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Although the Law Stacks the Deck Against You, Leaving a Foreign Body in a Patient Doesn’t Always Mean Negligence or Discipline

George IndestBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Leaving a foreign object (sometimes referred to as a “retained foreign body” or “RFB”) in a patient, such as a sponge, clamp, forceps, surgical needle, guide wire, part of a surgical instrument or other paraphernalia commonly used in surgical, examination, or other diagnostic procedures, does not necessarily mean that the physician has committed an act of negligence or that the physician will be disciplined by the Board of Medicine (BOM) or Department of Health (DOH). There are many defenses in such a case and many incidents which do not constitute negligence. However, as a preliminary matter, the law does seem to stack the deck against the physician in such cases.

Medical Negligence Statutes.

Section 766.102(3)(b), Florida Statutes (previously Section 768.45, Florida Statutes),
states:

The existence of a medical injury does not create any inference or presumption of negligence against a health care provider, and the claimant must maintain the burden of proving that an injury was proximately caused by a breach of the prevailing professional standard of care by the health care provider. . . . However, the discovery of the presence of a foreign body, such as a sponge, clamp, forceps, surgical needle, or other paraphernalia commonly used in surgical, examination, or diagnostic procedures, shall be prima facie evidence of negligence on the part of the health care provider.

Grounds for Disciplinary Action Against a License.

Chapter 456, Florida Statutes, applies to all health professionals who are licensed by the Florida Department of Health (DOH). Section 456.072(1), Florida Statutes, which provides the grounds for possible discipline of any licensed health professional contains a subsection (cc), which provides the following as a basis for disciplinary action:

Leaving a foreign body in a patient, such as a sponge, clamp, forceps, surgical needle, or other paraphernalia commonly used in surgical, examination, or other diagnostic procedures. For the purposes of this paragraph, it shall be legally presumed that retention of a foreign body is not in the best interest of the patient and is not within the standard of care of the profession, regardless of the intent of the professional.

Applicable to Others than Just Surgeons and Physicians.

We typically envision objects such as clamps or lap pads (“sponges”) being left in a patient after surgery. Note, however, these provisions of the law could apply equally to a nurse practitioner’s leaving a broken needle in a patient or a dentist’s leaving a burr or broken probe in a patient.

Res lpsa Loquitur.

Many surgeons and other physicians who are charged with such an allegation just give up, do not defend themselves, and agree to accept punishment from their professional board. The statutes quoted above are, basically, a restatement of the common law rule known as “res ipsa loquitur in medical malpractice cases.

The term “medical injury” in the statute refers to an injury sustained as a direct result of medical treatment or diagnosis, and does not encompass injuries totally unrelated thereto. Thus, when a plaintiff establishes that the injury is outside the scope of medical treatment or diagnosis, and the facts and circumstances attendant to the injury are such that, in light of past experience, negligence is the probable cause and the defendant is the probable actor, the doctrine of res ipsa loquitur is applicable.

In Florida, there is a Florida law that is set forth within Chapter 456, Florida Statutes. Chapter 456 of Florida Statutes applies to all health professionals who are licensed by the Florida Department of Health (DOH).

Many surgeons and other physicians who are charged with such an allegation just give up, do not defend themselves, and agree to accept punishment from their professional board.

Florida Cases on Retained Foreign Objects.

Archer v. Maddux, 645 So. 2d 544 (Fla. 1st DCA 1994) a surgeon left a tube in a patient after surgery by accident. The trial court dismissed the case because there was no affidavit from a medical expert corroborating that medical negligence had occurred that had been filed before the running of the statute of limitations. The Court of Appeal upheld the dismissal of the case.

DeAlmeida v. Graham, 524 So. 2d 666 (Fla. 4th DCA 1987), a surgeon left a Kelly clamp inside of a patient.

