CEM Procedure Manual (NEW)

Clinical Equipment Management
Procedure Manual
CEM Procedure Manual.CEM.000
Clinical Technology Management
Purpose: Functional Area:

The CEM Procedure Manual is a proprietary compilation of procedures, Operations
instructions, and supplements containing Sodexo branded processes for CTM.
Scope: Application:
Ongoing management of this tool by CTM. Unit
Input / Resources:
Policies and procedures, reports, records, training and all other associated
operations, compliance and business management elements.
Output / Results:
Comprehensive central process, document and records management system
used for each Sodexo CTM operating unit.
1. The Clinical Equipment Management (CEM) Procedures Manual is provided to assure that a
comprehensive system of Sodexo Clinical Technology Management (CTM) clinical equipment
management and associated information and records management is maintained and up to date at this
operating location.
2. Changes to this Manual will be recorded as requests and forwarded to CTM Brand Management, who
will engage the stakeholders to approve the change order request. Final revision will be through the
publisher of record noted below (in the document footer) or as a supplement publication to this manual.
3. Stakeholders will review requested changes and forward response to the coordinator as:
a. Approved
b. Disapproved – (providing commentary as to reason for disapproval or request for added
information)
4. Table of contents for various procedures and supplements are as follows:
Ref # Table of Contents Titles Page
CEM.TC1 Table of Contents 2
CEM.TC2 Supplement Instructions 3
CEM.TC3 Abbreviations 5
References
N/A
Integrated Processes, Data & Information Source/s
N/A
Record Keeping
Hard Copy Files - per Unit location File Directory
Sodexo CTM SharePoint Site
This Document and everything contained therein is the property of Sodexo. Reproduction, adaptation, or translation is prohibited without express written permission.© Copyright 2016, Sodexo. All rights reserved.
Publication: 2016/09/01 by CTM Quality Department; Last Review: See Supporting Publication Page 1
Table of Contents.CEM.TC1
Ref # CEM Procedure Page
CEM.001 Procedure Development and Review 6
CEM.002 Equipment Management and Maintenance Responsibilities 13
CEM.003 Initial Orientation, Competency Assessment & Prof. Development 16
CEM.004 Initial Inspection and Disposition of Equipment 28
CEM.005 Removal/Disposal of Equipment with ePHI 33
CEM.006 Planned Maintenance Strategy 35
CEM.007 Service Manuals 43
CEM.008 Planned Maintenance 46
CEM.009 Clinical Equipment Testing/Repair/Labeling 53
CEM.010 Service Request Procedure, Priority, and Response Time 57
CEM.011 Emergency Procedure for Clinical Equipment Failure 63
CEM.012 Hazard Alerts and Recalls 65
CEM.013 Incident Involving Clinical Equipment/SMDA Reporting 68
CEM.014 End of Life Equipment Management 72
CEM.015 Test Equipment Calibration 74
CEM.016 Clinical Equipment Operations Training (In-service Training) 78
CEM.017 Clinical Equipment Procurement Specifications 80
CEM.018 Emergency/Disaster Preparedness and Recall 83
CEM.019 Clinical Equipment Alarm Management 86
CEM.020 Quality Management System 88
CEM.021 Safety 91
CEM.022 Rounding Procedure 95
CEM.023 Participation in Committees 100
CEM.024 Vendor Management 102
CEM.025 Parts or Service Requisition Process 108
CEM.026 Complaint Handling and Service Escalation/Recovery Process 113
Supplement Instructions.CEM.TC2
The following CEM Procedure supplements require creation and/or maintenance by the account Director, or
Supervisor. Details for the requirements are found with the corresponding CEM Procedure.
Ref # CEM Supplement Page
CEM.001, Sup 1 Facility Approval of CEM Procedures 9
CEM.009, Sup 1 Example Labels 56
CEM.018, Sup 1 Emergency Call Documentation 85
CEM.022, Sup 1 Rounding Schedule 97
CEM.024, Sup 1 Vendor Logbook 105
The following are templates for CEM Procedure supplements which require creation and/or maintenance by
the account Director or Supervisor. The templates are available on the Sodexo CTM SharePoint Site to
download and edit. An appropriate substitute document can be used in place of the template. The suggested
templates can be found with the corresponding CEM Procedure.
CEM.001, Sup 2 Program Exceptions 11
CEM.001, Sup 3 Training Documentation Form 12
CEM.003, Sup 1 New Employee Orientation Checklist 20
CEM.003, Sup 2 New Director / Supervisor Orientation Checklist 24
CEM.003, Sup 3 Unit Specific Work Rules 27
CEM.004, Sup 1 Disposition Form 32
CEM.007, Sup 1 Letter to OEM Requesting Maintenance Recommendations 45
CEM.008, Sup 1 Department Planned Maintenance Notification 49
CEM.008, Sup 2 Devices Overdue Notification 50
CEM.008, Sup 3 Devices Two Months Overdue Notification 51
CEM.008, Sup 4 Device Removal From Service 52
CEM.010, Sup 1 Service Request Instructions 60
CEM.010, Sup 2 Manual Form For Recording Service Requests 61
CEM.010, Sup 3 Service Request Response Time 62
CEM.020, Sup 1 Work Order Audit 90
CEM.022, Sup 2 Department Rounding Checklist 98
CEM.022, Sup 3 Formal Rounding Checklist 99
CEM.024, Sup 2 Service Provider Procedure 106
Supplement Instructions.CEM.TC2
CEM.025, Sup 1 Vendor Service Request 111
CEM.025, Sup 2 Business Associates Agreement 112
CEM.026, Sup 1 Complaint Acknowledgement Letter 117
CEM.026, Sup 2 Complaint Investigation Report 118
Abbreviations.CEM.TC3
Table of Abbreviations
AAMI Association for the Advancement of Medical Instrumentation
AEM Alternative Equipment Maintenance
AHJ Authority Having Jurisdiction
ANSI American National Standards Institution
CEM Clinical Equipment Management
CFR Code of Federal Regulation
CM Corrective Maintenance
CMMS Computerized Maintenance Management System
CMS Centers for Medicare and Medicaid Services
CTM Clinical Technology Management
DM District Manager
EOC Environment of Care
ESI Electrical Safety Inspection
ePHI Electronic Protected Health Information
FDA Food and Drug Administration
MEMP Medical Equipment Management Plan
NFPA National Fire Protection Association
NIST U.S. National Institute of Standards
OEM Original Equipment Manufacturer
OSHA Occupational Safety and Health Administration
PDF Portable Document Format
PM Planned Maintenance
PO Purchase Order
SMDA Safe Medical Devices Act
SVP Senior Vice President
UL Underwriters Laboratories
Table of Contents.CEM.001
Reference CEM Procedure/Supplement Page
CEM.001 Procedure Development and Review 7
Supplement 1 Facility Approval of CEM Procedures 9
Supplement 2 Program Exceptions 11
Supplement 3 Training Documentation Form 12
Procedure Development and Review.CEM.001

To establish specific guidelines for new and revised procedures by defining Operations
procedure adoption, review, revision, and implementation.
Scope: Application:
Review of all and development of revised CEM procedures in approved Unit
document formats for use within a unit.
Input / Resources:
Labor hours for development and review.
Output / Results:
Systematic and consistent method and references for document development.
1. Sodexo Clinical Technology Management (CTM) will provide a set of standard Clinical Equipment
Management (CEM) procedures to the healthcare organization. These procedures will define how clinical
equipment maintenance and management activities will take place.
2. The CTM Director, Supervisor, or District Manager (DM) is to obtain approval of the CEM procedures from
the Environment of Care (EOC) Committee, Safety Committee, equivalent healthcare organization
committee, or an authorized designee for the healthcare organization. Approval of all CEM procedures in its
entirety is expected, unless otherwise noted, upon program implementation. The healthcare organization
committee or authorized designee is to review the procedures at an interval deemed appropriate by the
healthcare organization.
a. A record of the approval will be maintained and a copy is to be provided to the DM, Regional Vice
President (RVP), and CTM Brand Management.
b. The record of approval may take the form of a signed page, memo, email or other mutually
acceptable documentation. Further instructions and an example of the information that the record of
approval should contain can be found in CEM.001, Sup 1.
c. The approval record at a minimum must include:
i. List of all CEM Procedures, including procedure reference number and name
ii. Indication of the level of approval per procedure, approval levels include:
1. Accepted – Indicates that the healthcare organization approves the CEM procedure
as is, without revision.
2. Modified – Indicates that the healthcare organization approves the CEM procedure,
but with some modifications.
3. Not Adopted – Indicates that the healthcare organization does not agree to use of
the Sodexo CTM CEM procedure.
iii. Revision Details or Justification
1. If “Modified” is indicated as the level of approval, then details of all the modifications
must be provided.
2. If “Not Adopted” is indicated as the level of approval, then justification must be
provided and the healthcare organization procedure or supplement that is to be
followed in lieu of the CEM procedure must be indicated in the table and a copy of
the procedure or supplement must be provided.
3. All CTM personnel will be familiarized with the CEM procedures:

a. Review and understanding for all CTM personnel is required.
b. Completion of the review must be documented.
c. A Training Documentation Form (CEM.001, Sup 3) or other suitable documentation format (such as
a format provided by the healthcare organization) may be used to document the review. As an
option, a record of the review of CEM Procedures by CTM personnel may be maintained in the
CEM manual as a supplement to this procedure.
d. This review of CEM Procedures will take place:
i. During initial orientation
ii. Annually
iii. At any time an amended CEM procedure is approved by the healthcare organization.
4. The need for revision to existing procedures may be identified by any CTM personnel and is communicated
to Sodexo CTM Brand Management through the appropriate DM. The following process is followed for
review and inclusion of any revision to CEM Procedures:
a. The DM in collaboration with personnel submitting revision suggestion will submit a draft revision
including all details of the suggested changes.
b. Draft revision will be submitted to CTM Brand Management for review. CTM Brand Management will
work in collaboration with DM and RVP, Operations to determine necessity and scope of suggested
revision.
c. If the scope of the suggested revision is limited to individual account operations, the DM will submit
a program exception memo (CEM.001, Sup 2 – template) to CTM Brand Management and RVP for
review and approval. The program exception memo will:
i. Provide an overview of the changes in local operations from Sodexo CTM standard
practices.
ii. Be maintained on-site for review by any quality assurance inspector.
iii. Serve as documented proof that the suggested revision has been reviewed and is in
compliance with Sodexo CTM standards.
d. If the scope of the suggested revision is beyond individual account operations, Sodexo CTM
Operations Leadership Team will review the suggested revision for program modification.
e. Upon final review and approval, the appropriate Sodexo CTM procedure will be modified for account
use. The standard Sodexo CTM CEM procedure must be replaced by the revised procedure.
f. Sodexo DM and CTM Director or Supervisor will be responsible for local review and approval of
revised procedure and the implementation of the updated procedure.
References
Sodexo Policy Document Standard.ADS.002
Sodexo Policy Document Administration and Management.ADS.003
Facility Approval of CEM Procedures.CEM.001, Sup 1
Program Exceptions.CEM.001, Sup 2
Training Documentation Form.CEM.001, Sup 3
Record Keeping
Facility Approval of CEM Procedures.CEM.001, Sup.1

Document authorized approval of the CEM procedure manual by the Operations
healthcare organization.
Information / Data Required: Application:
Identification and details regarding authorization, as specified. Unit
Instructions:
An authorized healthcare organization designee or the healthcare organization Safety Committee (or similar
committee) will approve the CEM procedures upon program implementation and will review the procedures at an
interval deemed appropriate by the healthcare organization.
The record of review and approval will be determined locally in accordance with the healthcare organization
policy. The record of review may take the form of a signed page, memo, email or other mutually acceptable
documentation. A record of the approval will be maintained and a copy is to be provided to the District
Manager (DM), Regional Vice President (RVP), and Brand Management.
The approval record at a minimum must include:

1. List of all CEM Procedures, including procedure reference number and name
2. Indication of the level of approval per procedure, approval levels include:
a. Accepted – Indicates that the healthcare organization approves the CEM procedure as is, without
revision.
b. Modified – Indicates that the healthcare organization approves the CEM procedure, but with some
modifications.
c. Not Adopted – Indicates that the healthcare organization does not agree to use of the Sodexo CTM
CEM procedure.
3. Revision Details or Justification
a. If “Modified” is indicated as the level of approval, then details of all the modifications must be
provided.
b. If “Not Adopted” is indicated as the level of approval, then justification must be provided and the
healthcare organization procedure or supplement that is to be followed in lieu of the CEM procedure
must be indicated in the table and a copy of the procedure or supplement must be provided.
It is important to understand that the delivery Sodexo CTM program is based on the Clinical Equipment
Management procedures. These procedures define how maintenance and associated tasks will be
performed. Active review and approval of these procedures is necessary for program delivery.
Approval Revision Details / Justification / Facility

Ref # CEM Procedure
Level Procedure Reference
CEM.001 Procedure Development and Review
Equipment Management and

CEM.002
Maintenance Responsibilities
Initial Orientation, Competency
CEM.003
Assessment & Prof. Development
Initial Inspection and Disposition of
CEM.004
Equipment
Removal/Disposal of Equipment with
CEM.005
ePHI
CEM.006 Planned Maintenance Strategy
Facility Approval of CEM Procedures.CEM.001, Sup.1
Approval Revision Details / Justification / Facility

Ref # CEM Procedure
Level Procedure Reference
CEM.007 Service Manuals
CEM.008 Planned Maintenance
Clinical Equipment
CEM.009
Testing/Repair/Labeling
Service Request Procedure, Priority, and
CEM.010
Response Time
Emergency Procedure for Clinical
CEM.011
Equipment Failure
CEM.012 Hazard Alerts and Recalls
Incident Involving Clinical

CEM.013
Equipment/SMDA Reporting
CEM.014 End of Life Equipment Management
CEM.015 Test Equipment Calibration
Clinical Equipment Operations Training

CEM.016
(In-service Training)
Clinical Equipment Procurement
CEM.017
Specifications
Emergency/Disaster Preparedness and
CEM.018
Recall
CEM.019 Clinical Equipment Alarm Management
CEM.020 Quality Management System
CEM.021 Safety
CEM.022 Rounding Procedure
CEM.023 Participate in Committees
CEM.024 Vendor Management
CEM.025 Parts or Service Requisition Process
Complaint Handling and Service

CEM.026
Escalation/Recovery Process
A copy of any healthcare organization procedure or supplement referenced is to be provided.

N/A
Record Keeping
Program Exceptions.CEM.001, Sup.2
Date:
TO: [Click here and Enter Name], District Manager
FR: [Click here and Enter Name, Title]
RE: Standard Program Exceptions
The following change(s) to the standard Sodexo CTM Clinical Equipment Management program have been
requested by[Click here and Enter Name, Title of requestor], for[Click here and Enter Name of facility]:
[Click here and Enter CEM Policy Number]

Change from: [Click here and Enter Text to be changed]
Change to: [Click here and Enter Requested change]
[Click here and Enter CEM Policy Number]

Change from: [Click here and Enter Text to be changed]
Change to: [Click here and Enter Requested change]
The Clinical Equipment Management procedures and any changes listed require approval by the appropriate
customer authority.
APPROVAL OF REQUESTED CHANGES
____________________________ _________________________
[Click here and Enter Name] Date
District Manager, Operations
Training Documentation Form.CEM.001, Sup 3
Training Documentation Form

Facility Name:
Training Subject or Title:
Training Dates:
Contents or summary of the training session(s):
Employees who completed this training:

Print or Type Name Job Title Employee Signature
Trainer- Print Name Trainer- Qualifications Trainer- Provide Signature
Note: Please complete ALL sections of this form and attached a copy of this document to the training record in the
Sodexo CTM Computerized Maintenance Management System (CMMS).
Table of Content.CEM.002
CEM.002 Equipment Management and Maintenance Responsibilities 14
Supplements None N/A
Equipment Management and Maintenance Responsbilities.CEM.002

To establish specific guidelines and responsibilities for equipment use and Operations
support.
Scope: Application:
Define medical equipment, maintenance responsibilities, and department Unit
manager responsibilities.
Input / Resources:
Inventory, maintenance, management and documentation.
Output / Results:
Systematic and consistent method for equipment management and
maintenance.
1. In general, equipment may be defined as Clinical and Non-clinical equipment. CTM primarily
maintains and supports clinical equipment. These two categories are defined as:
a. Clinical Equipment: This equipment may be therapeutic, diagnostic, or provides monitoring
care to a patient. Therapeutic equipment is related to direct treatment of patients. Diagnostic
equipment involves analysis of disease or medical symptoms. Monitoring equipment involves
observation of patient. Clinical equipment can also be referred to as medical equipment or
medical devices. Examples of clinical equipment are cardiac monitors, infusion pumps, lab
equipment, radiographic/fluoroscopic systems etc.
b. Non-clinical Equipment: Non-clinical equipment is defined as a device or appliance that will
not meet the definition of clinical equipment. Examples of non-clinical equipment are office
machines, vending machines, toasters, coffee makers, lamps, refrigerators, televisions, etc.
2. For regulatory compliance purposes the healthcare organization must maintain a written inventory of all
clinical equipment regardless of ownership, dollar value, or device risk. This requirement includes rigid and
flexible endoscopes.
a. Equipment within the scope of the Sodexo Agreement
i. Upon request, CTM will provide an inventory of the clinical equipment within the scope of
the Sodexo Agreement with the healthcare organization.
ii. Also upon request, the inventory can include a specific identifier for clinical equipment
following an Alternative Equipment Maintenance (AEM) Planned Maintenance (PM)
strategy and clinical equipment identified as Critical / High Risk equipment (in
accordance with Procedure CEM.006).
b. Equipment outside the scope of the Sodexo Agreement
i. The department(s) or outside service provider(s) that maintain any clinical equipment
that is outside of the scope of the Sodexo Agreement is expected to manage and
provide the inventory of such equipment.
3. CTM will repair and maintain equipment in accordance with the selected Service Coverage Level as defined
in Schedule B of the Sodexo Agreement. As applicable, the following items will be provided:
a. Planned Maintenance and performance testing procedures
b. A system to correct equipment malfunctions
c. Historical data for each listed device to include repair and maintenance actions performed
d. Access to documentation for equipment users detailing work performed on a device and the
equipment status upon request
e. Inspection of new clinical equipment prior to initial use (in accordance with Procedure CEM.004)
f. Inspect of loaner and demonstration clinical equipment prior to its use (in accordance with
Procedure CEM.004)
g. Monitoring of clinical equipment sub-contracts and services
Equipment Management and Maintenance Responsbilities.CEM.002
4. Department managers within the healthcare organization have responsibility to:

a. Notify CTM when problems occur with clinical equipment in their department and ensure that the
department staff is familiar with the service request procedure.
b. Ensure that staff members responsible for the operation of clinical equipment are thoroughly
trained. Such training will include emergency procedures to be followed in cases of device failure.
c. Maintain user/operator instructions for equipment in their area of responsibility.
d. Notify CTM of clinical equipment entering or leaving the facility.
e. Allow no clinical equipment to be used in the department until inspected and approved by CTM (as
required by Procedure CEM.004).
References
42 CFR 482.41 – CMS Condition of Participation
Deeming Authority Interpretive Guidelines
Initial Inspection.CEM.004
Planned Maintenance Strategy.CEM.006
Computerized Maintenance Management System
Record Keeping
Hard Copy Files – per Unit location File Directory

