dnv-gl medical equipment and iso 9001...if the hospital is using an aem program, the equipment...
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DNV GL © 2014 SAFER, SMARTER, GREENER DNV GL © 2014
DNV-GL Medical Equipment and ISO 9001
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Brennan Scott BA, CHOP
DNV-GL Sector Lead
DNV GL © 2014
Course Learning Objectives
This session will enable the attendee to:
1. Describe the DNV GL Physical Environment survey process,
including unique methods specific to medical equipment
management.
2. Discuss the NIAHO® Requirements that apply to Medical
Equipment
3. Outline how the integration of ISO 9001 concepts affect the
development of a hospital’s Medical Equipment Management System procedures.
4. Explain the lineage from a CoP to a medical equipment finding.
5. Discuss current issues and common findings related to the
NIAHO® Medical Equipment Management accreditation survey.
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Healthcare
Our services:
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More value, lower $
Focus on sequence and interactions of processes throughout the hospital
ISO 9001 Gradual Introduction @ no additional staff
Demeanor of the survey team
No survey findings “tipping” point
Constant readiness
Collaboration, sharing of ideas
Feature of NIAHO Benefit to Hospital
Fear becomes confidence
Clear, traceable pathway to improve
Stable standards, infrequent change Sustainable system
Annual Surveys
Key Features
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About ISO 9001
Who Developed ISO 9001?
– ISO 9001 was developed through the International Organization for
Standardization
– This organization began in 1946 and published the first revision of the ISO
9001 standard in 1987
– The current revision of ISO 9001 is the revision four dated 2015
– The 2015 9001 standard is a Quality Management System that requires the
organization to perform risk based thinking
When did ISO 9001 become recognized by healthcare?
– Healthcare has started to embrace ISO 9001 within the last several years,
(primarily since 2008)
– More recently with DNV-GL receiving deeming authority from the Centers for
Medicare and Medicaid Services, (CMS) to accredit hospitals in 2008, ISO 9001
is rapidly gaining recognition in healthcare
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DNVGL Accreditation Progression
1st visit:
– Gain Accreditation to NIAHO® - meet the requirements of CMS
– ISO introduction & education; compliance or certification within 3 years
2nd visit: 1 year after accreditation
– Continue Accreditation by undergoing a survey to NIAHO®
– Survey for progress in implementing ISO 9001
3rd visit: 2 years after accreditation
– Continue Accreditation by undergoing survey to NIAHO®
– Continue to work toward ISO 9001 Implementation (ISO dress rehearsal)
4th visit: 3 years after accreditation
– NIAHO® survey and last year to achieve ISO 9001 compliance/certification
– If in compliance with ISO 9001 – a statement included in Certificate of
Accreditation
– May choose to demonstrate compliance by obtaining a separate ISO 9001
Certificate
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ISO System Structure
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Operational-Business
Practices-Regulatory ISO 9001 Systems
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NIAHO® Standard Requirement Chapters
Quality Management System
Governing Body
Chief Executive Officer
Medical Staff
Nursing Services
Staffing Management
Rehabilitation Services
Obstetric Services
Emergency Department
Outpatient Services
Dietary Services
Patient Rights
Infection Control
Medical Records Service
Medication Management
Surgical Services
Anesthesia Services
Laboratory Services
Respiratory Care Services
Medical Imaging
Nuclear Medicine Services
Discharge Planning
Utilization Review
Physical Environment
Organ, Eye and Tissue Procurement
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Time Frame for ISO 9001 Compliance/Certification
QM.2 ISO 9001 QUALITY MANAGEMENT SYSTEM
SR.1 Compliance with the ISO 9001 standard must occur within three (3)
years after the initial deemed NIAHO® accreditation. The Organization shall
either demonstrate compliance with the ISO 9001 Quality Management System
principles through a NIAHO® accreditation survey or maintain Certification
through an Accredited Registrar. Only certificates covered by an accreditation
under an IAF MLA (International Accreditation Forum Multilateral Recognition
Agreement) signatory shall be eligible. The organization shall maintain ISO 9001
compliance or formal Certification in order remain eligible for NIAHO®
Accreditation.
DNV GL © 2014
NIAHO® Physical Environment (PE) Management Systems
PE.1 Facility
PE.2 Life Safety Management System
PE.3 Safety Management System
PE.4 Security Management System
PE.5 Hazardous Material (Hazmat) Management
System
PE.6 Emergency Management System
PE.7 Medical Equipment Management System
PE.8 Utility Management System
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Physical Environment - PE.7 Medical Equipment
PE.7 MEDICAL EQUIPMENT MANAGEMENT SYSTEM
SR.1 The organization shall establish a Medical Equipment Management System that provides
processes for the acquisition, safe use, and the appropriate selection of equipment.
