Download EC.01.01.01-EP7-Medi..

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Medical Equipment Management Plan
2017
I.
SCOPE
The Medical Equipment Management Plan describes the risk and daily management
activities that the organization has put in place to achieve the lowest potential for
adverse impact on the safety and health of patients, staff, and other people, coming to
the organization’s facilities. A Medical Equipment Management plan based on various
criteria including risks identified by outside sources to eliminate or reduce the probability
of adverse patient outcomes
II.
This plan covers activities performed in the various locations of the organization,
including the {{hospital campus, clinics and physician’s practices, nursing homes, and
other appropriate operations center}}.
.
PRINCIPLES
A. Selection of appropriate equipment to support the services of the organization is an
essential part of assuring safe effective care and treatment are rendered to persons
receiving services.
B. Orientation, education, and training of operators of medical equipment is an essential
parts of assuring safe effective care and treatment are rendered to persons receiving
services.
C. Assessment of needs for continuing technical support of medical equipment and
design of appropriate calibration, inspection, maintenance, and repair services is an
essential part of assuring that medical equipment is safe and reliable.
D. Effective management of medical alarms is a critical part of the patient safety
program.
III.
OBJECTIVES
The Objectives for this Plan are determined from the annual evaluation of the previous
year’s management plan and the results of other activities that include environmental
tours, risk assessment information collected and evaluated during the year, and special
incidents.
The Objectives for this year are: {{suggestions below}}
 Complete the list of equipment that should be replaced
 Install new telemetry system
 Provide training for radiology technicians on new CT system
IV.
PERFORMANCE ACTIVITIES
One part of determining the effectives of the Program is by selection and monitoring
specific performance measures. Performance measures are established to determine
the opportunity for action to improvement in the Program. This can include staff
knowledge questions, staff or equipment performance, and items identified from the
hospital’s risk assessment. These measures include a denominator and numerator for
determining performance
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The performance measures for the Program are: {{Suggestions below}}


V.
Percent of correct response for Staff knowledge: How to report a malfunctioning
piece of medical equipment
(Threshold = 95%)
Percent of repair work orders generated from PM work orders.
(Threshold = 10%)
PROGRAM MANAGEMENT STRUCTURE
A. The Board receives regular reports of the activities of the program from the
{{Environment of Care Committee, Safety Committee, etc}}. The Board reviews the
reports and, as appropriate, communicates concerns about identified issues back to
the {{Director of the Medical Equipment}} program and appropriate clinical staff. The
Board collaborates with Leadership and other senior Directors to assure budget and
staffing resources are available to support the ME program.
B. Leadership receives regular reports of the activities of the program. Leadership
collaborates with the program Director and other appropriate staff to address medical
equipment issues and concerns. Leadership also collaborates with the program
Director to develop a budget and operational objectives for the program.
C. The {{Director of Clinical Engineering}} assures that an appropriate medical
equipment maintenance program is implemented. The Director of the program also
collaborates with the Safety Officer to develop reports of performance for
presentation to the EC Committee on a quarterly basis. The reports summarize
organizational experience, performance management and improvement activities,
and other medical equipment issues.
D. The {{medical equipment technicians}} and selected outside service company staff
schedule and complete all calibration, inspection, and maintenance activities
required to assure safe reliable performance of medical equipment in a timely
manner. In addition, the technicians and service company staff perform necessary
repairs.
E. Individual staff members are responsible for being familiar with the risks inherent in
their work and present in their work environment. They are also responsible for
implementing the appropriate organizational, departmental, and job related
procedures and controls required to minimize the potential of adverse outcomes of
care and workplace accidents.
VI. ELEMENTS OF THE MEDICAL EQUIPMENT PROGRAM
EC.01.01.01-EP7 – Maintaining the Medical Equipment Management Plan
The Medical Equipment Management Plan describes the procedures and controls in
place to minimize the potential that any patients, staff, and other people coming to the
facilities of the organization experience an adverse while being monitored, diagnosed, or
treated with any type of medical equipment.