Initial Orientation, Competency Assessment, and Prof.
CEM.003 17
Development
Supplement 1 New Employee Orientation Checklist 20
Supplement 2 New Director / Supervisor Orientation Checklist 24
Supplement 3 Unit Specific Work Rules 27
Initial Orientation, Competency Assessment, and Prof. Development.CEM.003

To establish specific guidelines for initial and ongoing review of competency Operations
for CTM personnel.
Scope: Application:
Define responsibilities for initial orientation of new employees and on-going Unit
competency assessments.
Input / Resources:
Training requirements and filing of proper documentation.
Output / Results:
Proper training, education and development for all Sodexo CTM employees.
1. Initial Orientation: The Orientation Checklist is used to document all orientation provided.
a. The CTM Director or Supervisor will present and review all the topics listed in the New Employee
Orientation Checklist (CEM.003, Sup 1) with new CTM personnel.
b. In the case that the new employee is the CTM Director or Supervisor, the District Manager (DM) will
present and review all the topics listed in the New Director / Supervisor Orientation Checklist
(CEM.003, Sup 2) with the new employee.
c. The Orientation Checklist is to be introduced to the new CTM personnel within the first week of
initial assignment.
d. The Orientation Checklist is to be completed, signed by the employee and the employee’s
immediate supervisor, filed in the respective employee training file, and a copy sent to CTM
Corporate within thirty (30) days of initial assignment.
2. Unit Specific Work Rules: Unit specific work rules must be reviewed and approved by the DM and Sodexo
Human Resources (HR) Business Partner prior to implementation at the healthcare organization.
a. All CTM personnel working at that location must read and sign the work rule document.
b. The CTM Director or Supervisor will present and review the work rules with all new CTM personnel
within the first week of initial assignment.
c. CEM.003, Sup 3 is a draft template of the Sodexo CTM Unit Specific Work Rules.
3. CTM personnel and client employees working in the department will attend the first available healthcare
organization orientation within thirty (30) days of initial assignment whenever possible.
a. Documentation of healthcare organization orientation attendance will be kept in accordance with the
healthcare organization policy
b. Documentation will also be kept in the computerized management maintenance system (CMMS).
4. CTM personnel and client employees working in the department will be fully orientated to the operations and
responsibility of the CTM Department within thirty (30) days of initial assignment.
a. This orientation includes the CEM Procedure Manual review and Sodexo CTM safety training.
b. Documentation of CTM orientation will be kept in accordance with the healthcare organization policy
and in the CTM Department.
5. Within ninety (90) days of initial assignment to the healthcare organization, and at least annually thereafter,
all CTM personnel will be required to complete the following:
a. Any healthcare organization training requirement
b. Clinical Equipment Management (CEM) Procedure review as defined in CEM.001
c. Sodexo CTM safety training as defined in CEM.021
d. Review of job description
e. Document/update training and experience records
6. Education and Training Documentation: Within ninety (90) days of initial assignment, CTM personnel
shall provide copies of all relevant education and training records.
a. As part of the overall review of competency, CTM personnel are required to record all education and
training in the CMMS and upload electronic copies of all relevant documentation.
i. For education this includes but is not limited to: diplomas or transcripts of all formal higher
education or military training, and professional certifications.
ii. For technical training this includes but is not limited to: training provided by the original
equipment manufacturer (OEM), third-party or independent training organizations, and on-
the-job training.
b. CTM personnel are required to keep all records in the CMMS up-to-date, and these records will be
reviewed as part of the annual evaluation of performance.
7. Competency Assessment: Any personnel that services clinical equipment shall complete a
competency assessment. An initial competency assessment will be performed within the first six (6)
months of initial assignment after which the competency assessments will be completed as part of the
annual evaluation of performance for any personnel that services clinical equipment. The competency
assessment is to ensure personnel servicing clinical equipment are competent to perform assigned
repairs and planned maintenance.
a. Any healthcare organization personnel that services clinical equipment and is under a CTM
Director or Supervisor shall follow the healthcare organization’s policy for conducting employee
competency assessments. If the healthcare organization does not provide a Competency
Assessment form to use then the Sodexo CTM Competency Assessment Form will be used.
b. Any CTM personnel that services clinical equipment shall use the Sodexo CTM Competency
Assessment Form (which can be found on the CTM SharePoint site or a copy can be obtained
from the Sodexo CTM Brand Management department) and complete the self-assessment
portion of the Sodexo CTM Competency Assessment Form.
c. A copy of all competency assessment will be stored on under the appropriate personnel’s record
in the Computerized Maintenance Management System (CMMS).
d. The service personnel’s immediate supervisors shall then complete the manager assessment
portion of the Sodexo CTM Competency Assessment Form and shall review the completed
competency assessment with the service personnel. In the case that the employee being
assessed is the CTM Director or Supervisor, the DM will conduct the manager assessment.
e. The immediate supervisor shall compare the current job description, the service personnel’s
education and training record in the CMMS, and the competency assessment results to identify
opportunities to train and enhance skills and qualifications of the service personnel.
f. The immediate supervisor shall develop a technical training plan for the service personnel based
on the comparison and on the equipment and service delivery strategy needs of the account.
8. Annual Performance Review: CTM personnel performance shall be evaluated once a year using the
Sodexo Performance Review tool (located on SodexoNet). Items reviewed as part of the annual
performance include but are not limited to:
a. Performance (as compared to assigned goals)
b. Competency assessment
c. Training and education records in the CMMS
d. Training and career and development plan
9. Depending on the job description and duties assigned, CTM may be required to complete the following on
an annual basis:
a. Radiation Safety
b. Laser Safety
c. Other training necessary for the safety and performance of duties assigned. This type of training
will be determined by the CTM Director or Supervisor.
10. Development Plans: Within the first year of employment, all CTM personnel will spend time discussing
career aspirations and development plans with an immediate supervisor, focusing on developing technical
skills, capabilities, and behaviors to achieve better performance in the CTM personnel’s current role and
plan development for future role(s).
a. CTM personnel are required to create a Career Profile and Development Plan using the Sodexo
performance tool.
b. The CTM Director or Supervisor is required to discuss the Development Plan with the CTM
personnel.
c. Based on the discussion with the GM, CTM personnel are to update the Development Plan.
d. The CTM Director or Supervisor and CTM personnel are to meet regularly to discuss Career
Development Plans.
References
Safety.CEM.021
New Employee Orientation Checklist.CEM.003, Sup 1
New Director/Supervisor Orientation Checklist.CEM.003, Sup 2
Unit Specific Work Rules.CEM.003, Sup 3
Sodexo CTM Competency Assessment Form
Sodexo Performance Review Tool (Ingenium)
Record Keeping
Sodexo CTM Human Resources
Sodexo CTM
New Employee
Orientation Checklist
All new employees should have the opportunity to learn about Sodexo and the company’s commitment to them. The
Orientation Checklist will help the employee with valuable information to begin their career with Sodexo CTM.
The employee’s manager should begin to review this information with the employee within the first few days of
employment. All items on the checklist should be completed, signed by the employee and the manager, and sent to
Sodexo CTM Corporate Office within 30 days of the initial hire date.
Employee Start Date
Account Manager
Category Action Date Completed
Ensure Account Requirements are completed (i.e., Drug Screen, TB, Background
Check, Flu shot etc.) and communicate to Account Rep, badge access
Inform POC of new hire and start date
Create Onboarding training plan for new employee, schedule hospital orientation,
Pre-Employment etc.
Complete the Sodexo CTM Network Access Form, submit to CTM Helpdesk
Request employee added to Email Distribution Lists - CTM Helpdesk
Order equipment as needed (computer, phone, test equipment, etc)
eVerify- I9 Review employee documents and complete online eVerify
Introduction to team, POC, key contacts
Provide Employee Sodexo Credentials to set up email address
Review information available on SodexoNet and the Employee Self Service

Portal
First 3 Days Ensure Access to Sodexo CTM Intranet-- Highlight key data points and
information on this site
Ensure Access to SharePoint-- Highlight key data points and information on this
site
Review/ provide Employee ID #, Unit #, Cost Center # Explain purpose and

where to find for future reference
Ensure Completion of WOTC—directions were included on onboarding portal
Review expectations for recording time in Kronos tool. Demonstrate Log-in
Review Pay Cycles, pay period end dates, pay dates, and How to Read your pay
statement brochure
Review Schedule and On Call rotation/policy – Review how to record on-call &
call back
th
Understand Benefit Enrollment-- Provide Reminder to enroll by 89 day of
employment. Be on lookout for Benefit packet mailed to employee home address.
Provide overview of Sodexo North America, divisions, Sodexo CTM, Districts,

etc. Provide organizational chart of district.
Discuss/ Review SCTM Mission, Vision and Values

Sodexo
Orientation
Discuss / Review Sodexo CTM Strategic Mission and Pillars. Provide copy.
Highlight the Sodexo Perks program, concierge services, and EAP- LifeWorks
program
Discuss Account Goals/Strategy, review the hospital mission/vision/values
Discuss Communication expectations and Decision Making parameters
Review Rounding to include frequency, key outcomes, log
Discuss/ Review- Supply Chain to include national partners, approval levels, and
procedures
Account Complete all Required Hospital Orientation items

Orientation
Review all areas within the hospital specific Unit Work Rules document. Ensure
employee understands expectations. Employee will sign acknowledgement page
and send to Sodexo CTM Corporate/ATTN BWillette
CEM Policies and Procedures- Review Procedures Manual on SharePoint
Internal Policies and Procedures to include: Sodexo EEO and Harassment

policy, Smoking/Tobacco use, Meal Period / state requirements, OT/On-call
policy, Attendance policy, Expense reporting, reporting injury, Safety practices
Conduct/coordinate MinuteMan training to include:

• Work orders
• PM & CM
• Purchasing
Training • Documentation expectations
Ensure completion of FOSS Training – within first 30 days of hire
Ensure completion of Customer Service Training – within first 30 days of hire
Schedule any technical training classes/courses (As needed)
Request for Training
TRR Tool
TRR Safety Training Requirements

Customer
Review Customer Satisfaction Tool
Loyalty
Ingenium – Performance evaluation program and tools
Professional
Development
Performance Metrics
Annual Awards and Recognition
Employee Engagement Surveys/Plan

People
Engagement
Contacting HR, People Center
Complete Initial Competency Evaluation
National Agreements/Purchasing Requirements

Purchasing
Value Add and Documenting
Expense Reports
Resource
Concur
Management
SCOTT
Introduction to MinuteMan
Introduction to MinuteMan – Overall Inventory
Introduction to MinuteMan – Opening and Closing Work Orders
Introduction to MinuteMan – Reports
MinuteMan Introduction to MinuteMan – PM Schedules

Service
Excellence Introduction to MinuteMan – Amendment Process
Introduction to MinuteMan – Technology and Condition Codes
Introduction to MinuteMan – PO Module
MinuteMan Web App (MMWA)
MinuteMan Mobile (MMMobile)
Follow Up- Next

Schedule follow up conversations at 30, 60 and 90 Day intervals
Steps
Please email signed and completed checklists to Sodexo CTM Corporate office within 30 days of the initial
hire date.
The above orientation checklist was reviewed with the employee and is considered complete.
Manager Name Manager Signature Date
The above information has been reviewed by me and is considered complete.
Employee Name Employee Signature Date
New Director / Supervisor Orientation Checklist.CEM.003, Sup 2
Sodexo CTM
New Director / Supervisor
Orientation Checklist
All new directors and supervisors should have the opportunity to learn about Sodexo and the company’s
commitment to them. The Orientation Checklist will help the employee with valuable information to begin their career
with Sodexo CTM.
The employee’s manager should begin to review this information with the employee within the first few days of
employment. All items on the checklist should be completed, signed by the employee and the manager, and sent to
Sodexo CTM Corporate Office within 30 days of the initial hire date.
Employee Start Date
Account Manager
Ensure Account Requirements are completed (i.e. Drug Screen, TB,

Background Check, Flu Shot, etc.) and communicate to Account Rep
Inform POC of new hire and start date
Pre-Employment Schedule Manager to Corporate Orientation Program
Complete the Sodexo CTM Network Access Form
Request Email Distribution Lists
Request Automatic reports
Complete I9
Understand Sodexo North American, Sodexo CTM
Understand Support resources (Finance, HR, Sales, IS etc)
Sodexo CTM Mission, Vision and Values
Understand Area/District Review
Introduction to District Team
Discuss Division Goals/Strategy
Discuss Preference of Communication/Decision Making
Ensure Employee has Sodexo email address
Overall Orientation
Ensure Access to SodexoNet
Ensure Access to CTMNet
Ensure Access to CTM SharePoint
Employee has Unit #
Employee has Cost Center #
Employee has employee ID #
Ensure Completion of WOTC
CEM Policies and Procedures
Internal Policies and Procedures
Kronos
Pay Cycles
On Call
Review Performance Goals in Ingenium
Understand Benefit Enrollment
Contract Review (Schd A and B, Termination Language, Custom
Specifications, Term)
Review Staffing Matrix
EOC Reports
Hospital required email
Monthly Ops Summary Reports
Set Achievable expectations for next 30, 60 and 90 Days
Business Situation and Strategy for account
Account Orientation Understand Client Expectations
DM Perception of current and future status of the account
Develop client relation goals
Develop employee/team goals
Understand the Hospital Mission, Vision and Value
Value Add and Documenting
Required Hospital Orientation
Required Hospital Training
Determine communication plan with client
Unit Work Rules
On Call Schedule
Obtain Hospital ID Badge
Department Review Budget
Orientation Review any existing action plans, if applicable
Review any existing sub contract agreements, if applicable
Understand the Patient Experience
Complete the Reports to form, if applicable
Please email signed and completed checklists to Sodexo CTM Corporate office within 30 days of the initial
hire date.
The above orientation checklist was reviewed with the employee and is considered complete.
Manager Name Manager Signature Date
The above information has been reviewed by me and is considered complete.
New Employee Name New Employee Signature Date
Unit Specific Work Rules.CEM.003, Sup 3

Guidance to day-to-day activities and business Operations
Unit specific work rules for hourly employees Unit
Below is an excerpt from the Sodexo Work Rule Document template. For the complete template, go to CTM
SharePoint site.
Sodexo Health Care Unit Specific Work Rules
This guide has been carefully prepared for you! It offers guidance to Sodexo Health Care employees on
our day-to-day activities and business.
Some of the policies in here are taken directly from the Sodexo Employee Handbook, and others
are specific to the (ENTER UNIT NAME) account. Please understand that you must comply with
all of the policies contained in the Sodexo Employee Handbook, even if the policy is not
mentioned or included in this document.
This guide will: (1) give you the information you need to do your job and (2) provide you many of the work
rules we have established so as to offer you a safe and enjoyable work environment.
More specifically, this document:

• Applies to Sodexo employees at (Enter name of Hospital)
• Supersedes any previous guidelines on any of the subjects presented here
Please understand that while we hope that you will remain with us long term, your employment
with us is for no definite period and is terminable at any time by either you or us, with or without
cause and with or without notice. The document is not a contract of employment. It does not
create any contractual commitment by Sodexo and does not guarantee employment for any
period, or create or contribute in any way to a legal cause of action against the Company. We
reserve the right to change, modify, and/or discontinue any of the policies contained in this Unit
Specific Work Rules, and the right to interpret and apply the Unit Specific Work Rules in our
discretion.

N/A
Record Keeping
CEM.004 Initial Inspection and Disposition of Equipment 29
Supplement 1 Disposition Form 32
Initial Inspection and Disposition of Equipment.CEM.004

To establish specific guidelines for entry of equipment into the facility; initial Operations
inspections, defining long and short term requirements, transferring clinical
equipment between affiliates and equipment leaving the organization.
Scope: Application:
Define responsibilities regarding initial inspections or dispositions. Unit
Input / Resources:
Time spent conducting inspection, electrical safety test, and application of
control number, or filling out disposition forms if necessary.
Output / Results:
Systematic and consistent method for equipment inspections and dispositions.
1. Long Term Clinical Equipment (six months or longer on-site):

a. CTM will inspect new equipment for:
i. All accessories required for proper operation
ii. Operator manuals
iii. Technical service literature
iv. Proper operation
v. Electrical safety as required by NFPA 99 or other locally accepted authority
vi. Devices with measureable outputs will be inspected and documented in accordance with
Planned Maintenance (PM) procedures (see CEM.008).
vii. Purchase information (including purchase date, purchase price, purchase order number,
and manufacture date)
viii. IT relevant information, if applicable, to include device software versions, Medial Access
Control (MAC) address, and IP or subnet mask information
b. For devices requiring additional inspection or acceptance testing, the healthcare organization will be
notified.
c. All devices producing ionizing radiation will require acceptance by a licensed radiation physicist.
d. All devices returning from outside vendor service will be subject to the same initial inspection
requirements.
e. Any equipment that does not pass the procedures listed above will not be put in use and will be
returned to the appropriate healthcare organization personnel.
f. Clinical equipment that successfully passes the listed procedures will be labeled with a CTM Control
Number and entered into the equipment Computerized Maintenance Management System (CMMS).
g. A CM work order will be used to document steps taken for the inspection using Work Order Type –
Incoming Inspection – Incoming or Found in Use.
h. Clinical Equipment that will be on the PM schedule will receive a PM label, in accordance with
CEM.009. The month and year next due for PM will be recorded on the label.
i. Clinical Equipment that will not be on the PM schedule will receive an Initial Inspection label that
designates on the label that no additional inspection will be required.
2. Short Term Clinical Equipment (less than six months on-site)

a. Short term clinical equipment may include, but may not be limited to:
i. Demonstration equipment
ii. Trial equipment
iii. Physician-owned equipment
iv. Patient-owned equipment
v. Borrowed/Loaner equipment
vi. Rental equipment
b. Short term clinical equipment will require an Electrical Safety Inspection as required by NFPA 99 or
other locally accepted authority.
c. For devices with measurable outputs, the vendor/owner of the device must attest that the equipment
is operating within normal parameters. Operational readiness and correct operating specifications
are the responsibility of the equipment vendor/owner.
d. The equipment vendor/owner must provide a copy of all relevant documentation showing the most
recent PM performed, if applicable. The equipment vendor/owner is responsible for making sure the
equipment has PMs performed as appropriate. CTM is not responsible for tracking the PMs of short
term clinical equipment unless specified by the healthcare organization and with the appropriate
service coverage level adjustment.
e. Any equipment that does not pass the procedures listed above will not be put in use and will be
returned to the equipment owner or company representative.
f. An estimated date of equipment removal from the healthcare facility will be documented.
g. Clinical equipment that successfully passes the listed procedures will receive an Electrical Safety
Inspection label and designate on the label the next inspection due date based on either the
equipment removal date or the normal planned maintenance cycle for the device.
h. Short term clinical equipment will not receive a CTM Control Number but follow the local healthcare
organization’s process for controlling temporary non-facility owned assets. Documentation of
inspection performed will be recorded using a CMMS CM work order using a Work Order Type of
Initial Inspection – Incoming or Found in Use and designating the Cost Center Number of the
department.
i. When short term clinical equipment is removed from the healthcare facility, CTM must be notified of
removal. The CTM Director or Supervisor will work closely with the using department to monitor
usage of short term clinical equipment.
3. Preferred Vendors of Short Term Clinical Equipment

