Posts Tagged ‘MQA’

Florida’s Department of Health Investigative Services Unit or ISU

Monday, June 7th, 2010

The ISU investigates complaints against health care practitioners and facilities/establishments which are regulated by the Florida Department of Health, and investigates complaints against individuals practicing without a health care license in the State of Florida.  The Investigative Services Unit (ISU) functions as the investigative arm of the Florida Department of Health, a Division of Medical Quality Assurance (MQA).

The staff of the ISU includes professional investigators and senior pharmacists who do the following:

1.  Collect documents and evidence.

2.  Conduct interviews.

3.  Serve subpoenas and official orders of the department.

4.  Perform inspections of pharmacies and dispensing practitioners and enforce compliance of Florida’s Drug and Cosmetic Act.

5.  Perform probationary monitoring for the Compliance Management Unit of the Consumer Services Unit (CSU).

Investigations

The CSU refers the complaints to the ISU field office nearest to where the incident occurred.  The complaints that present an immediate threat to public safety are given top priority; however, all complaints are investigated as quickly as possible.

The investigative steps generally include the following:

1.  Obtaining documentation, medical records, and evidence relating to the complaint.

2.  Locating and interviewing the complainant, the patient, the subject and the witnesses.

3.  And drafting and serving subpoenas for the necessary information.

The investigator then writes a report which is forwarded on to the department’s attorneys for legal review.

Inspections

Drug Agents and Pharmacy Inspectors conduct opening, annual, out-of-business, change of address, and change of ownership inspections.

Pharmacy Inspectors routinely inspect 13 different types of facilities licensed through the Florida Board of Pharmacy working as field agents within Investigative Services.

Drug Agents enforce compliance of Florida’s Drug and Cosmetic Act, Chapter 499, Florida Statutes.  They routinely inspect facilities, products and merchandising involving drugs, devices and cosmetics and help protect the public from injury.

Soreide Law Group represents health care professionals brought in front of the Florida Board of Health, Florida Board of Pharmacy, and Florida Board of Nursing.  To speak to a lawyer regarding these issues please call: (888) 760-6552, or visit our website at: www.floridaprofessionallicense.com.

How to Prepare Yourself and Your Client for an Appearance Before a Florida Health Care Licensing Board on Disciplinary Matters

Wednesday, April 7th, 2010

In defending a health care practitioner before his or her licensing board in Florida is not  routine for you, the task may appear quite daunting. Where do you begin? Like most every task in law, the key to success lies in preparation. The right preparation can make your client’s appearance before the board bearable. This article will provide some general background information on how the disciplinary process for boards works, as well as some suggestions for preparing yourself and your client for an appearance before the board on a disciplinary matter.

Overview of Licensure Disciplinary Process

F.S. §20.43 charges the Department of Health with “regulating health practitioners, to the extent authorized by the Legislature, as necessary for the preservation of the health, safety, and welfare of the public.” The Division of Medical Quality Assurance (MQA) was established under the department to fulfill this charge, and is currently responsible for approximately 50 different health care professions in Florida. Most health care professions in Florida are regulated by boards, whose members are appointed by the governor for four-year terms, and confirmed by the Senate. These boards are composed of members who are licensed in the respective health care profession and consumer members. Boards make rules regarding the practice and regulation of their profession, make decisions on applications for licensure, and make determinations in disciplinary cases. For those health care professions that are not governed by a board, the department assumes the duties. 

Since July 1, 2002, MQA has taken an active role in providing consumer complaint, investigavtive,and prosecutorial services for the department. These services are divided among the consumer services unit, the investigative services unit, and the prosecution services unit. Most often, all complaints against health care practitioners are received by the consumer services unit, which will begin the investigation of legally sufficient complaints. A complaint is legally sufficient if it contains ultimate facts showing the subject of the complaint has violated F.S. Ch. 456, any of the practice acts relating to the professions regulated by the department, or any rule adopted by the department or a board. If more information is needed, the complaint may be transferred to one of 11 field offices under the investigative services unit for further investigation and collection of evidence, such as medical records. The department will then notify the subject of the complaint and provide the subject an opportunity to submit a response. After the investigation, the complaint is forwarded to the prosecution services unit where an attorney reviews the file and recommends either dismissal or the filing of an administrative complaint. F.S. Ch. 456 mandates that the department make a final recommendation to a probable cause panel on the complaint within six months of its receipt. Failure by the department to comply with the six-month time period constitutes “harmless error in any subsequent disciplinary action unless a court finds that either the fairness of the proceeding or the correctness of the action may have been impaired by a material error in procedure or a failure to follow prescribed procedure.”

