Change in Interpretive Guidance for A701 Standard: Buildings:

Courtemanche & Associates

By James Ballard
May 7, 2019

A-0701 Interpretive Guidelines §482.41(a) The hospital must ensure that the condition of the physical plant and overall hospital environment is developed and maintained in a manner to ensure the safety and well-being of patients.
The language in the standard has not changed but the survey process and the guidance for surveyors has significantly changed. Ensure that the Environment of Care committee is familiar with the following:
Accessibility: The hospital must ensure all buildings at all locations of the certified hospital meet State and Federal accessibility standards (e.g. Office of Civil Rights requirements). The requirements apply to the interior and exterior of all buildings.
Age-related safety features: Hospitals are expected to address safety hazards and risks related to age-related factors. Healthcare provided to neonatal, pediatric, and geriatric patients must be in accordance with nationally recognized standards. Age-related risks may include items such as security of inpatient and outpatient locations, access to medications, cleaning supplies and other hazardous materials, furniture and other medical equipment, and increased chance of falls.
Security: To minimize the risk of unauthorized access to or inappropriate departure from secured healthcare units, hospitals must demonstrate security features in accordance with nationally recognized standards to ensure the safety of vulnerable patients.
Ligature risk: The presence of unmitigated ligature risks in a psychiatric hospital or psychiatric unit of a hospital is an immediate jeopardy situation. Additionally, this also includes any location where patients at risk of suicide are identified. Ligature risk findings must be referred to the health and safety surveyors for further evaluation and possible citation under Patients’ Rights.
Weather-related exterior issues: Although hospitals cannot address all weather-related issues, they are expected to address potential safety hazards specific to weather on both the exterior and interior locations in accordance of nationally recognized standards.
Life Safety Code: surveyors assess the use of power strips in healthcare facilities. However, the following guidance is provided as reference for healthcare surveyors as they survey physical environment along with other CoP requirements.
If line-operated medical equipment is used in a patient care room/area, inside the patient care vicinity:
UL power strips would have to be a permanent component of a rack-, table-, pedestal-, or cart-mounted & tested medical equipment assembly
Power strips providing power to medical equipment in a patient care room/area must be UL 1363A or UL 60601-1
Power strips cannot be used for non-medical equipment
If line-operated medical equipment is used in a patient care room/area, outside the patient care vicinity:
UL power strips could be used for medical & non-medical equipment with precautions as described in the memo
Power strips providing power to medical equipment in a patient care room/area must be UL 1363A or UL 60601-1
Power strips providing power to non-medical equipment in a patient care room/area must be UL 1363
If line-operated medical equipment is not used in a patient care room/area, inside and outside the patient care vicinity:
UL power strips could be used with precautions Power strips providing power to non-medical equipment in a patient care room/area must be UL 1363. In non-patient care areas/rooms, other UL strips could be used with the general precautions.
The focus should be the statements made in the guidance related to nationally recognized standards. What are these standards, where to they come from and how do we obtain them? All great questions that should be being discussed in the Environment of Care Committee and amongst leadership. These standards come from various government agencies (FEMA, CDC, CMS, JC, OSHA, NWS) and professional associations (ASHRM, IAHSS, AHA, NFPA, ASHE). Remember, surveyors have new direction – be ready.

New CMS Immediate Jeopardy Process

The Centers for Medicare and Medicaid (CMS) issued a new approach to Immediate Jeopardy on March 6, 2019, found in State Operations Manual, Appendix Q: Core Guidelines for Determining Immediate Jeopardy (IJ). The introduction states: “Immediate Jeopardy (IJ) represents a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death.” The previous definition stated that IJ was a situation in which the provider’s noncompliance was likely to cause serious injury, harm, impairment or death. This change from individual compliance to entity compliance broadens the reach of the surveyor’s investigation when there is potential for an IJ situation.
While the new approach has revised definitions, be aware of the key components that are essential for surveyors to determine IJ. These include: 1) noncompliance, 2) serious adverse outcome or likely serious adverse outcome as a result of the noncompliance, and 3) need for immediate action to correct noncompliance and prevent occurring or recurring harm.

