ABSTRACT:
The State Medical Board of Ohio oversees more than 100,000 licensees and receives approximately 7,000 complaints yearly. Under the supervision of the State Medical Board, the Quality Assurance Committee was created to review closed complaints to serve as an additional safeguard for the protection of the public. The popular belief is that quality assurance relates to the production of an acceptable grade of a product or a brand. Quality assurance is also important regarding complaints against licensees. We present our experience in developing the program, lessons learned, and results obtained. The program has added an additional layer of protection to the public while treating all licensees fairly.
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Introduction
The mission of the State Medical Board of Ohio (SMBO) is to protect the public through effective medical regulation. The SMBO is composed of multiple divisions including Licensure, Enforcement, Investigation, Hearing, and Quality Intervention. The role of the Quality Intervention (QI) team is to oversee standard of care, licensee impairment, and quality assurance. As a branch of the Quality Intervention Team, the Quality Assurance Committee (QAC), comprised of SMBO members, was created to ensure a proper outcome after closure of the initial complaint. It also serves to identify issues within protocols and systematic problems. There are two modes in which the QAC operates. First, the QAC audits closed complaints to serve as an additional safeguard for the SMBO's investigative process. Second, the QAC provides an opportunity to further educate board members about SMBO internal procedures for processing complaints. State medical boards vary enormously in terms of structure, process, and authority. Therefore, there is scant literature published on other state medical boards quality assessment programs. This publication will assist other state medical boards in establishing their own programs.
History
In response to the SMBO's handling of a pivotal investigation involving Richard Strauss and alleged sexual misconduct at The Ohio State University, a governor's working group was established.1
In 2019, the working group made a series of recommendations to the board. These recommendations included changes to the Ohio Revised Code or Ohio Administrative Code, encouragement to the SMBO to engage in a performance audit with an external reviewer, and a host of policy and practice changes. Additionally, the Governor asked the board to review 25 years of closed sexual impropriety cases to ensure they had been handled properly.
The board engaged the Federation of State Medical Boards (FSMB) to perform the recommended external review. On June 30, 2020, the FSMB issued a report which included, among many suggestions, a recommendation to reestablish the Quality Assurance Committee, which SMBO had in place from 1993-2002.2
The QAC was previously made up of four physician board members that would meet regularly and was responsible for reviewing closed complaints of all types. Following the recommendations of the governor's working group and the FSMB audit, the SMBO decided to restore the QAC in October 2020.
Methodology
The QAC is comprised of 3 physician members and 1 consumer member. All QAC reviewers are members of the board. The board members are appointed by the Governor and serve five-year terms. Appointment terms are staggered to provide continuity and Board members may be reappointed.
The committee reviews 8 total closed complaints per month with each committee member assigned 2 closed complaints for review per month. A closed complaint is defined as one that after thorough investigation does not support disciplinary action. The licensee/respondent, in most complaints is never aware that a complaint has been filed, if after investigation, the complaint is closed. Complaints for review are selected based on specific criteria, excluding complaints that are outside the jurisdiction of the SMBO.3 For example, any sexual impropriety complaint chosen in the random sample will be directed to the consumer member of the committee for review. The SMBO also gives due consideration if a complaint is recommended for re-opening by the reviewing member. The main reason for a recommendation to re-open is when the QA reviewer “felt additional aspects of the complaint should be investigated.” In that instance, the reviewing committee member will meet with the Secretary of the SMBO, the Supervising member of the board, and the Executive Director to discuss the case and recommend next steps, either forwarding the matter to enforcement or maintaining a closed status. The committee also reviews quarterly metrics regarding the status of open and closed complaints. To provide transparency to the licensees and the public, any complaint may be re-opened if additional substantial information is presented or found after the fact.
It is important to know the structure of the SMBO to understand how the QA process works. The SMBO is comprised of 12 members: 9 physicians and 3 consumer (public) members. Two members are selected by their peers on the Board to serve one-year terms as the Board's Secretary, who must be a physician, and Supervising Member, both of which oversee the SMBO's investigatory and enforcement processes. They review information and make a final determination whether to close a complaint without formal action, whether to recommend nonformal action such as a caution or education letter, or whether to approve a complaint for a formal citation. Pursuant to Section 4731.22(F)(2) of the Ohio Revised Code, “No member of the board who supervises the investigation of a case shall participate in further adjudication of the case.” This results in the recusal of the Secretary and Supervising Member from voting on disciplinary actions at Board meetings. Independent external reviewers were not included in the QAC as this would hinder the education of board members.
Processes
The following describes the creation and subsequent modifications of the QAC processes since its reinstatement.
