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U.S. Department of Health and Human Services
Indian Health Manual

Chapter 14 - Clinical Engineering Program

Part 5 - Management Services

Title Section
Introduction 5-14.1
    Purpose 5-14.1A
    Background 5-14.1B
    Authority 5-14.1C
    Policy 5-14.1D
Responsibilities 5-14.2
    Director, Indian Health Service 5-14.2A
    Director, Office of Environmental Health and Engineering 5-14.2B
    Director, Division of Facilities Operations 5-14.2C
    Clinical Engineering Program Manager 5-14.2D
    Area Director 5-14.2D
    Area CEP Manager 5-14.2F
    Service Unit CEP Manager 5-14.2G
Area Biomedical Equipment Governance Committee 5-14.3
    Area Biomedical Eqquipment Governance Committee 5-14.3A
    Members 5-14.3B
    Acquisition Planning and Support 5-14.3C
Procedures 5-14.4
    Biomedical Systems Management Activities 5-14.4A
    Technical Services and Support 5-14.4B
    Patient Safety and Risk Management 5-14.4C
    Facilities Management-Related Services 5-14.4D

5-14.1  PURPOSE

  1. Purpose.  This chapter revises program elements and updates responsibilities for the administration and maintenance of the Indian Health Service (IHS) Clinical Engineering Program (CEP).
  2. Background.  The IHS CEP interfaces with all clinical programs (e.g., medical, pharmacy, dental, radiology/imaging, lab, etc.); information technology (IT) (e.g., healthcare network systems, telehealth, telemedicine, electronic health record, etc.); business office; institutional health; risk management and safety; and facilities management.  The IHS CEP provides:
    1. Acquisition planning and analysis for supporting the IHS/Tribal/Urban Health Program (I/T/U) goals.
    2. Installation, service, monitoring, training, and support of biomedical systems for safe health care delivery.
    3. Integration of biomedical equipment with clinical or health information systems for improved patient and population health management.
  3. Authority.The Indian Health Care Improvement Reauthorization and Extension Act of 2009.
  4. Policy.  The IHS will provide biomedical systems and medical equipment devices to support, enhance, and advance the delivery of health care to ensure American Indians and Alaska Natives (AI/AN) achieve the highest possible health status.

5-14.2  RESPONSIBILITIES

  1. Director, Indian Health Service.  The Director, IHS, is administratively responsible for and sets the goals for the delivery and improvement of health care services to AI/AN.
  2. Director, Office of Environmental Health and Engineering.  The Director, Office of Environmental Health and Engineering (OEHE) ensures support for clinical and patient care processes through CEP quality management activities, and appropriate biomedical systems planning, acquisition, and management, including:
    1. Planning and allocating budgets for the CEP.
    2. Monitoring continuous program improvement.
    3. Promulgating guidance to the Area Offices.
  3. Director, Division of Facilities Operations.  The Director, Division of Facilities Operations, OEHE shall:
    1. Support, monitor, and advocate for the CEP.
    2. Ensure policies and program guidance are effectively communicated, administered, and best-practices are shared.
    3. Allocate funding for the biomedical programs.
  4. Clinical Engineering Program Manager.  The IHS CEP Manager shall:
    1. Serve as the Headquarters principle technical consultant for biomedical systems.
    2. Provide guidance to Area and Service Unit CEP staff to implement an effective biomedical program.
    3. Publish technical handbooks, guidelines, and documentation to implement the CEP.
    4. Utilize computerized maintenance management systems to monitor and report biomedical device, system recalls, and hazard alerts.
    5. Oversee the planning, technical review, acquisitions, life-cycle management, segmenting Medical Device Data Systems onto appropriate Virtual Local Area Networks, and security practices for IHS biomedical systems in accordance with Departmental, regulatory, and accreditation guidelines and standards.
    6. Coordinate with the Office of Information Technology (OIT), IHS, to ensure biomedical technology aligns with IHS policies and standards for information technology.
    7. Review and coordinate approval by the Agency Information Technology Investment Review Board as outlined by the Capital Planning and Investment Control processes for medical devices that interface with IHS enterprise architecture.
    8. Coordinate with the Director, OIT, IHS to ensure biomedical technology aligns with IHS policies and standards for information technology.
    9. Represent IHS biomedical systems interests with the United States Food and Drug Administration and other Federal agencies through engaging interagency committees and standards bodies.
    10. Ensure the effective dissemination of biomedical knowledge and best-practices between the IHS and I/T/U to the widest extent possible, to continue both patient safety and clinical process automation.
  5. Area Director.  The Area Director shall:
    1. Monitor the Area CEP and implement continuous quality management activities to efficiently acquire, manage, integrate, secure, and support the safe and effective use of biomedical systems.
    2. Allocate available funds for CEP staff to conduct all necessary routine services including preventive maintenance activities, repairs, calibrations, and routine inspections of medical equipment.
    3. Provide appropriate CEP medical equipment and staffing funding.
    4. Ensure that medical equipment funds are used exclusively for biomedical systems purchase, maintenance, monitoring, testing, and repair.
    5. Establish an Area biomedical equipment governance committee and charter.
  6. Area CEP Manager.  The Area CEP Manager shall:
    1. Serve as the principle technical consultant for biomedical systems within the Area.
    2. Review Service Unit CEPs to ensure compliance with policy and procedures, and provide technical and policy guidance as appropriate.
    3. Coordinate, review, and provide technical assistance of acquisition and management plans within the Area and supported Service Units.
    4. Oversee and monitor an IHS standardized computerized maintenance management system equipment inventory, related support activity, and reporting alerts or recalls.
    5. Evaluate Area and Service Unit service contract expenditures and monitors operation and maintenance costs to maintain biomedical systems reliability, clinical performance, and ensure safe and appropriate use of patient care equipment.
    6. Share best practices for managing, replacing, and training on biomedical systems.
  7. Service Unit CEP Manager.  The Service Unit CEP Manager shall:
    1. Serve as the principle technical consultant for biomedical systems within the Service Unit.
    2. Ensure that medical equipment management plans support compliance with both IHS and Area policies and procedures.
    3. Establish cost-effective service contracts to support health systems performance and reliability.
    4. Maintain an updated biomedical system inventory in the IHS-standardized computerized maintenance management system including inspection and testing reports; warranty and repair records; preventive maintenance records; and ongoing schedules for future preventive maintenance activities.
    5. Review and update (as necessary) biomedical policies, procedures, and annual biomedical systems acquisition plans.
    6. Share best practices for biomedical systems acquisition, operation, maintenance, Electronic Health Records (EHR) interfacing, systems monitoring, and cyber security guidelines.
    7. Provide and document technical training to CEP staff and clinical services providers (in-service training) as recommended by the manufacturers, regulatory agencies, and accrediting bodies.  This includes:
      1. Clinical and biomedical engineering/technician 'technical' training.
      2. User training (e.g., nurse, laboratory/radiological/pharmacy technician training).
      3. Continuous quality management of programs.
      4. Accreditation, regulatory, standards, and applicable codes.

