Author: Courtney Patterson

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.