Greeley Response to Recent CMS Statements about Temporary Privileges

Recent public statements by CMS representatives have raised questions about the mechanism a hospital should use to authorize /approve temporary privileges. Specifically, that the CMS CoPs do not allow the CEO to sign off on temporary privileges and that only the governing body can grant privileges (including temporary privileges).  These statements have caused a great deal of discussion in the field.  We are monitoring the discussion and provide the following analysis:

The CMS Conditions of Participation (“CoPs”) require that a hospital’s Governing Body approve each practitioner’s Medical Staff privileges. Neither the CoPs nor the corresponding CMS interpretive guidelines specify the method that must be used for such Governing Body approval. Most Governing Bodies appoint a Chief Executive Officer (“CEO”) to act on its behalf to award privileges on a temporary basis (e.g., until the next Board or Board Committee meeting for new applicants or when necessary to meet urgent patient care needs) … just as the Board empowers the CEO to enter into contracts and perform other governance functions on the Board’s behalf.

Greeley is working with CMS, the Joint Commission, Healthcare Facilities Accreditation Program, the American Health Lawyers Association, and others to resolve this situation. We recognize that hospital Boards must have a reliable and safe mechanism to award privileges in the face of urgent patient care needs: whether it be to treat patients during a community wide disaster, to enable a sub-specialist to perform a rare or new procedure on a hospital’s patient, or to assure that there are sufficient physicians to examine and treat patients presenting to the emergency department. Awarding temporary privileges has been a mechanism used for decades to safely and reliably meet this need. We also recognize the Board’s responsibility to oversee the Medical Staff credentialing and privileging process and to assure that each practitioner to whom it awards privileges is fully qualified (by credentials and proof of current competence).

We will continue our discussions and keep our consultants and clients advised in the days and weeks ahead.

Sally Pelletier, Chief Credentialing Officer

 

The Greeley Company – Online Learning: Exciting Enhancement for Members

We are every excited to announce that in January 2019, The Greeley Company is launching a new online learning platform which will replace your current webinar offering.  Going forward Greeley will offer two types of online learning opportunities: Premium and Standard.

There is no charge for Greeley’s Standard presentations.  However, our Premium series will include downloadable, editable model policies and procedures, customizable slide decks and monitoring tools, etc.  There is a charge for these Premium sessions.  However, as a Greeley Member the charge for all Premium sessions will be waived for 2019. Members will be issued a special code for use during registration.

If you have any questions please feel free to reach out to Michelle at membership@greeley.com

We are thrilled to offer our Members this incredible benefit and thank you for being a valued  participant in this Greeley community.

Common Survey Challenges: Infection Control

Common Survey Challenges: Restraint Orders

Common Survey Challenges: Medication Security

Common Survey Challenges: Suicide Screening, Assessment and Precautions

Common Survey Challenges: Contract Monitoring

Looking forward to 2019

If hospital survey results during the past year is any indication, 2019 should be a very busy and challenging year for hospitals across the country. For CMS: we’ve seen an uptick in EMTALA citations and continue to see termination actions focused on infection prevention and the care of suicide patients. Joint Commission averaged over 30 finding per survey in 2018 and will continue its enhanced survey process into 2019 as it introduces ten new elements of performance for its suicide prevention National Patient Safety Goal (NPSG 15). DNV and other accreditation agencies are expected to increase the number of findings in response to a recent CMS inspector general’s report.

In recognition of these and related challenges, Greeley is offering a webinar on December 2, 2018: “CMS and Accreditation Survey Hot Spots: Looking ahead to 2019″ Registration Link

Greeley experts will explore common vulnerabilities that trigger to 90-day CMS “terminations” or preliminary denial of Joint Commission (and other) accreditation … or worst.

We will review successful strategies for common pitfalls related to:

  • Suicide screening and assessment (enhanced for 2019 with new Joint Commission requirements),
  • Ligature resistance in the behavioral health setting,
  • Sterilization and High-level disinfection or reusable equipment,
  • Restraint,
  • EMTALA,
  • and other areas of high vulnerability.

Who should attend:

Those responsible for quality, safety and compliance in hospitals and critical access hospitals, including:

  • Survey Coordinators
  • Quality Directors
  • Infection Control Practitioners
  • Environmental Safety Officer

The webinar will be led by Bud Pate, Vice President of Content at Greeley, a nationally recognized expert in CMS and Joint Commission Compliance. He will be joined by Lisa Eddy, an Executive Consultant with Greeley who leads teams across the country as they help clients respond to threats to accreditation and CMS certification.

No matter where you are in your accreditation cycle, a survey team could arrive at your door any time. Don’t go into 2019 unprepared!

