medical staff bylaws

June 23, 2022

Posted on by Courtney Patterson

QUESTION:
We’re updating our process for peer review of clinical concerns. We want it to be more effective and less feared by Medical Staff members. Any tips?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:
Yes!  Here are a few:

  1. Create a Multi-Specialty Committee. Create a multi-specialty committee that works with practitioners on a voluntary basis to address clinical concerns.  If the multi-specialty committee believes there’s an opportunity for improvement with the care provided by a practitioner, the committee presents an improvement plan to the practitioner and asks the individual to voluntarily participate.  If the practitioner disagrees with the need for the improvement plan, the matter would be referred to the Medical Executive Committee for its independent review under the Medical Staff Bylaws/Credentials Policy.  This approach allows the multi-specialty committee to remain a supportive committee with no disciplinary authority, while the MEC is a second layer of review when needed.
  1. Obtain Specialty Expertise. Identify small committees or individuals (depending on state law) for each specialty that provide the specialty expertise that informs the decisions of the multi-specialty committee.  In larger hospitals with more volume, these committees/individuals can be authorized to take certain performance improvement actions (such as sending educational letters or engaging in collegial counseling discussions) while more significant concerns are sent to the multi-specialty committee for its review.
  1. Get Input from the Practitioner. A process will be perceived as more fair and credible if the practitioner under review has been provided notice of any concerns and an opportunity to provide input about those issues.  No performance improvement action should occur until the practitioner’s input has been obtained.
  1. Adopt Mechanisms to Identify “Lessons Learned” and “System/Process Issues.” Peer review should help everyone get better.  Case review forms and committee minutes should specifically ask if a review identified a lesson that would be of value to others in the specialty, or a system/process issue that needs to be fixed.  There should be mechanisms to ensure that such lessons learned or system/process issues are shared with the appropriate individuals or committees for follow-up action, and the multi-specialty committee should keep these items on its agenda until it receives word that they have been addressed.
  1. Stop Scoring. Rather than asking reviewers to assign a numerical value or category to a case, the reviewer should simply assess whether there was a concern with the care provided.  If so, how could that concern be addressed?  Scoring causes practitioners to be defensive and diverts energy away from what really matters in the review process (i.e., how to help a practitioner improve).
  1. Words Matter! The term “peer review” is viewed negatively by most practitioners.  Using new terminology will help to emphasize that a new process has been created that is educational and not focused on restrictions of privileges.  Consider creating a “Committee for Professional Enhancement” or “Performance Improvement Committee” rather than a more traditional “Peer Review Committee.”  Similarly, refer to the process as the “professional practice evaluation” process rather than “peer review” process.

For more information about creating an effective peer review process for clinical concerns, please join us this season at The Peer Review Clinic in Las Vegas, Orlando, or Nashville!

May 5, 2022

Posted on by Courtney Patterson

QUESTION:
We’ve got a debate going on at the MEC.  Does the Chief of Staff vote, not vote, or vote only when needed as a tie-breaker?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY RACHEL REMALEY:

No need to debate any longer!  The good news is that, for the most part, Medical Staffs and their leaders are free to conduct their meetings however they wish.  You are not bound by any sort of formal parliamentary procedure (e.g. “Robert’s Rules of Order”) and, in turn, can set your own rules.  So – the answer to your question is that your Chief of Staff, who chairs the MEC, can vote if your Bylaws and related Medical Staff documents say so.  If the documents are silent, as a general rule, the chair decides procedural matters for the committee.  Since the chair, in this case, has a bit of a conflict of interest, the committee itself may wish to weigh in and make a determination (or develop a policy/guideline for how it will conduct meetings/voting).

If you are wondering how other organizations do it, note that there is not one, “right” position on this matter.  We see some Medical Staff committees that lean toward inclusivity and let all members of the committee vote, whether or not they are the chair, whether or not they are an administrator (e.g. CMO, Medical Director, Service Line Director), and whether or not they are physicians.  I tend to prefer this type of organizational structuring, since I believe providing voting rights to each member of the committee honors the time and energy that they commit to the committee’s work.

We also see Medical Staff committees that only allow physician members to vote (including any chairs, employed physicians, administrators).

Finally, we sometimes see Medical Staff committees that only allow voting by specified, physician members (sometimes limited to physicians who are members of the Active Staff category).

Again, as a general rule, it is up to each organization to establish its own culture and rules regarding meetings and voting.  Note, however, that you should always check with your medical staff counsel before making changes to committee membership and/or voting, since counsel can verify that any changes are consistent with the statutes and other laws in your state that exist to protect (through immunities and privileges) the peer review activities that your Medical Staff conducts through its committees.  Some states have a more narrow definition of a “peer review committee” or “quality assurance committee” that requires membership to be all or mostly physicians, etc.  Counsel can help to make sure you stay within the confines of applicable law and maximize your protections.

April 28, 2022

Posted on by Courtney Patterson

QUESTION:
We are preparing for a medical staff hearing and a member of our Medical Executive Committee asked why our Medical Staff Bylaws say that the CEO 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?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
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 that led to the hearing.  When an involved Chief of Staff is then responsible for appointing the hearing panel and presiding officer, it makes it easy for the argument to be 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.