The attorney’s recommendation is then presented to the probable cause panel of the board. Probable cause panels are composed of at least two members, as required by statute, and the larger boards often have more than one probable cause panel. A probable cause panel must include a present board member, a former or present board member, and a former or present consumer member, if one is available, willing to serve, and authorized by the board chair to do so. The probable cause panel is given a copy of the department’s complete investigative file, any expert opinions obtained by the department, and the subject’s response to the complaint, if there was one submitted. The department is required to furnish a copy of these materials to the subject of the complaint upon written request if the department is recommending a finding of probable cause, or if the subject of the complaint waives confidentiality. After a review of the materials supplied by the department, the probable cause panel makes the ultimate determination of whether a complaint should be closed or an administrative complaint filed. A decision to either find probable cause on a complaint or to dismiss it must be made by a majority vote of the probable cause panel.

If the panel does not find probable cause, the complaint is closed and remains confidential. If the probable cause panel determines that probable cause exists to go forward with a complaint, then an administrative complaint is filed with the agency clerk for the department, and becomes public 10 days after probable cause is found. The administrative complaint is then served on the subject, usually by personal service or by certified mail, and the subject has 21 days to respond.

If the subject disputes any allegation of material fact in the administrative complaint, he may request a formal evidentiary hearing before an administrative law judge assigned by the division of administrative hearings, as provided for in F.S. §120.57(1). These evidentiary hearings are similar to bench trials. The Florida Rules of Evidence apply with one key exception. Hearsay is allowed, but an administrative law judge cannot make a finding of fact or conclusion of law based solely on hearsay without some other form of supporting evidence, unless the hearsay would be otherwise admissible. After conducting the evidentiary hearing, including taking testimony and receiving documentary evidence, the transcript will be filed and the parties will be given a certain period of time in which to submit proposed recommended orders incorporating proposed findings of fact and conclusions of law based on the evidence presented to the administrative law judge. The administrative law judge will then enter a recommended order that is presented to a board for final action. The parties are given 15 days after the filing of the recommended order in which to submit written exceptions that will be considered by the board, along with the recommended order, in determining the final disposition of the case.

If the subject does not dispute any allegation of material fact in the administrative complaint, he may request an informal hearing before the board, as provided for in F.S. §120.57(2). The subject does not contest any material facts in an informal hearing, and is only allowed to offer mitigation for the board’s consideration in determining appropriate penalty.

Regardless of which kind of hearing the subject chooses, the department usually offers the option of resolving the case by entering into a consent agreement, or stipulation, which is later presented to the board for approval. These consent agreements contain disciplinary terms, such as suspension, probation, fines, continuing education, or other restrictions on practice, that the department and the subject consider a reasonable disposition of the case. The consent agreement becomes binding on the subject only if the board accepts it and renders a final order incorporating it. The board will either accept the consent agreement as written or will reject it. If the board rejects a consent agreement it may offer the subject a counter proposal, and give the subject a specific time period in which to either accept the counter proposal and allow a final order to be entered in the case, or elect to proceed with either a formal or informal hearing. The majority of all disciplinary cases that come before boards are consent agreements and it is in your client’s best interest to settle as early as possible in the disciplinary process, not only because it may show the board that your client accepts responsibility for the violations alleged in the complaint, but also because it will save your client from having to pay as much in costs as if the case was settled further down the road after litigation had begun.

Preparing for a Board Appearance

Now that you have basic understanding of how the disciplinary process works, here are some helpful suggestions for preparing for a board appearance.

Research your client’s licensing board. This point cannot be stressed enough. Different boards have different compilations of members. Find out the number of board members on your client’s licensing board, who the members are, and how long they have been members of the board. Look carefully at the background of each member. Do any of the board members specialize in your client’s area of practice? If so, find out if they have stated a position on any of the issues present in your client’s case. Where do the members practice their profession? Is it a small town or big city? Do they have their own practice or work for a hospital or other health care facility? Also, find out if there have been previous disciplinary cases presented to your client’s licensing board with facts or issues similar to your client’s case; if so, how has the board ruled on them? All of these factors will have an impact on how your client’s case is decided, and it behooves you to take the time to do this research.