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The Organization is responsible for coordinating the evaluation, purchasing, installation,
and commissioning processes related to the selection and acquisition of medical
equipment. Appropriate department directors and representatives of senior
management collaborate to select and acquire medical equipment.
The selection and acquisition process includes the following steps:
1.
Marketplace evaluation of equipment to determine which equipment of a given
type best meets current and future clinical care needs
2.
Negotiation of price and other issues to assure all resources required for the
installation and commissioning of the selected equipment are accounted for at
the time of purchase
3.
Evaluation by individuals who operate and service the equipment to assure
appropriate utilities, safety, and other environmental factors are addressed during
installation, training, and operation of the equipment. In addition, the evaluation
includes a determination of how the equipment will be serviced once it is placed
into operation.
4.
Orientation, education, and training of the operators, including physicians, of the
selected equipment
5.
Acquisition of training resources to assure effective orientation, education, and
training of employees not trained as part of the initial group
EC.02.04.01 EP2 – Maintaining a written inventory of medical equipment
The organization maintains a written inventory for the inspection, testing, and
maintenance of all the medical equipment used for the treatment, care, diagnosis, or
therapy of the patients ( not required if not using TJC for Deemed Status purposes, the
organization may use a risk based inclusion program to select equipment for the
inventory). The {{Director of Clinical Engineering}} maintains the inventory and updates
it as appropriate based on risks identified. The inventory includes medical equipment
maintained by the {{Clinical Engineering Department}} and by vendors.
EC.02.04.01 EP3 – Identifying high-risk medical equipment
The Director of Clinical Engineering serves as the qualified individual to identify “highrisk” medical equipment within inventory for which there is a risk of serious harm or
death to a patient or staff member should the equipment fail. The high-risk medical
equipment includes life-support equipment and is specifically defined within the current
computerized medical maintenance system (CMMS).
EC.02.04.01 EP4 – Identifying activities and frequencies
The organization identifies the activities and associated frequencies, in writing, for
inspecting, testing, and maintaining all medical equipment on the inventory. These
activities and associated frequencies are in accordance with manufacturers’
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recommendations, or with strategies of an Alternative Equipment Maintenance (AEM)
program. The strategies of an AEM program will not reduce the safety of equipment and
must be based on accepted standards of practice.
A computerized maintenance management system is used to schedule and track timely
completion of scheduled maintenance and service activities. The Director is responsible
for assuring that the rate of timely completion of scheduled maintenance and other
service activities meets regulatory and accreditation requirements, including medical
equipment maintained by vendors.
EC.02.04.01 EP5 – Maintaining specific medical equipment
The organization’s activities and frequencies for inspecting, testing, and maintaining the
following items are conducted in accordance with manufacturers’ recommendations:
•
•
•
•
Medical equipment subject to federal or state law or Medicare Conditions of
Participation in which inspecting, testing, and maintaining be in accordance with
the manufacturers’ recommendations, or otherwise establishes more stringent
maintenance requirements
Medical laser devices
Imaging and radiologic equipment (whether used for diagnostic or therapeutic
purposes )
New medical equipment with insufficient maintenance history to support the use
of alternative maintenance strategies
The maintenance history used to determine the activities and frequencies may include,
records provided by the organization’s contractors used to service the equipment, and
information made public by nationally recognized sources, such as ECRI. The
organization’s experience of testing, maintaining, and inspecting medical equipment will
also be used as history to determine the activities and frequencies required.
EC.02.04.01 EP6 – Assessing the equipment for maintenance with a written criteria
The organization identifies a qualified individual, or individuals if necessary, that will use
written criteria to support the determination whether it is safe to permit medical
equipment to be maintained in an AEM program. The written criteria will include:
• How the equipment is used, including the seriousness and prevalence of harm
during normal use
• Likely consequences of equipment failure or malfunction, including seriousness
of and prevalence of harm
• A availability of alternative or back-up equipment in the event the equipment
fails or malfunctions
• Incident history of identical or similar equipment
• Maintenance requirements of the equipment
Once the appropriate program is determine, the information is entered into the record
for the medical equipment in the inventory.
