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

 

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.

FOCUSING ON HIGH-LEVEL DISINFECTION

Among the topics slated for “enhanced” attention during Joint Commission surveys are high-level disinfection and sterilization, which continue be problematic for hospitals across the country. Issues related to disinfection usually lead to condition-level findings, sometimes placing the hospital into “Immediate Threat to Life” or “Immediate Jeopardy” status.

BACKGROUND

In early 2012 the FDA issued an alert regarding outbreaks of CRE (Carbapenem-Resistant Enterobacteriaceae) in Illinois, Pennsylvania, Seattle, and Los Angeles. These outbreaks were associated with the incomplete disinfection of duodenoscopes used for ERCP (Endoscopic Retrograde Cholangiopancreatography) procedures. On April 3, 2012, CMS issued a survey and certification memo instructing survey teams to focus on the processing of such scopes, which in turn led to a broader look at disinfection and sterilization by survey agencies.

ADDRESSING VULNERABILITIES

One would think that findings related to disinfection would have subsided over the six years since this issue has been on the front burner, but not so. Our experience with hundreds of hospitals in recent years tells us that this issue is far from resolved. And, as Joint Commission surveyors dive deeper, we fear many facilities will find themselves in a tight spot. So, here are a few tips, remembering that the overall secret to sustainable compliance lies in simplification: making the right thing to do the easy thing to do.

  1. Simplify and Customize: Don’t overcomplicate your policies and procedures. Remember that the key to effective disinfection and sterilization lies in the FDA-cleared Instructions for Use: the “IFUs” for 1) the device being disinfected, 2) the solutions and equipment used for cleaning and disinfection, and 3) any materials used for packaging. However, DON’T try to repeat these IFUs in your policy. Instead, assure that IFUs applicable for the setting are conspicuously posted and that quality control sheets capture the important steps specified in the IFUs.
  2. Quality Control and Supervision: Establish logs for site-specific quality control and supervision, including a documented double-check by operational leadership.
  3. Monitoring: Regularly monitor the supervision process by observing actual practice. Greeley advocates a “care facilitation” approach – an approach we typically work with clients to implement through in-person or online education, but here are a high-level few tips you can try on your own:
    • Monitoring should be done with an open hand (of help) rather than a closed fist (of enforcement). For example, infection prevention and compliance representatives should be viewed as a resource for operational leadership and front-line personnel rather than something to be feared.Monitoring should focus on actions rather than documentation alone.
    • The expected practice should be immediately reinforced when variations are identified. Monitoring personnel should seek to understand the “why” behind any observed variance. (One cannot correct the what, only the why.)Data collected should reflect practice before and after
    • If the data suggest persistent non-compliance, the process should be improved. The instructions, the logs, the layout, the materials, and so forth should be simplified. Remember:
      • Focusing on the right thing being the easy thing and using the collective “whys” as a resource for this simplification,
      • Continuing to reinforce a broken process will not result in compliance, and
      • Little monitoring and reinforcement is necessary for a well-designed process.
  1. Oversight: The final step is meaningful and productive oversight. Effective oversight means:
    • Meaningful data analysis before the oversight meeting,
    • More thoughtful recommendations with respect to adverse situations,
    • Credible and thorough accountability tracking, and
    • Less meeting time with more accomplished.

Mock Surveys: Helpful, or Not So Much…?

There are two types of recommendations that can come out of a mock survey: good recommendations and unhelpful recommendations.

If you’ve had a mock survey before, it may have been delivered with recommendations like:

  • “Staff should be educated…,”
  • “Be sure to remind the physicians…,” or
  • “Don’t do this anymore!”

Two of these are “managed loose” accountability black holes. The other is a hard stop with no alternatives offered, which is a very hard direction to follow. Neither is going to solve the problem, and both will likely compound issues further. Unhelpful.

A good recommendation from a mock survey should be helpful. It should do one or more of the following:

  • Make an actual recommendation like, “The policy should be reworded to say…”
  • Reward critical thinking by reinforcing a care facilitation approach and concurrent monitoring suggestions.
  • Provide a practical tool like a form or checklist to assist with quality control.
  • Define a path for next steps when more analysis is needed to determine if a cited issue is isolated or related to a significant process flaw.