a. Preferred vendors for short term clinical equipment may be established.
b. Equipment delivered by a preferred vendor will not be required to undergo an initial inspection by
CTM provided the following criteria are met:
i. Vendor agrees to participate in an annual review of maintenance practices conducted by
CTM.
ii. Vendor agrees to use a mutually acceptable label on all equipment indicated initial
inspection, electrical safety inspection or PM.
iii. Vendor agrees to verify items listed in section 1.a. of this procedure as part of the PM of the
equipment.
iv. Vendor agrees to provide a listing of equipment located at the healthcare facility upon
request of CTM. This listing will include the date of next PM due for each equipment item
listed.
c. At a minimum, a listing of any Preferred Vendors for Short Term Clinical Equipment will be
maintained and updated by CTM annually.
d. The listing of Preferred Vendors for Short Term Clinical Equipment will be submitted to the
healthcare organization Safety Committee (or other designated committee) for final review and
approval.
4. Clinical Equipment Transferred Between the healthcare organization Affiliated Campuses and Clinics.
a. Clinical equipment transferred between affiliated campuses and clinics will not require an initial
inspection, provided the following criteria are met:
i. The equipment is labeled with a current PM or Initial Inspection label.
ii. The equipment has not left the control of healthcare organization personnel.
iii. Healthcare organization personnel believes that no “rough handling” of the equipment has
taken place.
b. If at any time there is suspicion that equipment safety or performance has been compromised, CTM
personnel must inspect the equipment before use at the receiving facility.
c. In the absence of a local disposal form CEM.004, Sup 1 should be used for tracking and record
keeping of clinical equipment assets internal and external to the organization.
5. After receiving authorization from the appropriate healthcare organization and before disposing of the
equipment, the following checks shall be performed:
a. CTM personnel shall review the Incident Investigation file to verify whether the device has been
involved in any incident. If so, the CTM Director or Supervisor shall discuss with the Legal
Department whether any pending or potential litigation may prevent the permanent disposal of the
equipment. If no reason has been found to prevent disposition, CTM personnel shall remove the
equipment from the active inventory and all equipment identification tags and inspection stickers.
b. CTM personnel shall determine if the equipment has electronic Protected Health Information (ePHI)
as defined by the Health Insurance Portability and Accountability Act of 1996 – HIPAA. For
equipment that is being disposed of by the facility that either does or could contain electronic
Protected Health Information (ePHI), Section 3 of (CEM.004, Sup 1) is required to be completed.
This record should be attached to the CMMS record for the device for later retrieval if necessary.
CTM personnel shall follow CEM.005 and work with the Information Technology department to
remove all ePHI from the equipment before it is disposed.
c. The healthcare organization Materials Management manager shall review appropriate laws,
regulations, and codes on environment protection to ensure that disposal of the equipment does not
violate any of those requirements or there are specific guidelines that must be followed.
d. If the equipment is deemed “trackable” by the FDA, the Materials Management Director or CTM
Director or Supervisor shall inform the respective manufacturer and all other applicable agencies of
the final disposition.
References
NFPA 99
Removal/Disposal of Equipment with ePHI.CEM.005
Planned Maintenance.CEM.008
Clinical Equipment Testing/Repair/Labeling.CEM.009
Disposition Form.CEM.004, Sup 1
Record Keeping
Disposition Form.CEM.004, Sup 1
Instructions: Fill out one form per asset for any of the following action: Asset Transfer, Trade-In, Sale, Donation, Hold,
Disposal, or Lost/Stolen. Contact the prevalent departments involved with the disposition. This may include one or more of
the following: Facilities, Clinical Engineering, Purchasing, Building Services, IT, and Finance.
Section 1: Department Information Section 2: Asset Information
Facility (Entity): Sodexo Control #:
Department: Asset Tag:
Cost Center #: Description:
Contact: Manufacturer:
Phone: Serial #:
Email: In-Service Date:
Date: Original Cost:
Section 3: Compliance / HIPAA / PHI
☐Yes ☐ No ☐ N/A All required clinical data (quality control data, statistics, etc.) have been transferred to an in-
house storage device or otherwise properly stored.
☐Yes ☐ No ☐ N/A All patient data have been removed or cleansed from the hard drive OR the hard drive has
been removed and securely stored prior to equipment disposition.
Section 4: Action
☐ Transfer to Another Department ☐ Donated
Dept. Name: Recipient:
Dept. Cost Center: ☐ Hold / Place in Storage
Dept. Mgr. Signature: Location:
☐ Traded-In ☐ Disposal (Indicate Reason for Disposal)
☐Bad
Company: Condition ☐No Longer Needed
Trade-In Allowance: ☐Obsolete ☐Other:
Item To Be Purchased: ☐ Used By Biomed/CE for Spare Parts
CE Mgr
New Asset P.O. #: Signature:
☐ Sold ☐ Lost / Stolen
Recipient:
Sale Price:
Section 5: Approvals
Department Manager: Date:
Department Director: Date:
*If Required
Section 6: Comments
CEM.005 Removal / Disposal of Equipment with ePHI 34
Removal/Disposal of Equipment with ePHI.CEM.005

To comply with the HIPAA Privacy & Security Rule’s requirements pertaining Operations
to the disposal of equipment or removal of hardware and electronic media that
contain electronic Protected Health Information (ePHI).
Scope: Application:
Define Sodexo CTM’s involvement with removal or disposal of equipment that Unit
contains or may contain ePHI.
Input / Resources:
Proper disposal requirements.
Output / Results:
Systematic and consistent method for proper removal / disposal of equipment
with ePHI.
The Sodexo CTM computerized maintenance management system (CMMS) designates which assets under the
Sodexo CTM program are capable of storing confidential data. This designation helps Sodexo CTM assure that
the clinical equipment that is serviced gets special handling at the time of disposal if it contains electronic
Protected Health Information (ePHI).
1. All medical devices, systems, and components falling under Sodexo CTM’s responsibility will receive a
technical evaluation for the presence of electronic Protected Health Information (ePHI) before leaving the
healthcare organization’s environment.
2. Whenever Sodexo CTM is disposing of any device which is identified to contain ePHI, one of the following
procedures will be followed:
a. Sodexo CTM personnel or a representative of the equipment supplier/manufacturer will wipe the
hard drive to remove any ePHI
b. The hard drive is removed or destroyed
c. The hard drive is sent to the appropriate healthcare organization department to be wiped clean of
any ePHI before reinstallation in the device
3. This guideline is applicable to all possible avenues of PHI release outside of the healthcare organizations
environment; including but not limited to:
a. System disposition
b. Failed hard drive replacement
c. Leased equipment return
d. Computer chassis replacement
4. If a system/device is being traded-in or sold to a Business Associate of the Covered Entity (healthcare
organization) or of Sodexo CTM with which a Business Associate Agreement (BAA) has been previously
executed, the BAA will negate the need to remove PHI from the system.
a. PHI removal is preferred if it is determined by the owning department that a negative financial
impact would not be incurred.
5. The PHI removal process will be scheduled so that there is minimal impact to the workflow of the owning
department.
6. The technical evaluation will include the following considerations:

a. Potential need for software re-load
b. Marketability of the device/system being dispositioned
References
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
MinuteMan ePHI Data
Record Keeping
CEM.006 Planned Maintenance Strategy 36

To establish specific guidelines for the evaluation, prioritization of the medical Operations
equipment, and determination of the Planned Maintenance (PM) strategy.
Scope: Application:
Define risk of equipment covered as part of the Sodexo CTM agreement. Unit
Input / Resources:
Determination and evaluation of risk category scores and Planned
Maintenance strategy.
Output / Results:
Risk evaluation score, PM strategy determination, and Planned Maintenance
frequency.
1. The Sodexo Clinical Technology Management (CTM) Planned Maintenance (PM) program establishes that
clinical equipment is maintained to ensure an acceptable level of safety and quality for patients and
equipment users. The PM program is based on clinical equipment maintenance being performed in
accordance with the manufacturer’s recommendations or, as regulatory requirements allow, the use of
alternative maintenance frequencies or activities when the manufacturer’s recommendations are not
available or when experience shows acceptable alternative methods. The PM strategy indicated by this
procedure is a recommendation which must be reviewed by the healthcare organization.
2. Sodexo CTM utilizes a risk-based program for PM strategy decisions. The PM program consists of the
following three strategies:
a. Alternative Equipment Maintenance (AEM): A strategy where maintenance activities or
frequencies of clinical equipment may not be the same as those recommended by the manufacturer
because more efficient or effective maintenance activities which do not reduce the safety of the
clinical equipment are being followed.
b. Original Equipment Manufacturer (OEM): A strategy where all maintenance activities (i.e.
maintenance, inspection, and testing) and the PM frequency of equipment is performed in
accordance with the manufacturer’s recommendations.
c. Run-to-Failure Maintenance (RTFM): A strategy, also known as Reactive Maintenance, where
maintenance or replacement is performed only after equipment fails or experiences a problem.
3. All newly acquired and existing clinical equipment covered as part of the Sodexo CTM agreement is
reviewed corporately at a device code and/or TradeName level and locally at the individual device level to
determine if an AEM PM strategy should be used.
a . The risk evaluations are performed by qualified personnel (i.e. clinical engineers, service engineers,
or biomedical technicians) based on the assessment of certain risk criteria to determine the eligibility
of the equipment to be place on an AEM or RTFM PM strategy.
b. If the risk assessment determines that equipment is not eligible to be maintained in accordance with
the AEM PM strategy, then the OEM PM strategy shall be used as long as the OEM has provided
the required service literature (CEM.007).
4. The decision for which PM strategy to use for a particular piece of equipment is based on an assessment of
the following risk categories:
a. Risk Category I: Functional Risk

i. This category is used to assess the functionality of the equipment, how the equipment is
used, and the criticality of use.
ii. The highest Functional Risk category level, Critical / High-Risk, includes life support
equipment as well as any clinical equipment for which there is a risk of serious injury or
death to a patient or user should the equipment fail.
b. Risk Category II: Physical Risk

i. This category is used to access the potential health and safety risks to the patient and/or
user based on the potential consequences of equipment failure or malfunction, including:
seriousness of harm, prevalence of harm, and the potential widespread impact of harm.
ii. For any clinical equipment that is determined to have the highest Physical Risk category
level, Potential Cause of Patient / User Death, will also be assigned to the highest
Functional Risk category level, Critical / High-Risk.
c. Risk Category III: Scheduled Maintenance

i. This category is used to identify when equipment is not eligible for placement in an AEM
program, which includes, but is not limited to the following:
1. Equipment subject to federal or state law or Medicare Conditions of Participation in
which inspecting, testing, and maintaining must be in accordance with the
manufacturer’s recommendations, or otherwise established more stringent
maintenance requirements.
2. Imaging and radiologic equipment (whether used for diagnostic or therapeutic
purposes)
3. Medical laser devices
4. New medical equipment with insufficient maintenance history to support the use of
alternative maintenance strategies
ii. This category is also used to establish an experience base of alternative maintenance
history, for new equipment where sufficient maintenance history is not available or for
equipment under review by the CTM Corporate Clinical Engineers. Maintenance history is
based on Sodexo CTM records, the healthcare facility records, and publicly available
records from nationally recognized, credible sources. This maintenance history is used to
establish a baseline Device Reliability rate. If such maintenance history does not exist then
an experience base is to be established.
1. New medical equipment with insufficient maintenance history will be assigned the
maximum amount of points available in this category and will be maintained in
accordance with manufacturer’s recommendation until an experience base has
been collected. After which a baseline Device Reliability rate will be established.
2. The alternative maintenance experience base is then established by allowing
gradual adjustments to the equipment risk score until the clinical equipment is
moved into a different PM Strategy / Priority level (in accordance with the PM
Strategy / Priority table). After a sufficient amount of maintenance history has been
collected under the new PM Strategy / Priority Level the Device Reliability rate is
calculated and compared to the baseline Device Reliability rate to determine
whether alterations to the manufacturer’s recommendations are safe and effective
and do not degrade the performance of the equipment.
a. If there is no change or no statistically significant deviation in the Device
Reliability rate, then the Scheduled Maintenance risk score can continue to
be decrease using the process outline above until a Schedule Maintenance
risk score of 0 is reached.
b. If there is statistically significant deviation in the Device Reliability rate, then
the Scheduled Maintenance risk score will be reset to the previous value.
iii. A risk score of 0 in this category does not automatically qualify equipment to be placed on
the AEM program, all other risk category scores must also be taken into consideration.
d. Risk Category IV: Device Reliability

i. This category is used to assess the aggregated incident history of identical or similar
equipment to determine the reliability of the device and likelihood of failure based on work
order failure code analysis.
ii. The assessment is based on calculation of the mean time between failure (MTBF) rate.
iii. Device reliability is one of the factors used to measure the safety and effectiveness of the
AEM program.
1. After a sufficient amount of equipment history has been collected a baseline device
reliability rate is calculated and the point score assigned to this category is based
on the Risk Category IV: Device Reliability table.
2. If a sufficient amount of equipment history has not yet been established, then this
category will be assigned a point score equivalent to a “Poor Reliability” rating.
e. Risk Category V: Incident History

i. This category is used to assess the nature of the equipment incident and whether the
omission of maintenance activities or adjusted maintenance frequency potentially contributed
to a patient and/or user incident.
ii. This category is also used to evaluate the safety and effectiveness of the AEM program.
iii. A local assessment is conducted by qualified personnel, and the assessment is based on
work order failure code analysis and incident investigation. Equipment malfunctions shall be
investigated to determine the following:
1. Whether the equipment was included in the AEM program
2. Whether the failure could have realistically been prevented by scheduled
maintenance
a. If it was determined that the failure could have been prevented by
scheduled maintenance then the local assessment team will contact the
Sodexo CTM Corporate Clinical Engineers for a corporate assessment to
also be conducted.
3. Corrective actions necessary to repair the equipment
4. Preventive actions necessary to prevent future malfunctions.
a. If based on the incident investigation it was determined that the likelihood of
failure in the same manner is low and does not affect identical or similar
equipment, then preventive actions may include but are not limited to:
i. Adjustments to AEM program maintenance activities
ii. Increase to the Conditional Planned Maintenance Factor, of the
specific device, to either increase the equipment Risk Priority Level,
and thereby increase the AEM PM frequency
iii. Increase to the Conditional Planned Maintenance Factor, of the
specific device, to change to the OEM PM strategy
b. If based on the incident investigation it was determined that the same
failure could likely occur again or could affect identical or similar equipment,
then preventive actions may include but are not limited to:
i. Adjustments to AEM program maintenance activities
ii. Increase to the Incident History Risk score, of all identical or similar
equipment, to either increase the equipment Risk Priority Level,
and thereby increase the AEM PM frequency
iii. Increase to the Incident History Risk score, of all identical or similar
equipment, to change to the OEM PM strategy
f. Risk Category VI: Conditional Planned Maintenance Factor

i. This category allows qualified Healthcare Technology Management (HTM) personnel such
as; a clinical engineer, service engineer, or biomedical technician that is knowledgeable of
the specific equipment being assessed, the ability to adjust the Risk Score based upon local
factors.
ii. This category can only be used to shorten the time between PMs, and in cases where
required, the equipment risk score can be increased to where the equipment is no longer
eligible to follow an AEM PM strategy and thereby is placed on an OEM PM strategy.
iii. The local factors that are assessed and documented in the equipment file include, but are
not limited to:
1. Department or program accreditation / certification requirements (e.g. CAP, AABB,
CARF, ACR, etc.)
2. Equipment condition and performance / maintenance history
3. Setting and environment in which the equipment is used (a.k.a. equipment
environment)
4. Volume of use
5. Availability of alternative devices or backup systems in the event of equipment failure
or malfunction
6. Healthcare organization requirement(s)
5. Risk Score Assignment Tables:
a. Risk Category I: Functional Risk

Point Score Functional Description
10 Critical / High-Risk
9 Crucial – Therapeutic
8 Crucial – Diagnostic
7 Essential – Therapeutic
6 Essential – Diagnostic
5 Analytical – Therapeutic
4 Analytical – Diagnostic
3 Miscellaneous – Therapeutic
2 Miscellaneous – Diagnostic
1 Non-Clinical
b. Risk Category II: Physical Risk

Point Score Physical Risk Description
9 Potential Cause of Patient / User Death or Widespread Impact
6 Potential Cause of Patient / User Injury
3 Potential Disruption of Care
0 No Physical Risk to Patient / User
c. Risk Category III: Scheduled Maintenance

Point Score Scheduled Maintenance Description
Requires maintenance in accordance with Manufacturer’s
20
Recommendations
20 Insufficient maintenance history
1-19 Under Review
0 Eligible for alternative equipment maintenance strategy
d. Risk Category IV: Device Reliability

Point Score Device Reliability Description MTBF Rate (days)
9 Poor (or Unknown) Reliability ≤ 121.67
6 Fair Reliability > 121.67 to < 243.33
3 Good Reliability ≥ 243.33 to < 365
0 Excellent Reliability ≥ 365
e. Risk Category V: Incident History

Point Score Incident History Description Priority Increase
11-20 Critical Incident History 3+ Levels
6-10 Major Incident History 2 Levels
1-5 Minor Incident History 1 Level
0 No Incident History None
f. Risk Category VI: Conditional Planned Maintenance Factor

