March 3, 2022

QUESTION:
Has The Joint Commission (“TJC”) issued new Elements of Performance (“EPs”) regarding obstetrical/maternity care?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Yes, TJC issued these new EPs in the early days of the pandemic, so it’s not surprising that these may have received little attention.

The new EPs are under the Provision of Care (“PC”) chapter, at PC.06.01.01 and PC.06.01.03, and were effective July 1, 2020.  TJC’s press release stated that the EPs were implemented because maternal morbidity and mortality was becoming worse, especially in the areas of maternal hemorrhage and severe hypertension/preeclampsia.

The new EPs require assessments regarding hemorrhage and hypertension/preeclampsia risk on admission to labor and delivery and on admission to postpartum.  These EPs also require that the quality improvement committee establish criteria that trigger reviews for such cases, and that the reviews evaluate the effectiveness of the hemorrhage response team.  There are also requirements that education be provided to patients and families regarding signs and symptoms of postpartum hemorrhage and severe hypertension/preeclampsia.

The Medical Executive Committee is also involved, since it is required to assign a multidisciplinary committee the task of developing procedures to manage pregnant and postpartum patients who experience maternal hemorrhage, and for measuring and managing blood pressure to lessen the likelihood of harm relating to maternal severe hypertension and/or preeclampsia.

So, this may be a good time to update your rules and regulations to make sure that these new EPs are covered.

December 16, 2021

QUESTION:
Our Medical Executive Committee initiated a formal investigation a few weeks ago – the first one we have done in years.  The investigating committee has met several times and is ready to make its recommendations. The bylaws reference a “report,” but the committee members would rather just come to the MEC meeting and give the findings in person. Is a written report really necessary?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
Yes, yes, and YES.  A written report is required not only because your medical staff bylaws require one (which frankly, in a heightened legal process like a formal investigation would be reason enough to ensure a written report is created), but, more importantly, should a matter that led to an investigation result in an adverse recommendation (i.e., revocation of appointment and/or privileges, a restriction of privileges, etc.), the investigating committee report will likely be the most important document that helps to explain the reasoning of the MEC when it made that adverse recommendation.  Most medical staff bylaws permit the MEC to delegate the investigation process to another standing committee or to an ad hoc committee, and they do not require the MEC perform the investigation itself.  The MEC then relies heavily on the fact-finding, conclusions, and recommendations made by the investigating committee.  It is vitally important that such information be reduced to writing in order to create a strong record.

The report should include a summary of the review process (e.g., a list of documents that were reviewed, any individuals who were interviewed, etc.), specific findings and conclusions regarding each concern that was under review, and the investigating committee’s ultimate recommendations.  Capturing that level of detail in a verbal discussion in a (typically) one hour or less meeting, where individuals are asking questions and side discussions often occur, is very difficult.  You really want to have more than a set of minutes to rely upon in explaining the findings that were made.

November 11, 2021

QUESTION:
Last month, our hospital announced a policy requiring individuals who are physically present on the premises to be fully vaccinated with the COVID-19 vaccine.  We understand that this policy applies to advanced practice professionals and members of the Medical Staff, but we are not sure how to enforce it.  Any suggestions would be appreciated.

ANSWER:
The Medical Staff Bylaws and Credentials Policy (“Medical Staff Governance Documents”) probably require members “to abide by the medical staff documents and the policies of the Hospital.”  That’s a start, but you may want more.  Here are some ideas.

We recommend that the Medical Staff Governance Documents include a threshold criterion that requires individuals to “document compliance with immunization and health screening requirements (e.g., TB testing, mandatory vaccines, and infectious agent exposures).”  We also recommend that your documents expressly state: “Failure of an individual to continuously satisfy any of the threshold eligibility criteria will result in the administrative relinquishment of appointment and clinical privileges, unless a waiver is granted.”

If you don’t have that language now, the Medical Executive Committee may be able to add it to your Medical Staff Governance Documents, but you’ll have to check the notice requirements and the amendment process.

Another alternative is to rely on language in your Medical Staff Governance Documents that requires individuals to provide information when it is requested by a medical staff leader.  Specifically, we recommend the following language:  “Failure of an individual to provide information pertaining to an individual’s qualifications for appointment or clinical privileges in response to a written request from any medical staff leader or any other authorized committee will result in the administrative relinquishment of appointment and clinical privileges until the information is provided to the satisfaction of the requesting party.”  Since the hospital policy requires proof of vaccination, we are comfortable using this language to help enforce the hospital policy.

Remember, a relinquishment is administrative in nature and is not considered an adverse professional review action.  Therefore, the individual is not entitled to a hearing and the hospital is not required to report the individual to the National Practitioner Data Bank or the State Board.