When you receive a report from a mock survey, and there are findings outlined, you should feel like a root cause is known, or that you have a path to find it. If recommendations you receive are falling into the “unhelpful” category, you are left to either find the root cause yourself, or make changes without a real understanding of what the root cause is.

A mock survey should leave you with:

  • A clear understanding both requirements and findings,
  • An understanding of root causes of noncompliance (or likely culprits and how to single them out and address them), and
  • Practical solutions for policy/process/care delivery to get you to compliance without undo complexity.

Your membership benefits can help.  Please reach out to mcampbell@greeley.com to learn more.

Areas of Focus: Enhanced Joint Commission Survey Process

If your hospital is accredited by The Joint Commission (TJC), your CEO recently received a letter. That letter alerts the CEO that Joint Commission surveyors have been given additional training in four subjects to focus on when they arrive at your door for a survey. These subjects are:high-level disinfection and sterilization;

  • sterile compounding of medications;
  • identification and protection of potentially suicidal patients; and
  • hemodialysis.

Each of these is the source of many “Immediate Threat to Life” findings by TJC. Greeley has also found them to be the subject of many adverse actions by CMS. So, it behooves all hospitals to pay special attention to these areas (and not just immediately before your next survey window opens.)

TJC encourages hospital leadership to put these items on its agenda and to deploy resources with expertise in these areas to review and monitor performance. We agree. We also have some thoughts about how your hospital might go about it.

What To Look For In General

Greeley has learned from our experience helping hospitals work through hundreds of TJC and CMS adverse actions over the years, there are a few general principles that will help you get out and stay out of trouble. Paramount among these approaches (which are components of Greeley’s 14-point Framework for Sustained Compliance) are simple expectations, care facilitation, and effective oversight.

Simple Expectations

Don’t overbuild your policies and procedures. No one is able to understand or follow long and complex documents and you will be unable to monitor them. We understand, however, that these simple expectations are very, very difficult to craft. But that difficult work is necessary if you hope to avoid safety and accreditation vulnerabilities.

Care Facilitation

It is not possible to monitor performance in any of these areas through a simple review of logs or repeated training. If those approaches worked, these subjects would not be singled out for “enhanced survey” review.

Instead, one must understand the problematic steps in each of these processes (outlined in related blog posts) and combine monitoring and reinforcement in one step. We think of it as reinforcement with an open hand vs. a closed fist. Data are collected through the reinforcement process. It takes focus. It takes resources. But it does not take too much time: using this approach makes a real difference… quickly.

Effective Oversight

It’s difficult for large, multidisciplinary committees to be effective in closing the loop. So, although these “performance improvement committees” need to be involved, oversight must also be provided by the leadership team. In Greeley’s model, we recommend a final quality and safety oversight committee.

Convening the groups (or adding to the agenda of existing leadership team meetings) is the first step. Additional steps (effective presentations, realistic recommendations, accountability tracking, etc.) will increase the effectiveness of this group as it seeks to mitigate patient safety risks and regulatory/accreditation vulnerabilities. Greeley does a lot of work with clients on effective meeting management, or #enddeathbymeeting, as they call it in the Twitter-sphere.

Stay Tuned

You will see our summaries of common risk points in separate but related blog posts. Remember that none of these areas are new; they’ve been problematic for years. But now is the time to do something to address each of these once and for all. A good start is by following TJC’s recommendation: get these issues on leadership’s agenda (and stay tuned to Greeley for additional tips and advice.)

Marijuana in the Hospital Environment

As more states legalize marijuana, more physicians have begun recommending cannabis to their patients for the management of pain, nausea, anxiety, and loss of appetite. Recent literature also suggests that cannabis may be effective in treating other conditions. For example, the Federal Food and Drug Administration (FDA) recently approved a drug whose active ingredient is an extract from the marijuana plant, cannabidiol (CBD), for the treatment of a rare form of epilepsy. Some physicians would like to prescribe marijuana or marijuana extracts for hospital patients and have asked that these substances be added to the hospital formulary, but strictly speaking it that would require the breaking (or bending) of federal regulations.

