October 2017 PHC Newsletter

by dawnconrey
Patton Healthcare Consultants

Accreditation – Compliance – Patient Safety

October 2017

Inside This Issue

  • Perspectives
    • Changes to Emergency Management Standards
    • Succession Planning – Delegation of Authority – Transplant Centers
    • Maintaining Contact Information
    • Training
    • System-Wide Preparation
    • 7 Recommended Steps for Handoff Communication
    • Increased Scrutiny of Sterile Compounding During Next Survey
    • To Do: Self-Assess Handling of Hazardous Medications
    • Trial Version Available on TJC Website
  • EC News
    • Infection Prevention During Construction
  • CMS Updates
    • Defining “Hospital”
    • CDC on Flexible Endoscopes
    • Ligature Hazards Once Again

October 2017 PHC Newsletter


Changes to Emergency Management Standards:

The lead article this month is about the Joint Commission’s new elements of performance required to comply with the recently published CMS requirements. These new EP’s are available from the home screen of your hospital’s secure Joint Commission extranet. The usual prepublication route has not been used because these are still considered a draft, not yet approved by CMS. Unfortunately, the implementation date is November 15, 2017, less than one month away. These changes will require some modifications to your emergency operations plan documents, so assuming they will be approved, you should make those edits now so you don’t get surprised on a survey after November 15.

Succession Planning – Delegation of Authority – Transplant Centers:

EM.02.01.01, EP 12 has been added to require a succession plan in the event key leaders are not available during an emergency. In addition, EP 12 requires a “delegation of authority” document describing the decisions and policies that can be implemented by authorized successors. EP 13 requires a representative from each of the hospitals transplant centers to be involved in the development of the emergency preparedness program. In addition, this EP requires the hospital to develop and maintain mutually agreed upon protocols that address the duties and responsibilities of the hospital, each transplant center, and the organ procurement organization in the hospitals service area, unless the hospital has been granted a waiver to work with a different OPO during an emergency. EP 14 requires the hospital to have a procedure for requesting an 1135 waiver for care and treatment at an alternative site.

Maintaining Contact Information:

EM.02.02.01, EP 20 has been added requiring that the hospitals communications plan maintains contact information for staff, physicians, other acute and critical access hospitals, volunteers, entities providing contract services, relevant federal, state, tribal, regional and local emergency preparedness staff, and other sources of assistance. EP 22 requires the hospital to maintain documentation of completed and attempted contact with local, state, tribal, regional and federal emergency preparedness authorities.


EM.02.02.07, EP 13 requires the hospital to provide initial and ongoing training for staff, volunteers, and individuals providing on-site services under arrangement relevant to their roles in emergency response. This training will need to be repeated annually and when the roles of these staff or others change.

System-Wide Preparation:

Lastly EM.04.01.01 has been added describing the requirements for hospitals which are part of a larger health system in participating in the system-wide preparation and response.  So, while this may be short notice, the modifications at this time are not too extensive and parts of the new requirements may already be in place.

Perspectives also describes the next phase of the EP review project which results in a number of EP consolidations in the HR, IC and RI chapters. No new requirements are being added and essentially no requirements are going away, but there is some merging of EP’s, which had separate and discreet expectations into one more expansive EP. You can think of these changes as basically formatting changes, thus there is nothing to study or be concerned about at this time. It will be interesting to see over the coming years if the consolidation adds clarity, or diminishes clarity because of the compound expectations in the new EP’s.

7 Recommended Steps for Handoff Communication:

During the past month, TJC published a new Sentinel Event Alert #58 on Handoff Communication. Something seemingly so simple is not in actuality and the Alert identifies the alarming discrepancy in perceived quality of the handoff between senders or receivers of the handoff. We also know that communication breakdowns are a frequently cited root cause in sentinel event analysis. As with all of their Sentinel Event Alerts, you want to analyze the recommendations, conduct a gap analysis, and consider their recommendations at your organization. While there is no requirement to implement all recommendations, there is a requirement to analyze the suggestions. The basic recommendations are as follows, although the Alert itself has more extensive content descriptions.