Moreover, the provision of Fla. Stat. ch. 766.102(4) that discovery of a “foreign body” such as surgical paraphernalia is prima facie evidence of negligence, is clearly inapplicable in a case where the mesh was intentionally placed in patient’s body as part of her treatment, and like screws, plates, pacemakers, and/or artificial joints was intended to permanently remain in her body. (Kenyon v. Miller, 756 So. 2d 133 (Fla. 3d DCA 2000)

Smith v. Zeagler, 116 Fla. 628, 157 So. 328 (1934)
It is negligence per se for a surgeon to leave a sponge in an abdominal incision made in his patient in the course of his performance of a surgical operation upon such patient. The burden of showing due care is upon a surgeon who leaves a sponge enclosed in a wound after the performance of an operation, and he cannot relieve himself from liability unless the sponge was so concealed that reasonable care on his part would not have disclosed it, and conditions were such that, in his professional judgment, a special exploration for the sponge would have endangered the safety of the patient. Where a patient’s condition is critical and the paramount requirement is complete the operation in the shortest possible time, the failure to remove a sponge may be an accidental and excusable ship or inadvertence that is not actionable negligence, depending upon the circumstances of the case, the burden being on the physician to show to the satisfaction of the jury that the particular act was not blame-worthy because of the supervening necessity to complete the operation without delay.

The authorities are legion to the effect that it is negligence [***3] per se for a surgeon to leave a sponge in an abdominal incision made in his patient in the course of his performance of a surgical operation upon such patient. Ruth v. Johnson, 172 Fed. 191; Reeves v. Lutz, 179 Mo. App. 61, 162 S.W. Rep. 280; Rayburn v. Day, 126 Oregon 135, 268 Pac. Rep. 1002; Wynne
v. Harvey, 96 Wash. 379, 165 Pac. Rep. 67; Harris v. Fall, 177 Fed. 79, 27 L.R.A (N.S.) 1174; Moore v. Ivey (Texas Civ. App.), 264 S.W. Rep. 283; 21 R.C.L. 388.

The burden of showing due care is upon a surgeon who leaves a sponge enclosed in a wound after the performance of an operation, and he cannot relieve himself from liability unless the sponge was so concealed that reasonable care on his part would not have disclosed it, and conditions were such that, in his professional judgment, a special exploration [*631] for the sponge would have endangered the safety of the patient. Davis v. Kerr, 239 Pa. 351, 86 Atl. Rep. 1007, 46 L.R.A. (N.S.) 611.


Adverse Consequences of Accepting Discipline in a RFB Case.

Many health professionals agree to accept punishment from their professional board without realizing the harsh consequences. Any disciplinary action will be reported to the National Practitioner Data Bank (NPDB). If you are reported to the NPDB or another health care data base, you could have issues obtaining hospital privileges, state licenses, you may be excluded from the Medicare and Medicaid Programs, and it could also affect your ability to work in the health care field. Additionally, similar actions will be taken against any licenses you have in other states.

Shared Responsibility Between Surgeon and Hospital Staff.

Most hospitals have internal policies and procedures which make it a shared responsibility between the surgeon and the hospital’s staff (especially surgical technicians and operating room nurses) to safeguard against leaving foreign objects in patients.

The Health Law Firm has successfully defended physicians and other licensed health care professionals in administrative investigations and patients complaints relating to retained foreign bodies.

For more information on how we can help you in situations such as this, visit our Areas of Practice page on our website.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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National Practitioner Data Bank (NPDB) Update

On March 23, 2010, President Barack Obama signed into law the Patient Protection and Affordable Care Act (PPACA).  This legislation made many reforms to the American health care system and with it came many changes that will affect both health care providers and consumers alike.  One such change brought about by this legislation was the elimination of the independent Health Integrity and Protection Data Bank (HIPDB), and its merger with the National Practitioner Data Bank (NPDB).  This will not affect the purpose of the federal government’s clearing house for disciplinary and malpractice information, but will forever change how the information is disseminated.

 To understand the changes, one must first know the history of the NPDB.  The NPDB was established by Title IV of Public Law 99-660, of the Health Care Quality Improvement Act of 1986.  Its purpose was to improve the quality of health care by encouraging State licensing boards, hospitals and other health care entities, and professional societies to identify and discipline those who engage in unprofessional behavior.  The NPDB has been expanded and revised a number of times, but its greatest expansion came on January 28, 2010, when the U.S. Department of Health and Human Services issued a final rule implementing Section 1921 of the Social Security Act. 