Key Components in Determining IJ Include:
• Noncompliance: An entity has failed to meet one or more federal health, safety, and/or quality regulations;
• Serious Adverse Outcome or Likely Serious Adverse Outcome: As a result of the identified noncompliance, serious injury, serious harm, serious impairment or death has occurred, is occurring, or is likely to occur to one or more identified recipients at risk;
Need for Immediate Action: The noncompliance creates a need for immediate corrective action by the provider/supplier to prevent serious injury, serious harm, serious impairment or death from occurring or recurring.
Determining noncompliance requires the survey team to gather enough evidence through observation, interview, and record review to support the citation of noncompliance, and to understand the extent, nature and scope of noncompliance, as well as the impact or likely impact of risk to others. Surveyors must identify and analyze noncompliance against all relevant regulations or tags.
CMS expects surveyors to identify when the IJ began if possible, to learn how long the IJ existed before action was taken to correct it. An example provided suggest that a power outage may have relatively minor consequences to the general population of recipients yet could have life-threatening consequences for ventilator-dependent recipients if adequate contingencies had not been in place.

Immediate Jeopardy Template
Surveyors must use the IJ template to document their determination of IJ and will rely on these definitions:
• Likely/Likelihood means the nature and/or extent of the identified noncompliance creates a reasonable expectation that an adverse outcome resulting in serious injury, harm, impairment, or death will occur if not corrected.
• Noncompliance means failure to meet one or more federal health, safety, and/or quality regulations.
• Recipient at Risk is a recipient who, as a result of noncompliance, and in consideration of the recipient’s physical, mental, psychosocial or health needs, and/or vulnerabilities, is likely to experience a serious adverse outcome.
• needs, and/or vulnerabilities, is likely to experience a serious adverse outcome.
Serious injury, serious harm, serious impairment or death are adverse outcomes which result in, or are likely to result in:
• death; or
• a significant decline in physical, mental, or psychosocial functioning, (that is not solely due to the normal progression of a disease or aging process); or
• loss of limb, or disfigurement; or
• avoidable pain that is excruciating, and more than transient; or
• other serious harm that creates life-threatening complications/conditions.
*NOTE: IJ does not require serious injury, harm, impairment or death to occur. It is enough that non-compliance makes serious injury, harm, impairment or death likely to occur to one or more recipients.

Removing Immediate Jeopardy
When the survey teams determine that that entity noncompliance rises to the level of IJ, the team consults with the State Agency and notifies the administrator of the entity. The team uses the IJ template to clearly and concisely communicate the finding of IJ. The entity responds by developing a Removal Plan that focuses on assuring that serious harm will not occur or recur. The entity includes the immediate actions the entity will take to address the noncompliance, prevent serious harm from occurring or recurring, and keep recipients safe and free from harm.

By Judy Courtemanche March 26, 2019


What Kind of Leader Are You

At MBD Consulting we inspire our clients to visualize what they can become in patient quality and safety by following CMS and accreditation requirements and standards.  As partners with out clients we resolve issues, make believers  see their future and create a vision that becomes a rally cry for the entire organization.

We are with our clients long after we have left their organization to continue to inspire and provide solutions as long as necessary to achieve their goal.

No alt text provided for this image

TJC De-escalation in Health Care Quick Safety

Issue 47 | January 2019

The need for using de-escalation techniques has become more prevalent as violence in health care settings increases. De-escalation is a first-line response to potential violence and aggression in health care settings. The Centers for Disease Control and Prevention (CDC) has noted a rise in workplace violence, with the greatest increases of violence occurring against nurses and nursing assistants. A three-year study in the American Journal of Nursing noted that 25 percent of nurses reported being assaulted by patients or the patient’s family members. Statistically, higher rates of health care violence are reported to occur in the emergency department (ED), geriatric and psychiatric settings.

The purpose of this Quick Safety is to present some de-escalation models and interventions for managing aggressive and agitated patients in the ED and inpatient settings. There are many different de-escalation techniques; this Quick Safety is intended to guide health care professionals to resources for more information and training.

Framework for Effective Board Governance of Health System Quality

The IHI Lucian Leape Institute’s research scan on board governance of health system quality, evaluation of governance education in quality, and expert interviews made it clear that board members, and those who support them, desire a clear and consistent framework to guide governance of all dimensions of quality beyond safety, including identification of the core processes and necessary activities for effective governance of quality.

