health laboratory professionals in diverse settings.

PO-8. Improved awareness of public health laboratory informatics capabilities. ☐ PO-9. Improved implementation of quality and safety systems and model practices in public health laboratories.

PO.10. Improved knowledge of technical assistance needs and priorities in state and local public health laboratories.

PO-11. Improved and ongoing awareness and understanding among stakeholders of emerging methods and processes in public health laboratories.

PO-12. Improved dissemination of evidence-based practices to public health laboratories and other stakeholders.

PO-13. Improved laboratory testing capability and surge capacity for emergency response through equipment procurement, competent staff and partnerships.

NEW S1.PO-14 Implement approaches to ensure efficiency for committee/subcommittee functions ☐ NEW S1.PO-15 Maintain monitoring and evaluation processes across all focus areas ☐ NEW S1.PO-16 Maintain and ensure process and system of effective knowledge management and commitment to rigorous scientific integrity, quality, and professional standards of practice in development of APHL products

NEW S4.PO-1 Better informatics solutions available for public health laboratory system-wide adoption ☐ NEW S4.PO-2 Improved, timely public health laboratory access to and awareness of needed resources ☐

NEW FLS.C.PO-1 Improved dissemination of clear, compelling, targeted, and timely messages using appropriate communication channels for relevant audiences

NEW FLS.C.PO-2 Increased production of communications materials, websites or other digital platforms, or any other resources with APHL-CDC logo use (i.e., co-branding and logo licensing)

NEW FLS.C.PO-3 Improved dissemination of APHL-CDC co-branded materials or resources for public health laboratories and other stakeholders

NEW Ph2.ID.PO-1 Improve testing capability/capacity to conduct and report low-volume or highly-specialized testing efficiently.

NEW Ph2.PHPR.PO-1 Ensure compliance and access to essential, centralized resources for laboratory testing capability and surge capacity for coordinated emergency response.

NEW QSS-S4.2-PO1. Increased public health laboratory and system partner participation/commitment to L-SIP assessment/reassessment process.

NEW QSS-S4.2-PO3. Improved implementation of quality and safety system model practices across participating public health laboratory system (state/local level).

NEW QSS-S4.2-PO2. Increased participating public health laboratory, system partner knowledge of quality needs and model practices.

IO-1. Expanded Communities of Practice and other collaborative relationships among public health laboratories and other stakeholders.

IO-2. Strengthened information sharing across public health laboratory networks and other stakeholders. ☐ IO-3. Improved engagement and participation of current and potential public health laboratory workforce through application of best practices.

IO-4. Enhanced practices, methods, and infrastructure within the public health laboratory system. ☒ IO-5. Improved data exchange and interoperability among public health laboratories and their partners. ☐ IO-6. Improved public health laboratory detection, surveillance, and response. ☐ IO-7. Improved quality and safety in public health laboratories. ☒ NEW S1.IO-8 Ensured effective leadership and management system for committees/subcommittees ☐ NEW S1.IO-9 An effective monitoring and evaluation system across the organization ☐ NEW S2.IO-3 (Old PO-3) Improved support for public health laboratories among policy makers ☐ NEW S3.IO-1 Leadership development participants granted increased leadership roles and/or responsibilities ☐ NEW S4.IO-1 System-wide adoption of informatics and data management solutions among public health laboratories and their partners

NEW S4.IO-2 Increased use of resources/outputs created and shared via technical assistance responses ☐ NEW S4.IO-3 Improved technical capability among recipients as a result of fulfilled requests ☐ NEW FLS.C.IO-1 Improved reach of clear, compelling, targeted, and timely messages among relevant audiences

NEW FLS.C.IO-2 Enhanced adoption or use of APHL-CDC co-branded materials or resources among public health laboratories and other stakeholders

SECTION 3: PROPOSED BUDGET

Instructions for Use of funds: Provide any restrictions or instructions for applicant use of funds, as applicable:

12-month period of performance

SECTION 4: ADDITIONAL CONSIDERATIONS

Reviewers’ feedback on additional considerations (if any):

We’ll work with APHL to complete Evaluation plan.

2/24/2021

X

Technical Monitor/Submitter

Signed by: PIV