Law Feature - May 2010
Tex Med. 2010;106(5):39-44.
By Crystal Conde
The small West Texas town of Kermit was the unlikely birthplace of one of the most outlandish criminal cases this year. The case against Anne Mitchell, RN, which many health professionals say should never have gone to trial, focused a national spotlight on a practitioner's duty to protect patients and to report quality-of-care concerns to state agencies. The trial was so controversial the judge moved it to neighboring Andrews.
Last April, Ms. Mitchell, who had worked for Winkler County Memorial Hospital since 1986, sent an anonymous, confidential complaint letter to the Texas Medical Board (TMB). Vickilyn Galle, RN, helped Ms. Mitchell write the letter. Their concerns centered on Rolando G. Arafiles Jr., MD, who'd joined the hospital staff in 2008. The nurses alleged the physician improperly prescribed herbal medicines that he sold on the side and performed unauthorized surgical procedures. (See " TMA, AMA Guidelines on Sale of Health Products .")
Scott Tidwell, JD, a Winkler County attorney who prosecuted the case because District Attorney Mike Fostel, JD, was ill, and who is also Dr. Arafiles' attorney, didn't respond to a request for comment.
Among the quality-of-care concerns the nurses cited in their complaint was that the physician sewed a rubber tip onto a patient's crushed finger. The Texas Department of State Health Services (DSHS) flagged the nonstandard procedure as deficient during an investigation of the hospital last September.
What the two nurses called their mission to protect the health and safety of their patients quickly turned into an interrogation. TMB advised Dr. Arafiles last April that it had received a complaint against him. Robert L. Roberts Jr., Winkler County sheriff and a friend and former business partner of Dr. Arafiles, began investigating the source of the TMB complaint when the doctor asked him for help.
Sheriff Roberts wrote to TMB last May and requested a copy of the complaint against Dr. Arafiles. TMB says it released the information with the understanding that the sheriff would use it to assist in conducting a criminal investigation of the doctor. Upon reading the anonymous complaint, signed by a woman who described herself as older than 50 and having worked at the hospital since the 1980s, the sheriff was able to deduce who likely wrote the letter.
The sheriff's deputy obtained a search warrant and found the original complaint letter on Ms. Mitchell's computer. In June, a Winkler County grand jury indicted Ms. Mitchell and Ms. Galle for "misuse of official information," a third-degree felony. The indictments charged they forwarded to TMB nonpublic information they had access to as public employees and used it for a nongovernmental purpose, namely to harm Dr. Arafiles.
Not only were both nurses arrested and forced to post $5,000 bonds, but they also lost their jobs. Hospital Administrator Stan Wiley fired Ms. Mitchell and Ms. Galle in June, shortly before their indictments. Ms. Mitchell was the hospital's compliance officer, and Ms. Galle was the quality assurance officer.
At the conclusion of a three-and-a-half-day trial in February, the jury took less than one hour to find Ms. Mitchell not guilty. If convicted, Ms. Mitchell could have spent up to 10 years in prison. The prosecutor dismissed charges against Ms. Galle before the trial started.
Josie Williams, MD, TMA past president, calls the outcome of the case a victory for quality of care and safe reporting in Texas and the nation.
"It's a victory in that people who have honest concerns about health care can report them in a safe manner. It's a tragedy the case was ever brought forward, if as the jury believed, a health care professional raised an honest concern, had a duty to report, and was prosecuted for doing so," she said.
Indeed, Texas laws and the Code of Ethics for Nurses advocate an environment that allows health care professionals to report concerns about a practitioner's standard of care. Texas law requires nurses to report concerns about patient safety regardless of hospital policy or other orders. State whistle-blower laws protect people who make reports in "good faith." The Texas Supreme Court has held that "good faith" under the Texas Public Whistleblower Act requires only that the person honestly and reasonably believe that a law was violated.
Section 164.007 of the Medical Practice Act declares that any complaint filed with TMB is "privileged and confidential and is not subject to discovery, subpoena, or other means of legal compulsion for release to anyone other than the board or its employees or agents involved in discipline of a license holder."
"The board's position is that confidentiality of complainants is important so that individuals can report patient safety concerns without fear of reprisal," said TMB Executive Director Mari Robinson, JD.