This white paper includes:
Framework for Governance of Health System Quality: A clear, actionable framework for oversight of all the dimensions of quality.
Governance of Quality Assessment: A tool for trustees and health system leaders to evaluate and score current quality oversight processes and assess progress in improving board quality oversight over time. [*online tool also available]
Three Support Guides: Three central knowledge area support guides for governance of quality (Core Quality Knowledge, Core Improvement System Knowledge, and Board Culture and Commitment to Quality), which health system leaders and governance educators can use to advance their education for trustees.
The framework, assessment tool, and support guides strive to reduce variation in and clarify trustee responsibilities for quality oversight, and also provide practical tools for trustees and the health system leaders who support them to govern quality in a way that will deliver better care to patients and communities.

How to Cite This Paper: Daley Ullem E, Gandhi TK, Mate K, Whittington J, Renton M, Huebner J. Framework for Effective Board Governance of Health System Quality. IHI White Paper. Boston, Massachusetts: Institute for Healthcare Improvement; 2018. (Available on


CMS NEWS FOR IMMEDIATE RELEASE October 4, 2018 Contact: CMS Media Relations (202) 690-6145 | CMS Media Inquiries

CMS to Strengthen Oversight of Medicare’s Accreditation Organizations
Agency’s website will increase transparency into Accrediting Organization performance, and CMS will streamline and strengthen the validation of Accrediting Organization surveys
Today, the Centers for Medicare & Medicaid Services (CMS) took action to improve quality and safety in healthcare facilities and empower patients with information to make decisions about where to receive care.
“Today we are taking action to improve our oversight of Accrediting Organizations, including by increasing transparency for patients on the organizations’ performance,” said CMS Administrator Seema Verma. “The public trusts CMS to ensure the quality and safety of patient care, and we take this responsibility very seriously. Today’s changes will bolster the processes for overseeing how effective Accrediting Organizations, who work on CMS’ behalf, are in evaluating healthcare facilities.”
Currently, Medicare-participating healthcare providers and suppliers are surveyed either by State survey agencies or by Accrediting Organizations (AOs) to ensure that they meet CMS’ quality and safety standards. AOs receive deeming authority from CMS, which affirms that AOs’ health and safety standards meet or exceed those of Medicare. Only facilities and suppliers that have been deemed by state or AO surveyors to meet CMS’ standards may receive payments from Medicare. There are currently 10 CMS-approved AOs, each of which surveys one or more different types of facilities.
CMS will enhance and strengthen its oversight and quality transparency of AOs in three ways: 1) the public posting of AO performance data; 2) a redesigned process for AO validation surveys and 3) the release of the Annual Report to Congress. Taken together, these efforts will provide important insights to the public and assist AOs, providers, and suppliers in ensuring patient health and safety.
Posting AO Performance Data Online
To increase transparency for consumers, CMS will post new information on the CMS.Gov website, including: The latest quality-of-care deficiency findings following complaint surveys at facilities accredited by AOs; a list of providers determined by CMS to be out of compliance, with information included on the provider’s AO; and overall performance data for AOs themselves. To view AO performance data, visit:
Today, the public relies on accreditation status as a way to gauge providers’ and suppliers’ quality of care. By posting more detail—accredited hospitals’ complaint surveys, out-of-compliance information, and performance data for AOs themselves—CMS will offer the public more nuanced information than accreditation status alone provides. The agency is currently prohibited by law from disclosing the actual surveys done by AOs, except for surveys of home health agencies and surveys related to an enforcement action.
Pilot Testing Direct Observation for AO Validation Surveys
CMS is testing a more streamlined, efficient way to assess AOs’ ability to ensure that facilities and suppliers comply with CMS requirements.
CMS evaluates the ability of AOs to accurately assess providers’ and suppliers’ compliance with health and safety standards through a validation survey process. Historically, CMS has measured the effectiveness of AOs by choosing a sample of facilities, performing state-conducted assessment surveys within 60 days following AO surveys, and comparing results of the state surveys with the AO surveys. In a pilot test, CMS will eliminate the second state-conducted validation survey and instead use direct observation during the original AO-run survey to evaluate AOs’ ability to assess compliance with CMS’s Conditions of Participation.
Direct observation will enable CMS not only to evaluate AO performance more effectively, but also to suggest improvements and address concerns with AOs immediately. This approach will relieve providers from having to undergo the burden of a state’s follow up assessment. The approach is another example of the wide-ranging effort at CMS to eliminate duplication and relieve burden, reducing the amount of time that healthcare facilities must spend on compliance activities.
CMS will also analyze and incorporate State complaint investigations of accredited facilities as part of the agency’s strengthened validation program. This work will focus on identifying and monitoring accredited facilities that are out of compliance with Medicare health and safety requirements. CMS will use this information as an additional indicator of AO performance.
Posting the Most Recent Annual Report to Congress Regarding AO Performance
CMS has also posted the most recent annual Report to Congress, the “Review of Medicare’s Program for Oversight of Accrediting Organizations and the Clinical Laboratory Improvement Validation Program Fiscal Year 2017,” on the CMS website. As the changes announced today inform and bolster our oversight of AOs, CMS will continue to publish this report online annually to demonstrate the impact of these changes on the oversight of AOs and to provide greater transparency for the public. The FY 2017 Report to Congress is posted online:
Get CMS news at, sign up for CMS news via email and follow CMS on Twitter @CMSgovPRESS