Prior to this the NPDB dealt only with licensure and malpractice reports of physicians, dentists, and health care entities. This new regulation expanded the information collected and disseminated through the NPDB to include reports on all licensure actions taken against all health care practitioners.

Like the NPDB, the HIPDB was created to improve the quality of healthcare in America.  The HIPDB was formed under the Health Insurance Portability and Accounting Act of 1996 (HIPAA) and  specifically focused on combating fraud and abuse in health insurance and health care delivery, and promoting quality care.  The HIPDB collected reports made by federal and state licensing agencies, federal and state prosecutors, and federal and state government agencies that had excluded a practitioner, provider or supplier from their health plan.

The NPDB and the HIPDB were created to provide a resource for state licensing boards, hospitals, and other health care entities to assist them in their investigations of the qualifications of the healthcare practitioners they sought to license or hire.  These two data banks served this purpose independently of each other until the passing of PPACA on March 23, 2010.

Section 6403 of PPACA requires the Secretary of Health and Human Services (HHS) to maintain a national health care fraud and abuse data collection program for reporting certain adverse actions taken against health care providers, suppliers, and practitioners, and to submit information on the actions to the NPDB.  Section 6403 further requires the Secretary to establish a process to terminate the HIPDB and ensure that the information formerly collected in the HIPDB is transferred to the NPDB.

What does this mean to you?  Specifically, the NPDB has now become one large, all encompassing central data bank for all reports made against all health care professionals, whether the report deals with fraud, abuse, licensure actions, or malpractice.  The HIPDB has been eliminated as an independent data bank and in its place the Secretary of Health and Human Services has implemented a process in which all fraud and abuse reports will be collected and transferred to the NPDB.  Additionally, all information that was previously held in the HIPDB has been transferred to the NPDB.

For more information about the National Practitioner Data Bank and how it might impact you and your practice, visit www.TheHealthLawFirm.com.

At Last, a Ray of Hope for Florida Health Professionals Who Have Paid Their Debt to Society After Criminal Conviction

The Florida Legislature unanimously passed HB 653 which relaxes some of the draconian exclusions enacted under SB 1986, which went into effect on July 1, 2009. SB 1986, which added provisions to Chapter 456, Florida Statutes, among others, prevented numerous healthcare providers from obtaining or renewing licenses based on prior criminal convictions, which could have occurred decades earlier.

As of this writing (March 16, 2012), HB 653 has been passed unanimously by the Florida Legislature, but awaits the Governor’s signature.

Under HB 653, the professional boards within the Department of Health (such as the Board of Medicine, Board of Nursing, Board of Psychology, Board of Massage Therapy, etc.) now will, if signed by the Governor, only prohibit the renewal or granting of a health professional’s license, certificate or registration, if the individual:

1. Has been convicted of, or entered a plea of guilty or no contest to, regardless of adjudication, a felony under Chapters 409 (Medicaid offenses), 817 (theft or fraud) or 893 (drug offenses), Florida Statutes, or similar laws in other jurisdictions, unless the individual successfully completed a drug court program for the felony and provides proof that the plea was withdrawn or the charges were dismissed, or unless the sentence and any related period of probation for such conviction or plea ended:

– For first and second degree felonies, more than fifteen (15) years before the date of application;

– For third degree felonies, more than ten (10) years before the date of application, except for third degree felonies under Section 893.13(6)(a), Florida Statutes; and

– For third degree felonies under Section 893.13(6)(a), Florida Statutes, more than five (5) years before the date of application.

2. Has been convicted of, or entered a plea of guilty or no contest to, regardless of adjudication, a felony under 21 U.S.C. Sections 801-970 or 42 U.S.C. Sections 1395-1396 (federal Medicare & Medicaid offenses), unless the sentence and any subsequent period of probation for such convictions or plea ended more than fifteen (15) years before the date of application; or

3. Is listed on the OIG’s list of excluded individuals and entities.

This new legislation has the effect of reducing the period of time a health professional may be prohibited from holding a license because of a conviction for one of the enumerated felonies. Under the current law, there is a fifteen (15) year prohibition for all enumerated offenses. The new legislation, if signed, will reduce the period to as little as five (5) years for drug offenses.