Faculty:

Bud Pate, Vice President of Content and Development at The Greeley Company

Bud Pate is a nationally recognized expert in CMS and Joint Commission compliance, clinical process simplification, clinical quality and patient safety. Prior to joining The Greeley Company, Bud spent 15 years as an executive consultant and director of licensing and accreditation for Kaiser Permanente’s Southern California region. Before joining Kaiser, Bud was responsible for state licensing and Medicare certification for all hospitals, home care agencies, and specialty clinics in Los Angeles County. Bud also represented the American Hospital Associations on various Joint Commission committees.

Lisa Eddy, RN, MSN, MHA, CPHQ, Executive Consultant, The Greeley Company.

Lisa Eddy brings over 20 years experience in Joint Commission and CMS accreditation and certification. Lisa’s background in nursing administration, regulatory compliance, and quality and risk management allows her to apply real world healthcare knowledge to the challenges of meeting regulatory requirements.

A second “time out” is required by NFPA 99 for some surgical procedures

Joint Commission representatives have begun emphasizing the need for an additional “NFPA Time Out” for some surgical cases. This time out is not required by the Joint Commission’s Universal Protocol, but it is referenced in the NFPA (National Fire Prevention Association) standards. We’ve received a number of questions as a result. In this blog, we provide you with insights to help you understand these frequently asked questions:
· Which cases require an NFPA time out?
· How do you tell if the skin preparation solution is flammable?
· What are the elements of an NFPA time out?
· Etc.

Cases requiring an NFPA Time Out.
NFPA 99 (2012) is a national guideline (adopted by CMS) that addresses fire prevention in health facilities. Section 15.13.3.6 requires “a preoperative ‘time out’ period … prior to the initiation of any surgical procedure using flammable liquid germicides or antiseptics.”

How to tell if the skin preparation solution is flammable.
There’s only one way to tell if a solution is flammable: you must read the package insert or the label on the original bottle (the Instructions for Use or “IFUs”).
In general, flammable germicides tend to have isopropyl alcohol as a primary ingredient.
“Povidone iodine such as Betadine® and chlorhexidine solutions such as Hibiclens® are not flammable prep solutions …” according to the Anesthesia Patient Safety Foundation (Cowles, CE; Chang, JL: “Flammable Surgical Preps Require Vigilance,” APSF Newsletter, Volume 29, No. 2. October 2014) and an NFPA Time Out would not be required when these or other non-flammable solutions are used.

The NFPA Time Out is separate from the Universal Protocol Time Out.
NFPA does not say these are separate events. However, the NFPA Time Out must be performed prior to draping to verify that the antiseptic has dried and the Universal Protocol Time Out must be performed immediately prior to the procedure and after draping to verify the right patient, procedure and site. They therefore seem to be separate events.

Elements of an NFPA Time Out.
The NFPA Time Out should verify that:
· The application site of the flammable germicide or antiseptic is dry prior to draping and use of electrosurgery, cautery, or a laser.
· Pooling of solution has not occurred or has been corrected.
· Any solution-soaked materials have been removed from the operating room prior to draping and use of electrosurgery, cautery, or a laser.

Individuals involved in the NFPA Time Out.
The NFPA guidelines do not say.

Other Issues Related to Surgical Fires.
Most of the other requirements related to surgical fires have been in place for some time and we won’t review them here. However, we encourage each hospital’s perioperative leadership team to work with the organization’s environmental safety officer to carefully review and validate compliance with NFPA 99 (2012), Chapter 15, Section 13, “Fire Loss Prevention in Operating Rooms.”

Bud Pate, Vice President, Content
Steve MacArthur, Consultant

The Joint Commission’s “Enhanced Survey Process” put’s a microscope on the disinfection cycle

The Joint Commission has changed its survey process to focus on four areas:

  • suicide prevention
  • hemodialysis
  • sterile medication compounding, and
  • high-level disinfection

As part of this refocusing the Joint Commission has sharpened the way it will score IC.02.02.01. Citations under that section often lead to condition-level findings.

The following is Greeley’s recommendation for steps all health care organizations do to prepare for this closer look at the disinfection cycle.

Step 1: Put disinfection on leadership’s agenda.

The infection control representatives at your institution have probably been monitoring sterilization / disinfection issues years. So, how’s that working for you? At most hospitals, it’s not working well because: 1. Infection control representatives are quite busy with many, many, many, (many) other things on their plate; 2. there are a number of other locations outside of central sterile processing to worry about (like ambulatory care); and 3. disinfection may seem easy and natural, but it’s not.

So … it’s probably time to expand compliance efforts beyond infection control and put it on the priority lists for managers across the organization.

Disinfection is not infection control’s issue, it is an issue for each clinical manager!

Step 2: Establish local responsibility with central oversight.

We recommend presenting the following process for leadership’s approval:

1. The manager of each patient care location should become clearly and unequivocally responsible for the elements of the disinfection cycle performed in their unit or setting. Although not all locations perform high-level disinfection or sterilization, virtually all patient care areas participated in one or more aspects of the disinfection cycle: collection, transportation, cleaning, etc.