Conditional Planned Maintenance Factor
Point Score Priority Increase
Description
20 Department accreditation/ certification requirement OEM PM Strategy
11-19 Requires extensive increased maintenance 3+ Levels
6-10 Requires increased maintenance 2 Levels
1-5 Requires limited increased maintenance 1 Level
0 No local variance None
6. Device Score Risk Assessments:

a. The total risk score is based on the summation of all the risk categories. Each risk category includes
levels of risk and each level is assigned a point score based on the Risk Score Assignment Tables.
b. The total risk score determines the PM strategy (AEM, OEM, or RTFM) and for the equipment on
the AEM strategy this assessment also determines the equipment priority level.
i. Risk Categories I, II, III, IV and V scores are assessed at a corporate level by a Sodexo
CTM Corporate Clinical Engineer.
1. Results of the corporate assessment can be viewed in the computerized
maintenance management system (CMMS).
2. Documentation of these assessments will be maintained at the Sodexo CTM
Corporate office and located on a Sodexo CTM intranet site accessible to all
Sodexo CTM accounts and personnel.
3. Qualifications for the Sodexo CTM Corporate Clinical Engineers will be maintained
at the Sodexo CTM Corporate Office and located on a Sodexo CTM intranet site
accessible to all Sodexo CTM accounts and personnel.
ii. Risk Category VI scores are assessed at a local level by qualified Healthcare Technology
Management (HTM) personnel such as; a clinical engineer, service engineer, or biomedical
technician that is knowledgeable of the specific equipment being assessed.
1. Upon a new startup, this category will be defaulted to “No local variance” and the
risk score will be based on the corporate assessment until a local / device specific
assessment is performed. The local / device specific assessment may identify a
need for a more stringent PM strategy or PM frequency, or the local assessment
may confirm the corporate assessment.
2. The initial local / device specific assessment should be completed within a year of
the startup date, after which the local / device specific assessments are to be
reviewed and re-evaluated on an annual basis.
3. Results of the local / device specific assessment can be viewed in the
computerized maintenance management system (CMMS).
4. Documentation of these local / device specific assessments will be maintained at
the Sodexo CTM account in which the assessment was performed.
5. Qualifications for the Sodexo CTM personnel that performed the local / device
specific assessments will be maintained at the Sodexo CTM account in which the
assessment was performed.
7. Priority Description: Using the criteria system described above, clinical equipment is categorized
according to the following eligibility, priority of testing, and degree of risk:
a. OEM
i. Equipment risk scores of 25 or more on the criteria evaluation system.
ii. All maintenance activities (i.e. maintenance, inspection, and testing) and PM frequency of
equipment in this priority level will be performed in accordance with the manufacturer’s
recommendations.
b. AEM Priority 1
i. Equipment scoring between, and including, 22 to 24 points on the criteria evaluation system.
ii. This equipment is included in the AEM program and has been given the highest priority for
testing, calibration and repair.
iii. Equipment in this priority group is tested on at least a quarterly basis.
c. AEM Priority 2
ii. This equipment is included in the AEM program and every effort should be made to test,
calibrate and repair this equipment promptly, but only after OEM and AEM Priority 1
equipment requirements have been completed.
iii. Equipment in this priority group is tested on at least a semi-annual basis.
d. AEM Priority 3
ii. This equipment is included in the AEM program and every effort should be made to test,
calibrate and repair this equipment promptly, but only after OEM, AEM Priority 1 and AEM
Priority 2 equipment requirements have been completed.
iii. Equipment in this priority group is tested on at least an annual basis.
e. RTFM
i. Equipment with scores of 13 or less points, poses no threat to patient safety if not subjected
to PM and will therefore be placed on the Run-to-Failure (aka Reactive) Maintenance
strategy.
8. PM Strategy / Priority Table

Total Risk Score PM Strategy / Priority PM Frequency
In accordance with manufacturer
≥ 25 OEM
recommendations
≥ 22 to ≤ 24 AEM Priority 1 Quarterly
≥ 19 to ≤ 21 AEM Priority 2 Semi-annual
≥ 14 to ≤ 18 AEM Priority 3 Annual
≤ 13 RTFM No PM
9. Priority Reclassification
a. In situations where it is desired to place equipment in a higher priority level than is indicated
by the scoring formula, then the CTM Director or Supervisor at the account should re-evaluate
the Conditional Planned Maintenance Factor.
b. When it is desired to place equipment in a priority level than is different than the one indicated
by the scoring formula, Sodexo CTM must make a recommendation and approval must be
obtained from the department manager of the affected equipment. A detailed explanation and
reasoning for this request must be submitted and approved by the healthcare organization
Safety Committee, Safety Officer and/or other designated personnel.
10. Evaluating Safety and Effectiveness of the AEM Program

a. All clinical equipment that is included in the AEM program is evaluated on an annual basis to ensure
that any maintenance activities or frequencies that differ from those recommended by the
manufacturer do not negatively affect the equipment’s safety, reliability, or effectiveness.
b. The corporate evaluation is based on:
i. Manufacturer recommended maintenance activities and frequencies and/or generally
accepted standards of practice
ii. AEM program risk assessment review based on performance data, specifically looking at
MTBF rates and incident investigation outcomes
iii. Additional resources used to determined equipment safety, reliability, and effectiveness
include, but are not limited to:
1. Association for the Advancement of Medical Instruments (AAMI)
2. American National Standards Institute (ANSI)
3. American Society for Healthcare Engineering (ASHE)
4. American College of Clinical Engineering (ACCE)
5. ECRI Institute
c. The local / device specific evaluation is based on:
i. The CTM Director or Supervisor review of local and device specific conditions as indicated
in section 4.f. Risk Category IV: Conditional Planned Maintenance Factor
ii. The CTM Director or Supervisor review of any repair work orders that indicated that the
failure was potentially predicable and potentially preventable by either a change in the PM
frequency or a change to the PM procedure. After reviewing the work orders, if the CTM
Director or Supervisor believes the repair could have be PM preventable the CTM Director
or Supervisor is to report the findings to the CTM Corporate Clinical Engineers.
References
ANSI/AAMI EQ56:2013
ANSI/AAMI EQ89: 2015
CMS S&C 14-07-Hospital Memo 2013
Service Manuals.CEM.007
Record Keeping
CEM.007 Service Manuals 44
Supplement 1 Letter to OEM Requesting Maintenance Recommendations 45
Service Manuals.CEM.007

To verify availability of appropriate manufacturer maintenance Operations
recommendations for clinical equipment in the inventory
Scope: Application:
Define responsibilities for acquiring and managing service manuals Unit
Input / Resources:
Inventorying available service manuals
Output / Results:
Helping the healthcare organization remain in compliance with federal
regulations
1. The CTM Director or Supervisor shall verify that manufacturer service documentation is available, for clinical
equipment purchased or leased by the healthcare organization. This documentation should include
recommendations for maintenance and safety inspections, including the recommended schedule and
procedure.
2. It is recommended that when the healthcare organization purchases or leases clinical equipment a copy of
the service literature (in addition to other pertinent documentation) from the manufacturer is included with the
acquisition (CEM.017). When new clinical equipment is received and inspected by CTM in accordance with
CEM.004, the CTM Director or Supervisor shall verify that there is service documentation from the
manufacturer regarding PM recommendations and safety inspections, including the recommended schedule
and procedure.
3. A master listing of all service manuals available and the location for accessing each manual is to be
maintained in the CTM computerized management maintenance system (CMMS). The master listing should
be reviewed and updated at least quarterly.
4. If the manufacturer’s recommendations are not available, the CTM Director or Supervisor will work to obtain
the recommendations with assistance from the healthcare organization Materials Management department.
5. If the manufacturer refuses to provide the recommendations to Materials Management, then the CTM
Director or Supervisor shall recommend to the Environment of Care Committee, Safety Committee, or other
designated committee that the healthcare organization’s Legal Department should send an official notification
(CEM.007, Sup 1 – template) to the manufacturer. The notification should include that the refusal is in
violation of federal and state regulations, as the provision of service manuals are required by the National
Fire Protection Agency (NFPA) 99 Health Care Facilities Code standard (10.5.3.1.1), which is incorporated in
hospital licensing code.
a. If the requested documentation does not exist or in the event the manufacturer refuses the request
from the healthcare organization, then an Alternative Equipment Maintenance (AEM) strategy will
be instituted in accordance with CEM.006 based on CTM knowledge and experience and based on
generally accepted standards of practice.
References
CMS S&C 14-07-Hospital Memo 2013
NFPA 99 Health Care Facilities Code (10.5.3.1.1), 2012 edition
Initial Inspection.CEM.004
Clinical Equipment Procurement Specifications.CEM.017
Letter to OEM Requesting Maintenance Recommendations.CEM.007, Sup 1
Record Keeping
Letter to OEM Requesting Maintenance Recommendations.CEM.007, Sup 1
LETTER TO OEM REQUESTING MAINTENANCE RECOMMENDATIONS EXAMPLE:
Instructions: This letter template can be used for requesting maintenance recommendations from manufacturers for
clinical equipment. For clinical laboratory equipment use CLIA reference and for all other equipment use the CMS
reference. Send the completed letter as a CERTIFIED/REGISTERED letter with return receipt of courier service and
save the signed receipt together with a copy of the original letter for legal purposes. This letter should preferably be
printed on Healthcare organization letterhead and signed by a healthcare organization representative.
EXAMPLE LETTER
Date
OEM NAME
Attn: Technical Support Department
OEM address
OEM city, state, zip
Dear Sir/Madam:
This is to request maintenance (preventive and/or corrective) and function check recommendations for the
equipment listed below [or attached], including but not limited to the procedure(s) and frequency, manufactured by
your company.
• [list of equipment]
This request is based on the Clinical Laboratory Improvement Act – CLIA (42 CFR 493.1254) and NFPA 99
10.5.3.1.1 (2012 edition). [for Clinical Laboratory equipment]
OR
This request is based on the State Operations Manual issued by the Centers of Medicare and Medicaid
Administration (CMS), within Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals,
as update on 12/20/2013 (S&C 14-07) and NFPA 99 10.5.3.1.1 (2012 edition). [for non-Clinical Laboratory
equipment]
As the information hereby requested is needed to fulfill statutory and/or federal regulatory requirements, we would
appreciate to receive it as soon as possible. The lack of a timely response (i.e., within 30 (thirty) days) from your
company shall be documented in our records and provided to inspectors of the above mentioned agencies. While
waiting for the requested information, we shall not be liable for any patient harm caused by insufficient or incomplete
maintenance or function check.
Please contact me at ___________________ if you have any questions regarding this request. Thank you for your
cooperation in this matter.
Sincerely yours,
Signature
Name of Healthcare Organization Representative

Title of Healthcare Organization Representative
CEM.008 Planned Maintenance 47
Supplement 1 Department Planned Maintenance Notification 49
Supplement 2 Devices Overdue Notification 50
Supplement 3 Devices Two Months Overdue Notification 51
Supplement 4 Device Removal From Service 52

To establish specific guidelines for how Planned Maintenance will be tracked, Operations
monitored and reviewed.
Scope: Application:
Define responsibilities regarding Planned Maintenance. Unit
Input / Resources:
Complete inspection, evaluation and correction, if deemed necessary.
Output / Results:
Supported safety and reliability of medical devices.
1. After equipment has been evaluated according to Procedure CEM.006 for inclusion in the clinical equipment
Planned Maintenance (PM) Program, PM inspections are performed according to the intervals established
in the Priority Description.
2. Each month, work orders will be created for devices due for PM on the first business day of the month.
3. Each CTM Director or Supervisor, or designated authority, will ensure the PM work orders are distributed
and that each technician is aware of assigned responsibilities for the scheduled month.
4. A device is considered to have “on time” PM Completion when all associated work and data entry is
completed on or before the last business day of the scheduled month.
5. Devices with the highest Priority Description are completed earliest in the month, to the extent that is
practical and possible.
6. During any month, devices can fall into five categories, with regard to PM status:
a. PM complete
b. Open - Unable to PM because device is in use
c. Open – Sent out for Repair
d. Open - Unable to locate device
e. PM open
7. PM Completion
a. Departments that have devices that are due for PM are notified (CEM.008, Sup 1 – template).
b. Planning for PM completion of high utilization devices is completed in conjunction with the
department manager.
c. At mid-month, follow-up communication to the department manager is provided regarding status of
PM completions and if there have been any difficulties accessing devices due for PM.
d. Communication with the department manager will continue every few days in regards to devices in
use or devices that are unable to be located. This will ensure a “best effort” in regards to making
devices available.
e. All PM work should be completed and documented, with the PM work order closed by close of
business of the last business day of the scheduled month.
f. All PM’s not completed in this time frame will be considered incomplete and overdue. The
department manager will be notified in writing of any device that has not had a PM completed during
the month that the PM was scheduled.
8. Open - Device In Use

a. At the beginning of the month following the month the PM was scheduled, the department manager
will be notified in writing (CEM.008, Sup 2 – template) of any device that has not had a PM
completed because that device was unavailable.
b. If possible, the device will be tagged with a notification that the device must be returned to CTM
when it has been removed from the patient and disinfected.
c. At a minimum, weekly follow-up regarding the availability will take place with the department
manager.
d. If the item remains unavailable into the beginning of the next month (second month after PM was
due), the healthcare organization Safety Officer or other designated personnel will be notified in
writing (CEM.008, Sup 3 – template) with a request for assistance in making the device available for
PM.
e. Steps 8.c. and 8.d. will be repeated for as long as necessary to complete the PM of the device.
9. Open – Out for Repair

a. Device is out for repair and unavailable for local PM to be completed.
b. When device is returned it will have the current Open PM accomplished and work order
documentation will be completed accordingly.
10. Open - Unable to Locate Device

a. At the beginning of the month following the month the PM is due, the department manager will be
notified in writing (CEM.008, Sup 2 – template) of any device that has not had a PM completed
because that device was not able to be located.
b. During the month following the month the PM was due, CTM will request help from the department
manager with locating the device. A best effort will be made by CTM to locate all devices overdue
for PM.
c. At the beginning of the third month (second month after PM due), any device that is still unable to
be located will be presented in writing to the department manager for removal from service
(CEM.008, Sup 4 – template). If uncertainty remains regarding device retirement, follow local facility
guidance for retirement decisions.
d. The department manager must sign, signifying agreement that the device is no longer in use.
e. The device will then be removed from the active inventory of medical equipment.
11. PM Open
a. At the beginning of the month following the month the PM was due, the department manager will be
notified in writing (CEM.008, Sup 2 – template) of any device that has a PM remaining open.
b. During the month following the month the PM was due, CTM will complete the PM on these devices
with a priority second only to any Priority One (Critical / High-Risk) equipment that is due for PM in
that current month.
c. A list of open PMs will be provided to healthcare organization Environment of Care (EOC)
Committee, Safety Committee, or equivalent committee.
d. PMs open due to Device In Use, Out for Repair, or Unable to Locate Device will not be included in
the PM completion calculation provided to the healthcare organization Environment of Care (EOC)
Committee, Safety Committee, or equivalent committee.
References
Department PM Notification.CEM.008, Sup 1
Devices Overdue Notification.CEM.008, Sup 2
Devices Two Months Overdue Notification.CEM.008, Sup 3
Device removal from Service.CEM.008, Sup 4
Record Keeping
Department Planned Maintenance Notification.CEM.008, Sup 1
DEPARTMENT PM NOTIFICATION EXAMPLE MEMO:
Date
TO: Name, Department
FR: Name, CTM
RE: Planned Maintenance Due
The CTM department will be performing rounds and planned maintenance (PM) actions on equipment
located in [insert department name] during the month of [insert month]. Staff and patient inconvenience will
be kept to a minimum. Should we require assistance to accommodate PM actions that may require patient
inconvenience we will be sure to inquire.
Thank you for helping to ensure patient safety and reliability of medical equipment in the facility and
department is consistently maintained.
Devices Overdue Notification.CEM.008, Sup 2
DEVICES OVERDUE FOR PM EXAMPLE MEMO:
Date
FR: Name, CTM
RE: Devices Overdue for Planned Maintenance
The following list includes devices that are currently overdue for Planned Maintenance (PM). These
devices are associated with a cost center that is designated with you as the responsible manager.
A brief indication as to the status of the device is listed:

• In Use indicates that device was being used during attempts at PM.
• Unable to Locate indicates that device could not be found during multiple attempts.
• Sent out for Repair indicates a device was not available for PM activities.
• Open indicates that CTM personnel were unable to complete because of other priority
maintenance during the month.
Please assist [NAME OF RESPONSIBLE TECH] or any technician from CTM in locating and making
available the following equipment as soon as possible.
Thank you for your help in ensuring patient safety and reliability of medical equipment.
Control Number Manufacturer Device Description Status
Devices Two Months Overdue Notification.CEM.008, Sup 3
DEVICES TWO MONTHS OVERDUE FOR PM EXAMPLE MEMO:
Date
TO: Name, Safety Officer
FR: Name, CTM
RE: Devices Two Months Overdue for Planned Maintenance
The following list includes device(s) that are currently at least two months overdue for Planned Maintenance
(PM). The listed device(s) have repeatedly been found to be In Use during attempted PM. We have made
attempts to schedule this maintenance with the department staff and management.
The CTM Department is requesting your assistance in communicating the importance of PM and helping
with scheduling the device(s) for PM. Please contact the department manager with this request. I would be
happy to meet and discuss this situation.
Thank you for helping to ensuring patient safety and reliability of medical equipment.
Control Number Manufacturer Device Description Department
Devices Removal From Service.CEM.008, Sup 4
DEVICE REMOVAL FROM SERVICE EXAMPLE MEMO:
Date
FR: Name, CTM
RE: Device Removal
The CTM department has made multiple attempts to locate the following medical devices [insert list of
devices or individual list] in [insert Department Name] for PM completion.
After several attempts and based upon staff input, it is believed the device is no longer located at the facility
and should be set to inactive or retired from service. If the device is located later it will need to be re-
evaluated for inclusion into the program and appropriate PM actions completed.
Thank you for helping to ensure patient safety and reliability of medical equipment in the facility and
department is consistently maintained.
CEM.009 Clinical Equipment Testing/Repair/Labeling 54
Supplement 1 Example Labels 56