What is included in an effective Medical Equipment Management Plan/System?
SR.2 The Medical Equipment Management System shall address issues related to the
organization’s initial service inspection, the orientation, and the demonstration of use.
This includes rented equipment, loaned equipment and demonstration equipment.
SR.3 The Medical Equipment Management System shall address criteria for the selection of
equipment.
SR.4 The Medical Equipment Management System shall address incidents related to serious
injury or illness or death (See SMDA 1990).
SR.5 The Medical Equipment Management System shall have a process for reporting and
investigating equipment management problems, failures, and user errors.
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DNV GL © 2014
Physical Environment - PE.7 Medical Equipment
When reviewing a report from the Bio-Medical Department, the report must be accurate and
contain the appropriate information.
It is common for these reports to show preventative maintenance completion rates above the
hospitals goal, however upon a thorough review, UTL, UFM, CIU has been entered as
completed or not accounted for in the total number.
These reports should indicate a corrective action plan when targets or goals are missed.
These reports should be reported to the Quality Management Oversight group to ensure that
leadership is aware of the current conditions of the hospital medical equipment.
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Physical Environment – PE.7 Medical Equipment
SR.6 The Medical Equipment Management System shall address a process for determining
timing and complexity of medical equipment maintenance.
All Alternative Equipment Maintenance must meet the steps described in the Interpretive
Guidelines within PE.7 of the NIAHO standards.
Imaging/radiologic equipment, whether used for diagnostic or therapeutic purposes, is
governed by 42 CFR 482.26(b)(2) and must be maintained per manufacturer’s recommendations.
• SR.7 The Medical Equipment Management System shall address the process of receiving and
responding to recalls and alerts.
Records of calibration for measuring equipment must be retained and responded to when found
to be “Out of Tolerance.” This also includes hospital operations equipment.
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NIAHO® PE.7 MEDICAL EQUIPMENT MANAGEMENT SYSTEM
Alternate Equipment Management (AEM) Program
A hospital may, under certain conditions, use equipment maintenance activities
and frequencies that differ from those recommended by the manufacturer.
Hospitals that choose to employ alternate maintenance activities and/or schedules
must develop, implement, and maintain a documented AEM program to minimize
risks to patients and others in the hospital associated with the use of facility or
medical equipment. The AEM program must be based on generally accepted
standards of practice for facility or medical equipment maintenance.
An example of guidelines for a medical equipment maintenance program may be
found in the American National Standards Institute/ Association for the
Advancement of Medical Instrumentation document: ANSI/AAMI EQ 56:1999/ (R)
2013, Recommended Practice for a Medical Equipment Management Program.
Likewise, an example of guidelines for physical plant equipment may be found in
the American Society for Healthcare Engineering (ASHE) 2009 document:
Maintenance Management for Health Care Facilities. There may be similar
documents issued by other nationally recognized organizations which hospitals
might choose to reference.
DNV GL © 2014
NIAHO® PE.7 MEDICAL EQUIPMENT MANAGEMENT SYSTEM
Decision to Place Equipment in an AEM Program
The determination of whether it is safe to perform facility or medical equipment
maintenance without following the equipment manufacturer recommendations
must be made by qualified personnel, regardless of whether they are hospital
employees or contractors.
In the case of medical equipment, a clinical or biomedical technician or engineer
would be considered qualified. Highly specialized or complex equipment may
require specialized knowledge or training in order for personnel to be considered
qualified to make a decision to place such equipment in an AEM program.
A hospital is expected to identify any equipment in its AEM program which is
“critical equipment,” i.e., biomedical or physical plant equipment for which there is a risk of serious injury or death to a patient or staff person should the
equipment fail. Surveyors must focus their review of a hospital’s AEM program on critical equipment in that program and the hospital’s documentation of the factors and evidence it considered in developing an AEM strategy for that equipment.
DNV GL © 2014
NIAHO® PE.7 MEDICAL EQUIPMENT MANAGEMENT SYSTEM
Equipment not Eligible for Placement in the AEM Program:
Imaging/radiologic equipment, whether used for diagnostic or therapeutic
purposes, is governed by 42 CFR 482.26(b)(2) and must be maintained per
manufacturer’s recommendations.
The equipment is a medical laser device. It should be noted that for medical
lasers the U.S. Food and Drug Administration requires manufacturers to provide a
schedule of maintenance and adequate instructions for service adjustments and
service procedures to purchasers and, at cost, to any other parties requesting
them.