2. Training and tools should be provided to these managers about your requirements for each phase of the disinfection cycle (see below).

3. An individual (infection control? quality / compliance?) should be responsible for creating an inventory of all units and settings where non-disposable items are used (items what have been or will need to be sterilized or disinfected). Our sample inventory tool should give you an idea about what to look for.

4. Each unit or location on the inventory should be reviewed against the following criteria, based on the Joint Commission scoring guidelines, for the corresponding part of the sterilization / disinfection cycle.

[NOTE: The following guidelines apply to sterile / disinfected items that will be re-used. It is important to make sure that hospital policies are followed, which should address all of the elements listed below. However, we do not recommend trying to repeat or summarize the IFUs for items to be disinfected, disinfecting solutions or equipment, and wrapping materials. It is also necessary to have access to and comply with the manufacturer’s instructions or IFUs for the sterile item, the packaging for the sterile item, the sterilizer / processor and any disinfecting solution.]

  • Storage of Sterile / Disinfected Items
    1. Items that are ready for use should not be visibly soiled.
    2. Items are stored to prevent contamination (e.g. solid bottom shelf)
    3. For drawers used to store items that were processed through high-level disinfection
      1. Storage is consistent with the IFUs (or facility guideline if IFUs don’t address storage) of the disinfected items.
      2. Container or location of storage is not visibly soiled
      3. Materials are handled to avoid contamination
    4. Collection / Holding and Sterile Items After Use
      1. Wiping or flushing of soiled instruments at the location of use (e.g. procedure room, operating room, utility room for bedside procedures)
      2. There must be a process for keeping soiled instruments moist immediately following use (check instrument IFUs and hospital policy). [Example: Some IFUs recommend using enzymatic solutions to keep the instrument moist.
    5. Transportation
      1. Sharps in compliance with OSHA regulations
        1. Puncture resistant
        2. Biohazard label
      2. Non-sharps transmitted to prevent contamination
        1. Biohazard label
        2. Covered
        3. Drip prevention
      3. Decontamination
        1. Use of PPE
        2. Negative air balance
      4. Packaging
        1. Hinged instruments in the open (not ratcheted) position.
        2. Disassembly of instruments per IFUs
        3. Use of packaging per IFUs
          1. No folds for any internal (double) package
          2. Beyond use dates or criteria
        4. Disinfecting / Sterilizing
          1. Hinged instruments in the open (not ratcheted) position.
          2. Sterilizers (Check IFUs)
            1. Monitoring
              1. Daily biological monitoring for each sterilizer
              2. Routine sterilizer function monitoring
            2. Release of loads after
              1. Internal chemical indicator
              2. External chemical indicator
  • Physical monitoring of sterilizer functioning
  • For Implants: Reading of biological indicator
    1. Exception for emergency situations
  • Disinfectants (Check IFUs)
    1. Chemical Monitoring
    2. Exposure monitoring when indicated
  • IFUs for drying and frequency of disinfection are followed for scopes.

Policy, Procedure, or Guideline?

If you are looking to make a change at your hospital to define or revise the way you do or should be doing things, be sure you understand whether the change should be made in policy, procedure, or guideline, or to what extent in each.

Policies are broad expressions of the intent or desired outcome of a process, typically multi-disciplinary in nature. For example, a hospital would have a Restraint and Seclusion Policy to ensure a process is in place for the appropriate management of behavioral health patients, with the compliance obligations being that patients are restrained only when clinically justified to prevent them from causing injury to themselves or others, or to enhance medical healing in accordance with applicable regulations. A good rule of thumb: If you can’t do it 100% of the time for 100% of applicable patients, it absolutely should not be a policy. Policies are not the place for idealism or wishful thinking.

Procedures are required steps that must be taken to complete a process when there can be no exception from the expectation. A common procedure at hospital might be for disinfection of endoscopes; the expectation is that an endoscope would be disinfected using the correct substance in the correct concentration, following the correct steps in the correct order. If operational considerations make one or more of the required steps impossible (e.g. ran out of disinfectant), then the scope is taken out of service until the procedure can be followed in its entirety.

Guidelines are steps that are normally taken to complete a process. Many hospitals will have a guideline for how to manage range orders with the goal being to assure the safety of the patient and the effectiveness of the intervention. Deviations from guidelines do not constitute a violation of the associated policy when justified by valid clinical or operational considerations. Hint: Any document addressing the details of a clinical process should be considered a guideline.

Understanding the working definitions of these terms is critical. Be sure all the members of your executive team, medical executive committee, physician leadership, policy steering committee, and governing body have a common understanding of these terms. Absent this understanding, hospitals can fall prey to overly complex policies that exceed the requirements of federal and state regulators, accreditors, and payers. All over the country, in facilities large and small, this “over-compliance” is leading to noncompliance, physician and nurse burnout, and decreased care quality, patient safety, and satisfaction.