Author: Courtney Patterson

May 27, 2021

Posted on by Courtney Patterson

QUESTION:   “When a hospital receives a peer review incident report on a practitioner, is the medical director of an affiliated physician group practice that employs the practitioner allowed to see the occurrence?”

ANSWER:      This is a question that we receive quite frequently and one in which most hospitals are having to answer because they are part of a system with affiliated groups that employ physicians practicing at one or more hospitals within the system.  The bottom line is that information sharing among relevant entities within a system is an important part of credentialing, privileging, and peer review.  Information sharing ensures patient safety and the quality of care across the system.  However, before any information sharing occurs, there should be a process outlined in your Medical Staff policies so that you don’t inadvertently violate your state’s peer review privilege.

While the details of the process for information sharing in your policies is too detailed to fully outline in an answer to the Question of the Week, below are some important points you should consider addressing in your Peer Review Policy.

If the practitioner involved is employed by the hospital, the Peer Review Committee (or “Professional Practice Evaluation Committee” or “Committee for Professional Enhancement” depending on the terminology you use) may notify an appropriate hospital representative with employment responsibilities (such as the medical director of the group) of the review of the incident report and request assistance in addressing the matter.

Whether notification occurs may depend on the circumstances underlying the incident report and the contemplated intervention by the Peer Review Committee.  For example, the medical director of the group should generally be notified when the concern is more significant and an intervention such as a Performance Improvement Plan/Voluntary Enhancement Plan is being considered.  On the other hand, if a practitioner simply receives an educational letter (e.g., on the need to round daily on patients and record progress notes consistent with the Medical Staff Rules and Regulations), the Peer Review Committee may choose not to notify the group.

Nonetheless, if the group is notified, a representative may be invited to attend meetings of the Peer Review Committee, participate in discussions and deliberations, and participate in any interventions to make sure that the group and Peer Review Committee are on the same page.

You want to make sure you consult your state’s peer review statute because it could affect the way that this process is structured and carried out.  Some state laws specifically address the sharing of peer review information with physician group practices while others are silent.  You also want to be mindful of the fact that some state courts have interpreted peer review statutes to limit what you can do with peer review information.  For example, in a case called Yedidag v. Roswell Clinic Corporation, the New Mexico Supreme Court concluded that “the acquisition and use of confidential peer review information for purposes of employee discipline is not a statutorily permissible use of peer review information.”

Finally, it is helpful also to have an Information Sharing Policy in place that, among other things, spells out the rationale for the Policy, the types of information sharing that will occur, the entities that will be subject to the Policy, and an explicit statement that the Policy has been drafted to comply with the state peer review law and is not intended to waive any applicable peer review privilege.

May 20, 2021

Posted on by Courtney Patterson

QUESTION:   “It’s been a long time since we first adopted our bylaws. Some leaders are hoping for a clean slate with a total rewrite, others want to continue to tweak the bylaws we have. What’s the best approach?”

ANSWER:     There is no single right answer to this question but it is a question we get quite a bit.  We have found that if you have done a major revision of your bylaws documents (including your related credentialing, peer review, health and professionalism policies) within the last five years or so, you should be able to tweak the existing documents to reflect any changes in the law and recommended best practices.

Even if it’s been ten years or so since you totally revised your bylaws, you can probably stick with the current documents.  There are a couple of critical qualifications.  First, it’s important that you are starting with an excellent set of bylaws.  This means that the bylaws you have in place are easy to read and follow, the bylaws do not contain lots of internal cross-references (these are almost impossible to keep up-to-date), and the bylaws reflect best practices.  And second, it’s also important that you have been careful, thorough, and diligent in updating the bylaws every two years or so.  In our experience, updating a mediocre set of bylaws only takes you from a bad situation to one that is worse.

If it’s been more than ten years since you’ve done a major overhaul of your bylaws, it’s time to do so.  Just about everything has changed in the medical staff world in the last decade.  Whether it’s the role of APPs, the use of telemedicine, the need for consistency between and among sister hospitals, the focus on collegial efforts and progressive steps in the peer review process, or the non-punitive approach to dealing with health issues, the list of issues that have substantially changed is almost endless.

It’s so important to have modern, up-to-date bylaws, and related policies, to reflect the world in which you are practicing and to provide the necessary tools to solve the challenges you are likely to face.  A major overhaul of your bylaws documents might seem like a daunting task, but we can assure you the time you devote to the project on the front end, will be time well spent.  And you and your colleagues will reap the rewards for many years to come.

For more information on developing BFB (aka Best Friend Bylaws), join us live for The Complete Course for Medical Staff Leaders in Disney (September 19-21), Phoenix (November 18-20), Naples (January 27-29) or New Orleans (April 7-9).

 

 

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.

April 29, 2021

Posted on by Courtney Patterson

QUESTION:    “What is the history of the peer review process in the United States?”

