$50
“CMS Maintenance Requirements
Revised (TJC Standards Align with
CMS CoPs)”
Larry Barlow, CHSP, VP Mid West Region
TSIG Consulting
Cell: 615-330-1907
barlowl@tsigconsulting.com
Contents
• Aligning TJC Standards with Centers for Medicare &
Medicaid Services Conditions of Participation (CoPs)
• CMS Memorandum Summary for Hospital Equipment
Maintenance Requirements
• Alternative Equipment Maintenance (AEM) Program
• AEM Qualified Personnel and AEM Frequencies
• Evaluating Safety & Effectiveness of AEM Program
• AEM Equipment Inventory
• Types of Maintenance Strategies
• TJC Effective Date for Medical Equipment and Utility
System Maintenance
• Preparing for Survey
Aligning TJC w/CMS
Aligning
TJC Standards
& CMS CoPs
• Survey-and-Cert-Letter-14-07(3).Hosp
Equip.pdf
TJC Aligning with CMS
Changes to The Joint Commission standards,
elements of performance, and notes are a result of
TJC demonstrating that its standards are aligned
with or equivalent to the Centers for Medicare &
Medicaid Services’ Conditions of Participation
(CoPs). These changes allow TJC to maintain
CMS deeming authority and better reflect the intent
of CMS’s CoPs and ensure that both TJC and CMS
surveys have similar outcomes.
(See standards EP language: “For hospitals
that use Joint Commission accreditation for
deemed status purposes…”)
CMS Memorandum Summary
Summary of December 20, 2013 Memorandum
Ref: S&C: 14-07-Hospital (Effective Immediately):
• Hospital facilities, supplies and equipment must
be maintained to ensure an acceptable level of
safety and quality.
• A hospital may adjust its maintenance,
inspection, and testing frequency and activities
for facility and medical equipment from what is
recommended by the manufacturer, based on a
risk-based assessment by qualified personnel,
unless:
(cont.)
CMS Memorandum Summary
• Other Federal or state law; or hospital
Conditions of Participation (CoPs) require
adherence to manufacturer’s recommendations
and/or set specific requirements. For example,
all imaging/radiologic equipment must be
maintained per manufacturer’s
recommendations; or
• The equipment is a medical laser device; or
• New equipment without sufficient amount of
maintenance history has been acquired.
(cont.)
CMS Revised State Operations Manual
Hospital Appendix A
• Note: The NFPA Life Safety Code requirements
incorporated by reference at 42 CFR 482.41(b)
has some provisions that are pertinent to
equipment maintenance and; 482.41(b)(9)(v)
requires hospitals to adhere to the
manufacturer’s maintenance guidelines for
alcohol-based hand-rub dispensers.
Compliance with these requirements are
assessed on Federal surveys.
CMS Memorandum Summary
• Hospitals electing to adjust “facility” or “medical”
equipment maintenance must develop policies
and procedures and maintain documentation
supporting their Alternative Equipment
Management (AEM) program, They must
adhere strictly to the AEM activities and/or
frequencies they establish.
CMS Memorandum Summary
• Facility equipment refers to devices intended to
support the physical environment of the
hospital.
• Medical equipment refers to devices intended to
be used for diagnostic, therapeutic, or
monitoring care provided to a patient by a
hospital.
Alternative Equipment Maintenance
• Hospitals that choose to employ alternative
equipment maintenance (AEM) 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.
(cont.)
Alternative Equipment Maintenance
• Example of Standards for a medical equipment
program may be found in the American National
Standards Institute/Association for the
Advancement of Medical Instrumentation
document: ANSI/AAMI EQ 56:1999/® 2008,
Recommended Practice for a Medical
Equipment Management Program.
(cont.)
Alternative Equipment Maintenance
• Example of written guidelines for physical plant
equipment maintenance may be found in the
American Society for Healthcare Engineering
(ASHE) 2009 document: Maintenance
Management for Health Care Facilities.
Note: CMS welcomes identification of other
recognized sources of recommendations for
facility and equipment maintenance.
Alternative Equipment Maintenance
• 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.
AEM Qualified Personnel
• Decision to perform facility or medical
equipment maintenance without following the
manufacturer recommendations must be made
by qualified personnel, regardless of whether
they are hospital employees or contractors.
• For medical equipment, a clinical or biomedical
technician or engineer would be considered
qualified.
(cont.)
AEM Qualified Personnel
• For facility equipment, a Healthcare Facility
Management professional (facility manager,
director of facilities, vice president of facilities)
would be considered qualified.
Note: The hospital must maintain records of the
qualifications of hospital personnel who make
decisions on placing equipment in an AEM
program, and must be able to demonstrate how
they assure contracted personnel making such
decisions.
AEM Frequencies
• Maintenance strategies are various
methodologies used for determining the most
efficient and effective maintenance activities &
frequencies. Manufacturers’ recommendations
and hospital P&Ps may use one or more
strategies in order to determine the appropriate
maintenance, inspection, and testing activities
and frequencies, based upon the nature of the
equipment and the level of risk it presents to
patient or staff health or safety.
Evaluating Effectiveness of
AEM Program
Policies & Procedures needed for:
• How equipment is evaluated to ensure there is
no degradation of performance, particularly for
equipment where such degradation may not be
readily apparent to staff using the equipment,
e.g., miscalibration.
• How incidents of equipment malfunction are
investigated, including: whether or not the
malfunction could have been prevented, and
what steps will be taken to prevent future
malfunctions; and
(cont.)
Evaluating Effectiveness of
AEM Program
• The process for the removal from service of
equipment determined to be unsafe or no
longer suitable for its intended application; and
• The use of performance data to determine if
modifications in the AEM program procedures
are required.