To establish guidelines for the clinical equipment testing and repair supported Operations
by CTM.
Scope: Application:
Define protocol for testing, repair and labeling of all clinical equipment covered Unit
as part of the Sodexo CTM agreement.
Input / Resources:
Planned Maintenance, Electrical Safety Inspection, and Corrective
Maintenance actions.
Output / Results:
Systemic and consistent method for testing, repairing and labeling clinical
equipment.
1. A data record will be maintained in the computerized maintenance management system (CMMS) for each
item of clinical equipment supported by CTM. Each file will contain equipment information, historical data,
and other operational information.
2. Documentation of all work actions completed will be maintained electronically. Documentation provided by
vendors and any other hardcopy information must be converted to an electronic format and attached to the
equipment data record.
3. All electrically operated clinical equipment must comply with currently accepted standards of electrical
safety.
4. All Corrective Maintenance (CM) actions will be performed in accordance with accepted industry standards
and be documented with the appropriate Problem/Failure and Resolution. Timestamps will be recorded in
the work order as CM actions are completed, actions include but are not limited to:
a. Repair Request Time / Work Order Opened
b. Work Order Acknowledgement Time
c. Call Back Time
d. On Site Response
e. Repair Completed / Work Order Closed
5. The CTM Director or Supervisor will make recommendations to the healthcare organization in regards to
repair versus replacement determinations.
a. Under the following circumstances, before beginning any repair work the CTM personnel assigned
to the CM is to consult with the GM, and the CTM Director or Supervisor will make a replacement
recommendation to the healthcare organization:
i. If the accumulative total maintenance cost of a repair exceeds fifty percent (50%) of the
clinical equipment’s current replacement value, or the percentage specified in the contract
between Sodexo CTM and the healthcare organization.
ii. If any equipment is designated as being at the end of service life (see CEM.014) by the
Original Equipment Manufacturer (OEM) and CTM can no longer find a source to provide
parts or services.
iii. If the equipment is deemed to be beyond economical repair.
b. The final decision to replace equipment will be made in coordination with the using department and
healthcare organization Administration.
6. All clinical equipment included in the Sodexo CTM agreement with the appropriately selected Service
Coverage Level shall be tested for performance and electrical safety. All electrical safety inspections (ESI)
will be performed in accordance with the standards set forth in the currently adopted version of NFPA 99 as
follows:
a. As part of the Initial Inspection
b. After each repair that may affect the electrical safety or performance
c. As part of the Planned Maintenance (PM) inspection
d. After any reported incident/accident
e. Before a unit is placed into service after temporary storage
7. CTM will perform ESI in accordance with the following:

a. ESI will be conducted in accordance with current NFPA 99 standards or other locally accepted
authority
b. Measurable parameters will be evaluated with a calibrated electrical safety analyzer
c. The performance of ESI will be documented on the PM Work Order by completing the appropriate
PM task
d. When the performance of an ESI is necessary after CM actions, the ESI will be documented on the
CM Work Order
e. Equipment not meeting standards will not be placed into service until corrections have been made
8. PM will be performed in accordance with CEM.006, applicable PM tasks may include:

a. General inspection
b. Operational checks
c. General maintenance
d. Device specific maintenance
e. Verification of output parameters
f. ESI performance
9. Clinical equipment receiving inspection will be labeled.

a. At a minimum, the label will contain the following information:
i. Initials of personnel completing inspection
ii. Month of next inspection due
iii. Year of next inspection due
b. New labels should not be placed over old labels. Old labels are to be removed along with any old
adhesive reside before applying the new label.
c. Labels that have become illegible, washed out, or have peeling edges should be replaced.
d. Any quality issues with the labels should be documented and shared with the Sodexo CTM Brand
Management department.
10. An example listing of all labels to be used is included as a supplement to this procedure (CEM.009, Sup 1).
a. Alternate labels may be used so long as they contain the minimum information listed above, and
they are purchased through an approved vendor.
11. Clinical equipment users will receive training regarding the labeling system during their departmental
orientation.
12. A monthly performance summary reflecting CM, PM, and other maintenance activities will be available to
the department managers, through intranet access.
13. Upon request, an updated listing of all historical data records and inventory will be provided to the
healthcare organization in an electronic format.
References
NFPA 99
Example Labels.CEM.009, Sup 1
Record Keeping
Example Labels.CEM.009, Sup 1

Document labels used for clinical equipment receiving inspection. Operations
At minimum, initials of personnel completing inspections, month of next Unit
inspection due and year of next inspection due.
ELECTRICAL SAFETY
PLANNED MAINTENANCE PLANNED MAINTENANCE
INSPECTION
Month Due: Completed By: Month Due: Completed By: Month Due: Completed By:
JAN JUL
Year Due: Year Due: Year Due:
PLANNED MAINTENANCE PLANNED MAINTENANCE INITIAL INSPECTION

Month Due: Completed By: Month Due: Completed By: Initial inspection Completed By:
FEB AUG completed,

no additional
Year Due: Year Due: inspection
required.

Month Due: Completed By: Month Due: Completed By:
MAR SEP
Year Due: Year Due:

APR OCT
Year Due: Year Due:

MAY NOV
Year Due: Year Due:

JUN DEC
Year Due: Year Due:

N/A
Record Keeping
Table of Contents. CEM.010
CEM.010 Service Request Procedure 58
Supplement 1 Service Request Instructions 60
Supplement 2 Manual Form for Recording Service Requests 61
Supplement 3 Service Request Response Time 62
Service Request Procedure and Response Time.CEM.010

To establish specific guidelines for requesting service for clinical Operations
equipment, priority level assignment, and initial response time.
Scope: Application:
Define protocol for requesting clinical equipment service. Unit
Input / Resources:
Provide a system to respond to service requests twenty-four (24) hours a day,
seven (7) days a week.
Output / Results:
Effective communication and efficient response to all service requests.
1. All local information, such as business hours and telephone numbers will be defined through a site specific
Contact Process following the guidelines in CEM.010, Sup 1 – template.
2. In order to expedite all service requests, the following information is necessary:

a. Equipment control number
b. Equipment description
c. Problem description
d. Contact person name and contact information (preferably telephone number and email address)
e. Location of equipment
f. Priority level of the service request
3. In cooperation with the requesting equipment user, a priority will be assigned to each work request received
by CTM and the work will be completed accordingly.
4. To expedite the processing of corrective work requests, the following priority guidelines will be used:
a. Urgent: Failure to take immediate action will negatively impact the delivery of patient care,
operation of the requesting department, or the healthcare organization with respect to its primary
function and service. This is for emergencies such as when the patient is on the table and there is
not available backup or alternative device, there is no workaround available, and it needs to be
resolved as soon as possible.
b. High: Equipment is either considered Mission Critical (as defined by the healthcare organization),
has been involved with a patient incident, or continued use will increase risk to patient care/delivery.
c. Routine: To be completed at the first opportunity. However, primary function of the requesting
department or healthcare organization is not significantly affected.
d. Deferred: Completion may be scheduled as opportunity permits with no effect on the primary
function of the requesting department or healthcare organization.
5. CTM personnel responding to the service request will finalize the priority, and all valid Urgent corrective
requests will be given a higher priority than Planned Maintenance (PM) actions assigned at the time the
request is received.
6. Urgent maintenance requests must be made by using direct contact or telephone:

a. During normal business hours, directly telephone CTM.
b. After normal business hours, contact the on-call technician by using the locally established
emergency service request procedure.
7. Routine or Deferred maintenance requests may be made by:

a. Direct telephone to CTM.
b. Using the healthcare organization’s intranet to access the CTM maintenance database and request
a work order.
8. After-hours requests for urgent service will follow site specific protocols using pager or direct call process as
defined by the healthcare organization.
Service Request Procedure and Response Time.CEM.010
9. When requests are made using pager or direct call processes, then the CTM personnel receiving the
request shall immediately open a work order and set the Request Date/Time to accurately reflect the time in
which the page or call came in.
10. In the event of the computerized maintenance management system (CMMS) is experiencing an automation
failure or is not available CTM staff should use CEM.010, Sup 2 – template to record receiving the service
request, and enter the information into the CMMS once it is available for use.
11. All corrective maintenance (CM) actions involving equipment covered as part of the Sodexo CTM
agreement will be performed under the direction of the Sodexo CTM Director or Supervisor. Any equipment
that was involved with a patient incident will be handled in accordance with CEM.013.
12. CTM personnel will respond via telephone or in person, and this initial response time to the service request
will depend on the following:
a. Priority level of the service request
b. Time of service request (during normal business hours or after hours)
c. Location of the equipment (main campus or off-site clinic)
13. CTM will notify the requesting department if the work requested cannot be completed in a timely manner.
14. Electrical safety inspection (ESI) and/or performance verification will be performed upon completion of the
corrective maintenance request, in accordance with CEM.009.
15. The healthcare organization is responsible for cleaning and disinfecting all clinical equipment in accordance
with the healthcare organization’s infection control procedures after potential contact with blood or bodily
fluids and prior to providing to CTM for service, unless decontamination of such equipment or portions of
such equipment is not feasible. CTM employees should always use universal precautions when handling
clinical equipment, and should refer to the Sodexo CTM Safety Procedure on Bloodborne Pathogens.
References
Incident Involving Clinical Equipment/SMDA Reporting.CEM.013
Bloodborne Pathogens.SA.111
Service Request Instructions.CEM.010, Sup 1
Manual Service Request.CEM.010, Sup 2
Service Request Response Time.CEM.010, Sup 3
Healthcare Organization Staff
Record Keeping
Service Request Instructions.CEM.010, Sup 1
For Maintenance Requests:
Please provide as much of the following information as possible, to help expedite your
service request.
1. Equipment identification tag number

2. Equipment description
3. Problem description
4. Name and telephone number of contact person (preferably telephone number and email address)
5. Location of equipment
6. Priority level of the service request
Normal Operating Hours:
Monday – Friday, AM to PM
Routine or Deferred Requests:
All repair requests may be entered using the healthcare organization intranet to access the CTM
Department maintenance database or may be called into CTM Department Extension ______.
Urgent or High Requests:
Urgent or High repair requests must be called into CTM Department Extension . If the
request is being made after normal business hours or if the attempt at live contact was unsuccessful,
the following emergency contact procedure will be used:
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Request Escalation:
If the request for maintenance has gone unanswered for a period of time that the equipment user
deems as unacceptable, the following request escalation procedure will be used:
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Manual Form for Recording Service Requests.CEM.010, Sup 2
MANUAL SERVICE REQUEST
Date of service request
Time of service request
Equipment Identification Tag Number
Equipment description
Problem description
Contact person name

telephone number/email address
Location of equipment
Priority
NOTE: This form is to be used when the Sodexo CTM computerized maintenance management system
(CMMS) is not available. When CMMS is available this information will be uploaded into a Corrective
Maintenance (CM) work request.
Service Request Response Time.CEM.010, Sup 3
SODEXO CTM SERVICE REQUEST RESPONSE TIME

TARGET TARGET
RESPONSE TIME RESPONSE
(NORMAL TIME (AFTER
PRIORITY CRITERIA HOURS) HOURS) EXAMPLES
Urgent Emergency. No workaround Within 15 Return Call • Central monitoring
available. Needs to be Minutes Within 15 system failure
Please call for urgent resolved as soon as Minutes, • Major imaging modality
issues possible. Senior staff issue. On-site Within 2 down
Hours
• Major laboratory
Emergency analyzer down
High Device has been involved in Within 30 Return Call • Equipment items
a patient incident or Minutes Within 30 involving patient incident
continued use will increase Minutes, On-site • Anesthesia machine
risk to patient care/delivery. Within 4 Hours failure
• Ventilator not
Mission Critical operational
Routine Device failure is impaired Within 2 Within 1 • Ultrasound probe
but requestor can carry out Hours Business Day damage
normal work responsibilities • OR table drift
Routine and/or temporary alternative • Radiology room, partial
is available. down
Requests
Deferred Device failure where Within 1 Within 2 • Infusion pump failure
multiple back-up equipment Business Business Days (unless patient incident)
General are available. Day • Defibrillator / Monitor
Requests failure
Note: It is important to understand the difference between the "Initial Response Time" and "Resolution
Time". "Initial Response Time" is how long it takes for CTM personnel to acknowledge and contact the
person requesting service. "Resolution Time" is how long it takes from the time a problem gets
reported until the time it gets resolved. Resolution time can be affected by a number of issues, such as
service request priority level, delay in getting parts, etc.
CEM.011 Emergency Procedure for Clinical Equipment Failure 64
Emergency Procedure for Clinical Equipment Failure.CEM.011

To establish specific guidelines for emergency procedures in the event of Operations
critical equipment failure.
Scope: Application:
Define protocol for handling failure of clinical equipment covered as part of the Unit
Sodexo CTM agreement.
Input / Resources:
Assistance in any way possible in the procurement of replacement equipment
that is critical to patient care.
Output / Results:
Systematic and consistent method for responding to urgent requests and
repairing equipment in the most expedient way possible.
1. CTM personnel will inform the clinical manager of any failures of a critical nature to owning departments that
are expected to be out of service for any length of time.
2. CTM personnel will inform the healthcare organization Department Manager of possible equipment
substitutes available from within the healthcare organization.
3. CTM will assist in coordination between clinical areas if equipment sharing is necessary or where equipment
loaner pools are unavailable.
4. CTM technicians will consult with the CTM Director or Supervisor to determine the most expedient form of
repair.
5. CTM will inform the departmental clinical manager of estimated time required to complete the repair and
return-to-service.
6. If a suitable equipment substitute cannot be found within the healthcare organization, the CTM Director or
Supervisor will coordinate efforts to acquire loaner or rental equipment with the clinical user and facility
vendor.
7. Each healthcare organization department manager will ensure that their staff is oriented to the proper
procedures to follow if critical patient care equipment or utility systems in their area fail.
References
Record Keeping
CEM.012 Hazard Alerts and Recalls 66
Hazard Alerts and Recalls.CEM.012

To establish specific guidelines for appropriate action by CTM Operations
personnel upon receipt of a hazard alert or recall.
Scope: Application:
Define protocol for handling clinical equipment with a hazard alert or recall. Unit
Input / Resources:
Provided support in accordance with the healthcare organization’s policy for
managing hazard alerts and recalls.
Output / Results:
Effective, proper and timely management of any pertinent hazard alert or
recall.
1. Sodexo Clinical Technology Management (CTM) will participate in the healthcare organization’s policy
for managing hazard alerts and recalls.
2. Recall and alert notices may come from one or more of the following sources:
a. FDA
b. OEM or equipment distributor
c. Healthcare organization’s Risk Management, Materials Management Department, etc.
d. Monitoring service, such as:
i. ECRI Institute Alerts Tracker
ii. NRAC
iii. RASMAS
3. The CTM Director or Supervisor is to use the Sodexo CTM defined monitoring service for receiving
recall and alert notices, unless the healthcare organization specifies the use of an alternative
monitoring service.
4 . Upon receipt of a hazard alert/recall notice, CTM will search the clinical equipment database for
equipment that is potentially affected by the hazard alert/recall.
a . If the notice was received by a source other than the monitoring service, then CTM will also
search for the notice in the monitoring service program. If the notice received is not located in
the monitoring service program, then the monitoring service provider should be notified as well
as Sodexo CTM Brand Management.
b . If it was found that there was no affected clinical equipment in the database, then the status of
the alert in the monitoring service database should be set to “Not Applicable”.
i. If is it suspected that the alert may be pertinent the healthcare organization but is
outside of the scope of the Sodexo CTM agreement (e.g. accessories, disposables,
etc.), then the alert should be forwarded to the appropriate healthcare organization
personnel and it should be documented in the alert Action Notes section that the alert
was not applicable to Sodexo CTM but was shared with healthcare organization
personnel (include name and title).
c . If it was found that there is affected clinical equipment in the database, then the status of the
alert in the monitoring service database should be set to “Applicable – Open”.
5 . For affected devices, all corrective actions will be coordinated with the department and as required by the
scope of the hazard alert/recall, a device may be immediately removed from service.
6. A work order will be generated for each piece of clinical equipment reference in the recall.
a. Select “Hazard Alert/Recall Action Required” as the Work Order Type
b. The Problem / Failure code should be set to “Hazard Alert / Recall”
c. The WO Risk should be set to “High – Hazard Alert / Recall”
d. After all instructions in the notice have been followed, then the Work Performed field should
be set to “Hazard Alert/Recall Action Performed” and the hazard alert/recall number and all
work performed in conjunction with the hazard alert/recall should be documented in the Work
Performed comments section of the work order to indicate completed actions taken to address
the hazard alert/recall.
Hazard Alerts and Recalls.CEM.012
e. Then in the monitoring service database the status of the alert should be changed to
“Applicable – Closed”, the appropriate action taken selection should be filled in, and the WO
Number should be recorded in the Action Notes section.
7. The healthcare organization Safety Committee (or other designated committee) will be notified of all hazard
alert/recalls work performed that affect devices operating within the scope of CTM services.
References
Record Keeping
CEM.013 Incident Involving Clinical Equipment/SMDA Reporting 69

To establish specific guidelines for response to incidents involving clinical Operations
equipment.
Scope: Application:
Define protocol for handling all incidents involving serious illness or injury with Unit
regard to clinical equipment.
Input / Resources:
Immediate corrective action in accordance with the healthcare organization’s
incident policy.
Output / Results:
Systematic and consistent method for responding to incidents involving clinical
equipment.
1. CTM personnel will assist the healthcare organization during an incident investigation, but CTM personnel
are strictly limited to providing technical information and historical service records regarding any clinical
equipment involved in the incident investigation. All investigations are to be controlled by the healthcare
organization Risk Management department, and investigations should only be started with authorization
from the healthcare organization Risk Management department.
2. Upon notification of an incident involving clinical equipment, CTM personnel will immediately notify the
following personnel:
a. Sodexo CTM Director or Supervisor
b. Healthcare Organization Safety Officer (or similar designee)
c. Healthcare Organization Risk Manager (or similar designee)
d. Sodexo District Manager (DM)
e. Sodexo CTM Corporate (Quality Department)
3. CTM personnel will not offer any opinions as to what caused or may have caused the incident, CTM
personnel will only obtain facts about the incident and document equipment settings and statements issued
from clinical staff regarding the incident.
4. Any clinical equipment and accessories that may have been involved in the incident will be sequestered
immediately after the patient involved in the incident is stabilized. Any device involved in investigation
should remain sequestered and not be returned to operational use until released by the authorized
healthcare organization personnel.
5. Attempting to verify operation of the clinical device may affect the integrity of the situational evidence.
Equipment function testing will not be performed until consent of all of the following personnel has been
granted:
a. Sodexo GM
b. Healthcare Organization Safety Officer (or similar designee)
c. Healthcare Organization Risk Manager (or similar designee)
d. Sodexo DM
6. A work order will be generated for each piece of clinical equipment involved in the patient incident.
a. Select “Patient Incident Investigation” as the Work Order Type
b. Indicated the level of impact to the patient and/or user, this information is to be provided by the
healthcare organization
c. Indicate if the patient incident was due to equipment malfunction / failure
d. Document the root cause of the patient incident
e. Indicate who is responsible for servicing the equipment
f. Investigate whether the clinical equipment has ever been involved in a hazard alert or recall notice
g. Document all equipment settings
i. Take pictures and attached to the Work Order
ii. Also record the equipment settings in the Work Performed comment section as well as the
date of when the equipment was sequestered
h. Do not capture or record any protected health information
7. Protect memory by keeping the devices plugged in and charging while device is in a sequestered state.
8. If litigation is possible, the healthcare organization may consider using an independent investigator to
examine the equipment and to advise on what further steps need to be taken.
9. Upon determination by the healthcare organization Risk Manager, Safety Officer, investigation sub-
committee, or other designated personnel that the device may have contributed to the serious injury or
illness, the following steps will be taken:
a. Under the supervision of CTM or other healthcare organization personnel, an authorized
representative of the Original Equipment Manufacturer (OEM) will conduct equipment operational
verification.
b. If OEM support is not available for the device in question, a qualified, independent testing
organization should be engaged to perform operational verification.
c. The equipment shall not be altered (i.e. opened, repaired, recalibrated, have any part replaced or
setting reset/adjusted) during the investigation.
d. Do not release the equipment to a representative of the manufacturer or owner of the equipment (if
not owned by the healthcare organization) in order to avoid issues with the integrity of evidence.
e. If any deficiency or problem is found with the device, no repair will take place at this time.
f. Do not release information regarding the incident to unauthorized individuals.
g. Do not openly discuss the situation with other staff members or individuals other than with the
healthcare organization Safety, Risk Management and Administration, or other designated
personnel.
h. All service reports and written communication will be reviewed by the Sodexo DM and Sodexo CTM
Corporate Quality Department before being released.
10. Findings from the above listed steps will be presented to the healthcare organization Risk Manager, Safety
Officer, investigation sub-committee, or other designated personnel. The responsible personnel will decide if
the device in question will remain sequestered or may return to operational use.
11. Before returning the device to operational use the device must:
a. Be released by the authorized healthcare organization personnel
b. Have corrective maintenance performed (if required)
c. Have a complete performance assurance test
d. Have all actions performed documented in the historical maintenance record
e. In the Work Performed comment section, record the name and title of the healthcare organization
personnel who authorized the release of the device and note if the device was returned to service.
12. CTM personnel will assist the healthcare organization in reporting the incident to the appropriate authority,
but the healthcare organization Risk Management Department or Safety Committee (or other designated
committee) is responsible for determining whether the specific incident is reportable under the Safe Medical
Devices Act (SMDA) of 1990. This SMDA reporting will include an injury or illness that is:
a. Life-threating
b. Results in permanent impairment of body function or permanent damage to a body structure
c. Necessitates medical or surgical intervention to preclude permanent impairment of body function or
permanent damage to a body structure
d. Significant adverse device experiences other than deaths, serious injuries, or serious illnesses that
the FDA determines are necessary to be reported
13. The documents, Medical Device Reporting: An Overview and Medical Device Reporting for User Facilities
are available from the FDA and may be attached as a supplement to the procedure. These documents
provide detail necessary for Medical Device Reporting.
References
Safe Medical Devices Act of 1990
Healthcare Organization’s Safety Committee Reporting
Medical Device Reporting: An Overview
Medical Device Reporting for User Facilities
Record Keeping
CEM.014 End of Life Equipment Management 73
End of Life Equipment Management.CEM.014