Get to know the board counsel and lead prosecutor for each board. This point is a continuation of the one above, but is mentioned separately due to its importance. These two individuals are great sources of information and insight on boards. For most boards, the attorney representing the board is an assistant attorney general assigned by the Office of the Attorney General of the State of Florida, and the lead prosecutor is an assistant general counsel from the Department of Health assigned by the department to present the disciplinary cases to the board. The primary responsibilities of the board counsel are to advise the board on legal and procedural matters relevant to each disciplinary case and to instruct the board on options they may have in resolving each disciplinary case. The lead prosecutor prepares and presents all disciplinary cases to the board for resolution, advocates the department’s position on each respective case, and answers any questions board members may have regarding the facts or procedural history of the case. Please be aware the lead prosecutor for each board may, or may not, be the same attorney you dealt with before making your appearance before the board. Both the board counsel and the lead prosecutor are a wealth of information regarding your client’s board. The board counsel can tell you the appropriate procedure for appearing before the board, when you or your clients will be given the opportunity to speak, and if there are any potential problems with your client’s case. The lead prosecutor can give you insight into how the board has resolved cases similar to your client’s case, and let you know the board’s concerns about practitioners who have committed similar disciplinary violations.

Study the disciplinary guidelines for your client’s board. This point is especially helpful when your client is appearing before the board for an informal hearing and you have not agreed upon a disciplinary recommendation with the department’s prosecutor. Most boards have adopted disciplinary guidelines, which can be found in Ch. 64 of the Florida Administrative Code within the respective board’s rules. These guidelines will set out minimum and maximum penalties for each disciplinary violation and will establish a different range of penalties for each violation depending on whether this is your client’s first offense. In addition, there is usually a section within the disciplinary guidelines that contains a list of factors a board may consider as either mitigating or aggravating circumstances to justify either a downward or upward departure from the disciplinary guidelines. Carefully study this list and find as many mitigating factors as possible to argue in favor of your client, in order to present him in the best light possible before the board.

Prepare your client for his board appearance. It is strongly suggested that you take some time to prepare your client for the board appearance. The best way to do this would be to have your client attend a board meeting to experience what goes on with disciplinary appearances. This will show your client what can be expected at the appearance, as well as the right and wrong things to do at an appearance. If this is not possible, then conduct a mock appearance. If available, have one or more similarly licensed health care practitioners, along with one or two persons in your office act as board members who can grill your client on the case. The harder the questioning, the better prepared your client will be. You must take no prisoners when conducting these mock appearances—the board most certainly will not. Keep in mind that boards are hard on their own licensees, so going easy on your client during a mock appearance will not be beneficial. You will also be able to discover your client’s temperament for such questioning and true feelings about the case, both of which are important to learn before the actual board appearance.

You should strongly encourage your client to dress and act appropriately at the board appearance. The members of the board are among the most respected members of the particular profession and deserve, and even demand, a certain level of respect from licensees. If your client comes before the board wearing a t-shirt and shorts, any negative impressions that board members may have had about your client from a review of the disciplinary record will be greatly multiplied. This is also true when it comes to the manner in which your client addresses the board. Your client should address board members in a respectful manner. Arguing with, or yelling at, board members is a futile endeavor and will certainly not benefit your client.

Prepare yourself for the board appearance. This may appear to be a no-brainer for most attorneys, but I still see some who do not take the time to do this, and their clients end up paying for their mistakes. You need to know every little detail of your client’s case, because board members will ask very detailed questions. If a particular case involves a complex procedure you just don’t grasp from reading the case file, then make an effort to sit down with your client, or an expert, and have him or her explain the procedure step by step in layman’s terms, using visual aids if necessary. It’s okay to admit that you don’t understand something. I do it frequently with the experts in my cases.

Prepare a brief oral statement on behalf of your client to give at the board appearance. The word “brief” is emphasized because most boards like to keep the pace of the meeting moving, and are more interested in questioning your client than in hearing you give a long-winded speech on his behalf. If you are arguing mitigation on behalf of your client, then make a list of mitigating factors to refer to during the appearance. In standard of care cases, be prepared to answer questions, or more importantly prepare to have your client answer questions, regarding what he or she would have done differently in the case, or what steps have been taken to correct the problems at issue in the case. For example, in wrong-site surgery cases, it is common for a physician or nurse facing discipline to have conferred with the facility’s risk management department and staff in order to develop a set of revised protocols or policies to prevent future incidents of that nature from occurring. If any corrective measures were taken by your client to prevent a recurrence of the incident giving rise to the disciplinary action, point out the corrective measures and emphasize them as mitigating factors. This will show the board your client not only took responsibility for the incident, but also was concerned enough to try to prevent it from ever happening again.