EC.02.04.01 EP7 - Identifying medical equipment that is using the AEM program
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The medical equipment that will be included in the AEM program will be clearly identified
in the medical equipment inventory. The inventory is updated at the time of this
determination. The {{Risk Manager}} is responsible for monitoring and reporting all
incidents in which medical equipment is suspected in or attributed to the death, serious
injury, or serious illness of any individual, as required by the Safe Medical Devices Act of
1990. The {{Risk Manager}} collects information about potentially reportable events
through the incident reporting and investigation process. The {{Risk Manager}} and
appropriate clinical staff conduct investigations of medical equipment incidents to
determine if the incident is reportable under criteria established by the Food and Drug
Administration.
The {{Risk Manager}} uses the Sentinel Event Process to investigate and document
reportable incidents. Quarterly reports are prepared for the Safety Committee on those
incidents determined to be reportable. The {{Director of Clinical Engineering}} is also
responsible for completing all reports and handling other communications with medical
equipment manufacturers and the FDA required by the Safe Medical Devices Act.
Appropriate changes in processes and training are made through the performance
improvement process. The changes are communicated to all appropriate staff.
EC.02.04.01 EP9 - Developing emergency clinical intervention procedures
The {{Director of Clinical Engineering and appropriate clinical caregivers}} collaborate to
identify high-risk medical equipment that could require emergency clinical interventions
for the patient. Life-support equipment is defined as equipment, the failure or
malfunction of which would cause immediate death or irreversible harm to the patient
dependent on the function of the equipment.
The Director and the caregivers are responsible for developing appropriate resources
needed to manage the response to the failure or disruption of the function of the
identified life-support equipment. These resources are designed to minimize the
probability of an adverse outcome of care. These resources include, but are not limited
to information about the availability of spare or alternate equipment, procedures for
communication with staff responsible for repair of the equipment, and specific
emergency clinical procedures needed to mitigate the situation.
EC.02.04.01 EP10 - Establishing quality control & maintenance of diagnostic Imaging
The {{Director of Radiology}} in collaboration with the {{Medical Physicist}} and the
{{Director of Clinical Engineering}} establish effective quality control measures and
defined maintenance intervals that are consistent with manufacturer’s recommendations
to assure equipment functionality and quality of the following imaging equipment:
 computed tomography
 positron emission tomography
 magnetic resonance imaging
 nuclear medicine
EC.02.04.03 EP1 - Conducting initial testing of medical equipment
Prior to the initial use of medical equipment on patients or after major repairs or
upgrades (not required if not using TJC for Deemed Status purposes), to the medical
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equipment, the appropriate safety, operational, and functional tests are performed. This
includes equipment owned by the organization, leased, demonstrational and rental
equipment, and personally owned equipment used for the diagnosis, treatment, and
monitoring of patients.
EC.02.04.03 EP2 - Testing of high-risk medical equipment
The organization assures that scheduled inspection, maintenance and testing of all
“high-risk” equipment identified in the inventory, including life support equipment, is
performed in a timely manner. Reports of the completion rate of scheduled inspection
and maintenance are presented to the EC Committee each quarter. If the quarterly rate
of completion falls below 100%, the Director will also present an analysis to determine
what the cause of the problem is and make recommendations for addressing it.
EC.02.04.03 EP3 - Testing of non-high-risk medical equipment
The organization assures that scheduled inspection, maintenance and testing of all nonhigh-risk equipment, is performed at the frequency identified in the inventory. Reports of
the completion rates of scheduled inspection and maintenance are presented to the EC
Committee each quarter. If the quarterly rate of completion falls below 100%, the
Director will also present an analysis to determine what the cause of the problem is and
make recommendations for addressing it.
EC.02.04.03 EP4 - Testing of sterilizers
The {{Director of Sterile Processing Department}} is/are responsible for testing and
maintenance of all types of sterilizers used in the organization. Records of load testing
and regular maintenance are maintained by {{Director of Sterile Processing
Department}}. Any improper results of load testing are documented and reported to the
Risk Management and the Infection Prevention departments for evaluation and action.
The results of the actions will be reported to the EC Committee.