September 30

QUESTION:
As we are preparing for a medical staff hearing, a member of our Medical Executive Committee asked why our Medical Staff Bylaws state that the Chief Executive Officer appoints the hearing panel and not the Chief of Staff since it’s the Chief of Staff who knows most of the members of the medical staff.  We are trying to figure out whether this was a typo or not.  Should the Chief of Staff appoint the panel?

ANSWER:
No – that’s not a typo!  While we do still sometimes see bylaws which assign the Chief of Staff the responsibility to appoint the hearing panel (and worse yet, occasionally it’s the whole Medical Executive Committee that does so), it’s long been our recommendation that the CEO or the CMO fulfill that responsibility – in consultation with the Chief of Staff.

This is because, generally speaking, the Chief of Staff, both in his/her role as a Medical Staff officer as well as a member of the MEC (the body that will most often be making the adverse recommendation that triggers a hearing) tends to be someone who is very intimately involved in the underlying matter that led to the hearing.  The Chief of Staff will frequently be the individual who engaged in collegial intervention and other progressive steps with the affected physician, who was involved in the development of any conditions or restrictions and, ultimately, is involved in the adverse recommendation made by the MEC as the chair of that committee.  When an involved Chief of Staff is then responsible for appointing the hearing panel and presiding officer, we have seen the argument made that the selections were biased in favor of the MEC and are not neutral – which can lead to objections and legal challenges (both before and after the hearing) to the appointment of the panel.

While we know that these claims are largely groundless, it is very important to manage the appearance of fairness at all steps of the hearing process.  The goal is to isolate the volunteer physician leaders – like the Chief of Staff – from these types of claims and allegations as much as possible, which is why the CEO or CMO should appoint the panel after consulting with the Chief of Staff.

May 6, 2021

QUESTION:    “We are in the midst of a review of our Medical Staff Bylaws and one of the Bylaws Committee members said that she heard that we shouldn’t be including our hospital’s Institutional Review Board (“IRB”) in the Bylaws with all of the other medical staff committees. Is that true?”

ANSWER:       Yes.  The federal Food and Drug Administration regulations pertaining to IRBs, 21 C.F.R. §56.101 et seq., define an IRB as “any board, committee, or other group formally designated by an institution to review, to approve the initiation of and to conduct periodic review of biomedical research involving human subjects.”  The Department of Health and Human Services’ regulations echo the “institutional” aspect of the formal designation of IRBs (45 C.F.R. Part 46).  Federal regulations require the IRB to be a committee formally designated by a hospital’s Governing Board to review biomedical research involving human subjects at the hospital.

This issue has been gaining momentum lately in research audits performed by both the Office of Human Research Protections and the Food and Drug Administration in which the agency has taken issue with the fact that the institutions included their IRBs as one of several “medical staff committees” that lived in a medical staff governance document like the bylaws.  The auditors pointed generally to the regulatory language, that it is an institutional responsibility to maintain an appropriate IRB, not a medical staff responsibility.  As a practical matter, the concern is that (while very unlikely) if the IRB procedures need to be revised because of a regulatory change, the medical staff could refuse to do so, as is contemplated by the amendment process to these rules.  By comparison, if the IRB is a hospital committee, hospital administration and/or the Board could implement a change on its own action.  Again, while the likelihood of a Medical Executive Committee or a medical staff as a whole acting in such an obstructionist manner is very slim, in the eyes of the audit agencies, it is a valid concern.

Therefore, we recommend that the IRB be created by a Board resolution and thereafter function as a committee of the hospital, rather than the medical staff, with its independent authority derived from the Board.  There may be substantial overlap of the IRB membership with that of a medical staff committee.  However, the IRB should be constituted as a separate committee of the Board in accordance with the membership requirements set forth in the federal regulations.

May 28, 2020

QUESTION:        We have a physician who is up for reappointment and when we started to pull the credentialing, peer review, and quality information together we realized there were very serious concerns that might warrant an adverse recommendation.  We were wondering, do we have to start a formal investigation or, if warranted, can we just make an adverse recommendation at reappointment?  Are there any steps we should follow to make sure we are being fair to the physician and protecting ourselves at the same time?

 

ANSWER:           Reappointment should be an opportunity to make an evidence-based decision that reflects data that has been gathered during the most recent appointment period.  (You can certainly look back further if you need to gain perspective or discern if there are patterns of care or conduct that have been developing.)  Ideally, you will address issues as they come up through the peer review process.  But sometimes, even with a robust peer review process, you don’t see the whole picture until reappointment.