AEM 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 the manufacturer recommendations or is in
an AEM program, is expected to be listed in an
inventory which includes a record of
maintenance activities.
AEM Equipment Inventory
• 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 identifiable as such.
AEM Equipment Inventory
Inventory for All Equipment Included Requires:
• 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;
(cont.)
AEM Equipment Inventory
• Identification of the service provider;
• The acceptance date; and
• Any additional information the hospital believes
may be useful for roper management of the
equipment
Types of Maintenance Strategies
• Preventive Maintenance (Time-based
Maintenance) – a maintenance strategy where
maintenance activities are performed at
scheduled time intervals to minimize equipment
degradation and reduce instances where there
is a loss of performance.
• Example: Replacing a battery every year, after
a set number of uses or after running for a set
number of hours, regardless.
(cont.)
Types of Maintenance Strategies
• Predictive Maintenance (Condition-based
Maintenance) – a maintenance strategy that
involves periodic or continuous equipment
condition monitoring to detect the onset of
equipment degradation.
• Example: Replacing a battery one year after the
manufacturer’s recommended replacement
interval, based on historical monitoring that has
determined the battery capacity does not tend
to fall below the required performance threshold
before this extended time.
(cont.)
Types of Maintenance Strategies
• Reactive Maintenance (Corrective, Breakdown
or Run-to-Failure Maintenance) – a
maintenance strategy based upon a “run until it
breaks” philosophy, where maintenance or
replacement is performed only after the
equipment fails or experiences a problem.
• Example: Replacing a battery after equipment
failure when the equipment has little negative
health and safety consequences associated
with a failure and there is a replacement readily
available In supply.
(cont.)
Types of Maintenance Strategies
• Reliability-Centered Maintenance – a
maintenance strategy that not only considers
equipment condition, but also considers other
factors unique ti individual pieces of equipment,
such as equipment function, consequences of
equipment failure, and the operation
environment.
• Example: Replacing a battery in an ambulance
defibrillator more frequently than the same
model used at a nursing station, since the one
in the ambulance is used more frequently.
TJC Effective Date
• Effective July 2, 2014, TJC revised hospital and
critical access hospital requirements to align
with CMS CoPs.
Note: See TJC Prepublication Requirements:
Standards Revisions and Clarifications Related to
Medical Equipment and Utility System Maint.
Standard:
• EC.02.04.01 -The hospital manages medical
equipment risks.
• EC.02.04.03 –The hospital inspects, tests, and
maintains medical equipment.
(cont.)
TJC Effective Date
Standard:
• EC.02.05.01 –The hospital manages risks
associated with its utility systems.
• EC.02.05.05 – The hospital inspects, tests , and
maintains utility systems.
Preparing for Survey
ZZZ
Tips During Surveys
– Train staff to not answer questions outside their
areas of job responsibilities, e.g., “Sorry,
I’m not able to answer that question. It isn’t
within the scope of my job responsibilities.”
Don’t say, “Sorry, but I’m too busy to answer your
questions now” or “My mother told me never to
speak to strangers!”
– Those who accompany surveyors should be
knowledgeable about the standards, survey
process and environment being surveyed,
especially the Life Safety Code survey!
– Right people at right place – have preplanned back-up staff whenever possible.
– Know where inspection logs and documents
are stored.
Being Prepared for Survey
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Obtain Most Current TJC Accreditation Manual
Review Chapters You are Responsible For
Highlight Situational Decision Rule EPs
Highlight Direct Impact Requirement EPs
• Highlight Risk Icon – R*
•
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Ensure Policies & Procedures are In Place
Ensure Management Plans are In Place
Ensure P&Ps and Mgt. Plans are Implemented and Enforced
Ensure Applicable Staff Training is Provided
* Indicates an identified risk [per NPSGs; selected direct &
indirect impact requirements; and program-specific risk areas]
for the purpose of the Focused Standards Assessment (FSA)
(formerly Periodic Performance Review) See APR.03.01.01
Sage Advice to Organizations
Note: Be prepared to prove that you do
what you say you do via:
Accurate & Up-to-Date
- Minutes of Meetings (e.g. Safety Committee,
EM Committee, Infection Control Committee,
etc.)
- Documented Risk Assessments
- Records, Logs, Manifests
- Performance Indicators
Disputed Survey Findings
During Survey
Whenever you feel a surveyor
has
has “mistakenly” cited you for a
LS, EC, EM, LS, EC, EM, or any standards issue:
p
You may
phone a friend; or
At your earliest opportunity, get out the LSC or your
accreditation standards manual and, together with
the surveyor, review and discuss the applicable
section(s) and specific requirements. It may also be
necessary to call TJC’s Department of Engineering
(with the surveyor) to obtain further clarification.
Surveyors have an 800 #
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NFPA 110 (1999) 3-5.4.5* Type of Battery.
The battery shall be of the nickel-cadmium or lead-acid type. Lead-acid batteries shall
be furnished as charged when wet. Drain-dry batteries or dry-charged lead-acid
batteries shall be permitted. Vented nickel-cadmium batteries shall be filled and
charged when furnished and shall have listed flip-top, flame arrestor vent caps. The
manufacturer shall provide installation, operation, and maintenance instructions, and,
when shipped dry, electrolyte mixing instructions. Batteries shall not be installed until
the battery charger is in service.
All batteries used in this service shall have been designed for this duty and shall have
demonstrable characteristics of performance and reliability acceptable to the authority
having jurisdiction. Batteries shall be prepared for use according to the battery
manufacturer’s instructions.
Starting batteries for Level 1 installations shall not be of the maintenance-free variety.
A-3-5.4.5
It is recommended that lead-acid starting batteries be replaced every 24 to
30 months.
Questions?
Thank You!
Larry Barlow
TSIG Consulting
615-330-1907
barlowl@tsigconsulting.com