  1. Demonstrate leadership’s commitment to successful hand-offs
  2. Standardize critical content both verbal and written.
  3. Conduct the hand-off in locations that limit interruptions.
  4. Standardize training on how to conduct the hand-off from both a sender and receiver perspective.
  5. Use your EMR and other technology capabilities to enhance the hand-off.
  6. Monitor success of interventions to improve the hand-off and lessons learned.
  7. Sustain and spread best practices to make high quality hand-offs a cultural priority.


Increased Scrutiny of Sterile Compounding During Next Survey:

Probably the most concerning and important article in Perspectives is the one on reducing risk associated with sterile compounding. In our July Newsletter,  we warned that we were starting to see enhanced scrutiny on sterile compounding. This perception has certainly become a reality and it will catch many hospitals by surprise if not prepared properly. The October Perspectives mentions how multiple sessions in the survey process will now include expanded dialogue about sterile compounding. This will include tracers conducted by the life safety code specialist, document review, discussion during the MM and IC system tracers and the competency assessment tracer. Joint Commission published 3 tables along with the article, one on the physical environment for compounding, a second on issues the surveyors may observe during survey, and a third on competency expectations that pharmacy staff preparing sterile products must have documented. These competency expectations come directly out of USP Chapter 797. Based on our consulting work it is our observation that many hospitals considered these competencies to be optional, but that clearly would be a mistake to continue that belief. Those staff that prepare sterile products must have documented competencies including:

  • Written didactic testing,
  • Media fill testing, and
  • Gloved fingertip sampling.

If you are not familiar with these terms and techniques you will want to rapidly become expert in these processes. Also, you must know if your hospital only performs low risk and medium risk category compounding, or if it performs any high-risk compounding. If you perform high risk compounding the previously mentioned competency assessment techniques must be conducted every 6 months and there must be what is called end product testing.

This sterile product preparation sounds to us like another problematic area where the expertise of those surveying the hospital has the potential to exceed the content knowledge of those performing the job. We have seen the in recent years the enhanced expertise of the life safety code surveyors and the expertise of those evaluating high level disinfection and sterilization to the point that these are the most frequently scored issues on everyone’s hospital survey. Sterile product preparation may be the next huge survey issue facing hospitals. There are many learning opportunities from USP, American Society of Health-System Pharmacists (ASHP) and even commercial software tools to help you prepare, so our advice is don’t wait.

To Do:  Self-Assess Handling of Hazardous Medications:

While we are on this subject we have seen a recent notice from the people at USP that their new Chapter 800 on compounding of hazardous medications, and the planned revisions to Chapter 797 have been delayed until December 1, 2019. Although Chapter 800 has a delayed publication date, the Perspectives article does discuss the concept that staff should understand the workflow and precautions needed when handling hazardous medications. It also states that surveyors will be looking for competencies related to proper garbing for protection and written didactic testing when handling hazardous medication.

To better understand the details behind these expectations we suggest having your pharmacy staff self-evaluate the medication compounding certification standards or the home care medication compounding standards to help understand the depth of their expectations.

Trial Version Available on TJC Website:



Infection Prevention During Construction:

EC News this month has part 2 of an article on managing infection prevention and control risks during construction or renovation. There is a very worthwhile table of infection prevention strategies developed by the CDC in the article. This content should be shared with your facilities leadership and infection control team. This table provides guidance on both containing dust and debris, as well as a checklist of items to evaluate before re-opening the space for patient care.

Sadly, there is no Clarifications and Expectations column this month. TJC refers to it as being on hiatus with the 11th and final portion of the series planned for publication in November. The author of the series, George Mills has left TJC.  We wish him the best in his new role.