First Year—Creation and implementation of QA
Complaint selection: At the beginning of each month, a confidential report of complaints closed the previous month is processed. The report included complaints that are closed without formal action by the Secretary and Supervising Member in 1 of 3 sections: Investigation, Enforcement, or Standard Review (The Standard Review Section typically is assigned complaints alleging failure to maintain minimal standards of care). Complaints are chosen using the following criteria: the oldest complaint closed, the most recent complaint closed, and a random complaint closed in each of the 3 sections, resulting in 9 complaints per month.
The tenth closed complaint is also chosen at random from one of the three sections that rotate each month. This ensures that an equal number of cases are chosen from each section over the course of a year.
Special care is taken in assigning the complaints for QAC member's review. If the complaint alleged sexual impropriety, it is assigned to the QAC consumer member if possible.
If the QA complaint involved minimal standard of care, preference is given to assign the review to a QAC physician member. If there are more than eight closed complaints involving minimal standard of care, the first eight are assigned to QAC physician members and the remainder may be assigned to the consumer member. If a licensee had a prior closed complaint already reviewed by a QAC member, preference is given to assign any subsequent randomized complaints to the same QAC member to ensure continuity. After the assignment, the QAC reviewer had 30 days to complete the review. Standard of care review determinations are subjectively based due to QAC reviewer expertise.
A determination is made whether the complaint was closed appropriately with no further action needed, whether the QAC member disagreed with some aspects of the closed complaint, but agrees that it should remain closed, whether further information is needed, or whether a recommendation is to re-open the closed complaint.
Due to confidential information provided to the QAC members for complaint review, they are not eligible to vote on possible formal action stemming from the reviewed complaint at board meetings and must recuse.
During the first year in operation, a SMBO staff-Initiated QA procedure was also created allowing internal staff, who questioned whether a complaint/case was appropriately closed, to request that the complaint/case be re-opened and re-evaluated.
The QAC completed 112 closed complaint reviews during the first year after inception.
QAC members after review agreed that:
Closure of the complaint was appropriate – 86.6%.
Disagreed with some aspects of the complaint but agreed that it was appropriate to remain closed – 11.6 %.
2 QA reviews resulted in the originating complaint being re-opened – 1.8%.
Feedback provided by QAC members helped to highlight needed internal procedural changes.
Second Year of Operation
At the beginning of the second year and after committee discussions, the QAC and SMBO staff modified the Quality Assurance Program to analyze more complex complaints. In addition, an internal QA staff review of closed sexual impropriety complaints was added to QAC reviews. A lesson learned after the first year of operation is that the report of investigation, created by board investigators, needed additional details to be complete.
The new selection criteria now consists of selecting the oldest complaint closed and a random complaint from each of the three sections (Investigation, Enforcement, and Standard of Care), as well as two sexual impropriety complaints, regardless of section. This ensures that the QAC is always reviewing at least two sexual impropriety complaints per month. These changes have ensured that more substantive complaints are being reviewed by the QA Committee members.
Due to committee member changes, the QAC also voted to reduce the number of members from 5 to 4, consisting of three Physician members and one consumer member. As a result of this, 8 complaints are selected each month instead of 10. Each QAC member completes 2 reviews every 30 days.
The QAC completed 107 closed complaint reviews.
QAC members after review agreed that:
Closure of the complaint was appropriate – 95.1%.
Disagreed with some aspects of the complaint but agreed that it was appropriate to remain closed - 3%.
2 QA reviews resulted in the originating complaint being re-opened – 1.9%.
To give the reader a better understanding of the process, a hypothetical case scenario is provided.
Hypothetical Case Scenario—Based on a Blend of SMBO Complaints
Complainant alleged unlicensed practice and deceptive advertising. The respondent is board certified in Internal Medicine and owner of the IV therapy center.
SMBO investigator interviewed the respondent regarding IV vitamin infusion and IV hydration.
Respondent reported that the center has a terminal distribution certificate and personally compounds all IV bags’ ingredients prior to administration. Respondent initially declined to provide the investigator with the components of the IV therapy. However, after discussion agreed to provide the information.
All patients are evaluated medically by respondent prior to providing any IV infusions.
It was later discovered that the vitamin and mineral components of the IV bag were being mixed and infused by a medical assistant.
Report of investigation recommended that medical records be subpoenaed for standard of care review and possible review by enforcement. Pharmacy Board has been contacted and will be investigating possible infractions on their license.
Ten patient medical records internally reviewed. Documentation was noted to be sparse and incomplete. There was concern raised regarding dosages of vitamins and minerals being infused. An independent expert review was recommended.