Here Greeley paints a picture of the current state and federal situation and suggests a few approaches hospitals might consider if they choose to support the use of marijuana in the hospital environment.

State of the States

  • It remains illegal to possess or provide marijuana in some states. For example, it is still a felony to possess cannabis in Alabama.
  • Currently, 31 states allow the use of marijuana and marijuana extracts for medical purposes. In these instances, marijuana extracts may be obtained from cannabis dispensaries, not pharmacies, with the authorization, not prescription, of a state-approved prescriber — typically a physician with a state-issued medical marijuana card.
  • Nine states now allow recreational marijuana use.

The Federal View

The marijuana plant is classified as a Schedule I substance along with heroin, LSD, ecstasy, and peyote. Marijuana extracts too!

The Federal Drug Enforcement Agency (DEA) maintains five lists, or “schedules,” of the substances it controls. Schedule V lists the most benign medications and Schedule I lists those that are all but prohibited. The marijuana plant (drug code 7360) is classified as a Schedule I substance along with heroin, LSD, ecstasy, and peyote. Marijuana extracts (drug code 7350), including tetrahydrocannabinol (THC), cannabinol (CBN), and cannabidiol (CBD), are also listed as Schedule I substances.

  • The DEA requires an individual or organization to possess a valid certificate to receive, store, dispense, provide or prescribe any “scheduled” medications in situations where interstate commerce is involved and by Medicare providers, including practitioners and hospitals.
  • With rare exceptions, the DEA does not issue Schedule I certificates to physicians or hospitals. Such certificates are only issued for special situations, such as use in an approved clinical trial with a very narrow use case.

    With rare exceptions, the DEA does not issue Schedule I certificates to physicians or hospitals.

Marinol®

Physicians and hospitals have the option of prescribing, dispensing, and administering THC in the form Marinol (dronabinol). This drug is listed on the DEA’s Schedule III and has been approved by the FDA for many years for chemotherapy-induced nausea and vomiting and anorexia associated with weight loss in patients with AIDS.

Pressure from CBD advocates

There is growing pressure on the DEA to remove the marijuana extract CBD from Schedule I. CBD is reported to have most of the medical benefits of marijuana without the side effect of intoxication. CBD is commonly used by individuals undergoing chemotherapy for appetite stimulation, anxiety relief, and other benefits. Advocates argue that there is little risk of abuse. The DEA, however, has taken a strict interpretation of the definition of “marijuana” as used in the federal drug classification statute: since CBD can be extracted from the potent parts of the marijuana plant (flowers, etc.), the DEA continues to list it in Schedule I.

Stay tuned: On June 21, 2018 the FDA approved Epidiolex® (active ingredient CBD) to treat a rare form of epilepsy. This may trigger the removal of CBD from Schedule I. We’ll have to see. Keep in mind that dronabinol (Marinol — above) is a Schedule III medication even though its active ingredient, THC, remains on Schedule I.

Why can I buy it down the street, but I can’t use it in the hospital?

There are domains where the state rules apply, and domains where the federal rules apply, which are best explained by constitutional scholars. Put simply, the federal rules apply when 1) interstate commerce is involved, or 2) the federal government is paying.

Federal rules apply when 1) interstate commerce is involved, or 2) the federal government is paying.

So, in some states an individual may buy marijuana, THC, CBN, or CBD at a local retailer, but (for now) the hospital can’t receive, store, dispense, order, or administer any of these substances while dealing with interstate suppliers and/or while accepting federal payments (from Medicare, Medicaid, among others.)

Confused? You are not alone.

Options

Hospitals continue to struggle with the disconnect between state and federal requirements and there is no consensus approach.  We, therefore, offer the following “thought stimulators” for hospitals attempting to navigate these murky waters.

Option 1: Just say no

Even though it may be legal for the patient to possess and use marijuana in your state, the hospital may choose not to allow possession on hospital property. Hospitals adopting this approach treat any recognizable marijuana as it would any other “contraband” like firearms: legal, but not allowed on hospital property. Policies typically ask the family to take disallowed items home. Otherwise, illegal items are usually turned over to authorities by security according to local protocol. It is important that pharmacy and pharmacy personnel not be involved in the holding of marijuana in any form not approved by the FDA. It is incompatible with their overall responsibility for compliance with DEA and FDA requirements.

