Source:

JONA's Healthcare Law, Ethics, and Regulation

December 2006, Volume 8 Number 4 , p 96 - 105 [FREE]

Author

  • Rebecca F. Cady RNC, BSN, JD

Abstract


Cady, Rebecca F. RNC, BSN, JD

NEWS

Six infants in the Newborn Intensive Care Unit at Methodist Hospital in Indianapolis, IN, received adult doses of heparin, causing 2 to die. It appears that adult doses were placed in a computerized drug cabinet by pharmacy technicians, and that the adult and infant doses of this medication are similarly packaged. (2 Infants die after getting adult doses of drug, CNN.com , September 17, 2006).

A recent study suggests that the psychological difficulty of telling a patient about a medical error may do more to prevent physician disclosure than the litigious medical malpractice climate. In the survey of 2,637 physicians in the United States and Canada, 98% supported disclosing serious errors to patients and 78% supported disclosing minor errors, but when presented with 4 scenarios of common physician errors they were divided about what to say. Only 42% would use the word 'error,' 56% would mention the adverse event but not the error, 50% would give the patient ...


PLEASE NOTE: The information on the FEMA URL appears to have been removed. You can access that information in the following PDF file: http://www.fema.gov/pdf/emergency/nims/imp_hos.pdf

NEWS

 

Six infants in the Newborn Intensive Care Unit at Methodist Hospital in Indianapolis, IN, received adult doses of heparin, causing 2 to die. It appears that adult doses were placed in a computerized drug cabinet by pharmacy technicians, and that the adult and infant doses of this medication are similarly packaged. (2 Infants die after getting adult doses of drug, CNN.com, September 17, 2006).

 

A recent study suggests that the psychological difficulty of telling a patient about a medical error may do more to prevent physician disclosure than the litigious medical malpractice climate. In the survey of 2,637 physicians in the United States and Canada, 98% supported disclosing serious errors to patients and 78% supported disclosing minor errors, but when presented with 4 scenarios of common physician errors they were divided about what to say. Only 42% would use the word "error," 56% would mention the adverse event but not the error, 50% would give the patient specific information about what the error was, and 13% would not reveal any details not requested by the patient. These attitudes appear to clash with what patients say they want from physicians: an admission of error, information about the health ramifications, steps taken to prevent repetition of the same mistake, and an apology. (Pierce, O. Analysis: Why docs. Don't say sorry, UPI.com, August 15, 2006).

 

A study released earlier this year suggests that the number of frivolous medical malpractice lawsuits is not as large nor as expensive as many assert. The study showed that nearly one third of claims lacked clear-cut evidence of medical error, but most of these suits did not result in compensation. The number of "meritorious" claims that did not result in compensation was larger than the group of meritless claims that were paid. The authors of the study reviewed 1,452 closed claims from 5 malpractice insurance companies across the country. They focused on 4 clinical categories that account for about 80% of all malpractice claims filed in the United States. Physicians specializing in these clinical areas reviewed the claims and the associated medical records to determine whether the plaintiff was injured from care and, if so, how likely it was to have been due to medical error. They found that almost all of the claims involved a treatment-related injury, and that 63% of the injuries were due to error. Of those, 73% received compensation. The study also found that the costs of litigating claims averaged $52,521 per claim, which amounted to 54% of the compensation paid to plaintiffs, and that it took an average of 5 years from injury to resolution of the claim. Lastly, the researchers determined that eliminating those claims would decrease the system's compensation and administrative costs by no more than 13% to 16%. (Harvard School of Public Health Press Release, Study casts doubt on claims that the medical malpractice system is plagued by frivolous lawsuits, May 10, 2006).

 

Duke University Medical Center researchers have published a study suggesting that patients who undergo surgery late in the afternoon are more likely to experience unexpected adverse events related to their anesthesia than are patients whose operations begin in the morning. However, only a small percentage of the adverse events actually caused harm to the patients. The vast majority of the events involved problems such as postoperative nausea and vomiting, and increased postoperative pain. (Press Release. Time of surgery influences rate of adverse health events due to anesthesia.) (Dukemednews, Duke.edu, August 3, 2006).