High Level Disinfection Scoring Re-Evaluated

By Sylvia Garcia-Houchins, RN, CIC, director of infection prevention and control, The Joint Commission

After a careful evaluation of high-level disinfection (HLD) and sterilization process steps, The Joint Commission has refined its scoring as of September 1 to focus on the process steps that pose the highest risk to patients if they fail.

Last year, 72 percent of surveyed hospitals and critical access hospitals were found to be noncompliant with The Joint Commission’s high-level disinfection and sterilization standard IC.02.02.01. We are refining some of the scoring guidelines to clarify expectations.

Seven areas have scoring revisions specific to High Level Disinfection—the common theme is establishing processes that support manufacturers’ instructions.

The Joint Commission will continue to score IC.02.02.01 as noncompliant whenever manufacturer instructions are not followed. Over the next several months, we will closely monitor the revisions to ensure consistent scoring.

Wipe & Flush at Point of Use, As Needed
There is no expectation that visible blood or tissue be removed from instruments at the point of use.

Clinically appropriate wiping/flushing of soiled instruments may be observed during a case in the operating or procedure room. Facilities may be asked about their wiping/flushing policy, but there’s no expectation that all instruments will be wiped or flushed. Instrument cleaning should be performed in the decontamination area with appropriate personal protective equipment (PPE), facilities and other equipment that will protect employees from possible exposure/ injury.

Organizations will also be scored if an instrument that is ready for use on a patient is visibly soiled.

Surveyors may ask staff to:
watch the case being opened
describe what they check for when opening a tray
open a tray that will not be needed for 24 hours
explain what they would do if they found an instrument with bioburden when opening a sterile pack or tray.
Maintain the Moisture of Soiled Instruments
The facility may choose the manner in which it keeps soiled instruments moist. The Joint Commission requires that a process is in place to maintain moisture, as recommended by the instrument manufacturer, the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of perioperative Registered Nurses (AORN). The process and product choice are the organization’s decision.

Options include:
moistened towels
containers that maintain moisture,
products for maintaining moisture in accordance with manufacturer instructions
Transporting Soiled Instruments Safely
Non-sharps must be transported in a way that cannot lead to contamination.

Occupational Safety and Health Administration (OSHA) states reusable sharps must be placed in a puncture-resistant red container or one marked “biohazardous”, and this requirement is reflected in the refined scoring guidelines.

AAMI provides reasonable guidance on transportation and the issue of bottom or side leaks on crash carts in section 6.5.3 Transportation Equipment, if you’ve purchased the manual. In a nutshell, carts need to be appropriate for transport of the items being moved. If the instruments are in containers with solid sides and bottom and are covered, an open cart may be appropriate. If the items are placed in open bins and then on an open cart, the organization should use a cover for the cart. Items in closed case carts do not need to be covered.

The cart should be designed to prevent items from falling off. Surveyors may ask infection control/operating room and Central Sterile Processing management if they have evaluated that risk and if items have ever fallen off.

Ensuring the Sterilant Reaches All Surface
All surfaces of the instruments undergoing sterilization must be accessible for the sterilant to reach them. Manufacturer instructions provide information on how to prepare items for sterilization. In addition, AAMI and AORN state that items should be sterilized in the open (unratcheted) position and disassembled in accordance with manufacturer instructions.

