Health Care Department Operations Manual

Chapter 1 – Health Care Governance and Administration

Article 2 – Health Care Program Governance

1.2.7 Institution Patient Safety Program

Policy
- California Correctional Health Care Services (CCHCS) shall maintain a Patient Safety Program at each California Department of Corrections and Rehabilitation (CDCR) institution to prevent and mitigate risk to patients through comprehensive system surveillance, including a robust health care incident reporting system; process improvement; and a culture of sustainable high performance, safety, and learning.
Procedure
- Institution leadership including, but not limited to, the Chief Executive Officer (CEO), or designee, Chief Support Executive, Chief Medical Executive, Chief Nurse Executive, Chief of Mental Health, Chief Psychiatrist, Pharmacist-in-Charge, Supervising Dentist, and the Health Program Manager (HPM) III, Quality Management (QM) shall:
  - Establish a Patient Safety Subcommittee (PSS) utilizing the institution quality committee structure and processes to oversee operation of the local Patient Safety Program.
  - Maintain a daily process for reviewing and following up on health care incident reports.
  - Monitor local patient safety surveillance data and use the Patient Safety Dashboard and electronic Health Care Incident Reporting (eHCIR) registry to conduct analyses for review and presentation of findings and recommendations to the institution PSS.
  - Elevate urgent patient safety matters or trends that are identified through patient safety surveillance data to the CEO, regional leadership, and headquarters Patient Safety Program.
  - Ensure that health care staff have access to patient safety training and decision support tools (e.g., toolkits, job aids, guides, forms, checklists, and flowcharts) to support patient safety surveillance, health care incident reporting and review, Root Cause Analyses (RCAs), problem analysis, and process redesign.
  - Support outreach and other activities that encourage timely reporting of all health care incidents including near misses, medication events, and sentinel events by institution health care staff.
  - Communicate and promote patient safety awareness to institution staff by sharing patient safety stories, alerts, findings and recommendations from reports and special studies, RCA recommendations, as well as engagement in Patient Safety Week, celebrating local Patient Safety Champions, encouraging participation in patient safety surveys, and other awareness initiatives.
  - Ensure patient participation in the evaluation and improvement of the health care system, including establishing a Patient Advisory Council (health care-focused Incarcerated Person Advisory Council meetings) as a means of regular information sharing, problem-solving, and collaboration, and regular communication with Peer Support Specialists and other peer mentor groups.
  - Promote an organizational culture of continuous learning and improvement.
- Identification of Health Care Incidents and Duty to Report
  - All CDCR and CCHCS staff have a duty to report health care incidents within 24 hours of occurrence or discovery using the eHCIR System. The eHCIR System is available to all staff via eHCIR Application and allows health care incidents to be reported anonymously.
  - Although many health care incidents will be initially detected by institution health care staff, they can also be identified by other staff, patients, and stakeholders through existing feedback forums and communication channels.
  - Program leads and any person with a leadership role or authority shall not prohibit, discourage, or create any physical, electronic, or process barriers that prevent or delay staff from reporting health care incidents to the eHCIR System.
  - Health care incident reports do not satisfy compliance with any other legal obligations to report.
- Immediate Action Following a Health Care Incident
  - Mitigate Risk
    - Upon discovering a health care incident, institution health care staff shall immediately take steps to ensure patient safety including, but not limited to:
    - Stabilizing the patient by providing all necessary and appropriate care.
    - Removing all unsafe devices, equipment, and medications.
    - Determining whether the health care incident places other patients, staff, or visitors at immediate risk of harm and addressing those risks appropriately.
  - Notification
    - During regular business hours, staff who have identified a health care incident shall immediately notify their direct supervisor.
    - After regular business hours, staff who have identified a health care incident shall immediately notify the program supervisor or nursing program lead on duty.
    - For all deaths and sentinel events as defined in policy, including medication events with an assigned severity level (Appendix 2: Table 1. eHCIR – Health Care Incident Security Levels) of Moderate or Severe, the notified supervisor or nursing program lead shall immediately contact the CEO, who shall then determine which additional institution staff must be apprised of the situation and within what timeframes.
    - When appropriate, notification to the CEO shall include, at a minimum, the following information:
      - Name of patient, staff, or visitor involved.
      - Nature of the health care incident (what occurred).
      - Location of the health care incident.
      - Date and time of the health care incident.
      - Actions taken, treatment provided, and the effects.
      - Current condition of patient, staff, or visitor.
      - Any other pertinent information.
    - Institution staff shall document notification of patients as required by state law.
    - The supervisor shall notify the Pharmacy program lead of an adverse drug reaction. The Pharmacy program lead shall complete a United States Food and Drug Administration (FDA) MedWatch Form FDA 3500 if appropriate per FDA instructions.
    - The CEO, or designee, shall elevate urgent patient safety risks which require headquarters or regional involvement to mitigate risk.