 

A report by the Commonwealth Fund Commission on a High Performance Health System released on August 2, 2006, asserts that the US healthcare system fails to deliver adequate value for the large amount of resources devoted to healthcare. The report indicates that problems with the current system include misaligned payment incentives, inadequate information systems, and a system of regulatory oversight that is duplicative and expensive. Recommendations for improving the system include implementing major quality and safety improvements; expanding the use of information technology; rewarding performance for quality and efficiency through payment systems; increasing public reporting on quality and costs; and expanding health insurance coverage.

 

A pilot study has been released regarding the use of radio tagged sponges to avoid instances of retained sponges during surgery. The study reports that despite the practice of counting and recounting sponges and instruments, an estimated one in 10,000 patients leaves surgery with some retained foreign object. In this study, done at Stanford, a wand device to track radio tagged sponges was able to correctly identify all tagged sponges placed in volunteers who were undergoing elective procedures. (MedPage Today, July 17, 2006).

 

A new report from the Institute of Medicine (IOM), entitled Preventing Medication Errors, indicates that at least 1.5 million people are injured every year due to medication errors. The cost of treating these drug-related injuries that occur in hospitals alone amounts to at least $3.5 billion annually. The report found that medication errors are common at every stage of drug delivery, from procuring the drug to prescribing, dispensing, administering it, and monitoring its impact. The report suggests that there is, on average, at least one medication error per hospital patient per day. IOM reports that 400,000 of these preventable drug-related injuries (also known as adverse drug events) occur each year in hospitals; 800,000 occur in long-term-care settings; and about 530,000 occur in outpatient clinics. The report recommends specific steps that physicians, nurses, pharmacists, and other health professionals should take to help reduce these numbers. These steps include: formalize and ensure patients' rights regarding safety and quality in healthcare and medication use; inform patients about clinically significant medication errors made in their care even if they do not lead to harm; educate, consult with and listen to patients about their medications; and utilize electronic prescribing.

 

According to a report by the Office of Inspector General (OIG), hospitals failed to report to the Centers for Medicare and Medicaid Services (CMS) 44 of 104 documented deaths related to restraint and seclusion for behavior management between August 2, 1999 and December 31, 2004. The report also indicates that fewer than one third of the reported deaths were reported in a timely manner, and that CMS and state agencies regularly failed to meet established timeline for taking action on the reports. The report suggests that hospitals may not fully understand this mandatory reporting requirement, as only 52% of the state agencies reported having given information to hospitals about this requirement. As a result of these findings, the OIG has recommended that CMS attempt to establish, through legislation, sanctions for hospitals that fail to report deaths related to restraint and seclusion, consider regulatory changes to require reporting all deaths related to restraints or seclusion, and instruct its regional offices and state agencies to comply with timelines and provide ongoing training to hospitals about this reporting requirement. (Department of Health and Human Services Office of Inspector General, Hospital Reporting of Deaths Related to Restraint and Seclusion (OIG-09-04-00350), September 14, 2006).

 

The US Food and Drug Administration (FDA) and the Institute for Safe Medication Practices (ISMP) have launched a nationwide health professional education campaign aimed at reducing the number of common, but preventable, sources of medication mix-ups and mistakes caused by the use of unclear medical abbreviations. The campaign focuses on eliminating the use of potentially confusing abbreviations by healthcare professionals, medical students, medical writers, the pharmaceutical industry, and FDA staff. It will address the use of mistake-prone abbreviations in all forms of medical communication, including written medication orders, computer-generated labels, medication administration records, pharmacy or prescriber computer order entry screens and commercial medication labeling, packaging and advertising. ISMP has a list of abbreviations, symbols, and dose designations most often associated with medication errors, which is available at http://www.ismp/prg/PDF/ErrorProne.pdf. The campaign urges that this list be used whenever medical information is communicated. (FDA Press Release, June 15, 2006).

 

A report has been released by the American Medical Association (AMA) regarding how healthcare organizations can ensure effective, patient-centered communication with people from diverse populations. This report is the first product of the Ethical Force Program initiative on patient-centered communication. It lists a number of specific, measurable expectations for performance in the areas of:

 

* Understanding the organization's commitment

 

* Collecting information

 

* Engaging communities

 

* Developing workforce

 

* Engaging individuals

 

* Sociocultural context

 

* Language

 

* Health literacy

 

* Evaluating performance

 

 

A copy of the full report can be ordered from EthicalForce@ama-assn.org.

