demystifying the changes to tjc and cms...

Demystifying the Changes to TJC and CMS Standards11am-12pmFriday, January 6, 2017

Stephen L. Grimes, FACCE FHIMSS FAIMBEPrincipal ConsultantStrategic Healthcare Technology Associates, [email protected]

Demystifying the Changes to TJC and CMS Standards

Equipment class (i.e., High‐risk, non‐high‐risk, OEM, AEM)

Assuming existence of policies as outlined below

High‐risk (e.g., critical) equipment

Must have a 100% completion rate

Activities& frequencies per OEM recommendation(i.e., non‐AEM)


Activities & frequencies for non‐high‐riskequipment per AEMpolicy

Are to be completed at 100%

Available equipmentPolicy to conduct scheduled maintenance on equipment available (i.e., not “in‐use” or “missing” i.e., not found) during its maintenance window (i.e., scheduled date +/‐ grace period)

This equipment “must have a 100% completion rate” for scheduled maintenance

Equipment that is unavailable is not included in 100% completion rate calculation … but there must be an organization policy for effectively dealing with unavailable equipment and there must be evidence that policy is adhered to

This equipment “must have a 100% completion rate” for scheduled maintenance

Equipment that is unavailable is not included in 100% completion rate calculation … but there must be an organization policy for effectively dealing with unavailable equipment and there must be evidence that policy is adhered to

The policies addressing non‐high‐risk AEM equipment are “to be completed at 100%”

The organization may have a policy for conducting scheduled maintenance on a minimum percentage of non‐high‐risk AEM equipment (e.g., 90%) but must complete ALL scheduled maintenance activities on that equipment when maintenance is conducted on an item.






Activities & frequencies per OEM recommendation (i.e., non‐AEM)


Activities & frequencies for non‐high‐risk equipment per AEM policy


Equipment in‐usePolicy to flag equipment (in CMMS) that did not receive scheduled maintenance during its maintenance window because equipment was in‐use during that period.

An effective policy would require scheduled maintenance be conducted as soon as equipment becomes available and may include

• placing a prominent Inspection Due Before Next Use tag on in‐use equipment

• asking operator to notify HTM after removing from patient• notifying owners and organization leadership of all equipment not

receiving scheduled maintenance on time because it was in use• educating owners/users on the policy and process for informing HTM

when equipment becomes available

Equipment in this category that was not maintained on schedule because it was unavailable (in‐use) during the maintenance window is NOT included in the 100% completion rate calculation

Equipment in this category that was not maintained on schedule because it was unavailable (in‐use) during the maintenance window is NOT included in the 100% completion rate calculation

Equipment in this category that was not maintained on schedule because it was unavailable (in‐use) during the maintenance window is NOT a factor in “completed at 100%” calculation






Activities & frequencies per OEM recommendation (i.e., non‐AEM)


Activities & frequencies for non‐high‐riskequipment per AEMpolicy


Equipment missing‐in‐action (MIA)Policy to flag in CMMS equipment that did not receive scheduled maintenance during its maintenance window because equipment could not be located (i.e., was MIA) during that period.

An effective policy requires documented attempts to locate missing equipment and may include:• requesting aid in writing of owner/operators• requiring HTM staff performing sweeps • declaring equipment permanently gone (including notification of

owners & leadership of its status) and deactivating missing equipment in inventory after a reasonable period.

• Informing leadership regarding missing systems

Equipment in this category that was not maintained on schedule because it was unavailable (could not be located) during the maintenance window is NOT included in the 100% completion rate calculation

Equipment in this category that was not maintained on schedule because it was unavailable (could not be located) during the maintenance window is NOT included in the 100% completion rate calculation

Equipment in this category that was not maintained on schedule because it was unavailable (could not be located) during the maintenance window is NOT a factor in “completed at 100%” calculation


Implement an Alternate Equipment Maintenance (AEM) Program!!Start with OEM recommendations for scheduled maintenance activities and frequenciesDevelop AEM strategies and move any eligible equipment to AEM and adjust scheduled maintenance activities and frequencies from OEM recommendationsThe strategies of an AEM program must not reduce safety of equipment and must be based on accepted standards of practice, such as ANSI/AAMI EQ56To verify that safety will not be reduced by AEM conduct risk assessments

Reference CMS Letter S&C: 14‐07‐Hospital (December 20, 2013)including Revised State Operations Manual (SOM) Hospital Appendix A


Conducting Risk AssessmentRemember definition of Risk!

Risk = Function (Severity, Probability)

‐ and when we’re talking about maintenance issues ‐

Risk of scheduled maintenance‐related failure = Function (Severity of failure , Probability of scheduled maintenance‐related failure)


Determining risks requires we establish progressive scales for both Severity and Probability Note: # of levels are arbitrary … should be what works for you and your organization

Example of Severity Levels

Note that in this model, any equipment given a score of 4 (Catastrophic) or 3 (Critical) would be considered “Critical” by CMS and “High Risk” by the Joint Commission

Level # Level Description Criteria1 Negligible No or negligible adverse effect (e.g., little or no health or safety effect)

2 Marginal Reversible adverse effect (e.g., minor health or safety effect)

3 Critical Permanent adverse effect (e.g., serious health or safety effect)

4 Catastrophic Loss of life


Determining risks requires we establish progressive scales for both Severity and Probability Note: # of levels are arbitrary … should be what works for you and your organization

Example of Probability Levels of scheduled maintenance‐related failure

Example of Probability Levels

Level # Level Description Criteria

Examples: 1 ÷ MeanTimeBetweenMaintenanceRelatedFailure(years) = Annual Rate %

Mean Time Betweenmedical devices 10 yr life

expectancy on avgAnnual Rate

Percent of total sample

1 Improbable very unlikely to occur > 20 years < 5% per year

2 Remote unlikely but possible to occur > 10 and <20 years > 5% and < 10% per year

3 Occasional likely to occur > 5 and < 10 years > 10% and < 20% per year

4 Probable very likely to occur <5 years > 20% per year


Any eligible device identified as LOW risk based on incident/service histories … can be placed in an Alternate Equipment Maintenance(AEM) Program as long as risks to patients or staff do not increase


Any eligible device identified as LOW risk based on incident/service histories … can be placed in an Alternate Equipment Maintenance (AEM) Program reducing scheduled maintenance activities and/or frequencies as long you can demonstrate as risks to patients or staff do not increase

Assess maintenance related Risk

Consider whether risk indicates there should be a change in scheduled maintenance activities and/or frequencies

Monitor maintenancefailures

Feedback (regular review)


Medical Device Risk Assessment

Review Form for AEM

Policy for Medical Equipment Risk Analysis ‐ Determining Suitability for an Alternate Equipment Maintenance

(AEM) Program

Flow Process for implementing and maintaining an AEM

ANSI/AAMI EQ56:2013 Recommended practice for a medical equipment management program

ANSI/AAMI EQ89: 2015 Guidance for the use of medical equipment maintenance strategies and procedures

AAMI Reliability‐Centered‐Maintenance (RCM) Workgroupfocused risk assessment and maintenance strategies

Contacts:• Alan Lipschultz [email protected]• Malcolm Ridgway [email protected]• Steve Grimes [email protected]


12 © AAMI

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