We recognize that some instruments, such as scissors, are likely to close after sterilization when they are being transported or stored. Therefore, surveyors will review the process for ensuring the item is prepared in a manner that will ensure exposure to the sterilant. Surveyors will observe the instruments coming through the cleaning process to ensure that they have been disassembled and are packaged in accordance with manufacturer instructions. They will also review peel packs to see if items that are awaiting sterilization or have just been sterilized are in the unratcheted position.

In order to ensure accurate scoring, surveyors may ask for manufacturer instructions for use to confirm whether an item should be taken apart.

Surveyors may ask staff to prepare a tray from those waiting to ensure instruments are opened and inspected during assembly. They will be watching how staff checks for cleanliness of instruments that are being processed. In some cases, staff may be asked to open a rigid or wrapped tray awaiting sterilization to confirm that items are being opened or disassembled in accordance with manufacturer instructions.

Careful Instrument Release after Sterilization
Instrument release should be a thoughtful and deliberate process to ensure only sterilized items are released.

Internal and external, if the internal indicator is not visible through packaging, chemical indicators must be used for every item undergoing sterilization. Physical monitoring of cycle (e.g., time, temperature, and pressure) and a check of the external (or internal if visible through the packaging) chemical indicators must occur before each non-implant load is released. Implant loads may be released after all of the following actions:
verification that the physical parameters of the sterilization cycle have been met
a biologic indicator has been done and is negative
a type 5 integrating indicator (aka integrator) confirms the process.
Unless there’s a facility policy allowing emergent release of implant loads before the biologic indicators is read, surveyors will score as not compliant with the standard if the result of the biologic is not recorded prior to use. If a facility policy does allow individuals to proceed without reading the biological indicators in emergent situations, the policy must be followed.

Storage of Items that have undergone High Level Disinfection, including endoscopes and endocavity probe

Items must be stored in a way that’s consistent with their intended use. This means that items that require a minimum of high-level disinfection may be stored in a way that protects from contamination even if they were sterilized.

Again, manufacturers’ instructions for use must be followed for storage. If instructions for use do not provide direction on storage requirements, items should be stored in a way that prevents contamination. Surveyors will score based on compliance with facility policy or risk assessment unless the manufacturer’s instructions for storage were not followed, or the containers/ locations of storage are visibly soiled, or if staff are observed contaminating other high level-disinfected products.

Dry Endoscopes Before Storing
Recent articles have indicated that a key component of ensuring that microorganisms do not replicate during storage is careful drying – not the duration of storage. Surveyors will check for compliance with manufacturers’ instructions for drying scopes. but will no longer score any finding related to hang time unless a reprocessing frequency has been specified by the endoscope manufacturer and is not followed.

Any IC02.02.01 findings on survey before September 1 will not be removed. Hospitals that are in the clarification window or that are preparing their Evidence of Standards Compliance (ESC) report should document compliance based upon the refined scoring guidelines. If you believe that your organization received an adverse decision based solely on a finding that would no longer be scored, please contact the Standards Interpretation Group via the online form or email me directly.

We want the survey process to be as transparent as possible and hope that scoring refinements will help organizations focus their efforts on keeping patients safe!

On the Radar: TJC Provides Updated Guidance for Scribes

By Patricia Cook

Courtemanche & Associates
August 16, 2018

The Joint Commission announced the following updated guidance for scribes and/or documentation assistants this week:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Persons in the Role of Scribe and/or Documentation Assistants must have a job description and shall have the following competencies/education as a minimum standard:
Medical terminology
Principles of billing, coding, and reimbursement
Ability to navigate and understand the functionality of the organization’s Electronic medical record (EMR) as needed to function within their assigned duties
Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
TJC advises the amount of training required in these areas will vary depending upon the person’s past training and experience.
Organization should develop a policy/procedure regarding processes associated with the use of documentation assistants. Policies should:
Restrict /prohibit documentation assistants/scribes from using a physician or LIP’s log-in and define the proper log-in procedures and purpose.
Define the scope of documentation that may be entered by the documentation assistant/ scribe
Sets forth the requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
In alignment with the other standards in the Human Resources Chapter that apply to those who provide care, treatment and/or services to your patients; orientation and ongoing training and education to the role must be provided.
Organizations that elect to provide these services through a contractual arrangement are reminded that all clinical contracting requirements apply.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification. These specifications should be outlined within the organization’s policies and procedures and /or job descriptions.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
TJC has not indicated how the above guidance will be used as a component of the survey process.