 

Premier, Inc. has released a report showing that improving the care of pneumonia and heart bypass patients could save up to US$1 billion in healthcare costs. The analysis is based on data from Premier's pay for performance demonstration project with the Centers for Medicare and Medicaid Services (CMS). The data shows that if patients receiving a smaller percentage of widely accepted care measures had instead received most of the measures (76 % or more), then hospital costs would have been approximately $1 billion lower. Other projected outcomes include 3,000 fewer deaths, 6,000 fewer complications, 6,000 fewer readmissions, and 500,000 fewer days in the hospital. The clinical quality indicators tracked in this project were:

 

Pneumonia: oxygenation assessment; pneumococcal vaccination; blood culture before first antibiotic; adult smoking cessation counseling; initial antibiotic selection; initial antibiotic within 4 hours of hospital arrival; and flu vaccination.

 

CABG: aspirin prescribed at discharge; prophylactic antibiotic selection for surgical patients; prophylactic antibiotic within 1 hour prior to surgical incision; prophylactic antibiotic discontinued within 24 hours after surgery end time. (Premier, Inc. Press Release, June 20, 2006).

 

The death of a patient in Illinois after a 2-hour wait in a hospital's emergency room waiting room has been declared a homicide by a coroner's jury in that state. The patient, a 49-year-old woman, died of a heart attack. The coroner's jury ruled that her death was also a result of gross deviations from the standard of care. The patient came in complaining of classic symptoms of a heart attack: nausea, shortness of breath, and chest pain. She was seen by a triage nurse 15 minutes after her arrival, and was classified as having a semi-emergent condition. Her daughter asked nurses on 2 occasions after triage was completed when her mother would be seen by a physician. When the patient's name was finally called, she was found by a nurse unconscious and pulseless in the waiting room chair. This case is presently being reviewed by the state attorney's office regarding potential criminal charges. (Death after two-hour ER wait ruled homicide, CNN.com, September 15, 2006).

 

The National Incident Management System (part of the Federal Emergency Management Agency) has released a list of implementation activities for hospitals and healthcare systems. These activities are intended to help hospitals and healthcare systems to improve the efficiency and effectiveness of their ability to handle disasters. The activities are: organizational adoption, command and management, preparedness planning, preparedness training, preparedness exercises, resource management, and communication and information management. A complete description of the implementation activities with fact sheets is available at http://www.fema.gov/emergency/nims/index.shtm.

 

In an article published in the July issue of the Journal of the American College of Surgeons, researchers report that disruptive behavior in operating rooms is prevalent and also can result in negative outcomes for patients. Researchers found that 79% of those surveyed had observed disruptive behavior, including abusive language, yelling, insults, and even physical violence, and that 19% reported these actions had resulted in an adverse patient event. The researchers recommend that hospitals need to recognize that this behavior is a problem and develop codes of conduct that apply to physicians as well as other staff members. (Boodman S, No Place for a Tantrum, Washington Post, August 29, 2006).

 

A Detroit area hospital home care nurse employee's laptop was stolen in August 2006. The computer contained medical and personal information of more than 28,000 of Beaumont Hospital's home care patients. The information included names, addresses, social security numbers, and medical information on discharged patients who had received home care in the last 3 years. The nurse left the computer in her car along with her access code and password, in violation of hospital policy. Forensic examination of the computer after it was recovered indicated that the information was not accessed after the device was stolen, nevertheless, the hospital is offering credit monitoring service for a year to the affected patients. (Norris K, Patients' IDs safe; stolen laptop found, Detroit Free Press, August 24, 2006).

CASES

 

A physician and 2 nurses in Louisiana have been charged with second-degree murder in connection with the alleged deliberate deaths of some patients at Memorial Medical Center in New Orleans after Hurricane Katrina. Watch this column for updates regarding this case. (Three charged with second-degree murder in Katrina hospital deaths, CNN.com, July 18, 2006).