December 16, 2021

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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.

October 14, 2021

Posted on by Courtney Patterson

QUESTION:
What should be done if an applicant for reappointment is under investigation but his current term of appointment is set to expire before the investigation is completed?

ANSWER:
As most know, the Joint Commission has made it clear that privileges are granted for a period not to exceed two years and that continuations or extensions are not appropriate.  While this rule likely came about to avoid routine extensions due to administrative failures to process reappointments in a timely manner, it makes situations like the one above difficult to manage.

Keeping in mind this two-year limitation, we’ve found the best way to address applicants for reappointment who are currently under investigation is through a short-term conditional reappointment pending the outcome of the process.  This keeps the hospital on the right side of the Joint Commission, while providing time for the investigation to work its way out.

Having language in your Medical Staff Bylaws documents to support this approach is a key to good credentialing.

July 29, 2021

Posted on by Courtney Patterson

QUESTION:
“We are in the process of reviewing our Medical Staff Bylaws after a long period of neglect. While going over the provisions related to Medical Staff hearings, a Bylaws Committee member suggested that if a practitioner is under precautionary suspension, the hearing should be held within 10 days of the practitioner’s request. Ten days seems like a short time for us to prepare for a hearing. But, a few of the doctors on the committee really felt like it would be most fair to a practitioner whose livelihood is “on hold” to have the hearing occur in the most expedited way possible. What do you think?”

ANSWER:
It’s noble to consider the impact of a precautionary suspension on the practitioner who is affected, but holding a hearing within 10 days of a practitioner’s request will be almost impossible for you to manage, from a practical standpoint. Here’s why:

  • Thirty days is the minimum time you must give the practitioner to decide whether to request a hearing under the Health Care Quality Improvement Act (which provides certain immunities from liability to peer reviewers). Therefore, most organizations’ Medical Staff Bylaws and related documents, like the Medical Staff Credentials Policy, are drafted to give a practitioner 30 days to request a hearing.

Because the practitioner has 30 days to make the request, the hospital never really knows when the practitioner’s request will be received.  The request could come on day one or it could come at the close of business on day 30.  That’s a big window!

This matters because the Bylaws language your Committee member suggested states that you will hold a hearing within 10 days OF THE PRACTITIONER’S REQUEST.  If you don’t know when the practitioner’s request will come in, it will be very difficult to prepare (for example, recruiting hearing panel members who are available to serve).

  • Adding to the complexity here is the fact that the Health Care Quality Improvement Act requires, as a condition of immunity, that the practitioner be given at least 30 days to prepare for the hearing after being provided NOTICE OF THE HEARING. That is, you must give the practitioner 30 days to prepare after you send the notice that includes the time, date, and details of the hearing itself (this is different than the first notice, which tells the practitioner that he or she is entitled to request a hearing).

If a practitioner is subject to a precautionary suspension at the time, he or she may consent to have the hearing held in a shorter timeframe (e.g., 10 days) – but until you obtain the practitioner’s consent, you will not know whether you will be able to hold the hearing within 10 days of the practitioner’s request or, alternatively, after 30 (or more) days.  Again, this lack of knowledge regarding when the hearing may or may not occur will make it incredibly difficult for you to find a hearing panel and schedule the hearing – tasks that are essential to tackle if you are planning to hold a hearing within a 10-day timeframe.

WHAT THIS ADDS UP TO:  Imagine yourself, as a leader, approaching colleagues to see if they would be willing to sit on a hearing panel (which likely would mean giving up at least a couple of evenings and perhaps a couple of working days) – and then telling them that you are not sure when you will need them to do this, but think it will be sometime in the next one to 60 or so days!  It’s difficult enough to recruit a hearing panel member without this level of uncertainty in scheduling.

So, if we can agree that holding a hearing 10 days after the practitioner requests it is not practical, what options exist to provide some expedited assurance of fairness to a practitioner who is subject to precautionary suspension?

  • First, make sure you are considering precautionary suspensions separately from other adverse professional review actions. Try not to lump them all together.  That way, you can expedite the process for reviewing the precautionary suspension (e.g., deciding whether there continues to be an imminent risk to the health or safety of an individual) and, if possible, lift the suspension pending continued inquiry into the underlying matter or work with the practitioner to look for less restrictive alternatives (such as having the precautionary suspension apply to some, but not all, privileges held by the practitioner).
  • Second, in the case of precautionary suspension, provide expedited procedures that are “fair under the circumstances.” These procedures should be outlined in the Medical Staff Bylaws (or related documents, such as the Medical Staff Credentials Policy).  Consider requiring that the MEC meet to review the precautionary suspension within an expedited timeframe (e.g., no more than five or 10 days after the suspension is put in place) to decide whether it should be continued pending further review.  Include an opportunity for the practitioner to meet with the Committee to discuss the concerns and offer input (including suggesting any less restrictive alternatives that might be employed to address the concerns while the review continues – for example, strict compliance with patient selection criteria, the use of a consult/second opinion, etc.).
  • After the above review is conducted, the leadership will determine whether to keep the precautionary suspension in place pending further review. In that case, the Medical Staff leadership should be diligent in proceeding with the review of the underlying matter so that there is not unnecessary delay that prolongs the precautionary suspension period.
  • Finally, if anything changes in the interim, or additional facts are brought to light through the review of the matter, and that changes the assessment of whether an imminent risk exists – it is appropriate for the MEC to revisit the issue and lift the precautionary suspension as soon as plausible.