  - Preserve Materials, Supplies, and Other Related Items
    - When feasible and where indicated, staff shall ensure that physical materials, supplies, and other related items are retained for the health care incident review process and remain in the condition applicable at the time of the health care incident.
  - Provide Relief and Support to Caregivers
    - The program supervisor or nursing program lead managing the area where the health care incident occurred and the appropriate clinical program leads shall immediately evaluate the impact of the health care incident on all involved staff and provide support to staff as appropriate, such as redistributing patient loads to allow caregivers time to cope with the situation.
  - Documentation
    - Health care staff shall ensure that clinical information related to the health care incident, such as treatment provided, is documented appropriately in the health record.
    - If appropriate, the Local Health Care Incident Review section within the respective eHCIR incident report shall be updated to reflect follow-up actions taken by the institution.
- Deaths
  - Health care incidents that result in deaths shall receive a separate mortality review pursuant to the Health Care Department Operations Manual (HCDOM), Section 1.2.10, Mortality Review and Reporting and the Mental Health Services Delivery System Program Guide, Chapter 10, Suicide Prevention and Response, which covers a different scope than the RCA process.
  - Findings from the mortality review process may result in the assignment of an RCA.
- Local Health Care Incident Report Review
  - The eHCIR Registry shall be monitored by designated Quality Management Support Unit (QMSU) staff every business day to identify health care incident reports that may need local staff follow-up.
    - For incidents with a severity rating of None or Mild, QMSU staff shall enter follow-up information into the eHCIR or elevate to a subject matter expert (SME) for review and follow-up, if needed.
      - If follow-up is needed, the QMSU or SME shall document the action taken within the respective eHCIR incident report within seven business days.
    - For incidents with a severity rating of Moderate, Severe, or Death, QMSU staff shall assign the incident report to a SME for review.
      - The QMSU or SME shall complete follow-up documentation within the respective eHCIR incident report within seven business days.
    - Health care incidents that are potentially attributable, in whole or in part, to the pharmacy or its personnel shall be addressed pursuant to the HCDOM, Section 3.5.11 Pharmacy Quality Assurance Program.
    - Unexpected deaths, serious injuries or events, significant property damage or multiple similar acute incidents shall be assigned to a SME and elevated immediately to the QM HPM III and CEO.
    - Inaccurate demographic information found in the original health care incident report shall be communicated to the headquarters Patient Safety Program within two business days of discovery.
- Root Cause Analysis
  - RCA Assignment and the RCA Team
    - As soon as possible, and no later than 24 business hours after an RCA is assigned by the Statewide Health Care Incident Review Committee (HCIRC) and accepted by the CEO, the CEO shall convene a multidisciplinary team to conduct the RCA. This team shall be responsible for identifying and analyzing the primary system or process lapses that contributed to the sentinel event and developing a detailed Plan of Action to prevent similar events from occurring in the future.
    - The CEO shall determine the scope and membership of the RCA Team.
    - An institution may elect to initiate and self-assign an RCA.
      - Self-assigned RCAs are not required to be reported to the HCIRC, but if requested by institution leadership, the HCIRC can provide oversight.
      - If an incident that led to a self-assigned RCA is identified as a sentinel event and formally assigned an RCA by the HCIRC, the institution shall meet all RCA requirements described in this procedure.
  - Context of an RCA
    - Prior to beginning the RCA process, the RCA Team shall review the CCHCS Performance Improvement Culture Statement (Appendix 1) to ensure that all members understand the context of the RCA process and that the primary emphasis of an RCA is focused on system lapses, not the behavior of individual staff.
  - RCA Report and Plan of Action
    - The RCA Team shall utilize the CCHCS RCA Tool Kit to guide them through the RCA process, ensuring that all required elements described in the RCA Tool Kit are included in the final RCA Report. The CCHCS RCA Tool Kit is available on Lifeline.
    - The RCA Report shall be completed, approved by the CEO or Warden, or by both when joint approval is required, and submitted to the HCIRC within 45 business days from the date that the RCA was assigned.
    - Unless otherwise instructed by the HCIRC, the institution shall begin implementation of the Plan of Action as soon as possible, but no later than upon submission of the RCA Report to the HCIRC.
    - If upon review of the RCA Report the HCIRC requests clarification or revision of the report, the institution shall make necessary clarifications or revisions and submit the revised report to the HCIRC within 15 business days of the request.
  - Plan of Action Monitoring
    - The institution shall submit an RCA Plan of Action status update monthly to the HCIRC following submission of the RCA Report until the HCIRC formally closes the case.
- Institution Patient Safety Subcommittee
  - Institution PSS shall:
    - Conduct local patient safety surveillance per the PSS Measurement Plan and Schedule.
    - Identify problematic health care processes and establish priority areas for patient safety risk mitigation.
    - Initiate improvement projects in coordination and collaboration with various program areas to redesign local health care processes to improve patient safety.
    - Ensure oversight and timely completion of RCAs and monitoring of RCA Plans of Action, including monthly reporting to and coordination with the Statewide HCIRC.