Then-TMA President William H. Fleming III, MD, responded to the jury's acquittal of Ms. Mitchell by underscoring TMA's commitment to quality care and patient safety.
"What matters the most is that patients are confident they are receiving the highest quality of care and that their physicians are qualified, competent, and adhere to the highest ethical and professional standards. TMA supports these standards and works on the behalf of Texas patients to improve patient safety in all settings," he said.
Nurses' Case Matters to Doctors
Dr. Williams calls on physicians and other health care practitioners to support strong medical and nursing boards that can investigate legitimate patient safety concerns without hindrance from outside authorities.
"Anonymous complaints against physicians don't need to be aired in criminal courts. Physicians and TMA need to continue to work with TMB to ensure a fair, lawful process that allows the board to sort out concerns in a judicial manner that affords due process," she said. "If we don't have a strong board and people can't report true concerns about quality of care in good faith, it's dangerous for physicians and our patients."
She adds that physicians should consider both sides of this matter.
"I certainly don't want someone coming after me when I have a legitimate concern about patient care," Dr . Williams said.
Realizing the impact the case against the nurses could have on reporting, TMB responded. On June 17, 2009, Ms. Robinson outlined her concerns about the charges against the nurses in a letter to Mr. Fostel and Mr. Tidwell. She says the release of documentation related to their complaint and the indictments "effectively destroyed the legislatively related confidentiality that a complainant to the board would have."
She wrote that the prosecution's actions stifled the cooperation of any hospital personnel who could have helped the board complete its investigations. She added that the willingness of health professionals to file complaints is central to the board's successful regulation of medical practice under Texas law.
"Causing persons to fear criminal felony prosecution if they do so [report] undermines the board's ability to do its job," Ms. Robinson wrote.
Leigh Hopper, TMB public information officer, says the board cannot comment on whether it is investigating Dr. Arafiles because complaints and investigations are confidential by state law.
Despite Ms. Mitchell's victory in court, the battle isn't over. Last August, she and Ms. Galle filed a civil suit against Winkler County and the county hospital system, Mr. Wiley, Sheriff Roberts, Dr. Arafiles, Mr. Tidwell, and Mr. Fostel. At press time, the suit was pending in federal court.
For more information about the civil suit, visit the Texas Nurses Association (TNA) Web site . The site also features a chronological history of the events leading up to the trial, as well as attorneys' reports from Andrews. Access a PDF of the civil action filed by Ms. Mitchell and Ms. Galle online at news.justia.com .
The nurses charge, in part, that the defendants violated their right to free speech, denied them due process, and retaliated against them for reporting in good faith to TMB. The nurses seek monetary damages for past and future earnings, lost benefits, and emotional pain and suffering, as well as attorneys' fees and costs.
Lolly Lockhart, RN, PhD, testified as a nurse expert during the trial and identified some lessons learned from the case against Ms. Mitchell. Dr. Lockhart consults with health care facilities and professionals on performance improvement, patient safety, and compliance with regulatory and professional standards. She's also an associate professor in the Texas State University School of Nursing.
First, she says that if internal peer review had been properly conducted from the start, the trial "probably wouldn't have happened."
According to the nurses' lawsuit, any medical professional wishing to report an employee for quality-of-care concerns at Winkler County Memorial Hospital first had to receive approval from the hospital's Board of Control and the medical staff.
"This discouraged employees from publicly reporting matters of public concern regarding patient safety and the patients' health and welfare …," the lawsuit states.
"Hospitals have an opportunity through peer review to protect patients and to address quality-of-care concerns," Dr. Lockhart said. "To me, this case was a never event. It never should have happened."
Dr. Lockhart says external peer review is vital in addressing quality-of-care concerns, but she acknowledges that it's difficult for physicians to perform peer review on other physicians they work with or refer to and from. She says Texas A&M Health Science Center's Rural Community Health Institute's Rural Physician Peer Review Program is a good example of a way to facilitate blinded peer review and allow for reports back to the hospital chief executive officer and chief of staff for their follow up with the physician. Dr. Williams is the founding director of the center. (See " Program Promotes Fair Peer Review .")
TMA's policies on medical peer review advocate a fair, reasonable system; the association condemns manipulation of medical staff bylaws by hospitals attempting to silence health professionals' concerns for access to quality care at hospitals.