However, it also broadens the reach of the current Florida law by including, for the first time, convictions under “similar laws in other jurisdictions.” This may now “catch” many to whom the Florida law did not previously apply.

HB 653 also allows individuals previously denied renewals under SB 1986 who at are now eligible for renewal to obtain a license without retaking and passing their examinations.

The latter requirement above, number 3, may present a “catch 22” for many health professionals. Usually, if a licensed health professional is convicted of a felony, loses his/her license or is denied renewal of a health professional’s license, this is reported to the National Practitioner Data Bank (NPDB). The NPDB now includes reports previously made to the Healthcare Integrity and Protection Data Bank (HIPDB). If this occurs, in most cases the Office of Inspector General (OIG) commences action to exclude the professional from the Medicare Program. This automatically places the health provider’s name on the OIG’s List of Excluded Individuals and Entities (LEIE). Therefore, most licensed health professionals, even if they are no longer prohibited from holding a license under numbers 1 and 2 above, may still be prohibited because of requirement number 3 above.

Doubtless, this lacuna (gap) in this legislation will require additional corrective legislation in the future.

As previously indicated, HB 653 is currently (March 16, 2012) awaiting the Governor’s signature.

Adverse Consequences of Discipline Against Your Nursing License

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

If the Florida Department of Health (DOH) takes discipline against your Florida nursing license, this will have many significant consequences.

Investigation and Discipline of Other State Licenses.

The discipline will be reported to every other state in which you have a license and similar investigations will be opened by those states.

Many states also have laws similar to those of Florida which require you to report discipline yourself to the other state in which you are licensed. Sometimes this is very short, 15 or 30 days, for example. Check the other state’s laws to be sure.

Discipline Against Other Types of Licenses.

If you have other types of health professional licenses, such as a massage therapist (LMT) license, emergency medical technician (EMT) license, mental health counselor license (LMHC), advance registered nurse practitioner (ARNP) license, acupuncture physician (A.P.) license, etc., it is most likely that an investigation will be opened against the other license. This may result in discipline against your other license.

Discipline Will be Reported to the National Practitioner Data Bank.

Additionally, any discipline against your Florida nursing license will be reported to the National Practitioner Data Bank (NPDB), as well as other reporting organizations. You may also face action to exclude you from the Medicare Program by the Office of the Inspector General (OIG). If this occurs, it will be virtually impossible for you to get a job anywhere, especially in a hospital or facility.

Possible Loss of Certification.

In addition, if you are certified in a specialty, your certification organization may revoke or not renew your certification. It may also have rules requiring you to report disciplinary action.

Loss of Employment Opportunities.

Many health facilities, insurers, hospitals and other employers have policies against hiring nursing professionals with discipline on their licenses. Regardless of what an employer or supervisor might orally tell you, company policy, whether formal (written) or informal, may cause you to be terminated as an employee.

Buy Insurance to Cover License Investigation Legal Defense Expenses: It’s Cheap.

Most nursing malpractice insurance policies are very inexpensive and provide excellent coverage. Most contain insurance coverage that will pay for an attorney and other legal defense expenses if you are being investigated or charged with a licensure offense. Buy this. You should have at least $25,000 in coverage for such investigations and administrative proceedings. $50,000 in coverage would be better, even if you must pay extra or buy additional coverage.

If you are innocent of the charges alleged against you, a fully contested formal administrative hearing (trial) could easily cost $50,000. If you can’t afford to pay this amount yourself, you may have to give up your rights to proof of your innocence or guilt. Buy insurance to cover such unfortunate circumstances.

Obtain an Experienced Health Law Attorney Immediately After Receiving Any Notification of an Investigation from the Department of Health.

If the DOH is investigating you, you will receive a letter stating that an investigation has been opened by the DOH for discipline against your license. Do not speak with or make any statement to any DOH investigator (for more on this, see our previous blog post). Instead, immediately obtain an experienced health law attorney to represent you throughout the investigation and disciplinary proceedings.

Contact Health Law Attorneys Experienced in Board of Nursing Cases.

The Health Law Firm’s attorneys routinely represent nurses in Department of Health Investigations, before the Board of Nursing, in appearances before the Board of Nursing in licensing matters, and in administrative hearings.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

About the Author:  George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.