New equipment for which sufficient maintenance history, either based on the
hospital’s own or its contractor’s records, or available publicly from nationally recognized sources, is not available to support a risk-based determination must
not be immediately included in the AEM program. New equipment must be
maintained in accordance with manufacturer recommendations until a sufficient
amount of maintenance history has been acquired to determine whether the
alteration of maintenance activities or frequencies would be safe.
DNV GL © 2014
NIAHO® PE.7 MEDICAL EQUIPMENT MANAGEMENT SYSTEM
AEM Program Documentation:
The pertinent types and level of risks to patient or staff health and safety;
Alternate maintenance activities, and the maintenance strategy and any other
rationale used to determine those activities; the differences from the
manufacturer’s recommended maintenance activities are made explicit, unless the hospital is unable to obtain the manufacturer’s maintenance recommendations, due to the age of the equipment or the manufacturer’s restricting the availability of its recommendations;
Alternate maintenance frequencies to be used, if any, and the maintenance
strategy and any other rationale used to determine those frequencies.
The date when AEM program maintenance activities were performed and, if
applicable, further actions required/taken; and
Documentation of any equipment failures (not including failures due to operator
error), including whether there was resulting harm to an individual.)
DNV GL © 2014
NIAHO® PE.7 MEDICAL EQUIPMENT MANAGEMENT SYSTEM
Equipment Inventory:
All hospital facility and medical equipment, regardless of whether it is leased or
owned, and regardless of whether it is maintained according to manufacturer
recommendations or is in an AEM program, is expected to be listed in an
inventory which includes a record of maintenance activities.
If the hospital is using an AEM program, the equipment managed through that
program must be readily separately identifiable as subject to AEM. Critical
equipment, whether in an AEM program or not, must also be readily identified as
such.
DNV GL © 2014
NIAHO® PE.7 MEDICAL EQUIPMENT MANAGEMENT SYSTEM
To facilitate effective management, a well-designed equipment inventory contains
the following information for all equipment included. However, hospitals have the
flexibility to demonstrate how alternative means they use are effective in enabling
them to manage their equipment:
A unique identification number;
The equipment manufacturer;
The equipment model number;
The equipment serial number;
A description of the equipment;
The location of the equipment (for equipment generally kept in a fixed location);
The identity of the department considered to “own” the equipment;
Identification of the service provider;
The acceptance date; and
Any additional information the hospital believes may be useful for proper
management of the equipment.
DNV GL © 2014
NIAHO® MI.3 MEDICAL IMAGING EQUIPMENT
SR.2 Documentation of preventative maintenance and repairs of
radiology equipment shall be maintained (See PE.7).
Interpretive Guidelines:
The hospital must have policies and procedures in place to ensure that periodic
inspections of radiology equipment are conducted. When these periodic
inspections have identified that equipment is not operating or malfunctioning, this
equipment is removed from service and repaired and verified prior to being put
into operation for patient care. The hospital must maintain repair documentation
and records for periodic maintenance.
Either the hospital staff or a qualified contract entity must ensure that equipment
is inspected in accordance with manufacturer’s instructions, Federal and State laws, regulations, and guidelines, and hospital policy.
DNV GL © 2014
NIAHO® NM.3 NUCLEAR MEDICINE EQUIPMENT & SUPPLIES
SR.1 Equipment and supplies must be appropriate for the types of
nuclear medicine services offered and must be maintained for safe and
efficient performance (See PE.7).
SR.2 The equipment must be maintained in safe operating condition and
inspected, tested, and calibrated at least annually by qualified personnel
(See PE.7).
SR.3 Documentation of equipment testing and preventative maintenance
shall be maintained (See PE.7).
DNV GL © 2014
NIAHO® NM.3 NUCLEAR MEDICINE EQUIPMENT & SUPPLIES
Interpretive Guidelines:
The hospital must develop and implement a preventive maintenance process to
ensure that nuclear medicine equipment is maintained in safe operating condition
to ensure accurate results and patient, staff, and public safety.
Nuclear medicine equipment must be inspected, tested and calibrated at least
annually by qualified personnel in accordance with Federal and State laws,
regulations and guidelines and appropriate documentation (records) maintained.
Supplies must be appropriate for the types of nuclear medicine services offered
and must be maintained for the safety for the patients, staff, and public.
DNV GL © 2014
Patient Care Vicinity
What is the official definition of Patient Care Vicinity?
NFPA 99 2012 3.3.139 Patient Care Vicinity. A space, within a location
intended for the examination and treatment of patients, extending 1.8 m (6 ft)
beyond the normal location of the bed, chair, table, treadmill, or other device that
supports the patient during examination and treatment and extending vertically to
(7 ft 6 in.) above the floor.