By way of example, imagine a practitioner was precautionarily suspended after the Hospital learned he had been arrested for harassment of an individual who used to be his patient and who claimed that he continued to stalk her following the end of their relationship.  If you later learned from the police that the charges had been dropped after the patient recanted her story and attested to the fact that their relationship was consensual, the MEC might consider immediately lifting the precautionary suspension (on the basis that the concern of imminent risk has been eliminated), even though it would want to continue its underlying review of the matter (on the basis that a consensual sexual relationship with a patient is nevertheless a concern and ethics violation, even if it does not give rise to a concern of imminent risk).

July 8, 2021

Posted on by Courtney Patterson

QUESTION:
“We have an applicant who is refusing to answer one of the questions on our application form because she says that her lawyer told her it could violate a settlement agreement that she has with another hospital.  We think that information is relevant to her request for appointment at our hospital.  Can we still ask for the information?  Should we ask for a letter from her lawyer?  Should the application be held incomplete?”

ANSWER:
Yes!  Credentialers have a duty to review all of the relevant qualifications of each applicant for Medical Staff appointment and clinical privileges and cannot allow the legal interests of an applicant, in an unrelated matter, to interfere with that duty.  Accordingly, the Medical Staff Bylaws (or related policies) should state very clearly that every applicant bears the burden of submitting a complete application and of producing information deemed adequate by the hospital for a proper evaluation of current competence, professional conduct, character, ethics, and other qualifications – and for resolving any doubts.

A similar issue arose in a 1997 case, Eyring v. East Tennessee Baptist Hospital, 950 S.W.2d 354 (Tenn. Ct. App. 1997), in which a physician applicant refused to sign a release form authorizing a hospital where he had previously practiced to send information to another hospital where he had submitted an application.  The physician argued that he received legal advice that signing the release could compromise his lawsuit against the other hospital, which had revoked his privileges.  The court held that because the physician had not provided the additional information that the hospital requested – regardless of the fact that a settlement agreement was in place – he had not submitted a complete application and, thus, under its Bylaws, the hospital was not required to process his application further.

June 10, 2021

Posted on by Courtney Patterson

QUESTION:   “Can our hospital impose a requirement that all Medical Staff members get a COVID-19 vaccine?”

ANSWER:      While we are aware of some hospitals that are considering making COVID-19 vaccination mandatory for their Medical Staffs, most have not yet implemented such a policy.  We should also note that at least one health system is subject to a class action lawsuit filed by 117 of its employees because of its policy requiring employees to be vaccinated against COVID-19. Read about it here.

While the COVID-19 vaccination is proving to be remarkably effective in controlling the spread of the virus, one of the things that is holding some hospitals and health systems back is that the vaccine is currently under emergency use authorization, rather than the full vaccine authorization normally granted by the FDA.  However, at least two pharmaceutical companies are seeking full authorization from the FDA.  On May 7, 2021, Pfizer requested full approval for their COVID-19 vaccine from the FDA.  Moderna followed suit on June 1, 2021.

As noted above in Your Government at Work, the EEOC, in its updated guidance, emphasized that the federal employment equal opportunity laws do not prevent employers from requiring COVID-19 vaccinations, subject to reasonable accommodation provisions and other equal employment considerations.  But, the EEOC also notes that it is beyond its jurisdiction “to discuss the legal implications of [emergency use authorization] or the FDA approach.”

The section of the federal Food, Drug, and Cosmetic Act allowing emergency use authorization requires that individuals to whom a product subject to emergency use authorization is administered are informed of “the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”  A reasonable interpretation of this statute would give any individual the right to refuse a vaccine that has only been given emergency use authorization and thus preclude mandates.  A counter-interpretation is that an individual must be informed of the consequences of refusal to accept an emergency use authorization vaccination, such as, for example, automatic relinquishment of clinical privileges.

Nonetheless, if you do decide to move forward with a COVID-19 vaccination requirement, you want to make sure that it is consistent with your Medical Staff Governance Documents and Hospital policies.  There should not be anything to keep you from proceeding, but you will want to confirm this.  You will also want to check if your documents permit you to mandate any vaccines.  If they do, this could set the groundwork for a COVID-19 vaccine requirement.  For example, Medical Staff Bylaws often already require influenza vaccination.  Further, many Bylaws include a threshold eligibility criterion for appointment and privileges stating that an individual must complete all required health screenings and vaccinations prior to providing any patient care at the hospital and any appointment/privileges granted by the Board are conditioned on the individual’s compliance with those requirements.  If you have this threshold eligibility criterion language, it should be broad enough to include a COVID-19 vaccination requirement in a separate policy.

May 6, 2021

Posted on by Courtney Patterson

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.