To establish guidelines for managing medical equipment devices that have Operations
received End-of-Life or End-of-Service Notifications.
Scope: Application:
Define the process for medical equipment that have reached end of life or Unit
support from Original Equipment Manufacturers.
Input / Resources:
Original Equipment Manufacturers Notices and CTM SharePoint files
Output / Results:
Inventory of medical equipment that have reached their End-of-Life or Support
Original Equipment Manufacturers.
1. Identify all equipment where Original Equipment Manufacturer (OEM) notices have been provided for
inclusion as part of the service strategy for each device at the account.
2. Refer to the CTM SharePoint Document Library to obtain the latest End-of-Life (EOL) notifications to ensure
the latest up-to-date notifications are available for your healthcare organization.
3. Many manufacturers will continue to provide parts and limited support coverages beyond the date of notices
provided until such time they have depleted inventories. In addition, third-party parts and service companies
have built-up parts inventories as part of their strategies for ongoing support offerings.
4. When limited parts and support options become known, work with the healthcare organization, the District
Manager (DM), and the Sodexo CTM Procurement Director to identify other options that maybe available.
5. As EOL or End-of-Support (EOS) notices are provided, scan the notices and send as an attachment to
CTMEOL.USA@sodexo.com.
References
21 CFR 803.3 – Medical Device Reporting
Record Keeping
CEM.015 Test Equipment Calibration 75
Test Equipment Calibration.CEM.015

To establish specific guidelines for all test equipment to perform in Operations
accordance with industry recognized specifications.
Scope: Application:
Define protocol for handling all test equipment utilized for the service and Unit
repair of clinical equipment covered as part of the Sodexo CTM agreement.
Input / Resources:
Provide a system for re-inspection of medical devices affected by out-of-
tolerance test equipment.
Output / Results:
Systematic and consistent method for documentation of test equipment
calibration results and corrective actions if any are found out-of-tolerance.
1. All test equipment requiring ongoing calibration will be assigned a control number and entered into the
computerized maintenance management system (CMMS).
a. Sodexo CTM owned test equipment will be entered into the 0000 or the 0001 Equipment Entity.
These are national accounts in which all Sodexo CTM owned equipment is recorded and tracked.
b. If applicable, the healthcare organization owned test equipment will be entered into the Entity
Account established for the healthcare organization.
2. All test equipment will be assigned an annual Planned Maintenance (PM) work order.
3. Planned Maintenance will be completed by a calibration laboratory with standards traceable to the U.S.
National Institute of Standards and Testing (NIST) or international measurement standards.
4. The calibration laboratory will be required to return reports on all equipment calibrated. The report must
include:
a. Description of equipment
b. Equipment ID number
c. Location of equipment
d. Calibration date and next due date
e. “As Found” calibration data, to include actual instrument readings
i. Indication if the test equipment was found to be out of calibration
f. “As Calibrated” data, to include actual instrument readings
g. Standard used to calibrate the equipment. To include:
i. Name
ii. ID number
iii. Description
iv. Last Calibration
v. Next Calibration
vi. Whether the standard is traceable to NIST or a specific international standard
h. Name of person conducting calibration
i. Procedure or method used
5. For each device calibrated, a calibration report will be returned to the Sodexo CTM Director or Supervisor.
An individual electronic (PDF) format is the preferred method of delivery. The PDF files may be a native
(originally created) file or a scanned copy. Each PDF file will represent a single device. This will allow for the
file to be attached to the data record in the equipment management database.
6. Any test equipment that is found to be out of calibration upon receipt by the calibration laboratory will be
immediately identified to the Sodexo CTM Director or Supervisor by an authorized representative of the
calibration laboratory.
7. Sodexo CTM Director or Supervisor will evaluate the calibration report and determine the proper course of
action, using the following criteria as a guideline. All actions will be documented in the data record associated
with the test equipment.
8. Sodexo CTM Director or Supervisor will determine if test equipment was grossly out of calibration or
minimally out calibration upon receipt by the calibration laboratory.
a. Gross Error: Any calibrated reading greater than or equal to two percent of the standard.
b. Minimal Error: Any calibrated reading exceeding less than two percent of the standard.
9. An action plan will be developed and implemented for medical equipment having had maintenance
performed with test equipment found to be out of calibration. Maintenance is defined as both Planned
Maintenance (PM) and Corrective Maintenance (CM) tasks. The action plan will include:
a. Running a report from the CMMS to determine all medical devices tested by equipment found to be
out of calibration since the previous calibration.
b. Retesting of medical devices, beginning with the most recently calibrated devices. Retesting can be
limited to readings directly impacted by the test equipment.
c. Urgency of retesting will be performed in accordance with the medical equipment Risk Priority
Rating.
d. Evaluation of results found to determine necessity of continued retesting.
e. Documentation of actions for each medical device will be completed by creating a work order and
recording retesting results in the equipment database.
f. A formal report summarizing actions will be created and distributed to the healthcare organization
Environment of Care (EOC) Committee, Safety Committee, or equivalent committee, to the Sodexo
District Manager, and to CTM Brand Management.
10. For medical devices impacted by test equipment found to be grossly out of calibration:
a. OEM PM Strategy or AEM Risk Priority 1 medical devices (as defined in CEM.006) will be retested,
going back to the last maintenance activity performed with test equipment known to be within
calibration specifications.
b. Risk Priority 2 medical devices will be retested, starting with a random sampling of at least ten (10)
devices affected in the most recent three (3) month period. A review of the results found will
determine if further testing is required. If further testing is required, additional devices will be
reviewed in the same manner.
c. Risk Priority 3 medical devices will be retested, starting with a random sampling of at least five (5)
devices affected in the most recent month. A review of the results found will determine if further
testing is required. If further testing is required, additional devices will be reviewed in the same
manner.
11. For medical devices impacted by test equipment found to be minimally out of calibration:
a. OEM PM Strategy and AEM Risk Priority 1 medical devices will be retested, starting with a random
sampling of at least ten (10) devices affected in the most recent three (3) month period. A review of
the results found will determine if further testing is required. If further testing is required, additional
devices will be reviewed in the same manner.
b. Risk Priority 2 medical devices will be retested, starting with a random sampling of at least five (5)
devices affected in the most recent month. A review of the results found will determine if further
testing is required. If further testing is required, additional devices will be reviewed in the same
manner.
c. Risk Priority 3 medical devices will only undergo retesting if the need is evident that Risk Priority 2
devices require retesting for more than the most recent month. If further testing is required,
additional devices will be reviewed in one (1) month periods.
12. Test Equipment overall performance will be evaluated annually. If any test equipment is found to be
consistently out of calibration upon receipt by the calibration laboratory, such equipment should be
considered for replacement. Consistently out of calibration is defined as:
a. Finding test equipment with the same or similarly related calibration settings out of calibration for
two (2) calibration cycles in a row.
b. Finding test equipment with unrelated calibration settings out of calibration over the course of three
(3) calibration cycles.
References
ISO 9001 – Quality Management
Test Equipment Manufacturer’s Recommendations
Record Keeping
CEM.016 Clinical Equipment Operator Training (In-service Training) 79
Clinical Equipment Operator Training (In-service Training).CEM.016

To establish specific guidelines for knowing the proper use, maintenance Operations
and safety precautions of the clinical equipment at the healthcare facility.
Scope: Application:
Define responsibilities regarding proper training of equipment users. Unit
Input / Resources:
Time spent monitoring equipment maintenance trends and attending in-service
training.
Output / Results:
Consistent user knowledge base of proper clinical equipment operation.
1. CTM personnel will monitor equipment maintenance trends and recommend clinical equipment
operator/user training, if deemed necessary.
2. In-service training will be provided for the following equipment:

a. Equipment new to the hospital
b. Equipment on loan to the hospital
c. Equipment used on an evaluation or trial basis within the hospital
d. Equipment involved in consistent “operator error” calls
e. Equipment requiring extreme safety precautions
3. In-service training will be conducted by:

a. The vendor or their designated representative
b. Healthcare Organization Clinical Education Coordinator (or other designated personnel)
c. Department manager or other medically qualified individual
4. In-service training can be requested by:

a. Using department
b. Nursing Education
c. CTM
d. Others as defined by the healthcare organization
5. CTM personnel will attend in-service training and provide assistance at the direction of the qualified
individual providing training, as requested.
6. The Healthcare Organization Clinical Education Coordinator (or other designated personnel) will ensure that
all such training is documented for the healthcare organization staff and the CTM Director or Supervisor will
ensure that all such training is documented for CTM staff personnel.
7. In-service training must include emergency procedures in the event of equipment failure or other adverse
conditions (power failure, loss of piped gas pressure, etc.).
References
Healthcare Organization Training Policy
Record Keeping
CEM.017 Clinical Equipment Procurement Specifications 81

To establish specific guidelines for compliance of clinical equipment Operations
purchased by the healthcare organization.
Scope: Application:
Define compliance for all equipment safety requirements. Unit
Input / Resources:
Cooperation with Vendor for inclusion of operations and service literature,
software and other service tools.
Output / Results:
Cost effective ongoing maintenance.
1. All equipment purchased by the healthcare organization should meet applicable standards for medical
devices. Vendors are expected to comply with applicable standards set forth by the responsible regulatory
body. These authorities included, but are not limited to:
a. Food and Drug Administration (FDA)
b. Occupational Safety and Health Administration (OHSA)
c. American National Standards Institution (ANSI)
d. Association for the Advancement of Medical Instrumentation (AAMI)
e. National Electrical Manufacturers Association (NEMA)
f. Underwriters Laboratories (UL)
g. Local Authority Having Jurisdiction (AHJ) for NFPA 99 and 101.
2. In order to ensure that all clinical equipment purchased by the healthcare organization is supplied with the
necessary manuals and complies with applicable safety standards, it is recommended that the following
statements be included in all clinical equipment purchase orders. These statements should be included on
the equipment purchase order and be at no-cost to the acquiring organization.
a. The following items are expected to be part of the facility purchase order:
i. Two (2) copies of operations manuals
ii. One (1) operational and one (1) backup copy of operations software
iii. Vendor will provide operational training at the healthcare facility.
iv. One (1) copy of service literature
v. One (1) operational and one (1) backup copy of software necessary to maintain, calibrate
and service equipment.
vi. Specialized tools and test equipment necessary to maintain, calibrate and service
equipment that are exclusively available through the Original Equipment Manufacturer
(OEM).
vii. Vendor will provide service related orientation pertaining to the purchased equipment to
CTM while serving as an agent for the hospital in support of their medical equipment
service.
b. Any exception to the provision of the above listed items must be thoroughly defined and
documented in the sales agreement.
c. Any order received without the above listed items will be considered incomplete and the potential
exists that payment will be withheld until such item is provided.
3. Whenever possible, attendance and tuition for technical service training should be included with sales
agreements between the hospital and supplying vendor.
References
AAMI Standards
ANSI Standards
FDA Standards
NEMA Standards
NFPA 99 and 101
OHSA Standards
UL Standards
Condition of Sale.CEM.007, Sup 1
Record Keeping
CEM.018 Emergency/Disaster Preparedness Recall 84
Supplement 1 Emergency Call Documentation 85
Emergency/Disaster Preparedness Recall.CEM.018

To establish specific guidelines for providing a means of contacting CTM Operations
personnel in the event of an emergency/disaster.
Scope: Application:
Define responsibilities for all CTM personnel (management, technicians, Unit
clerical) and support personnel in the event of an emergency/disaster.
Input / Resources:
Provide on-site support in the event a disaster.
Output / Results:
Systematic and consistent method for emergency response.
1. A disaster is considered a hurricane, tornado, earthquake, flood, or other natural catastrophes, that can
negatively affect the healthcare organization’s ability to provide patient care.
2. An emergency recall list will be maintained by the Sodexo CTM Director or Supervisor or by their designee.
3. An emergency recall list will be maintained as a supplement to this procedure (CEM.018, Sup 1).
4. As required, the emergency recall list will be made available to the healthcare organization,
Emergency/Disaster Preparedness Coordinator or other designated personnel.
5. CTM personnel will adhere to the healthcare organization Emergency/Disaster Plan.
6. All CTM personnel assigned to the healthcare organization are considered essential personnel and will
report to work in the event of a pending emergency/disaster and be prepared to stay on-site until released
by the healthcare organization senior management team.
7. Upon communication of the potential emergency/disaster by the healthcare organization senior

management team, the CTM Director or Supervisor will contact the District Manager (DM).
8. The DM in consultation with the Sodexo Senior Vice President (SVP), Operations will develop plans to
immediately bring in additional CTM support personnel to the healthcare organization. If at all possible,
support personnel will be brought in prior to the emergency/disaster.
9. The additional CTM support personnel will offer assistance to the healthcare organization to be utilized in
any reasonable manner that supports the healthcare organization. As the situation allows, support
personnel will temporarily replace assigned CTM personnel. This will allow assigned personnel to handle
personal needs resulting from the emergency/disaster.
10. Depending upon the type of disaster and anticipated duration of the relief help, CTM will provide its support
personnel with emergency supplies, such as; communication tools, shelter, food, water, etc.
11. The healthcare organization will not be charged for the additional support personnel and resources.
12. On the last day of the support mission, CTM assigned personnel and support personnel will meet to critique
the CTM response to the event. Any suggested improvements will be forwarded to the Sodexo SVP,
Operations and appropriate changes will be made to this procedure.
References
N/A
Emergency Call Documentation.CEM.018, Sup 1
Record Keeping
Emergency Call Documentation.CEM.018, Sup 1

Document recall list for emergency situations. Operations
Details regarding personnel and contact information, as specified. Unit
An emergency recall list will be maintained by the Director or Supervisor

of the CTM Department or their designee.
[DEPARTMENT NAME] - EMERGENCY RECALL ROSTER

Name Position Home Phone Cell/pager Coverage
NOTE: Other information may be included in this roster as deemed appropriate by the healthcare
organization.

N/A
Record Keeping
CEM.019 Clinical Equipment Alarm Management 87
Clinical Equipment Alarm Management.CEM.019

To establish specific guidelines for managing medical equipment alarm Operations
activities.
Scope: Application:
Define the process for medical equipment that contains patient parameter Unit
alarms designed to alert medical staff in the event of an adverse patient
condition.
Input / Resources:
Hospital alarm committee assigned patient parameter definitions.
Output / Results:
Inventory of medical equipment that possess audible patient parameter alarms.
1. All patient care equipment that contain patient parameter alarms will be identified (as an example
physiological monitors, telemetry devices, infusion pumps, ventilators, and pulse oximeters) to ensure they
are included in the computerized maintenance management system (CMMS).
2. Sodexo CTM is responsible for performing regular planned maintenance (PM) and testing on all patient
parameter alarms for medical devices in accordance with CEM.006.
3. An alarm assessment for each device will be conducted in accordance with hospital alarm committee
determination and documented in the CMMS using a corrective maintenance (CM) work order. Sodexo CTM
will ensure all alarms are set to activate at appropriate settings for each patient area and are audible with
respect to distances and competing noise within the unit. In the comments section work order document
initial results and final settings as defined by the hospital alarm committee.
4. Each new or replacement medical device with patient parameters should go through the same testing for
proper alarm settings and audible assessment for competing noise levels in the unit to be assigned.
5. Annually, an alarm inventory should be created from the CMMS and reviewed with the hospital alarm
committee for awareness, education, acceptance and modification as new information becomes available to
the committee.
References
AAMI/Biomedical Instrumentation & Technology May/June 2016
ACCE Healthcare Technology Foundation “Impact of Clinical Alarms on Patient Safety”
ECRI Evaluations & Guidance – Starter List of Alarm Signals
ECRI Evaluations & Guidance – Care Area Assessment Checklist
Record Keeping
CEM.020 Quality Management System 89
Supplement 1 Work Order Audit 90
Quality Management System.CEM.020