This “just say no” approach would not necessarily apply to discharge instructions, which are not orders. Discharge instructions are the physician’s recommendations for post-hospital care. Although we urge you to involve your legal counsel and risk manager in the discussion, we see no regulatory vulnerability should the hospital include any otherwise legal product or activity in the discharge instruction process.

Also, the patient’s medication history recorded upon admission should include herbal preparations, including marijuana or its extracts.

Option 2: Allow recreational use

Hospitals may simply ignore the legal use of marijuana by an individual patient as long as it is not in conflict with his or her treatment plan or other hospital policies. There are a number of speed bumps down this road, so consider the following:

  • Pills, liquids, or oils containing marijuana extracts are similar to medications, except that they are not FDA approved. They cannot be “administered” by hospital staff and most hospitals do not allow the self-administration by inpatients of non-FDA-approved (e.g. herbal) preparations. If they are legal in the state, the family should be asked to take these products home when possible. If that’s not an option, security (or another department other than pharmacy) should hold the material until discharge following standard procedures.
  • Smoking marijuana, like smoking tobacco, is typically prohibited in hospital buildings and, in most cases, anywhere on hospital property. The Joint Commission allows patient-specific exemptions, but most hospital policies do not.
  • “Vaping” is lumped in with smoking by the Joint Commission, but hospitals may make patient-focused exemptions for vaping if they desire.
  • Brownies or other edibles brought in from the outside would be handled according to hospital policy.
    • Outpatients can typically eat whatever they want (unless they are NPO.)
    • Inpatients on a regular diet may or may not be allowed consume food from home, depending on hospital policy.
    • Food from the outside is usually prohibited for patients on a therapeutic diet.

Again, Option 2 is not for the faint of heart and should be explored only with very careful consideration by individuals with a comprehensive and in-depth knowledge of applicable external requirements (state marijuana laws, accreditation rules, CMS regulations, etc.)

Option 3: Allow use upon a physician’s order (not an option)

We cannot see any way for a hospital to allow a prescriber to order the administration of marijuana or marijuana extracts that are not approved by the FDA.

We would also advise against the hospital allowing physicians to issue orders authorizing the recreational use of marijuana during the patient’s stay … it cuts too close to the line of prescribing. As it says along the borders of ancient world maps, “There be dragons here.”

Conclusion (for now)

This is a rapidly-changing subject. Momentum is currently on the “legalize” side of the tug of war. But we see few options (other than plausible deniability) for hospitals wishing to acknowledge the use of an otherwise legal substance in the hospital setting.

The Greeley Company would like to thank D Ross Consulting and Ken Rohde for their consultation in the preparation of this post.

References:

 

Healthcare Water Works – CMS Clarifies Water Management Program Expectations

In June of 2017, Centers for Medicare and Medicaid Services (CMS) issued a guidance document establishing the general expectation that hospitals (acute care and critical access) and long-term care facilities would adopt programs for managing the potential impact of waterborne pathogens in their water systems. This guidance was issued primarily in response to an increase in reported cases of legionellosis in the use over the period 2000-2014. The indication is that there have been enough cases of legionellosis traced to healthcare facilities to warrant some focused attention on the management of healthcare water systems.

The key elements of the guidance document (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-And-Cert-Letter-17-30-.html ) revolve around the specific directions to healthcare organizations as well as to surveying organizations:

Expectations for Healthcare Facilities

CMS expects Medicare and Medicare/Medicaid certified healthcare facilities to have water management policies and procedures to reduce the risk of growth and spread of Legionella and other opportunistic pathogens in building water systems.

Facilities must have water management plans and documentation that, at a minimum, ensure each facility:

  • Conducts a facility risk assessment to identify where Legionella and other opportunistic waterborne pathogens (e.g. Pseudomonas, Acinetobacter, Burkholderia, Stenotrophomonas, nontuberculous mycobacteria, and fungi) could grow and spread in the facility water system.
  • Develops and implements a water management program that considers the ASHRAE industry standard and the CDC toolkit.
  • Specifies testing protocols and acceptable ranges for control measures, and document the results of testing and corrective actions taken when control limits are not maintained.
  • Maintains compliance with other applicable Federal, State and local requirements.