EC.02.04.03 EP5 - Testing of dialysis equipment and water systems
The {{Director of Dialysis Services}} is responsible for the maintenance of the dialysis
equipment used in the organization. This includes dialysis services provided by a
contracted vendor. The program of maintenance includes regular cleaning and
disinfection of all dialysis equipment and testing the dialysis water supply for compliance
with biological and chemical standards for. All out of range results will be documented
and reported to the {{Infection Preventionist}} for evaluation and action. Any event
resulting in a patient injury or death will be treated as a Sentinel Event.
EC.02.04.03-EP14 – Meeting all other Healthcare Code Facility Requirements
The healthcare organization complies with the patient care vicinity electrical equipment
requirements as published in the NFPA Healthcare Facilities Code 99(2012).
Relocatable Power Taps (RTPs) meet appropriate UL listing for the area of use and
ampacity restrictions are in place to ensure a safe environment for patient care.
EC.02.04.03 EP15 – Inspecting, test and calibrate nuclear medicine equipment
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At least annual, the Organization assures that scheduled testing by qualified technicians
of all nuclear medicine equipment is performed annually. Reports of the completion rate
of scheduled inspection and maintenance are presented to the EC Committee each
quarter. If the rate of completion falls below 100%, the Director will also present an
analysis to determine what the cause of the problem is and make recommendations for
addressing it.
EC.02.04.03 EP17 – Monitoring diagnostic imaging quality
The {{Director of Radiology}} assures that the quality of the diagnostic computed
tomography (CT), positron emission tomography (PET, magnetic resonance imaging
(MRI), and nuclear medicine (NM) images produced is consistently monitored and
maintained. The {{Medical Physicist}} is responsible for the actual review and approval
of image quality. The results of the quality program are reported to the {{Director of
Clinical Engineering}} periodically and the EC Committee when appropriate.
EC.02.04.03 EP19 Monitoring radiation dose from CT equipment
At least annually, the {{Medical physicist}} monitors the radiation doses from diagnostic
computed tomography (CT) services. This includes:
1. Measures the radiation dose (in the form of volume computed tomography dose
index (CTDIvol) produced by each diagnostic CT imaging system. The radiation
dose for following four CT protocols will be monitored:
a. adult brain,
b. adult abdomen,
c. pediatric brain, and
d. pediatric abdomen.
If one or more of these protocols is not used by the (critical access) hospital, other
commonly used CT protocols may be substituted.
2. Verifies that the radiation dose (in the form of CTDIvol) produced and measured for
each protocol tested is within 20 percent of the CTDIvol displayed on the CT
console. This applies only for systems capable of calculating and displaying radiation
doses. The dates, results, and verifications of these measurements are documented.
This element of performance does not apply to dental cone beam CT radiographic
imaging studies performed for diagnosis of conditions affecting the maxillofacial region
or to obtain guidance for the treatment of such conditions.
Even though the {{Medical physicist}} is accountable for these activities, they may be
assisted with the testing and evaluation of equipment performance by individuals who
have the required training and skills, as determined by the physicist.
EC.02.04.03 EP20 - Evaluating performance of CT equipment
At least annually, the {{Medical physicist}} evaluates the performance for all diagnostic
computed tomography (CT) services. The evaluation results, along with
recommendations for correcting any problems identified are documented and reported to
the {{Director of Clinical Engineering}}.
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The evaluation includes the use of phantoms to assess the following imaging metrics:
1) imaging uniformity
2) slice thickness accuracy
3) slice position accuracy (when prescribed from a scout image)
4) alignment light accuracy
5) table travel accuracy
6) radiation beam width
7) high contrast resolution
8) low contrast resolution
9) geometric or distance accuracy
10) CT number accuracy and uniformity
11) artifact evaluation
This element of performance does not apply to dental cone beam CT radiographic
imaging studies performed for diagnosis of conditions affecting the maxillofacial region
or to obtain guidance for the treatment of such conditions.
Even though the {{Medical Physicist}} is accountable for these activities, they may be
assisted with the testing and evaluation of equipment performance by individuals who
have the required training and skills, as determined by the physicist.