Certainly, if, in looking at relevant information at reappointment, you are concerned enough to consider an adverse recommendation because a lesser action will not be sufficient to protect patients, you have the authority to make that recommendation.  To answer your specific question, there is generally no reason why you would have to commence a formal investigation, separate and apart from the reappointment process.  While many bylaws require that the Medical Executive Committee commence an investigation before making an adverse recommendation, that step would not be required if you are already in the midst of the reappointment evaluation.

In most organizations, the Credentials Committee would do the heavy lifting at reappointment.  That means the Credentials Committee would evaluate the information including documents from the peer review process, incident reports, letters, minutes, and reports.  The Credentials Committee can also rely on the clinical expertise of the department chairperson at reappointment.

As a matter of fairness and good practice, even if your bylaws (or credentials policy) don’t require it, we strongly recommend that the Credentials Committee meet with the physician before it makes an adverse recommendation.  The physician should be given advance notice of the concerns and at the meeting (or in advance of it) the physician should have an opportunity to respond to the concerns.  It will be very helpful to keep a detailed summary of this meeting, including the physician’s response.  The minutes should also reflect, in some detail, the reasons for the adverse recommendation – you’ll need that when you get to the hearing.

One issue that sometimes comes up in difficult reappointment matters is timing.  If the physician’s current appointment is set to expire, you may need to grant a short-term conditional reappointment to give you time to conduct the evaluation and assessment, meet with the physician, and prepare a report of concerns to support an adverse recommendation.  The report and recommendation of the Credentials Committee will need to be forwarded to, and acted on, by the Medical Executive Committee.  If the Medical Executive Committee upholds the adverse recommendation that will trigger the physician’s right to a hearing.

Remember, the hearing and appeal processes are going to take months to complete.  The Credentials Committee and Medical Executive Committee should consider whether there are any conditions that need to be put in place while the processes are being carried out to keep patients safe in the interim.

June 28, 2018

QUESTION:        What happens if a member of our Medical Executive Committee is unable to attend a meeting?  Should we require that member to designate a substitute and, if so, should the process for choosing a substitute be written into our medical staff bylaws?

ANSWER:            Generally speaking, it is usually unnecessary to require members to send a substitute to cover their absence from a Medical Executive Committee meeting.  While you certainly want people to attend and be engaged at meetings, an occasional absence is unlikely to affect matters substantially.

There are also certain drawbacks that come with designating substitutes to attend as alternates in case of an absence.  For example, the substitute must be educated on all of the confidentiality requirements that attach to membership on an important committee.  In addition, the substitute may lack the necessary background and training to understand the full significance of a particular decision (since he or she will only attend the meetings sporadically).  This can potentially lessen the effectiveness of the committee.

If it is especially important for a particular set of views to be represented, you can always invite that person to present his or her perspective to the committee.  To allow for this, we often add language in Medical Staff Bylaws that states:  “Other individuals may be invited to Medical Executive Committee meetings as guests, without vote.”  This gives you the option to bring in others as necessary, but does not mandate that a substitute cover every absence.

 

May 25, 2017

QUESTION:        The Medical Executive Committee disagrees with the way the Credentials Committee is managing a particular issue that has come before the Credentials Committee for consideration.  Since the MEC has higher authority in the medical staff leadership structure, can it direct the Credentials Committee on how to manage the issue?  Or is the Credentials Committee free to proceed as it sees fit?

ANSWER:            While it is true that the Medical Executive Committee is the “supreme” authority in terms of the medical staff leadership, most medical staffs are structured with built-in checks and balances and roles and responsibilities that are assigned to specified individuals or committees.  While the Medical Executive Committee may exercise oversight over all medical staff activities, that does not mean it can intervene any time that it disagrees with the way that something is being done.  So, if the Credentials Committee is performing assigned functions, it has some discretion to determine how to perform those functions – provided that it abides by the Medical Staff Bylaws and other relevant policies.

The Medical Executive Committee can offer suggestions, but has no authority to intervene with the exercise of the Credentials Committee’s discretion by telling it how to perform its duties (again, unless the Committee is violating the Bylaws or a policy or acting unlawfully).  This does not mean that the MEC is powerless, however.  Remember that the activities of all medical staff committees are subject to oversight of the MEC.  So, if the matter is one in which the Credentials Committee is making a recommendation to the MEC (such as a recommendation for a waiver of threshold criteria, of criteria for new clinical privileges, of criteria for clinical privileges that cross specialty lines, of appointment and privileges for an applicant, etc.), then the MEC can take the opportunity, during its review, to “correct” any mistakes it thinks the Credentials Committee may have made.  That could mean gathering more information, if the MEC feels the Credentials Committee did not do enough to scour an applicant’s background.  It could mean reviewing the matter anew, if it felt the Credentials Committee did not adequately address conflicts of interest during its review.  It could mean talking to an applicant, if it felt the Credentials Committee did not give the applicant ample opportunity to be heard.  The list goes on and on.  The point is, the MEC – as a subsequent level of review – has the opportunity to set right a multitude of perceived wrongs.