Note: CMS does not require water cultures for Legionella or other opportunistic water borne pathogens. Testing protocols are at the discretion of the provider.

Healthcare facilities are expected to comply with CMS requirements and conditions of participation to protect the health and safety of its patients. Those facilities unable to demonstrate measures to minimize the risk of LD are at risk of citation for non-compliance.

Expectations for Surveyors and Accrediting Organizations

LTC surveyors will expect that a water management plan (which includes a facility risk assessment and testing protocols) is available for review but will not cite the facility based on the specific risk assessment or testing protocols in use. Further LTC surveyor guidance and process will be communicated in an upcoming survey process computer software update. Until that occurs, please use this paragraph as guiding instructions.

From the “tenor” of this particular missive, it seems likely that there have been some LTC surveyors citing folks for some of the practical/operational decisions they’ve made relative to decisions to (or not to) test for pathogens, what out-of-range values have been established, or indeed, the contents of the risk assessment itself.

All that said, there are vendors that are assisting facilities in developing water management programs, but in reviewing the guidance from CMS and the particulars of the CDC recommendations, it is certainly feasible to consider setting up programs utilizing internal resources. As Greeley members, we are happy to coordinate the use of Advisor time to obtain feedback on this topic from a Greeley consultant.

Updated Expectations for Managing Physical Environment Risks and the Potential For Suicide

As we (and Joint Commission) continue to evolve in our approaches to managing the physical environment as it relates to the management of behavioral health patients, I encourage you to check out the July 2018 issue of Joint Commission’s Perspectives (if you are not accredited by TJC and want to check out how at least one accrediting body is working through these issues, you can find the information as FAQ’s under the Hospital and Hospital Clinics section: https://www.jointcommission.org/standards_information/jcfaq.aspx ). There is a fair amount of content and splits up into three general categories: inpatient pysch units, emergency departments, and miscellaneous (I’m going to guess that the FAQ’s relative to managing at risk patients in acute care settings is going to merit their own FAQ edition, so I guess we’ll have to stay tuned).

I don’t know that I would term anything to be particularly surprising – lots of emphasis on having a robust risk assessment process that comprises an integrated approach to the management of any at-risk patient population. There is some discussion of environmental elements such as nursing stations on psych units, the use of suspended ceilings in corridors and common areas, height requirements relative to ligature risks, the use of specific equipment, etc. For the most part, organizations are going to have to self-determine how those risks are to be best managed.

They do make some efforts to describe/define what they would consider high-risk patients, going so far as to indicate that only patients with “serious” suicidal ideation (those with a plan and intent) need to be placed under “demonstrably reliable monitoring” (aka 1:1 monitoring), with the further caveat that the monitoring be linked to immediate intervention, which means something in terms of competency, education, experience, etc. There is a clear indication that there is an expectation relative to the preparation of those folks who will do the monitoring, which will likely drive survey scrutiny of processes relating to staff education, competency assessments, etc. It is also noted that if these high-risk patients move through the organization for care and/or treatment, they are to remain in a ligature-resistant environment.

Another interesting item is the indication that if you have designated a room in your ED as a “safe room”, then the expectation (at least for TJC) is that that room (or rooms if there are more than one) would be ligature-resistant. Makes sense from a practical standpoint, but I think it does represent something of a caution for those of you looking at officially designating safe rooms in your EDs (and perhaps extending to the inpatient side of things – probably in the next installment).

Another item of interest (and this probably doesn’t apply to all) relates to freestanding ED’s – the general recommendations (you can check out the November 2017 issue of Perspectives for the particulars if you’ve not yet done so) for ED’s would apply. I understand that this is rather a big deal in general and is very close to endlessly complex in the practical application of the management of risks. For better or worse, “safe” is in the eye of the beholder, so it makes sense to continue to leverage available resources, including the Greeley Membership Program, to ensure survey success in this area.

Steven A. MacArthur | Senior Consultant