    - Support outreach and other activities that encourage institution staff to report health care incidents including near misses, medication events, and sentinel events.
    - Communicate patient safety stories, alerts, issues, reporting trends, and RCA recommendations and associated systems improvements to institution staff.
    - Lead annual Patient Safety Week activities and engage in other patient safety awareness and educational initiatives.
    - Ensure the institution routinely involves patient representatives in the evaluation and improvement of the health care system through regular collaboration with the Patient Advisory Council, Peer Support Specialists, and other patient leaders.
    - Report to the Institution Quality Management Committee (QMC).
  - Membership, Quorum Requirements, and Meeting Frequency
    - The HPM III, QM shall serve as chairperson of the institution PSS. The chairperson is responsible for ensuring that the PSS meets regularly, the committee agenda reflects the responsibilities described in this procedure, and committee decisions are appropriately documented, and that each member of committee has signed a confidentiality agreement.
    - The institution program lead, or designee, for Dental, Medical, Mental Health, Nursing, and Pharmacy, as well as one designated custody representative shall serve on the PSS.
    - Each member has one vote, and a quorum exists when more than one-half of voting members are present. A quorum must be present to conduct a valid meeting and to protect the integrity of the decision-making process.
    - Non-voting participants and presenters may attend as appropriate if approved by the PSS Chairperson.
    - The PSS shall meet at least monthly or more often as necessary to carry out its responsibilities.
    - Electronic records of committee proceedings shall be kept in a secure location for ten years.
- Patient Advisory Council (PAC)
  - QMSU Leadership shall:
    - Coordinate and facilitate the PAC.
    - Advise institution leadership about effective change management strategies to incorporate patient feedback into health care program planning.
    - Report about the PAC to the Institution QMC at least quarterly.
  - Recommended PAC Responsibilities:
    - Disseminate information to the patient population about upcoming health care system changes.
    - Provide feedback to health care leaders about what is working and not working in the health care system from the patient perspective.
    - Assist health care leaders in collecting feedback from the broader patient population through mechanisms like surveys, focus groups, and continuous feedback mechanisms.
    - Assist health care leaders in improving the health care system, including assisting with targeted outreach to patient subpopulations, recommending and supporting implementation strategies, and problem-solving when programs are not getting the intended results.
    - Participate in health care process improvement projects, as appropriate.
  - Membership, Quorum Requirements, and Meeting Frequency
    - Membership criteria to select PAC members shall be consistent with that of the Inmate Advisory Committee (IAC) and representative of the incarcerated population.
    - The PAC shall meet monthly with health care staff.
    - Electronic records of committee proceedings shall be kept in a secure location for ten years.
- Confidentiality – Protected Proceedings and Records
  - The records of the committees and staff responsible for the evaluation and improvement of the quality of patient care shall be maintained as confidential and protected from discovery to the extent permitted by law.
  - All staff shall maintain confidentiality regarding patient safety records, including, but not limited to, health care incident reports and documentation from health care incident reviews or the RCA process.
  - Refer all requests for patient safety records (e.g., health care incident reports, RCA reports) to the Statewide Patient Safety Program at: m_PatientSafety@cdcr.ca.gov, for review and processing. Patient safety records may not be released to any unauthorized person, organization, or stakeholder prior to Statewide Patient Safety Program approval.
Appendices
- Appendix 1: Performance Improvement Culture Statement
- Appendix 2: eHCIR – Health Care Incident Security Levels
References
- California Health and Safety Code, Division 2, Chapter 2, Article 1, Section 1250
- California Health and Safety Code, Division 2, Chapter 2, Article 3, Sections 1279, 1279.1, and 1279.2
- California Department of Corrections and Rehabilitation, Department Operations Manual, Chapter 3, Article 2, Health and Safety Program
- California Department of Corrections and Rehabilitation, Department Operations Manual, Chapter 5, Article 11, Section 51110.11, Written Reports
- California Department of Corrections and Rehabilitation, Mental Health Services Delivery System Program Guide, Chapter 10, Suicide Prevention and Response
- Health Care Department Operations Manual, Chapter 1, Article 2, Section 1.2.6, Statewide Patient Safety Program
- Health Care Department Operations Manual, Chapter 1, Article 2, Section 1.2.10, Mortality Review and Reporting
- Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.11, Pharmacy Quality Assurance Program
- Food and Drug Administration, MedWatch: The FDA Safety Information and Adverse Event Reporting Program (http://www.fda.gov/safety/medwatch/default.htm)
- The Joint Commission https://www.jointcommission.org/topics/patient_safety.aspx
- National Commission on Correctional Health Care 2008 Standards for Health Services in Prisons
- National Coordinating Council for Medication Error Reporting and Prevention
- United States Department of Veterans Affairs – Veterans Affairs National Center for Patient Safety (http://www.patientsafety.va.gov/)
- Veterans Health Administration Vision 2020
- California Department of Public Health Center for Health Care Quality (https://www.cdph.ca.gov/Programs/CHCQ/Pages/CHCQHome.aspx)
Policy Control
Executive Sponsor: Deputy Director, Quality Management
Effective: 11/2012
Revised: 11/2018, 10/12/2026