Second, Dr. Lockhart says the case is a prime example of how a physician should not react to a complaint notice from the medical board.
Dr. Lockhart, who has helped physicians draft responses to TMB, says physicians need to realize the medical board is exempt under the Health Insurance Portability and Accountability Act. Therefore, physicians may legally give the board protected health information without patient consent. Dr. Lockhart worked as a consultant to TMB in 1986 and helped establish its clinical investigations program.
Third, Dr. Lockhart advises physicians to consider consulting with an attorney who has experience in working with TMB and is familiar with the board's rules and procedures.
"Physicians should also consult their medical staff bylaws because they may be required to notify the chief of staff of the correspondence from TMB," she said.
Potential Chilling Effect
John Cook IV, JD, and Brian Carney, JD, represented Ms. Mitchell during the trial. Mr. Cook says the case could have affected the future of patient safety throughout the United States.
"This case had significant implications for patient safety. If medical practitioners are reluctant to report problems, the true victims could be the patients," he said.
He fears that what happened to Ms. Mitchell could dissuade health care professionals from reporting quality-of-care concerns internally or to TMB.
"No medical professional should be afraid of going to prison for speaking out against concerns that place patients in danger. But the reality is these ladies [Ms. Mitchell and Ms. Galle] are still unemployed because they spoke up. I'm afraid this case will give other medical professionals pause to report, just based on the idea this could happen to them," Mr. Cook said.
Like Mr. Cook, Dr. Williams too fears the case could cause health professionals who wish to report to fear trepidation and criminal pursuit.
"Cases like this have the potential to drive reporting underground," she said.
Regardless of any damage done, TNA President Susy Sportsman, PhD, RN, says the not-guilty verdict reaffirms a nurse's duty to advocate for the health and safety of patients above all else.
Crystal Conde can be reached by telephone at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by e-mail at Crystal Conde .
TMA, AMA Guidelines on Sale of Health Products
The Texas Medical Association Board of Councilors' ethics opinion on selling health-related products raises the concern that "the for-profit sale of health-related products by a physician can create a conflict of interest for the physician."
The board's opinion further points to a concern that the sale of such products for financial gain could demean the patient-physician relationship and the professional practice of medicine.
To access the Board of Councilors' current opinions, click here .
The American Medical Association also has guidelines for physicians who engage in selling health-related products. In addition to creating a conflict of interest, AMA acknowledges that in-office or Web site sales of health-related products by physicians risk placing undue pressure on the patient, threaten to erode patient trust, and could undermine the primary obligation of physicians to serve the interests of their patients above their own.
For physicians who choose to sell health-related products from their offices or Web sites, AMA advises them not to sell any products for which claims of health benefit lack scientific validity. And to minimize financial conflicts of interest, AMA suggests physicians distribute health-related products to their patients free of charge or at cost.
AMA urges physicians to disclose fully the nature of their financial arrangement with a manufacturer or supplier of health-related products and not to participate in exclusive distributorships of health-related products that are available only through physicians' offices.
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Program Promotes Fair Peer Review
To help small rural hospitals accomplish unbiased peer review, Texas A&M Health Science Center's Rural and Community Health Institute (RCHI) created the Rural Physician Peer Review Program (RPPR) seven years ago. The program facilitates teleconferencing among physicians of similar specialties who live in different parts of Texas and practice in 48 individual hospitals.
RPPR focuses on shared learning by eliminating bias, promoting a "just culture," and removing the often punitive nature of peer review. Physicians submit and share peer review documentation via a Health Insurance Portability and Accountability Act (HIPAA) compliant, secure Internet portal. The actual meeting occurs through a secure conference call.
Lolly Lockhart, RN, PhD, says the program RCHI has developed allows an entire hospital system to learn through constructive, unbiased feedback on quality improvement measures.
"The results of RCHI's peer review program can be used by hospitals to enhance the system's quality and safety program," she said.
Dr. Lockhart consults with health care facilities and professionals on performance improvement, patient safety, and compliance with regulatory and professional standards.
In addition, physicians who take part in RPPR can receive continuing medical education credits through the Texas A&M Coastal Bend Education Center.
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