 

An appeals court in New Jersey has held a hospital civilly liable to the sexual partner of a patient for failing to notify the patient of positive HIV test results. The court found that the attending physicians and hospital who failed to notify a patient of his positive HIV test results are civilly liable not only to the patient but also to all reasonably foreseeable individuals who later contract the virus from the patient. C.W. v. The Cooper Health System (No. A-6100-04T2, NJ Super. Ct. App. Div., August 10, 2006).

 

The highest court in New York state has held that a physician who sued his former hospital employer need not exhaust administrative remedies provided under state law where his claims involved money damages only and he did not seek reinstatement of his privileges. The physician contended he was forced to resign after being told he would be "fired" and his termination reported to the National Practitioner Data Bank (NPDB) if he did not comply. Following his resignation, the hospital's risk manager filed a report with the NPDB alleging serious quality of care concerns. The physician argued that his claims were not subject to the statutory administrative grievance process because his dispute was about money damages and not reinstatement of privileges. The court held that the threshold issue turns on whether the dispute is about the physician's competency or ethics to continue to practice, and the kind of relief sought by the physician. Tsadik v. Beth Israel Medical Center (No. 100138-06, NY Sup. Ct., July 12, 2006).

 

A Federal District Court in Pennsylvania has determined that a hospital and its peer review committee are immune under the Health Care Quality Improvement Act (HCQIA) from antitrust and breach of contract claims by a physician whose privileges were suspended based on the peer review committee's recommendations. In December of 1999, the quality assurance committee of the facility's OB/GYN departments began reviewing this obstetrician's charts and identified him as falling outside of the standard of care for that department. In April 2002, the hospital's medical executive committee initiated a formal investigation into this physician's quality of care issues and ultimately voted to suspend his clinical privileges. The physician sued. The court found that the defendants were entitled to immunity because the physician did not show any evidence that the executive committee's actions against him were not taken in reasonable belief that this action would enhance the quality of healthcare. The court noted that the committee based its decision in part on the quality assurance committee's findings of substandard care which it had evaluated over a significant period and which were corroborated by the review of an independent OB/GYN expert. The physician had the burden of proof to show that the facility and its committee was not entitled to the presumption of immunity, and he failed to prove this. The court also rejected the physician's other claims. Bakare v. Pinnacle Health Hospitals, Inc. (No. 1:03-CV-1098, M.D. PA, August 24, 2006).

 

An appeals court in California has held that a nurse working three 12-hour shifts per week is entitled to overtime pay only for hours beyond a 40-hour work week. The nurse had asserted that he was entitled to time and a half pay for all hours he worked beyond the regularly scheduled alternative work week schedule of 36 hours. The court disagreed, and held that the language of section 3(B)(8) Wage Order 5 was clear and unambiguous in indicating that time and a half pay rate for healthcare employees under a 3-day 12-hour schedule was only required for work performed beyond 40 hours in a work week. Singh v. Superior Court of Los Angeles County (No. B187797, Cal.Ct. App. June 12, 2006).

 

The Kentucky Supreme Court has determined that the fact that a patient had signed a written consent form prior to colon surgery precluded her from establishing a claim for medical battery against the surgeons who authorized and performed additional procedures to remove her ovaries and uterus. The patient consulted with one of the defendants regarding the surgical removal of a lesion in her lower colon. The physician recommended a lower anterior resection of the colon, an appendectomy, and a hysterectomy and oophorectomy. Three days after this consultation, the patient presented to the hospital where the surgery was to be performed. A nurse described the risks of the surgical procedure and the patient signed a consent form stating that the physician had explained to her, in laymen's terms, the nature and risks of the surgical procedure. The consent form listed the procedures to be performed as anterior resection of the colon with appendectomy and possible bilateral oophorectomy. The form also contained language authorizing additional procedures that might be medically necessary. During the surgery, the surgeon discovered an abnormally large uterus, which impaired her ability to resect the lesion in the colon. She therefore consulted with a gynecologist, the second defendant, who performed the hysterectomy and oophorectomy while the patient was still on the table. The patient sued both physicians for medical battery, asserting that she had never consented to the removal of her uterus and ovaries. The court found that under the facts of this case, consent was implied for removal of the uterus and ovaries and that no reasonable person would have refused consent to such procedures under the circumstances. The court stated that the existence of a signed consent form gives rise to a presumption that patients ordinarily read and take whatever other measures are needed to understand the nature, terms, and general meaning of the consent, and that to hold otherwise would negate the legal significance of written consent forms signed by the patient and render the consent form completely unreliable. Hoofnel v. Segal (No. 2004-SC-0381-DG, KY, June 15, 2006).