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Electrical Equipment
Relocatable Power Taps (RPT’s) are now allowed in the patient care vicinity with the adoption of the NFPA 99 2012 edition.
RPT must be Permanently attached to equipment assembly
The sum of the ampacity ≤ 75% ampacity of the flexible cord connecting the
outlets
The means of preventing overloading ≤ 75%.
The electrical and mechanical integrity of assembly is regularly verified and
documented
• Extension cords are considered temporary wiring and RPT’s used in the patient vicinity must be of hospital grade.
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Equipment in Corridors
In the 2000 standard, there was very little allowance for items to be stored in the
corridors, mainly equipment and carts that were in use.
In the 2012 standard, there are a few allowances. In addition to equipment and
carts in use; crash carts; and isolation carts for isolation patients, wheeled patient
lift and transport equipment are permitted to be stored in corridors as long as they
don’t reduce the corridor width below 5 ft., and the fire plan and training
address relocation of the equipment in an emergency
(NFPA 101 2012 19.2.3.4(4)).
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ISO 9001 Resource Management Concepts
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
Personnel performing work affecting conformity to product requirements shall be
competent on the basis of appropriate education, training, skills and experience.
The organization determines the necessary competence for personnel
performing work affecting conformity to product requirements, provides training or
take other actions to achieve the necessary competence, evaluates the
effectiveness of the actions taken, ensures that its personnel are aware of the
relevance and importance of their activities and how they contribute to the
achievement of the quality objectives, and maintains appropriate records of
education, training, skills and experience.
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Awareness
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ISO 9001 Infrastructure and work environment
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
The organization determines, provides and maintains the infrastructure needed to
achieve conformity to product requirements. Infrastructure includes, as applicable,
– a) buildings, workspace and associated utilities,
– b) process equipment (both hardware and software), and
– c) supporting services (such as transport, communication or information
systems).
The organization determines and manages the work environment needed to achieve
conformity to product requirements.
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ISO 9001 Control of monitoring and measuring equipment
7.1.5 Monitoring and measuring resources
Where necessary to ensure valid results, measuring equipment shall
– be calibrated or verified, or both, at specified intervals, or prior to use,
against measurement standards
– traceable to international or national measurement standards; where no
such standards exist, the basis used for calibration or verification shall be
recorded
– be adjusted or re-adjusted as necessary;
– have identification in order to determine its calibration status;
– be safeguarded from adjustments that would invalidate the measurement
result;
– be protected from damage and deterioration during handling,
maintenance and storage.
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ISO 9001 Control of monitoring and measuring equipment
7.1.5 Monitoring and measuring resources
The organization assesses and records the validity of the previous
measuring results when the equipment is found not to conform to
requirements. The organization takes appropriate action on the equipment
and any product affected
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7.1.5 Monitoring and measuring equipment
Record
Traceability
NIST National Institute of Standards & Technology
Calibration Lab
Hospital
God of Weights
A
B
C
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ISO 9001 Top Management Responsibilities: Communication
7.4 Communication
The organization ensures that responsibilities and authorities are defined
and communicated within the organization.
The organization ensures that appropriate communication processes are
established within the organization and that communication takes place
regarding the effectiveness of the quality management system
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Ineffective communication does not achieve quality objectives
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7.5 Documented Information
7.5.1 General
The Hospital’s QMS shall include:
a) documented information required by this International Standard;
One type of Documented information consists of “documents” which gives instruction/information that must be “maintained”
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7.5 Documented Information
7.5.1 General
– b) documented information determined by the Hospital as being necessary for
the effectiveness of the quality management system.
Example: Emergency Management Program
NOTE: The extent of documented information is dependent on:
– a) the size of Hospital and its type of activities, processes, products and
services;
– b) the complexity of processes and their interactions;
– c) the competence of persons.
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The extent of documented information is up to you!!
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DNV GL © 2014
7.5 Documented Information
7.5.3.2 For the control of documented information, the Hospital shall address
the following activities, as applicable:
– a) distribution, access, retrieval and use;
– b) storage and preservation, including preservation of legibility;
– c) control of changes (e.g. version control);
– d) retention and disposition.
Documented information of external origin determined by the hospital to be
necessary for the planning and operation of the QMS shall be identified as
appropriate, and controlled.
Examples include:
– NIAHO
– ISO
– NFPA
– OSHA
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What do we need to keep again?
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ISO 9001 Purchasing Process Concepts
8.4 Control of externally provided products and services
8.4.2 Type and extent of control of external provision
8.4.3 Information for external providers
The organization ensures that purchased product conforms to specified purchase
requirements. The type and extent of control applied to the supplier and the
purchased product is dependent upon the effect of the purchased product on
subsequent product realization or the final product.