The board was unsuccessful in ascertaining an independent expert.
Enforcement recommended remedial education on medical documentation, of which the respondent complied, and the complaint closed.
The complaint was subsequently chosen for Quality Assurance review due to it being the oldest complaint closed.
The Quality Assurance reviewer requested re-opening the complaint to obtain supplemental information to determine if additional disciplinary action is appropriate. It was determined after discussion that the investigator would make unannounced visits to the center to obtain the following information:
Is the respondent physically present to evaluate new patients?
Who is preparing/compounding?
Who is obtaining patient consent?
Who is performing the procedure?
How is the documentation being performed?
After investigation, it was determined that the respondent was not medically evaluating patients and was not onsite. Aiding and abetting unlicensed practice was substantiated.
QAC members after review recommended:
Closure of the complaint – 98.2%.
Re-opening complaint with ongoing further investigation – 1.8%.
Sexual Impropriety Protocol Review
In the second year, an internal staff review procedure was created to audit 6 additional closed sexual impropriety complaints. Each month SMBO QA staff assesses the SMBO's sexual impropriety protocol that is followed by the QAC. Specific parameters of the protocol were selected, which include making a report to law enforcement; interviewing the complainant, victim, and respondent; consulting with the victim coordinator; and routing to the deputy director of enforcement.
A risk scoring system was then created, incorporating those parameters, to evaluate whether the investigative protocol has been followed. To date, over 100 Internal QA staff reviews have been completed. The internal review system has been an invaluable tool in highlighting strengths and areas for improvement within the protocol. Identified areas for improvement are reviewed by the Executive Director and Investigation Supervisors. This has resulted in significant improvements in accuracy and efficiency.
Conclusion
The Quality Assurance program at the State Medical Board of Ohio has proven to be an essential mechanism for ensuring accountability and maintaining high standards in medical regulation. By auditing closed complaints and assessing internal processes, the program has provided a method for continued analysis. The QA program has not only helped the SMBO identify inefficiencies in its complaint handling procedures, but it has also facilitated staff training, and the revision of SMBO protocols. An ongoing monthly lecture series has been initiated to provide education to staff to increase their awareness regarding prioritization, timeliness of complaint processing, and changes in protocols throughout the SMBO. The SMBO has also added additional investigators to reduce complaint backlog. The written reports of investigation have been enhanced by increased communication with SMBO nurse specialists. The program's impact has been significant in addressing sexual impropriety complaints. A new investigative department is now in place which focuses only on sexual impropriety complaints. Due to the unique nature of the SMBO structure, the framework that has been provided, may be modified to meet the needs of another state's medical board. Each state medical board should have a “check and balance system” in place. The main lessons learned are that reports of investigation need to be detailed to cover all aspects of the complaint and that timeliness without decreasing accuracy is paramount.
As the program evolves, the SMBO remains focused on expanding the scope of internal reviews and continually improving the QAC processes. The SMBO aims to maintain its focus on public safety while ensuring fair and transparent handling of complaints. This evolving framework underscores the Board's commitment to excellence in its mission to safeguard the health and well-being of Ohioans.
Footnotes
Open Access: © 2025 The Authors. Published by the Journal of Medical Regulation. This is an Open Access article under the terms of the Creative Commons Attribution-NonCommercial License (CC BY-NC, https://creativecommons.org/licenses/by-nc/4.0/), which permits use and distribution in any medium, provided the original work is properly cited, and the use is noncommercial.
Funding/support: None
Author contributions: Concept design, drafting of manuscript, and revision of content (JO), Acquisition of data and revision of content (JR), Revision of content (BD)
- Received June 21, 2024.
- Revision received September 3, 2024.
- Accepted January 14, 2025.
References
- 1.↵Governor's Working Group on reviewing the Medical Board's handling of the investigation Involving Richard Strauss. Published August30, 2019. Accessed April 29, 2025. https://dam.assets.ohio.gov/image/upload/med.ohio.gov/portals/0/transparency/gov%20working%20group%20strauss%20report.pdf
- 2.↵Review of the State Medical Board of Ohio. Report of the Federation of State Medical Boards review team to the State Medical Board of Ohio. Published June30, 2020. Accessed April 29, 2025. https://dam.assets.ohio.gov/image/upload/med.ohio.gov/portals/0/transparency/fsmb%20review%20of%20the%20state%20medical%20board%20of%20ohio.pdf
- 3.↵State Medical Board of Ohio website . For the public. Jurisdiction over licensees. Accessed April 29, 2025. https://med.ohio.gov/for-the-public/filing-a-complaint