 

A lawsuit has been filed in the US District Court for the District of Columbia by the American Nurses Association (ANA), the New York State Nurses Association, and the Washington State Nurses Association against the Department of Health and Human Services. The lawsuit alleges that the agency allows hospitals that fail to meet federal nurse staffing requirements to participate in Medicare and claims that DHHS unlawfully delegated its authority to JCAHO by allowing JCAHO to use nurse staffing standards that are not equivalent to those set by DHHS for participation in the Medicare program. The suit asks for declaratory and injunctive relief to prevent DHHS from delegating to JCAHO the authority to use its own nurse staffing requirements in accrediting hospitals. The suit asserts that JCAHO nurse staffing requirements are not equivalent to DHHS' conditions of participation in the Medicare program because they do not require the "immediate availability" of a registered nurse to give bedside care to patients. The suit alleges that the failure to require adequate staffing on medical-surgical units harms the public by increasing the likelihood that patients will die and that complications, such as urinary tract infections, pneumonia, shock, and gastrointestinal bleeding, will occur.

 

The Rhode Island Supreme Court has held that documents that did not originate with a peer review committee are not protected from discovery by the statutory peer review privilege. This case involved a wrongful death malpractice case and a claim of negligent credentialing against the hospital. The plaintiff sought production of documents relating to the credentialing or privileges of the physicians involved as well as documents sent to the physicians by any committee investigating or reviewing their request for or renewal of privileges, and all items limiting the physicians' privileges. The hospital objected to producing these documents, asserting peer review, attorney-client, and confidential healthcare information privileges. The court held that these documents were not shielded from discovery except for one report. This report summarized a hospital committee meeting involving whether the physician responded in a timely manner to a patient who needed care, and was determined by the court to qualify as a record of a peer review board, and thus, protected from discovery by the peer review privilege. However, the court also stated that parts of this, document which placed restrictions on the physician's emergency room privileges, were discoverable as long as the document was redacted to hide the summary of key items discussed during the meeting. The court affirmed its previous decisions, which held that the peer review privilege protects only those records and proceedings which originate with the peer review committee. It also noted that a plaintiff asserting a negligent credentialing claim is entitled to discover patient complaints, even when those complaints lead to peer review proceedings, as well as any information about restrictions on a physician's license to form the basis of the negligent credentialing claim. The court returned the case to the trial court to determine whether the attorney-client privilege or the privilege created by the Confidentiality of Health Care Information Act applied to any of the documents. Pastore v. Samson (No. 2004-110-MP, RI, June 16, 2006).

 

A Federal District Court in Ohio has ruled that a physician who resigned his hospital staff privileges when the hospital refused to adjust the on-call emergency room schedule so that he could attend a conference cannot bring antitrust claims against the hospital and its affiliated otolaryngology group practice. The court held that the physician failed to allege sufficient antitrust injury and failed to establish essential elements of his antitrust claims. The court rejected the physician's arguments that the hospital and the group practice conspired to refuse to cover his on-call schedule and therefore forced him to resign. The court determined that the allegations did not assert a marketwide injury nor did they specify any competition reducing effect of the defendants' alleged conduct. Gentile v. Fifth Avenue Otolaryngology, Inc. (No. 4:05-CV-02936-PCE, (N.D. Ohio, August 28, 2006).

 

An appeals court in Kentucky has determined that expert testimony is not needed to prove medical malpractice where the negligence is "obvious" under the facts of the case. The case involved a patient who presented to the emergency room complaining of stomach cramps. A physician did an ultrasound of the gallbladder and diagnosed the patient with gallstones. The next day another physician performed laparoscopic surgery to remove the gallbladder. During the surgery, it was discovered that the patient had no gallbladder; it had been removed by that same surgeon 5 years earlier. The patient sued both physicians for subjecting him to unnecessary surgery. The court found that in light of the fact that the surgeon admitted that he had previously removed the patient's gallbladder, the negligence of both physicians was well within the general knowledge of a layperson, thus expert testimony was not required to prove negligence. Matheney v. Sharpe (No. 2005-CA-001456-MR, KY, July 14, 2006).