Purchasing information describes the product to be purchased
– The organization establishes and implements the inspection or other activities
necessary for ensuring that purchased product meets specified purchase
requirements.
– Where the organization or its customer intends to perform verification at the
supplier's premises, the organization states the intended verification
arrangements and method of product release in the purchasing information.
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ISO 9001 Control of Nonconforming Product
8.7 Control of nonconforming process ,outputs,
products and services
The organization ensures that product which does not conform to product
requirements is identified and controlled to prevent its unintended use or delivery.
A documented procedure shall be established to define the controls and related
responsibilities and authorities for dealing with nonconforming product.
Where applicable, the organization deals with nonconforming product by one or
more of the following ways:
– by taking action to eliminate the detected nonconformity
– by taking action to preclude its original intended use or application.
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ISO 9001 Corrective Action Concepts
The organization takes action to eliminate the causes of
nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the
nonconformities encountered.
A documented procedure is established to define requirements for
– reviewing nonconformities (including customer complaints),
– determining the causes of nonconformities,
– evaluating the need for action to ensure that nonconformities do not
recur,
– determining and implementing action needed,
– records of the results of action taken
– reviewing the effectiveness of the corrective action taken.
DNV GL © 2014
CMS CoP Accreditation Oversight
482.41(c)(2)
Facilities, supplies, and equipment
must be maintained to ensure an
acceptable level of safety and quality.
(Please note that changes to the
interpretive guidelines per S&C:14-07
hospital were made but not in the
standard itself)
DNV GL © 2014
Physical Environment and Infection Prevention
DNV GL PE surveyors are
trained in infection
prevention and how the physical
environment relates to it.
DNV GL surveyors work
as a team to identify unsafe
concerns surrounding
infection within the hospital
DNV GL PE surveyors will
attend the infection
prevention interview
DNV GL PE surveyors will
write IC findings
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Physical Environment – PE.7 Medical Equipment
PE.7 Medical Equipment Management System - Common Findings
Oversight of contracted services.
Validation of corrective actions or deficiencies for medical equipment.
Broken LOTO process.
Improper application or unapproved AEM.
Quality data not reported up to QMS.
Training for in-house medical equipment staff.
20 August 2018 © Det Norske Veritas AS. All rights reserved
Slide 47
DNV GL © 2014
Example Finding
During the Physical Environment document review and staff interview of the
Medical Equipment Management System, the surveyor observed the organization
has up to 10,000 pieces of medical equipment that are considered exempt from
receiving preventive maintenance as per OEM recommendations. It was also
noted, no evidence was presented that the organization has performed an AEM
for the equipment placed on the exempt status. The hospital’s current process to determine the AEM is a risk assessment developed in the late 1990’s and has not been reviewed since 2011. No evidence of the required documentation history of
the operation of the equipment’s function, per NIAHO standards for establishing an AEM, has been utilized. Not all of the organization’s medical equipment items are found in the organization’s medical equipment inventory.
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Example Finding
During the Physical Environment document review of the Medical Equipment
Management System, the surveyor observed the most recent medical equipment
monthly PM completion report presented to the organization, consisted of 100%
Life Support and 100% non-life support PM completion rates. However, this
process is not effective as the report did not include “unable to locate equipment,” “equipment in use,” “user error,” and equipment being repaired. This does not
give the organization a clear understanding of reporting and investigating
equipment management problems, failures, and user errors.
In addition, the surveyor was presented a document that reflected an 8% rate of
equipment that was determined to be “unable to locate.” Given this information,
the reports presented by the organization cannot reflect a PM completion rate of
100%.
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Example Finding
During the physical environment/life safety tour, the surveyor observed the
following piece of medical equipment not being maintained in a safe manner:
Baroness – 1st floor Central Wing West – in corridor outside double doors
Carescape Dynamap V123, reference #1234567-002, insulated connectors were
frayed and exposed due to strain.
During the Physical Environment document review, the surveyor observed no
evidence the organization has developed and implemented a documented process
for reporting and investigating test equipment when found to be out of tolerance.
Note: Further review of the Medical Equipment documented information found that
3 certificates of calibration were found to be “Out Of Tolerance” when returned to
the hospital from the vendor. The hospital was unaware as to the status of the test
equipment when returned.
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What is Our #1 Finding?
Failure to analyze data
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Questions
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SAFER, SMARTER, GREENER
www.dnvgl.com
Brennan Scott BA, CHOP Physical Environment Sector Lead [email protected]
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