5-14.3  AREA BIOMEDICAL EQUIPMENT GOVERNANCE COMMITTEE

  1. Area Biomedical Equipment Governance Committee. The Area Biomedical Equipment Governance Committee shall:
    1. Recommend specific criteria for the planning, acquisition, testing, and certification of biomedical systems.
    2. Review Service Unit biomedical systems acquisition plans.
    3. Develop the Area biomedical systems acquisition plan.
  2. Members.  The committee may be comprised of representatives from staff specialties such as health program administration, professional services, patient safety, clinical engineering, facilities management, IT, and financial management.
  3. Acquisition Planning and Support.  Annually the CEP program staff identifies new and replacement biomedical systems and presents both clinical and business cases to the Area Biomedical Equipment Governance Committee.  The clinical and business cases shall include:
    1. Benefits to the program clearly identified (i.e., specify improved diagnostic quality, speed, or accuracy providing a stated clinical objective and/or improved clinical productivity by projected factor).
    2. Life cycle cost analysis conducted including installation, servicing (both in-house technical support and vendor service contract support), parts, updates, periodic testing, systems monitoring, help desk for customer service, and plans for excessing/disposal of any replaced equipment.
    3. Facilities preparation needs to be assessed to address requirements for routine and backup power, additional HVAC, x-ray shielding, structural enhancements, etc.
    4. Information technology interfacing/integration requirements (with the EHR, backup storage, etc.) and ongoing maintenance and monitoring support for additional systems.
    5. Cyber security requirements including ongoing patching, testing, validation/certification requirements, Business Partner Interconnection Security Agreement, and other agreements, as appropriate.

5-14.4  PROCEDURES

  1. Biomedical Systems Management Activities.  Clinical Engineering Program staff members provide supporting operations and management activities to achieve the best possible health outcomes through engaging and communicating broad activities including:
    1. Budget planning, development, and execution.
    2. Staff planning, personnel management and supervision.
    3. Technical and program guidelines.
    4. Policy and procedure development and execution.
    5. Conducting initial and ongoing testing, calibration, updating, and maintenance of owned, leased or patient-provided equipment, including maintaining and calibrating test equipment, shop spaces, and facilities used to repair medical equipment.
    6. Other general management support activities including consulting with I/T/U, contributing to Federal workgroups, engaging regulatory bodies, and supporting continuous training and development to maintain and strengthen professional competencies.
  2. Technical Services and Support.  The CEP Manager provides biomedical technical systems support either with in-house CEP staff or by contracted vendor/third-party support.  The support includes:
    1. Conducting initial inspections, installation acceptance testing, and performance validations.
    2. Ongoing performance testing, systems monitoring, maintenance, hardware and software updating, and medical equipment troubleshooting, repair, testing and performance verification/certification.
    3. Equipment records management using the approved computerized maintenance management system.
    4. Maintaining a parts inventory management program complete with appropriate test equipment.
  3. Patient Safety and Risk Management.  The CEP shall ensure patients receive care safely and effectively through the following activities:
    1. Training of clinical staff on the appropriate and safe use of medical equipment.
    2. Access control by 'authorized' and vetted personnel, such as vendors, and biomedical personnel, is critical to maintaining safe and effective diagnostic systems.
    3. Monitoring and implementation of patient safety and risk management processes and procedures.
    4. Managing medical device safety alerts, hazards, and recalls.
    5. Business partner interconnect services agreements (for vendor or health program partner access.
  4. Facilities Management-Related Services.  The CEP staff shall provide technical expertise in maintaining and operating biomedical systems present in healthcare facilities.  The CEP professional services/consultation support may include (but is not limited to):
    1. Facility emergency preparedness planning.
    2. Electrical power systems planning (continuous and emergency).
    3. Architectural/construction drawings and equipment review.
    4. Medical gas system testing and operations.
    5. Patient monitor/nurse call systems management.
    6. IT/Network Connectivity evaluation and planning.