 

The Wisconsin Supreme Court has overturned a previous ruling in finding that there is no global noneconomic damages cap in medical malpractice cases in that state involving wrongful death. The court held that plaintiffs could recover for predeath and postdeath pain and suffering claims up to the maximum allowed under the respective medical malpractice and wrongful death statutory caps. This plaintiff had filed a malpractice claim and later died from her injuries. At that point, her husband was substituted in as plaintiff and asserted claims both individually and on behalf of his wife's estate. Plaintiff argued that there should be a distinction between his predeath and postdeath pain and suffering claims for purposes of applying the statutory caps. The court agreed, and thus, overturned a previous case's decision that the state's medical malpractice and wrongful death statutes impose a single global wrongful death cap on all noneconomic damages. The court also agreed with the plaintiff that no cap applied to the $500,000 in noneconomic damages awarded to the estate for predeath pain and suffering claims. Bartholomew v. Wisconsin Patients Compensation Fund (No. 2006 WI 91, July 7, 2006).

 

An appeals court in Florida has determined that a constitutional amendment passed by that state's voters that gives patients the right to access information from healthcare providers regarding adverse medical incidents trumps any statutory privileges that protected this information from discovery during litigation. Florida Hospital Waterman, Inc. v. Buster (No. 5D05-2195, Florida District Court of Appeals, March 10, 2006).

 

The Ohio Supreme Court has held that patents in Ohio may state a claim for negligent failure to diagnose a fetal defect or disease in a child they would have elected to abort, but damages are limited to the costs of pregnancy and birth and do not include the extraordinary expenses the parents would incur as a result of the child's disability. Schirmer v. Mt. Auburn Obstetrics & Gynecologic Associates (No. 2004-0296, Ohio, March 3, 2006).

 

An appeals court in Louisiana has affirmed a jury's verdict that a nurse did not breach the standard of care when she left a recently admitted alcoholic patient unattended to contact his treating physician. The patient was admitted for alcohol withdrawal and was given medications to ease the symptoms. The nurse stepped out of the room (about 7 feet away from where the patient was sitting in his room in a chair) to call the physician to report what she believed were urgent symptoms. The patient tried to run away and was found seizing on the floor. He died the following day from head injuries sustained when he fell to the floor. Ball v. Forest Behavioral Health Systems (No. 41, 329-CA, La Ct. App. August 23, 2006).

 

An appeals court in California has determined that a patient who discovered that her inability to walk following spinal surgery was a permanent condition only after months of physical therapy is not barred by the statute of limitations from bringing a medical malpractice action against the surgeons who performed the surgery and repeatedly assured her that she would in fact be able to walk again. Ramirez v. County of Los Angeles (No. B186419, Cal. Ct. App. August 29, 2006).

 

An appeals court in Florida has found that a patient's lack of choice of anesthesiologists was sufficient to create an issue of fact, which would have to be decided by a jury, as to whether the hospital had apparent authority over its independent contractor anesthesiologists. Jones v. Tallahassee Memorial Regional Healthcare, Inc. (No. 1D04-4656, Florida District Court of Appeal, March 23, 2006).

 

The Illinois Supreme Court has determined that a patient who was injured by an independent contractor anesthesiologist during surgery does not need to establish detrimental reliance in order to support a vicarious liability claim against the hospital where the surgery was performed based on apparent agency. The court rejected the hospital's assertion that a plaintiff who did not know the employment status of a physician but would have nonetheless selected the same hospital should not be able to recover on an apparent agency theory. The court also rejected requiring the plaintiff show a "but for" causal connection between the holding out (failing to inform patients that care was provided by independent contractors) by the hospital and the injury suffered by the plaintiff. The court held that the reliance element of the plaintiff's apparent agency claim is satisfied if the plaintiff reasonably relies on the hospital to provide medical care, rather than upon a specific physician; even when the patient selects a particular physician to perform certain procedures, the patient may reasonably rely on the hospital to provide other support services such as radiology, pathology, and anesthesiology. The court found sufficient evidence that the plaintiff came into contact with the negligent physician because he relied on the hospital to provide the anesthesiologist. York v. Rush-Presbyterian-St. Luke's Medical Center (No. 99507, June 22, 2006).