EC.02.04.03 EP21 - Evaluating performance of MRI imaging equipment
At least annually, the {{Medical Physicist or Magnetic Resonance Imaging (MRI)
Scientist}} conducts a performance evaluation of all MRI imaging equipment. The
evaluation results, along with recommendations for correcting any problems identified
are documented and reported to the {{Director of Clinical Engineering}}.
The evaluation includes the use of phantoms to assess the following imaging metrics:
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
imaging uniformity
signal to noise (SNR) for all coils used clinically
slice thickness accuracy
slice position accuracy
alignment light accuracy
high contrast resolution
low contrast resolution (or contrast to noise ratio)
geometric or distance accuracy
geometric or distance accuracy
magnetic field homogeneity
artifact evaluation
Even though the {{Medical Physicist or Magnetic Resonance Imaging (MRI) Scientist}} is
accountable for these activities, they may be assisted with the testing and evaluation of
equipment performance by individuals who have the required training and skills, as
determined by the {{Medical Physicist or MRI Scientist}}.
EC.02.04.03 EP22- Evaluating performance of nuclear medicine imaging equipment
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At least annually, the {{Medical Physicist or Nuclear Medicine Physicist}} conducts a
performance evaluation of all nuclear medicine imaging equipment. The evaluation
results, along with recommendations for correcting any problems identified are
documented and reported to the {{Director of Clinical Engineering}}.
The evaluations are conducted for the entire image types produced clinically by each
NM scanner (for example, planar and/or tomographic). This includes the use of
phantoms to assess the following imaging metrics:
1)
2)
3)
4)
5)
6)
imaging uniformity/system uniformity
high contrast resolution/system spatial resolution
sensitivity
energy resolution
count rate performance
artifact evaluation
The tests for low contrast resolution or detectability for non-planar acquisitions may also
be conducted, even though it is not required.
Even though the {{Medical Physicist or Nuclear Medicine Physicist}} is accountable for
these activities, they may be assisted with the testing and evaluation of equipment
performance by individuals who have the required training and skills, as determined by
the {{Medical Physicist or Nuclear Medicine Physicist}}.
EC.02.04.03 EP23 - Evaluating the performance of PET imaging equipment
At least annually, the {{Diagnostic Medical Physicist}} evaluates the performance for all
positron emission tomography (PET) imaging equipment. The evaluation results, along
with recommendations for correcting any problems identified are documented and
reported to the {{Director of Clinical Engineering}}.
The evaluations are conducted for all of the image types produced clinically by each
PET scanner (for example, planar and/or tomographic). A phantom is used to assess
the following imaging metrics:
1) imaging uniformity/system uniformity
2) high contrast resolution/system spatial resolution
3) low contrast resolution or detectability (not applicable on planar
acquisitions)
4) artifact evaluation
The scanner tests for sensitivity, energy resolution, and count rate performance may
also be conducted, even though it is not required. Even though the {{Diagnostic Medical
Physicist}} is accountable for these activities, they may be assisted with the testing and
evaluation of equipment performance by individuals who have the required training and
skills, as determined by the {{Diagnostic Medical Physicist}}.
EC.02.04.03 EP24 - Annual performance evaluation of imaging display monitors
At least annually a performance evaluation is conducted by the {{diagnostic medical
physicist and / or MRI scientist}}. These tests are designed to assure the quality of all
image acquisition display monitors for maximum and minimum luminance, luminance
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uniformity, resolution, and spatial accuracy. The annual evaluation is reported to the
Radiation Safety Committee for review and approval.
EC.04.01.01-EP10 – Medical Equipment Management Reporting
The {{Director of Clinical Engineering}} reports quarterly to the {{Environment of Care}}
Committee on the medical and laboratory equipment management problems, failures
and use errors.
EC.04.01.01-EP15 – Annual evaluation of the management plan
On an annual basis, the organization evaluates the scope, objectives, performance, and
effectiveness of the Plan to manage the risks to the staff, visitors, and patients. The
findings of the annual review are used to develop the management plan for the following
year. The annual evaluation is presented to the EC Committee for review.
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