CMS Update:

Defining “Hospital”:

On September 6, CMS published SC memo 17-44, basically trying to define a hospital. This is unimportant for most of our readers, however those in smaller specialty hospitals with lots of outpatient services should download and review this memo. It appears that smaller hospitals, those with multiple emergency rooms, lots of outpatient surgical procedures and very limited inpatient capacity, short length of stay, and potentially closed on weekends may need to be redefined as something other than a hospital. CMS provides some examples of the types of service arrangements where they would conclude the organization is not really a hospital. We assume this has an underlying financial implication for CMS, and again most of our readers can ignore this one, but smaller organizations should take note.


CDC on Flexible Endoscopes:

Earlier this year the CDC published an update from HICPAC on the Essential Elements of a Reprocessing Program for Flexible Endoscopes. This document was published along with an extensive tool kit which includes forms for:

  • A policy template
  • An audit tool
  • A competency verification tool
  • An inventory and maintenance log
  • A gap analysis tool
  • A root cause analysis template specific to errors in scope processing

The document includes a lot of useful information about scope processing including the essential steps in the process, which would be a great outline format to mimic when refining your hospital’s policies and procedures. CDC then details the essential elements of a well-run program including administrative considerations, documentation requirements, inventory management, the physical environment, education, training and competencies, risk assessment and quality assurance, management of disinfection or sterilization breaches, and lastly unresolved issues such as supplemental processing after high level disinfection for duodenoscopes. The tool kit resources are perhaps the most useful portion of the release.


Ligature Hazards Once Again:

Everyone is waiting for final recommendations and conclusions from TJC and CMS on this in-flux topic, but some additional guidance was shared during the September Executive Briefings presentations conducted by TJC. We hope to see this guidance committed to writing soon, but until then our conclusions based on the verbal presentations are as follows:

  1. The patient rooms and bathrooms in the dedicated behavioral health space must be ligature resistant, including the door to the hallway. We did not hear any clear direction on the acceptability or lack thereof, of full height wooden doors to the bathroom. We do know that there are alarms/sensors, which can be purchased for full height doors that can detect any weight applied to a draped cord or sheet on the top of the door.
  2. Group rooms in the behavioral health unit should be identified as non-dedicated space and kept locked unless patients are directly supervised by staff.
  3. TJC will not be scoring toilet seats in patient bathrooms as a ligature risk. Additionally, TJC will not score dropped ceilings in the public hallway, which should be easily observable by staff.
  4. Non-dedicated spaces do not have to be redesigned, however anything that is removable and not needed for patient care, should be removed. The potential hazards in such an environment can only be overcome by application of 1:1 supervision if the patient is identified as a suicide risk.
  5. Ensure compliance with safety goal 15.01.01 by assessing each patient admitted for behavioral health services for risk. The verbal recommendation for a standardized clinical screening and assessment tool for suicide risk gets stronger each time we hear TJC discuss this subject. During the briefing TJC suggested either the Columbia scale or PHQ2/9. There is also a proposed revision to the safety goal that would codify the requirement for a screening tool and an assessment tool. In the draft safety goal TJC suggest the “ED-SAFE” or “SBQ-R” screening tools. For assessment tools, the NPSG suggests Columbia, along with an expanded ED-SAFE tool and a tool called “SAFE-T Pocket Card.”
  6. Assess the physical environment in dedicated space, and non-dedicated space being used to treat behavioral health patients to help you detect potential hazards in the physical environment. Plan to remove potential hazards that you identify in the patient bedrooms and bathrooms. Until these can be removed the only corrective action we have seen TJC accept is to apply 1:1 supervision to those patients you have identified as at risk for suicide. Use the hazards you identified in the non-dedicated space to help focus your training for the sitters that will be assigned to help keep the patients in the non-dedicated space safe from self-harm.

Please view our archived Newsletter issues: April, May, and July by visiting us at https://pattonhc.com/patton-healthcare-consulting-newsletters/ for more information on ligature risks.

Consultant Corner

We are now scheduling for all compliance and accreditation mock surveys in 2018. Please contact us to secure your team today. Have a wonderful month!

Thank you,

Jennifer Cowel, RN MHSA

Kurt Patton, MS RPh

John Rosing, MHA

Mary Cesare-Murphy, PhD