 

An appeals court in Mississippi has determined that a hospital did not violate the standard of care when it deviated from internal and national guidelines because the deviations were the result of reasoned medical analysis. The case involved a patient admitted with severe burns to 18% of his body who developed a bedsore on his tailbone. The claim asserted that the hospital's employees negligently failed to turn him at regular intervals, which resulted in the bedsore. National guidelines recommend that a patient at risk for skin breakdown be turned by staff at least once every 2 hours. The evidence showed that under hospital policies, the nurses and physicians have discretion to deviate from guidelines if warranted by the patient's condition, and showed that the patient's condition did in fact warrant such a departure. The evidence showed the patient needed to be kept in a supine position in order to keep his airway clear and it was determined that an open airway was more important than preventing bedsores. The court felt this was sufficient to establish that the departure was the result of reasoned medical analysis. Vede v. Delta Regional Medical Center (No. 2004-CA-01418-COA).

 

The Second Circuit court of appeals has held that the Protection and Advocacy for Individuals with Mental Illness Act (PAIMI) requires disclosure of all records including peer review materials to protection and advocacy systems monitoring the care of persons with disabilities and mental health disorders. The court found there was no conflict between the Connecticut law, which protects peer review documents in the context of civil litigation, and PAIMI because the records in this case were requested as part of a statutorily authorized investigation and not in litigation. Protection and Advocacy for Persons with Disabilities v. Mental Health and Addiction Services (No. 05-1457-CV, 2nd Circuit, May 5, 2006).

 

A Federal Court in Alabama has determined that a Centers for Medicare and Medicaid Services (CMS) investigation report was admissible in a lawsuit brought by a pregnant woman against a hospital alleging violation of the Emergency Medical Treatment and Active Labor Act (EMTALA). The patient was involved in a car accident when she was 38 weeks pregnant. Her physician advised her to go to Medical Center Enterprise hospital (MCE). She went to that hospital's emergency room and advised the clerk that she was pregnant and had been involved in a car accident earlier in the day, and was having contractions 2 minutes apart. She was asked to wait and then was called over to the clerk's desk and was told that the on-call obstetrician was being contacted by the labor and delivery nurse and that the obstetrician would decide whether or not he would see her because she was not a regular OB patient at the hospital. The patient opted to leave the facility and see her regular obstetrician. The patient then complained to CMS regarding the treatment she received at the facility. CMS investigated MCE's treatment and determined that it violated a number of federal regulations. The patient later sued the hospital, alleging that it violated EMTALA. The hospital moved for summary judgment. In opposition, the patient submitted exhibits related to CMS's investigation. The hospital asked the court to strike this evidence. The Federal court determined that the reports were admissible except for the portions which offered legal conclusions about the facility's conduct. Henderson v. Medical Center Entrerprise (No. 1:05-cv-823-MEF, M.D. AL, August 14, 2006).

 

A New York appeals court has reversed a lower court's ruling that a hospital could not demonstrate evidence of parental negligence in defending a medical negligence case arising from allegedly negligent emergency room treatment of a child. The appeals court held that precluding all evidence of parental negligence (in this case, failure to follow the emergency room discharge instructions) could prevent the hospital from showing that it satisfied the standard of care by discharging the child with specific instructions to the parent to follow up the next day with the child's pediatrician and to return to the emergency room if the child developed new symptoms or his condition became worse. Vaughan v. Saint Francis Hospital (No. 99283, N.Y. App. Div., May 11, 2006).

 

A physician in Missouri was not able to establish that he was a whistle-blower for complaining regarding his medical group's compensation policy. The doctor was a shareholder of the group, and after 14 years of membership, complained that the group's compensation formula violated federal Stark law. Six months later, two thirds of the group's board of directors voted to terminate his employment. After his termination, the physician sued the group and members of the board, alleging that his termination violated public policy because he was a whistle-blower. The court indicated that the reporting of possible violations of Stark laws to the group (ie, the purported wrongdoers) did not meet the criteria of whistle-blowing because it did not further the public policy goal of encouraging workers to report suspected wrongdoing to the proper authorities. Scott v. Missouri Valley Physicians (No. 05-4463, 8th Cir. August 17, 2006).