On a related matter, when medical staff leaders do not see eye-to-eye about how to manage day-to-day medical staff activities, that can indicate that it’s time for more education about the roles and responsibilities of hospital and medical staff leaders, as well as required credentialing and peer review functions (and the risks of not completing those functions well).  Leaders who are well-informed about the content of their Bylaws, the Credentials Policy, and related Medical Staff policies are likely to be more consistent in how they perform their leadership functions.  All medical staff leaders should also receive education about legal protections for leaders, the risks to legal protection (such as frolic and detour), and ways to maximize legal protections (e.g., through management of conflicts of interest, good documentation, reasonableness when dealing with other practitioners, and following a “patient safety first” rule of thumb).

March 9, 2017

QUESTION:        In our Medical Staff Professionalism Policy, should we have a different process for addressing reports of sexual harassment?


ANSWER:           
Since there are unique legal implications surrounding sexual harassment, we recommend that a policy addressing inappropriate conduct incorporate a modified process for review of reports involving sexual harassment.

We recommend that a single, confirmed incident of sexual harassment trigger a well-defined process that involves the medical staff and hospital taking immediate and appropriate action to address the conduct and to prevent it from reoccurring.  For example, a personal meeting should be held with at least two members of the professionalism committee (or similar committee) to discuss the incident.  If the physician acknowledges that the incident occurred and agrees not to repeat the conduct, the physician is sent a formal letter of admonition and warning that is placed in his or her file.  The letter should set forth any additional actions or conditions imposed on the physician’s continued practice at the hospital which result from the meeting.  If the physician refuses to acknowledge the confirmed incident of sexual harassment or there are confirmed reports of retaliation, the matter should be immediately referred to the Medical Executive Committee to conduct a review consistent with the credentials policy or bylaws.  A well-defined process which incorporates these details demonstrates the hospital’s efforts to address any incidents of sexual harassment and attempts to prevent them from occurring again, minimizing the risk of the hospital being held liable in court.

June 18, 2015

QUESTION:        I was recently appointed as chair of a medical staff committee and am very happy, but I just realized that instead of merely attending meetings, I’ll have to run them, so I’m also extremely nervous. Help!!!

ANSWER:          An efficient meeting is the key to making it an effective meeting, and running a meeting is hard work. Here are some tips:

Tip #1. Start on time. This is one of the most important tips. If a meeting isn’t started on time, chances are it won’t end on time, and that has consequences which we’ll discuss below. If a meeting always starts on time, the attendees will more than likely be there on time, since no one likes to walk into a meeting late, and being late disrupts the meeting.

Tip #2. Limit the conversation. What “limit the conversation” means is that if a couple of attendees in the room are making the same point, over and over again, that’s unproductive, so the chair should step in and say “Ok, any other points of view that we haven’t discussed yet?” Also, if a discussion “drifts,” the chair should step in and restate the purpose of the discussion. This can be hard to do, but it is a skill that needs to be developed. Otherwise, the participants start thinking the meeting is a waste of time, and the downward spiral begins.

Tip #3. Take an issue off-line. There are times when a meeting is getting bogged down because no one has the information needed to make a decision. For example, is the bylaws revision being discussed a Joint Commission Standard? A best practice? If no one knows for sure, further discussion will not help the committee make a decision, so that issue should be taken off the agenda until the next meeting, to research the issue.

Another reason to take an issue off the agenda is when there are so many conflicting points of view that the issue won’t be able to be resolved at the meeting. The chair knows that no matter how much more discussion there is, the issue won’t be resolved. So, the chair should stop the discussion, and maybe appoint a small group to investigate or research the issue, then bring the results back to the committee.

Tip #4. End on time. This is the most important tip. If a meeting is to end at 8:30 a.m., end the meeting. Although some attendees don’t mind going over, others will start thinking about work that needs to be done, or another meeting to go to, or an appointment to make – focus is lost. A meeting that runs on and on and on isn’t efficient and becomes much less effective as time goes on. Also, not ending on time affects meeting attendance. If an attendee knows that the meeting always goes over, he or she is less likely to attend the meeting.

Sometimes agendas are just too full, or there may have been too much discussion on one issue, etc. – that happens. But, instead of plowing on through with more and more disinterested attendees as each minute ticks by, just end the meeting, and hold those agenda items over for the next meeting. The exception is if the issue is of critical importance, but that will be few and far between.