To establish specific guidelines for continuous monitoring and improvement of Operations
the healthcare organization medical equipment management program.
Scope: Application:
Define responsibilities which promote customer loyalty. Unit
Input / Resources:
Time spent distributing, conducting, collecting and evaluating surveys and
assessing evaluation scores and responding to the results.
Output / Results:
Adaptability to changes in the needs of the equipment users and the
healthcare market.
1. The quality of the Medical Equipment Management Program will be monitored using several tools and
multiple monitors as described below. The key components of the program are:
a. Sodexo CTM Service Event Survey
b. Sodexo CTM Customer Satisfaction Survey
c. Sodexo CTM Gold Check (Quality Evaluation)
d. The healthcare organization Medical Equipment Management Plan (MEMP) and Annual Evaluation
e. CTM Clinical Equipment Management (CEM) Procedure Manual
2. The Medical Equipment Management Program will be improved based on the feedback gathered using the
tools indicated in item “1” above.
3. The scheduled events below will ensure a continuation of this process:

a. Annually, the MEMP will be reviewed, a written evaluation conducted and the plan altered
accordingly for the coming year. The healthcare organization Safety Committee (or other
designated committee) will oversee this process.
b. Semi-annually (recommended) or at least annual, Sodexo CTM will perform a Customer
Satisfaction Survey polling all departments on their level of satisfaction with the services provided
by the CTM Department.
c. Semi-annually, and in accordance with Sodexo requirements, Sodexo CTM will perform an internal
Gold Check quality evaluation to assess the effectiveness of the entire Clinical Equipment
Management Program. The results of this evaluation will be shared with the healthcare organization
administration and used to identify areas for improvement.
d. At least quarterly (with reporting divided by month), a report based on the indicators and standards
listed in the current healthcare organization MEMP will be discussed at the healthcare organization
Safety Committee Meeting (or other designated committee meeting).
e. Monthly, assessments of overall performance and specific work completed will be performed using
Work Order Audits (CEM.020, Sup 1 – template).
f. On a random basis, Sodexo CTM Service Event Surveys will be sent via email, provided all
information regarding who has placed the service call, email address and any other necessary
information for reference to the service event.
References
Annual Evaluation
Customer Satisfaction Survey
Gold Check
Medical Equipment Management Plan
Service Event Survey
Work Order Audit.CEM.020, Sup 1
Record Keeping
Work Order Audit.CEM.020, Sup 1
INSTRUCTIONS
Every month complete four (4) Work Order Audits per technician, in accordance with CEM.018 Quality Management System, and
maintain a copy of the audits on-site. Review the results of the audits with the technician being assessed.
GENERAL INFORMATION
Technician: Month of Work Order Audit: Year:
PLANNED MAINTENANCE (PM) WORK ORDERS
Work Order #: Control #:
PM Procedures
What is the PM strategy for this device?
Was the PM performed on time?
Were the proper PM procedures performed?
Did the technician document all necessary PM results?
Is all the necessary test equipment available to complete the PM?
Was the test equipment used to perform the PM documented in the Work Order?
Were filters and other consumable items cleaned and/or changed as appropriate?
Labeling
Does the equipment have an updated PM label?
Is all information complete and legible?
Documentation
Have all PM Tasks been properly completed in the Work Order?
If any PM Tasks were marked as “N/A” was an explanation provided in the Work Order?
Did the technician properly record their work hours against this Work Order?
Does the Physical Condition of the device match the level noted in the Work Order?
If applicable, were any parts usage properly documented?
If the PM was completed by a Vendor, was this properly documented and a copy of the service report attached?
Is all equipment information (i.e. OEM, model, serial, TradeName, etc.) completed and accurate?
If applicable, is all IT information (i.e. Software Version, MAC & IP Address, etc.) completed and accurate?
If this was an Initial Inspection, were the Purchase Date, Cost, PO #, and Manufacturer Date properly recorded?
Comments
CORRECTIVE MAINTENANCE (CM) WORK ORDERS

Work Order #: Control #:
Documentation
Were the WO Priority, WO Type, and Problem/Failure accurately documented?
Does the Physical Condition of the device match the level noted in the Work Order?
Were the results of electrical safety testing and performance verification recorded?
Did the technician properly record their work hours against this Work Order?
If applicable, were any parts usage properly documented?
If the CM was completed by a Vendor, was this properly documented and a copy of the service report attached?
Was the proper Work Performed option recorded?
Were enough details of the Work Performed included in the comments section of the Work Order?
Did the Work Performed comment section indicate the final status of the device (e.g. returned to service)?
If this was an Initial Inspection, were the Purchase Date, Cost, PO #, and Manufacturer Date properly recorded?
Comments
AUDITOR SIGNATURE & TECHNICIAN REVIEW

CTM Director / Supervisor: Date of Audit:
Technician: Date of Review:
CEM.021 Safety 92
Safety.CEM.021

To establish specific guidelines for knowledge of safe operating practices of Operations
Sodexo CTM and the healthcare organization by all CTM personnel.
Scope: Application:
Define responsibilities for all CTM personnel regarding safety training. Unit
Input / Resources:
Time spent in training.
Output / Results:
Systematic and consistent method and documentation for creation of a safe
work environment.
1. All Sodexo CTM personnel are required to complete initial and annual refresher training on safety subjects.
a. This is a requirement of Sodexo CTM.
b. Additional safety orientation and periodic review may be required by the healthcare organization.
2. Documentation of annual training regarding Safety Procedures is to be maintained at each business unit
and completion is to be recorded in the Sodexo CTM training documentation tool.
3. Sodexo CTM maintains Safety Procedures on the company intranet website. This site provides twenty-four
hour a day, seven day a week access for all employees.
4. In addition, individual site may print and retain hardcopies of Safety Procedures.
5. The following subject areas (procedure numbers listed) are defined in Sodexo CTM Safety Procedures:
a. General: SA.100
b. Work Areas: SA.101
c. Ladder: SA.102
d. First Aid: SA.103
e. Patient/Equipment User: SA.104
f. Personal Protective Equipment: SA.105
g. Hand and Power Tools: SA.106
h. Compressed Gas: SA.107
i. Electrical: SA.108
j. Steam: SA.109
k. Vehicle: SA.110
l. Bloodborne Pathogens: SA.111
m. Radiation: SA.112
n. Sharps: SA.113
o. Toxic and Hazardous Substances/SDS: SA.114
p. Laser: SA.115
q. Cryogens: SA.116
r. Lockout/Tagout: SA.117
s. Lifting: SA.118
t. Highly Magnetic Environment: SA.119
u. Fire Prevention and Response: SA.120
v. Isolation Areas: SA.121
w. Shipping Hazardous Materials SA.122
6. CTM personnel will also participate in any required healthcare organization safety training. CTM personnel
must maintain documentation of completion of such training at each business unit.
Safety.CEM.021
References
NRC Standards
OHSA Standards
Sodexo CTM Safety Procedure Manual
Record Keeping
CEM.022 Rounding Procedure 95
Supplement 1 Rounding Schedule 97
Supplement 2 Department Rounding Checklist 98
Supplement 3 Formal Rounding Checklist 99
Rounding Procedure.CEM.022

To establish specific guidelines for facilitating planned “rounding” with key Operations
stake holders.
Scope: Application:
Define responsibilities for CTM personnel to execute and document Unit
department rounds.
Input / Resources:
Routinely conducted rounding, visiting all key clinical equipment user
departments.
Output / Results:
Create a formal documented tracking mechanism that demonstrates
continual communications in addition to process improvement initiatives.
1. In general, rounding may be defined as Formal Rounds and Informal Department Rounds. CTM is to
conduct both types of rounding. These two categories are defined as:
a. Formal Rounds: Rounding by the CTM Director or Supervisor with key department managers and
C-suite personnel to strengthen relationships, increase visibility, create approachability, increase
communication, and assess process improvement opportunities.
b. Informal Department Rounds: Rounding by CTM personnel visiting with key clinical equipment user
departments on a recurring basis to communicate with clinical staff members and proactively search
for potential clinical equipment issues.
2. At the start of a new account the CTM Director or Supervisor will consult with the District Manager (DM) and
establish a schedule for conducting department rounds.
a. The department rounding schedule will identify the minimum standard for the rounding frequency
based on department needs.
b. The department rounding frequency will be increased for any department with an unsatisfactory
rating in a Customer Satisfaction Survey (CSS) as conducted in accordance with CEM.020.
c. A Department Rounds Schedule and Completion Log (CEM.022, Sup 1 or an equivalent approved
tool) will be maintained by the CTM Director or Supervisor or designee as a supplement this
procedure.
3. It is acceptable to contact any clinical staff member during department rounds, however, special effort will
be made to contact Department Managers and lead technicians.
4. During Formal department rounds, CTM personnel will discuss the following at a minimum:
a. Equipment issues
b. Corrective Maintenance (CM) action currently pending
c. Planned Maintenance (PM)
d. Device and system interfacing
e. Could not locates
f. Any other subjects related to the performance of clinical equipment and CTM personnel
5. During Informal department rounds, CTM personnel will proactively search for the following:
a. Damaged clinical equipment
b. Clinical equipment that does not appear to be working properly
c. Clinical equipment missing control numbers
d. Clinical equipment missing proper Planned Maintenance (PM) labels, in accordance with CEM.009
e. Clinical equipment out of compliance with the PM program as established according to CEM.006
and CEM.008
f. Short term clinical equipment (as defined in CEM.004) that has been in the facility longer than six
months
g. Repeat failure analysis as it relates to that department
h. Note proper care and handling of medical devices
Rounding Procedure.CEM.022
6. Equipment needing service found during Rounding or equipment service requests received during Rounding
will be prioritized according to normal CM Work Priority Guidelines (CEM.010) and documented as request
received during Rounds.
7. Rounding events will be recorded using the Sodexo Rounding Checklist (CEM.022, Sup 2 for department
rounds, CEM.022, Sup 3 for formal rounds, or equivalent approved forms) that should be attached to the
CM work order.
8. It is recommended that issues found during Rounding are documented by taking photos and attaching the
photos to the work order.
9. CTM personnel will follow-up with any clinical staff that brought up an issue during rounding. It is especially
important that the clinical staff is informed of when the issue is resolved.
10. DMs / CTM Quality audits will review logs upon each site visit:
a. Review of logs are to:
i. Look for timely implementation
ii. Documentation of what is working well and areas for opportunity
iii. Actions taken for remediation / improvement.
References
Service Request Procedure, Priority, and Response Time.CEM.010
Quality Management System.CEM.020
Rounding Schedule.CEM.022, Sup 1
Department Rounding Checklist.CEM.022, Sup 2
Formal Rounding Checklist.CEM.022, Sup 3
Record Keeping
Rounding Schedule.CEM.022, Sup 1
Department Rounds
MONTH/YEAR Week 1 Week 2 Week 3 Week 4

Monday
Department 1
Department 2
Department 3
Department 4
Department 5
Department 6
Week 1 Week 2 Week 3 Week 4
Wednesday
Department 7
Department 8
Department 9
Department 10
Department 11
Department 12
Week 1 Week 2 Week 3 Week 4
Friday
Department 13
Department 14
Department 15
Department 16
Department 17
Department 18
Department 19
Department Rounding Checklist CEM.022, Sup 2
INSTRUCTIONS
Department rounds should be conducted at the frequency defined in the account department rounds schedule. A copy of the rounding
checklist, or an equivalent approved form, is to be attached as part of the rounding work order in the CMMS database. Review the
results of the departmental rounding to determine methods for performance improvement and identify items that may have been missed
during routing work protocols.
GENERAL INFORMATION
CTM Personnel: Month/Day of Rounding: Year:
Department: Department Manager/Director
ROUNDING CHECKLIST
Rounding Work Order #:
Documentation
Yes / No Comments
Any equipment found without proper tags?
Any equipment found that was not properly documented in the CMMS?
Any medical devices found with frayed, broken wires?
Any medical devices found with damaged hardware?
Any general electrical safety problems?
Any missing, incorrect, or out-of-date PM labels?
Any rental/loaner/demo or patient devices that exceeded their length of stay?
Any unauthorized power strips, extension cords, or adaptors in patient care areas?
List the name and title of the people you spoke with during rounds:
Were any comments, concerns, issues, kudos, etc. surfaced?
Additional Comments
FOLLOW-UP
Any follow-up required?
If so, who does the follow-up need to be with?
Follow-up Date:
Formal Rounding Checklist.CEM.022, Sup 3
INSTRUCTIONS
Formal Rounds are to be conducted by the CTM Director or Supervisor who are to visit with key clinical department managers and C-
suite personnel. A copy of the rounding checklist, or an equivalent approved form, is to be attached as part of the rounding work order
in the CMMS database. Review the results of the rounding to determine opportunities for improvement.
GENERAL INFORMATION
CTM Personnel: Month/Day of Rounding: Year:
Client Name: Client Title:
ROUNDING CHECKLIST
Rounding Work Order #:
Documentation
Comments
Review updates for any pending

projects.
Review open work order list for

department.
Review equipment under Facility

contract due to expire.
Review PM schedule and Could Not

Locate(s).
Review any capital planning needs.

Ask for Feedback on the Following / Provide Comments
Ask about what has been working

well.
Ask about ease of contacting CTM

personnel.
Ask about the availability of

equipment in their department.
Ask about any training

needs/concerns?
Ask if there are any CTM personnel

that should be recognized.
Additional Comments
FOLLOW-UP
Any follow-up required?
If so, who does the follow-up need to be with?
Follow-up Date:
CEM.023 Participation in Committees 101
Participation in Committees.CEM.023

To establish guidelines for CTM staff to contribute to the hospital’s mission, Operations
vision, goals, and objectives by providing expertise in the management and
maintenance of medical equipment.
Scope: Application:
Define the process for participation in hospital committees from a consultative Unit
or advisory manner regarding medical equipment.
Input / Resources:
Hospital committee structures and organization.
Output / Results:
Systematic communications dependent on hospital group.
1. The Sodexo CTM Director or Supervisor is expected to be actively involved in the healthcare organization
committee structures and/or task forces to:
a. Offer knowledge around clinical equipment
b. Provide expertise regarding issues related to medical equipment at the hospital
c. Review regulatory issues related to medical equipment
d. Report on environment of care (EOC)/safety/risk related issues on medical equipment
e. Provide consultative capital equipment/evaluation/purchase considerations for new or replacement
medical equipment
2. Recommended committee participation may include, but is not limited to:

a. Safety or EOC
b. Risk Management
c. Capital Equipment
d. Regulatory Compliance
e. Infection Prevention
f. Emergency Planning
g. Performance Improvement
h. Radiation Safety
i. Laser Safety
j. IT Networking or Security
k. Nursing Operations or Education
l. Alarm
References
Record Keeping
CEM.024 Vendor Management 103
Supplement 1 Vendor Log 105
Supplement 2 Service Provider Procedure 106
Vendor Management.CEM.024

To establish specific guidelines for control of outside vendors. Operations
Scope: Application:
Define responsibilities for all outside vendors used to service clinical Unit
equipment covered as part of the Sodexo CTM agreement.
Input / Resources:
Vendor log book sign-in and sign-out, vendor documentation, and vendor proof
of competency.
Output / Results:
Accountability, cost effectiveness, and quality service for the healthcare
organization equipment.
1. All vendors must follow the vendor sign-in procedures as established by the healthcare organization. All
clinical equipment service vendor visits to the healthcare organization must be documented in the vendor
logbook located in the CTM Department, CEM.024, Sup 1 is an example logbook template.
2. During normal business hours, equipment service vendors will report directly to or contact the CTM
Department before beginning any service work. The equipment service vendor will be escorted by CTM
personnel to the location of the equipment or met by CTM personnel at the location of the equipment. At the
discretion of the CTM Director or Supervisor the CTM personnel may be required to remain with the vendor
while the vendor is servicing the equipment.
3. After normal business hours, the CTM on-call technician will authorize all repairs. The vendor sign in and
out and service documentation receipt will be coordinated with the on-call technician.
4. The Vendor Log Book, at a minimum, must be completed with the following information:
a. Date
b. Company Name
c. Representative Name
d. Equipment being Serviced
e. Time In
f. Time Out
5. Vendors will receive a copy of CTM Service Provider Procedure (CEM.024, Sup 2 – template). This memo
outlines vendor requirements for:
a. Service Calls
b. Parts Replacements
c. Documentation
d. Invoices
6. If the vendor must leave the facility for any reason, the action is to be documented in the Vendor Logbook,
and new entry must be made in the Vendor Logbook upon the vendor’s return to service activities.
7. A copy of all paperwork, work orders and/or parts, will be left at the CTM Department. The vendor may send
the documentation electronically. If this process is not followed, payment for services may be held
indefinitely.
8. Vendor service report will be reviewed to ensure accuracy. If discrepancy exists, the service report will not
be signed. Corrections must be reviewed and agreed upon before signature.
9. A copy of the vendor’s documentation will be placed in the equipment file, or scanned into the Computerized
Maintenance Management System (CMMS) corresponding work order.
10. Upon request by the healthcare organization CTM, or any regulatory agency, vendors must be able to
provide proof of the ability, qualification, and competency of the vendor personnel that serviced the clinical
equipment. The proof of competency will be attached to the corresponding work order in the CMMS.
Vendor Management.CEM.024
References
N/A
Vendor Log.CEM.024, Sup 1
Service Provider Procedure.CEM.024, Sup 2
Record Keeping
Vendor Logbook.CEM.024, Sup 1
INSTRUCTIONS
All clinical equipment service vendor visits must be documented in the vendor logbook located in the CTM Department. At
a minimum, the Vendor Log will contain the following information: date, company name, service technician /
representative name, equipment being services, time in and time out. Other information may be included in the Vendor
Log as deemed appropriate by the healthcare organization or by the CTM Director or Supervisor.
ACCOUNT INFORMATION
Account Name: Location:
Director/Supervisor: District Manager:
VENDOR SIGN-IN / SIGN-OUT

Service Technician /
Date Vendor Company Name Equipment Being Serviced Time In Time Out
Representative Name
«Facility» Service Provider Procedure
To: From:
Fax: Pages:
Phone: Date:
Re: «Facility» Service Provider Procedure CC:
Service providers doing business in all «Facility» facilities are advised that certain protocols have been established
and must be followed. These protocols ensure prompt payment of service invoices and enable the facility to manage
their assets in a more effective manner.
1. Service Calls
The Sodexo representative will place requests for service following the procedures of the service provider.
At the time of the call, the urgency of the call will be stated and instructions for overtime authorization will be
delivered. Please note that unauthorized overtime will not be considered for payment. The Sodexo
CTM Director or the designated representative can approve overtime for payment. The service call
representative should provide the Sodexo personnel the company’s call number, and an estimated
response time.
The service representative shall notify Sodexo that they are on site, either via phone or in person, and will
complete an entry in the Sodexo Service Vendor Log Book. It will be the responsibility of Sodexo personnel
to follow up with the service representative regarding the status of the repair, and determine if overtime
authorization is required. A purchase order is required for each service call. The purchase order will be
provided at the time of the call, and is only for that specific call. Sodexo will not honor invoices that do not
contain a valid purchase order issued by Sodexo for that call.
2. Parts Replacements
If parts are required to complete the repair, the service provider shall inform the Sodexo personnel of the
parts needed, an estimated price, credits, if any, for returned parts, and part warranty. The service provider
shall also provide an estimated arrival time for the parts, and estimated shipping costs. Parts installed for
troubleshooting purposes that do not resolve the problem, will not be considered for payment. The original
part must be reinstalled by the service provider at no cost to Sodexo. Sodexo must approve the replacement
of all parts.
3. Documentation
A completed legible service report will be provided to Sodexo before the service provider leaves the facility.
After working hours, the service provider will leave a copy of the service report in the Sodexo Service
Vendor Log Book. Service reports must contain at least the following:
• Positive identification of the equipment being serviced (serial #, model #, etc.)
• Description of the problem and resolution
• Labor and travel hours
• Parts used (including the part number, description, list price and return credit if any)
• Sodexo purchase order number
• Signature of the person performing the work
Service provider codes used to describe the problem and repair with no accompanying description are not
acceptable. Invoices will not be considered for payment without a signed copy of the service report.
The service provider shall also ensure that all documentation required by State and Federal regulatory
agencies is left on s ite. This includes, but is not limited to, documentation required by TJC, CAP, FDA,
NFPA, etc. Failure to provide the necessary documentation could result in invoice payment delays.
4. Invoices
All invoices shall be sent to the following address:
Sodexo CTM, Inc
Attention: Accounts Payable
7100 Commerce Way, Suite 280
Brentwood, TN 37027
All invoices must contain the following information:

• A valid Sodexo Purchase Order number
• Service provider call number
• Labor and Travel hours
• Overtime hours
• Zone Charges
• Parts used, quantity, part number, list price and return credit issued.
• Date of service
CEM.025 Parts or Service Requisition Process 109
Supplement 1 Vendor Service Request 111
Supplement 2 Business Associate Agreement 112
Parts or Service Requisition Process.CEM.025

To establish specific guidelines for standardization of sourcing activities. Operations
Scope: Application:
Define protocol for purchasing parts and services for clinical equipment Unit
covered as part of the Sodexo CTM agreement.
Input / Resources:
Purchase request requirements.
Output / Results:
Proper approval authority and expedient acquisition of parts and services.
1. The CTM Director or Supervisor has direct authority necessary to purchase required parts and services for
all equipment covered with the appropriate Service Coverage Level. The Service Coverage Level must
designate parts and outside services inclusion.
a. CTM personnel will consult with the CTM Director or Supervisor on decisions regarding equipment
to be sent out for service.
b. The CTM Director or Supervisor will directly approve all purchase requests or establish purchasing
authority level for CTM personnel.
2. Appropriate purchasing authority levels will be designated in the Computerized Maintenance Management
System (CMMS).
3. Purchase requests for equipment covered under the appropriate Service Coverage Level (designating parts
and outside services inclusion) will be completed using the CMMS database program.
4. Flat rate or estimate repair cost will be used to generate a Purchase Order (PO). For estimates, it is
important to distinguish what the estimate is for both labor and parts as separate items, not lumped
together.
5. Purchase requests for equipment not covered under the appropriate Service Coverage Level (designating
parts and outside service not to be included) will be completed using a method approved by the healthcare
organization.
6. Purchase requests exceeding the established purchasing authority level of CTM Department personnel are
placed in a pending status and must be approved by the CTM Director or Supervisor before a PO number
will be issued.
7. Receipt of all purchased parts or services will be documented in the equipment CMMS program.
8. A work order will be assigned in the CMMS database program to all clinical equipment requiring service
actions.
9. In event that equipment will be sent out for service, CTM personnel will contact the appropriate vendor for
the required information to send the equipment. Before sending out ensure that the organization has a
signed Business Associate Agreement (BAA) for equipment that contains ePHI information. If a Business
Associate Agreement is required and the organization does not have one available, use CTM Sodexo BAA
(CEM.025.Sup 2, Business Associate Agreement) and forward to Sodexo CTM Supply Chain.
10. CTM staff are expected to record all necessary information on a Vendor Service Request Form (CEM.025,
Sup 1 – template). This information will include:
a. All standard information
b. A Returned Merchandize/Goods Authorization number
c. Problem description
d. Designation of vendor action requested (this will determine in the purchase order number will be
included on the form)
11. The Vendor Service Request Form must be sent with any device sent out for repair. Suitable vendor forms
may be substituted for the Vendor Service Request Form.
Parts or Service Requisition Process.CEM.025
12. One copy of the form will be securely attached to the device, using tape or other means, to the unit being
sent out for service. A copy of the form will be retained for tracking purposes at in the CTM Department.
13. Appropriate Electrical Safety and Operational Verification tests, in accordance with CEM.004 will be
conducted on the device prior to returning to service to ensure correction of original problem(s), fitness for
intended use and electrical integrity.
14. Corrective actions taken by the vendor will be recorded on the work order and any documentation will be
included in the historical record for the device.
References
Vendor Service Request.CEM.025, Sup 1
Business Associate Agreement CEM.025, Sup 2
Record Keeping
Business Associate Agreement
Vendor Service Request.CEM.025, Sup 1
FACILITY INFORMATION
Facility Name:
Shipping Address:
Address Line 2:
Attention Line:
City, State, Zip:
Phone #:
WO #:
Technician:
Equip ID #:
VENDOR INFORMATION
Vendor:
Phone #:
Contact:
Vendor Shipping Address:
Address Line 2:
City, State, Zip:
Account #:
Item Description:
RMA / RGA #:
Problem Description:
VENDOR ACTION REQUESTED
• Call the phone number listed for approval prior to performing any repairs to this device.
• Reference the Equip ID and PO# listed on all billing statements/invoices.
• Call the phone number listed for approval if repair amount exceeds $
Approval: Date:
SERVICE INFORMATION
Reference #: Date:
PO #: Ordered By:
Amount: Billing Address: Sodexo CTM
7100 Commerce Way
Suite 280
Brentwood, TN 37027
(615) 844-8800
Business Associate Agreement.CEM.025, Sup 2

Compliance with HIPAA Operations
Signed agreement by any vendor hired to services equipment that contains Unit
protected health information
Below is an excerpt from the Sodexo Business Associate Agreement (BAA) template. For the complete BAA
template, go to CTM SharePoint site.
BUSINESS ASSOCIATE AGREEMENT
THIS BUSINESS ASSOCIATE AGREEMENT (this “Agreement”) is entered into as of the ________
day of ___________ by and between Sodexo Operations, LLC, a Delaware Limited Liability Company with
an address at 9801 Washingtonian Blvd., Gaithersburg, Maryland 20878, on behalf on itself and its
subsidiaries and affiliates (collectively “Sodexo”) and ____________________________, a
____________ corporation with an address at
________________________________________________________ (the “Business Associate”).

N/A
Record Keeping
CEM.026 Complaint Handling and Service Escalation/Recovery Process 114
Supplement 1 Complaint Acknowledgement Letter 117
Supplement 2 Complaint Investigation Report 118
Complaint Handling and Service Esclation / Recovery Process.CEM.026

To establish specific guidelines for handling and documenting complaints. Operations
Scope: Application:
Define the roles and responsibilities of CTM employees related to complaints Unit
handling activities.
Input / Resources:
Proper documentation and resolution of complaints
Output / Results:
Systematic and consistent method for delivering high-quality and accountable
responses to complaints to include follow through and follow up.
1. The following steps must be followed for all customer complaints received by CTM employees.
a. Receive & Classify
b. Acknowledge
c. Investigate
d. Resolve & Confirm
e. Respond
f. Follow-up
g. Quality Assurance
h. Review & Close
2. Receive & Classify: All potential issues must be captured and classified for escalation, review, and actions
as required.
a. Any complaint, issue, or negative customer interaction (whether this is formally logged by the
customer or not), must be documented and classified for action.
b. All of these complaints must be formally logged using the Complaint Report (CEM.026, Sup 1)
c. All complaints must be prioritized as follows:
i. Priority 1: Urgent
1. This should be used (sparingly) for major issues where the customer may be either
a large national client, or any customer who is considering moving their business
from CTM and there is a high business impact.
2. Also this could be used in a situation where the customer may be in a position to
influence or make public statements that would impact upon the CTM brand or
reputation.
ii. Priority 2: Important
1. This should be used for most issues there is potential for high business impact.
2. This should be handled after any Urgent complaint, but as soon as possible.
iii. Priority 3: Alert
1. This should be used for any issue with a lower business impact.
2. This should be used for most complaints with individual customers, as this allows a
reasonable time to collect information and produce a balanced response.
d. Discretion and flexibility should be exercised in prioritizing all complaints
e. The CTM employee logging the complaint should review the complaint and the priority with the CTM
Director or Supervisor before proceeding to the next step.
f. The CTM Director or Supervisor will decide on the appropriate person(s) to carry out subsequent
steps, including the investigation.
g. All complaints will be escalated and managed accordingly:
i. All Priority 1 complaints must be escalated immediately to the District Manager (DM),
Regional Vice President (RVP) and CTM Corporate.
ii. All Priority 2 complaints must be escalated immediately to the DM.
iii. A complaint will be automatically escalated if:
1. A maximum response time has been exceeded
2. The complaint becomes urgent
3. Another factor increases the seriousness of the complaint or the need for expedited
resolution.
Complaint Handling and Service Esclation / Recovery Process.CEM.026
3. Acknowledge: Every complaint will receive a formal written acknowledgement, containing an expectation of
when to expect a response and who will be handling the complaint.
a. All complaints, regardless of priority, should receive a complaint acknowledgement letter (CEM.026,
Sup 1) which must be sent out on the day of receipt by the GM.
4. Investigate: Follow up must be conducted on all aspects of the complaint, both internal and external to
ensure that the key facts are identified and clarified.
a. The priority of the complaint will drive the timescale for completion:
i. 48 hours for Priority 1: Urgent
ii. One (1) week for Priority 2: Important
iii. Two (2) weeks for Priority 3: Alert
b. All areas of interaction and communication should be established (who, what, where, when, why
etc) and documented where possible using the Complaint Investigation Report (CEM.026, Sup 2).
5. Resolve & Confirm: The final resolution must be clear and fair. Also confirm the proposed action and
resolution with another senior person.
a. The CTM Director or Supervisor must ensure that the proposed resolution meets corporate
guidelines and does not prejudice CTM in any unnecessary legal or financial manner.
b. Document the proposed corrective action and discuss and agree with the DM and/or RVP and CTM
Corporate, where appropriate.
c. Discuss and review the solution from both the corporate and customer viewpoint to ensure fairness
and clarity.
d. The review should include recognition and documentation of any underlying issues that have
contributed to the complaint and recommendations for actions to prevent further occurrence.
6. Respond: Provide the customer with the resolution within the timescales promised.
a. The details of the findings and proposed resolution should be clearly explained (in written or verbal
form as appropriate) to the customer- within the agreed timescales.
b. If this cannot be done on time the customer should be contacted by telephone to request further
time.
c. If the customer does not accept the resolution, the complaint should be escalated for investigation.
i. Escalation processed could include contacting the DM, CTM Corporate, RVP and/or the
Senior Vice President (SVP).
7. Follow-up: Ensure that complaints are followed up to confirm that customers are satisfied with the response
given.
a. All complaints must be followed up within a reasonable timescale.
b. The follow-up should identify:
i. Is the customer satisfied with the response?
ii. Did they feel that their complaint was properly and fairly handled?
c. Any negative responses to these questions should be referred to the CTM Director or Supervisor
and DM for action and direct follow up with customers.
8. Quality Assurance: Ensure that the organization as a whole is aware of complaints and any underlying
issues.
a. Perform a Root Cause Analysis (RCA), and address the following:
i. What happened to cause the complaint?
ii. Why did it happen?
iii. What are the contributing causal factors?
iv. What can be done to prevent this from happening again?
b. Create Action Plans to remove these contributing factors and prevent future recurrence.
c. Any complaints where action can be taken to avoid recurrent must be acted upon and raised with
the appropriate managers/teams across the CTM organization.
Complaint Handling and Service Escalation/Recovery Process.CEM.026
9. Review & Close: Ensure that the complaint has been managed properly and the client was satisfied with the
resolution.
a. A review of the Complaint Investigation Report should be performed by the immediate supervisor of
the Sodexo CTM employee that filled out the report.
b. The reviewer is to look over the entire report and make sure that all steps involved with handling the
complaint were properly documented.
c. The reviewer may return the report and request further information or for clarification. The report
can be re-submitted to the reviewer after the requested information has been added to the report.
d. After the reviewer closes the complaint the Complaint Investigation Report is to be kept at the
account and copy of the report submitted to the CTM Brand Management Department.
i. CTM Brand Management will keep a logbook of all complaints, along with a copy of all
documentation related to the complaint.
ii. CTM Brand Management along with other CTM Corporate staff will periodically review all
complaints.
10. Additional Notification for Contracted Services

a. The following applies when Sodexo CTM has been contracted by an entity outside of the healthcare
organization to provided services.
i. After becoming aware of any alleged deficiencies raised by the healthcare organization and
related to the identity, quality, durability, reliability, safety, effectiveness, or performance of
clinical equipment either through written, electronic, or oral communication:
1. The entity that contracted Sodexo CTM services will be notified within two (2)
business days in regards to the complaint received.
2. The complaint will be handled uses the steps outlined in this procedure.
References
N/A
Complaint Acknowledgement Letter.CEM.026, Sup 1
Complaint Investigation Report.CEM.026, Sup 2
Record Keeping
Complaint Acknowledgement Letter.CEM.026, Sup 1
EXAMPLE Complaint Acknowledgement Letter
Date
FROM: Name, Title
RE:
Thank you for contacting us today with your complaint/problem.
We are sorry that you have had to do this and apologize for any inconvenience this has caused you.
We view complaints as positive and helpful feedback and will do everything we can to resolve this fairly and
quickly to your satisfaction.
We aim to respond to you within 2 days/1 week/2weeks with a suitable resolution.
I look forward to reaching a suitable resolution to this matter and thank you again for taking time to raise this
with us.
Yours
CTM Director
COMPLAINT INVESTIGATION REPORT – Page 1 of 3: The Complaint
SECTION 1 : GENERAL DETAILS

Raised by:
Sodexo CTM employee receiving and logging the complaint.
Role / Position:
Facility / Account Name:
CTM Director / Supervisor:
District Manager:
SECTION 2 : RECEIVING & CLASSIFICATION
Customer / Complainant Name:
Date Complaint Was Made:
Customer Email Address:
Customer Phone Number:
Compliant Priority:
Description:
Description of complaint – details
Business Impact:
Description of impact on business/operation
SECTION 3 : ACKNOWLEDGMENT
Acknowledgement Recipient(s):
List all recipients that received the acknowledgement.
Date Acknowledgement Sent:
Contacted by:
Sodexo CTM employee who sent the Acknowledgement.
SECTION 4: INVESTIGATION
Investigator(s):
List all who were involved in the investigation.
Findings:
Details of the findings.
COMPLAINT INVESTIGATION REPORT – Page 2 of 3: The Resolution
SECTION 5: RESOLVE & CONFIRM

Proposed Resolution:
List the corrective action(s) to be taken and include any
deadlines for completion.
Resolution Approved by:

Must be approved by DM and/or CTM Corporate
SECTION 6: RESPONSE
Response Recipient(s):
List all recipients that received the response.
Date Response Sent:
Contacted by:
Sodexo CTM employee who sent the response.
Did the customer accept the resolution?
If No, provide details.
If No, list who the complaint was escalated to:

SECTION 7: FOLLOW-UP
Follow-up Recipient(s):
List all recipients that received a follow-up.
Date of Follow-up:
Contacted by:
Sodexo CTM employee who made the follow-up.
Is the customer satisfied with the response?

Does the customer feel that their complaint
was properly and fairly handled?
COMPLAINT INVESTIGATION REPORT – Page 3 of 3: Root Cause Analysis & Review
SECTION 8: QUALITY ASSURANCE

Analyzer(s)
List all who were involved in the Root Cause Analysis
Key Issues Identified:
What happened to cause the complaint?
Why did it happen?
What are the contributing causal factors?
Long Term Corrective Action(s) Required:

What can be done to prevent this from happening again?
Issues and Actions Accepted by:

Must be approved by DM and/or CTM Corporate
Additional Notes:
SECTION 9: REVIEW & CLOSE

Reviewer:
Date of Review:
Complaint Investigation Report Form Status:
Is further information needed or clarifications required?
Additional Notes:
Sodexo Healthcare
7100 Commerce Way, Suite 280
Brentwood TN 37207
Tel: 615 844 8800 – Fax: 615 844 8843
www.sodexo.com

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Clinical Equipment Management

Purpose: Functional Area:

4. Table of contents for various procedures and supplements are as follows:

Ref # Table of Contents Titles Page

CEM.TC1 Table of Contents 2

CEM.TC2 Supplement Instructions 3

Ref # CEM Procedure Page

CEM.001 Procedure Development and Review 6

CEM.002 Equipment Management and Maintenance Responsibilities 13

CEM.003 Initial Orientation, Competency Assessment & Prof. Development 16

CEM.004 Initial Inspection and Disposition of Equipment 28

CEM.005 Removal/Disposal of Equipment with ePHI 33

CEM.006 Planned Maintenance Strategy 35

CEM.007 Service Manuals 43

CEM.008 Planned Maintenance 46

CEM.009 Clinical Equipment Testing/Repair/Labeling 53

CEM.010 Service Request Procedure, Priority, and Response Time 57

CEM.011 Emergency Procedure for Clinical Equipment Failure 63

CEM.012 Hazard Alerts and Recalls 65

CEM.013 Incident Involving Clinical Equipment/SMDA Reporting 68

CEM.014 End of Life Equipment Management 72

CEM.015 Test Equipment Calibration 74

CEM.016 Clinical Equipment Operations Training (In-service Training) 78

CEM.017 Clinical Equipment Procurement Specifications 80

CEM.018 Emergency/Disaster Preparedness and Recall 83

CEM.019 Clinical Equipment Alarm Management 86

CEM.020 Quality Management System 88

CEM.022 Rounding Procedure 95

CEM.023 Participation in Committees 100

CEM.024 Vendor Management 102

CEM.025 Parts or Service Requisition Process 108

CEM.026 Complaint Handling and Service Escalation/Recovery Process 113

Ref # CEM Supplement Page

CEM.001, Sup 1 Facility Approval of CEM Procedures 9

CEM.009, Sup 1 Example Labels 56

CEM.018, Sup 1 Emergency Call Documentation 85

CEM.022, Sup 1 Rounding Schedule 97

CEM.024, Sup 1 Vendor Logbook 105

Ref # CEM Supplement Page

CEM.001, Sup 2 Program Exceptions 11

CEM.001, Sup 3 Training Documentation Form 12

CEM.003, Sup 1 New Employee Orientation Checklist 20

CEM.003, Sup 2 New Director / Supervisor Orientation Checklist 24

CEM.003, Sup 3 Unit Specific Work Rules 27

CEM.004, Sup 1 Disposition Form 32

CEM.007, Sup 1 Letter to OEM Requesting Maintenance Recommendations 45

CEM.008, Sup 1 Department Planned Maintenance Notification 49

CEM.008, Sup 2 Devices Overdue Notification 50

CEM.008, Sup 3 Devices Two Months Overdue Notification 51

CEM.008, Sup 4 Device Removal From Service 52

CEM.010, Sup 1 Service Request Instructions 60

CEM.010, Sup 2 Manual Form For Recording Service Requests 61

CEM.010, Sup 3 Service Request Response Time 62

CEM.020, Sup 1 Work Order Audit 90

CEM.022, Sup 2 Department Rounding Checklist 98

CEM.022, Sup 3 Formal Rounding Checklist 99

CEM.024, Sup 2 Service Provider Procedure 106

Ref # CEM Supplement Page

CEM.025, Sup 1 Vendor Service Request 111

CEM.025, Sup 2 Business Associates Agreement 112