Appendix 1

Performance Improvement Culture Statement
Patient safety is the fundamental responsibility of every person in the correctional health care delivery system. California Correctional Health Care Services (CCHCS) promotes a culture of continuous learning and improvement where all staff focus on making processes and outcomes as safe and effective as possible. CCHCS aims to develop and implement systems that support sustainable, high-quality performance. At CCHCS, leadership teams foster a culture of trust that empowers staff to report process breakdowns and take action to make improvements.
CCHCS recognizes that:
Most health care incidents are caused by systems problems that need to be examined and repaired before performance can truly improve.
To identify opportunities for improvement, CCHCS staff at all reporting levels must be able to report health care incidents without being subject to unjust punitive investigation and penalties.
Human error is unavoidable and it is through continuous systems improvement that we can help prevent errors.
Blaming people ignores systemic problems and leaves others at risk for harm. But, in rare cases such as reckless behavior or blameworthy acts, the involved person must be held accountable.
CCHCS staff shall:
Report health care incidents.
Review health care incidents to mitigate immediate harm and identify opportunities to improve.
Analyze processes and implement improvements that ensure safe health care delivery.
Work together across ranks and disciplines to find lasting solutions to patient safety issues.
Respond quickly and reasonably to actions, decisions, and behaviors that may result in unsafe acts, realizing that most actions, decisions, and behaviors do not warrant disciplinary action.
Policy Control
Executive Sponsor: Deputy Director, Quality Management
Effective: 11/2012
Revised: 11/2018, 10/12/2026
Appendix 2

Table 1. eHCIR – Health Care Incident Severity Levels

SEVERITY LEVEL	DESCRIPTION
None	Outcome was not symptomatic or no symptoms were detected, and no treatment was required.
Mild	Patient outcome was symptomatic, symptoms were mild, loss of function or harm was either minimal or intermediate but short-term and no intervention or only a minimal intervention, e.g., extra observation, investigation, review or minor treatment, was required.
Moderate	Patient outcome was symptomatic, required more than minimal intervention, e.g., additional operative procedure or additional therapeutic treatment and/or caused permanent or long-term harm or loss of function.
Severe	Patient outcome was symptomatic, required a life-saving or other major medical/surgical intervention, shortened life expectancy and/or caused major permanent or long-term harm or loss of function.
Death – Expedited HCIRC Review	Death with concern for incident contributing in the short-term to patient death.
Death – Routine Mortality Review	No obvious incident/likely natural or expected course.

Policy Control
Executive Sponsor: Deputy Director, Quality Management
Effective: 10/12/2026