Create a case notebook for you to take to the board appearance. If you have a relatively small case, consider making a copy of the complete case file and putting it in a notebook with tabs and a table of contents to help you to easily locate particular documents. For larger case files, with hundreds of pages of medical records, it would be wise to at least bring a copy of the investigativereport, including the list of exhibits, expert opinions in the case (if any), and any pleadings filed in the case. Consult with a medical expert to determine which documents are critical to your client’s position and make sure they are available to you and your client at the board meeting. Most board members, board counsel, and lead prosecutors will have copies of the complete case files on hand and easily accessible to them during the board meeting, and they will often refer to particular documents in the file during consideration of a disciplinary case. You will be at a considerable disadvantage if you do not have at least some of these materials on hand.

Consider preparing a written statement to give to the board prior to the board meeting. This written statement will be similar to your oral statement, but much more detailed in nature. The statement should be given to the board at least a month in advance of the board meeting so that it can be included with the agenda materials given to board members in advance of the board meeting. Do not bring a written statement to the board meeting as the board will not have an adequate amount of time to review it while your client is sitting there and may resent having additional materials given to them on such short notice. In cases that come before boards as either consent agreements or informal hearings, subjects are allowed to submit written materials either supporting the consent agreements or presenting mitigating factors. These written materials allow the board members to see your client’s position well ahead of the board meeting and may persuade them to view your client in a more favorable light. A well-organized written statement should contain the following: a brief summary of the allegations; the subject’s background and training, as well as any major accomplishments, awards, or recognition in his or her respective field; statements as to why the consent agreement is an appropriate resolution of the case (where there is one); all the mitigating factors relevant to the case; and letters of support from fellow licensees. These written materials are case specific and exact content will vary depending on the specific facts of your client’s case.

Remember that attitude is everything. While this point has already been alluded to in the previous sections, it is important enough to bear repeating. Having the right attitude can make all the difference in the outcome of a board appearance. If your client comes before the board on a consent agreement or informal hearing, the board will probably expect to see him or her take responsibility for his or her actions. Blaming others or making excuses, especially bad ones, will not work; it may end up costing your client more than was bargained for. In cases with recommended orders, when arguing exceptions to the recommended order, always do so in a respectful manner and back up your arguments with specific examples or case law. Always address the board. Do not argue back and forth with the board counsel or the lead prosecutor. If the board asks your client questions that might necessitate invoking the Fifth Amendment privilege, then please explain, or better yet have your client explain to the board that he or she would like to answer the question but is unable to do so because of a pending criminal investigation, instead of just saying, “I take the Fifth.” If at all possible, let your client answer questions from the board instead of answering on the client’s behalf. Odds are, you are not licensed in the same profession as your client. But even if you are, the board wants to hear from the licensee, not from counsel. Never interrupt a board member. If you feel that you must address the board, but the members are in the middle of a discussion, then try to signal the board counsel or the executive director, who will usually direct the chairperson of the board to recognize you, and let you speak. Remember to refer to board members by their title and name, such as Dr. So and So. If a board member asks your client a question that refers to a specific document that you do not have available with you, don’t be afraid to ask the board for a copy of the document so that your client can review it before answering the question. Following these suggestions may not make a difference in your client’s case, but it will make a difference in how the board views both you and your client, and that may benefit you in future board appearances.

Conclusion

The department is charged with regulating approximately 50 different health care professions in Florida. A complaint against a health care practitioner goes through a very detailed process before probable cause is found. Once probable cause is found, an administrative complaint will be served on the subject of the complaint, who may then elect to resolve the complaint by choosing either a formal or informal hearing. In most cases, the department will also give the subject an opportunity to resolve a case by consent agreement. Regardless of the subject’s choice, the majority of all disciplinary cases in which probable cause is found and are prosecuted by the department will eventually be presented to the subject’s board for final action. While the above suggestions are by no means a guarantee of a pleasant board appearance, they will at least make the appearance a little more bearable. These are not fun events for either you or your client, but at least you both will be better prepared to face judgment day.

This article was written by Richard J. Shoop for the “Florida Bar Journal.”

Soreide Law Group represents health care professionals brought in front of the Florida Board of Health.  To speak to a lawyer regarding these issues please call: (888) 760-6552, or visit our website at: www.floridaprofessionallicense.com.