ANSWER:       In the United States, the evolution of the peer review process was pioneered by the American College of Surgeons (“ACOS”).  In 1913, the year of its founding, the ACOS appointed a man named Ernest A. Codman to chair a committee on hospital standardization.  Codman was an outspoken critic of contemporary hospital recordkeeping practices and made public appearances speaking on the importance of adequate medical records, which he believed were essential for studying patient outcomes.

By 1919, the ACOS had created and adopted a document on hospital standardization.  The 1924 version of the ACOS “Minimum Standard” for hospitals is archived and easily accessible online.  In the 1924 Minimum Standard, the ACOS set forth the following mandates:

  1. That membership upon the staff be restricted to physicians and surgeons who are (a) full graduates of medicine in good standing and legally licensed to practice in their respective states or provinces; (b) competent in their respective fields and (c) worthy in character and in matters of professional ethics…
  1. That the staff initiate and, with the approval of the governing board of the hospital, adopt rules, regulations, and policies governing the professional work of the hospital; that these rules, regulations, and policies specifically provide…[t]hat the staff review and analyze at regular intervals their clinical experience in the various departments of the hospital, such as medicine, surgery, obstetrics, and the other specialties; the clinical records of patients, free and pay, to be the basis for such review and analysis.

These efforts by the ACOS continued for several decades until they eventually evolved into the Joint Commission on Accreditation of Hospitals in 1951.  Since its inception, The Joint Commission has promoted and surveyed the use of peer review (sometimes called “medical audits”) on hospital medical staffs.

You can find more information on the website of the American College of Surgeons, available here.

April 22, 2021

Posted on by Courtney Patterson

QUESTION:    “I hear that they changed the rules that apply to the Paycheck Protection Program so that nonprofits can qualify for PPP loan forgiveness if they employ no more than 500 employees at any given physical location, even if they employ more than 500 employees overall. Is that so?”

ANSWER:      Yes. Section 5001 of the so-called American Rescue Plan Act provides:  “a nonprofit organization shall be eligible to receive a covered loan if the nonprofit organization employs not more than 500 employees per physical location of the organization.”  An interim final rule implementing this change was promulgated by the U.S. Small Business Association on March 22, 2021.  86 Fed. Reg. 15083. This is so even if the organization employs more than 500 employees overall.

April 15, 2021

Posted on by Courtney Patterson

QUESTION:      Our hospital is considering adopting a standard, universal consent form for patients, or their representatives, to review and sign upon admission to our intensive care unit. This form will include a list of several commonly performed invasive procedures on the unit. What are the benefits and potential problems with universal consent?

ANSWER:       This is an interesting question. Universal, or “bundled,” consent can be efficient means to obtain permission to perform common procedures in the intensive care unit ahead of their indicated need. By obtaining informed consent for common procedures upon admission, the hospital’s intensive care unit may see an increase in documented informed consent, as well as a swifter response time to emergent events that require one or several procedures listed on the signed form.

In addition, obtaining universal consent at the outset can afford patients and their family members greater opportunity to dialogue with the physician regarding each of the procedures listed on the consent form and can better align these anticipated procedures with the patient’s goals of care. Overall, this practice may serve as an efficient alternative to obtaining per-procedure consent in haste or performing a procedure without the patient’s express consent.

However, there is a difference between merely asking the patient to sign-off on a laundry list of procedures and engaging in an informed discussion with the patient regarding each procedure and its risks, benefits, and alternatives. If it is the hospital’s practice to do the former, then there may be cause for concern that the patient, or their representative, is not providing actual informed consent.  In addition, expecting universal consent immediately upon admission for procedures that may occur could prove overwhelming, upsetting, or stressful to the patient or their representative. Therefore, when considering whether to adopt universal consent forms, it is important to ensure that patient understanding, patient goals, and good bedside manner are not compromised as a result of the appeal of efficient documentation and expeditious care.

April 8, 2021

Posted on by Courtney Patterson

QUESTION:       I’ve heard that the Centers for Medicare & Medicaid Services (“CMS”) have concluded their series of COVID-19 Office Hours Calls.  Are there any other channels we can use to pose questions to the agency?

ANSWER:          It’s true that the CMS Office Hours series has concluded.  The last call was Tuesday, April 6.  At the conclusion of that Office Hours session, CMS encouraged listeners to direct future COVID-19 questions to the Provider-Specific “Open Door Forums.”  A list of those regularly scheduled calls can be found here.  That page also includes the option to sign up for a mailing list that will notify you of upcoming sessions.

Depending on the nature of your question, you may also be able to find the answer in a transcript from an earlier call.  CMS has provided transcripts for each of its COVID-19 Office Hours Calls at this web page.

Of course, you can always skip that process and instead contact us.  We’ll be happy to assist you.