 

Four class action lawsuits have been filed in federal courts in New York, Illinois, Tennessee, and Texas, alleging that hospitals have conspired to keep the wages of their nurse employees at artificially low levels. The suit asserts that the hospitals have agreed to regularly exchange detailed and nonpublic information about the compensation each is paying or will pay to its registered nurse employees which has facilitated the formation, implementation, and enforcement of defendants' wage-fixing conspiracy in violation of the Sherman Act. The case suggests that in New York, nurses have, on average, been underpaid by $6,000 per year; Illinois by $5,000 per year; Texas by $1,300 per year; and Tennessee by $14,000 per year. (Four class action suits filed against major hospital systems alleging conspiracy to depress nurse wages, Health Lawyers Weekly, June 23, 2006).

 

An Alabama woman will be allowed to pursue an EMTALA claim against Medical Center Enterprise Hospital after a federal court found that a jury could reasonably decide that the hospital failed to give her an appropriate screening and unreasonably delayed her treatment while pregnant. The plaintiff was in a car accident at about 38 weeks of pregnancy. Her physician advised her to go to MCE as it was the closest hospital to where she lived. She presented to MCE's emergency room and advised the clerk that she was pregnant, had been in a car accident earlier that day, and was having contractions every 2 minutes. She was asked to wait. She was then called back to the clerk's desk and told that the on-call obstetrician was being contacted by labor and delivery and that the obstetrician would have to decide if he would see her or not since she was not an established obstetric patient of the hospital. The patient decided to leave the facility and see her regular physician. She then sued the hospital for violating EMTALA. The court noted that the hospital violated its own policy for obstetrical patients presenting to the ER, which indicated that any patient over 20 weeks of gestation, who had been in a car accident, should be evaluated by an ER physician prior to being sent to labor and delivery, since no ER physician ever saw her. The court also felt a jury could find that the patient was treated differently from other patients presenting with the same symptoms because her physician did not practice at the facility, which would violate the hospital's duty under EMTALA to provide a medical screening examination. The court also felt that a jury could determine that having to wait for the obstetrician on call to decide whether or not he would agree to see her caused an unreasonable delay in her screening or treatment. The court rejected the hospital's argument that by leaving the facility, the patient withdrew her request for treatment, and indicated that questions of fact remained as to whether the hospital met its obligations under EMTALA to the patient assuming she was refusing treatment at that point in time when she left the facility. Henderson v. Medical Center Enterprise (No. 1:05-cv-823-MEF, M.D. Alabama, August 14, 2006).

 

University of Southern California (USC) has filed a lawsuit to order a Tenet Healthcare Corporation subsidiary to give up ownership and control of USC University Hospital. The University asserts that the lease and operating agreement between Tenet and USC allow USC to terminate the agreement if there is an "event of default" on the part of Tenet. The suit asserts that the disputes and litigation Tenet and its subsidiaries have been involved in over the last 4 years have caused Tenet to alter its funding and capital investment for the facility, and that its resulting poor reputation has decreased its ability to maintain patient admissions and recruit and retain physicians. (USC News Release, August 22, 2006).

SETTLEMENTS/VERDICTS

 

Odyssey Health Care, a national hospice provider, has paid the United States $12.9 million to settle allegations that it submitted false claims to Medicare. The United States alleged that Odyssey billed Medicare for services provided to patients who were not terminally ill, and thus, were not eligible for hospice care. A former regional vice president for the company will receive $2.3 million under the whistle-blower provisions of the False Claims Act. Odyssey has also agreed to enter into a corporate integrity agreement with DHHS' OIG to address the company's compliance practices. (Department of Justice Press Release, July 14, 2006).

 

A medical center in Louisiana has agreed to pay the US government $3.8 million to settle claims it defrauded Medicare, Tricare, and Medicaid by submitting claims for medically unnecessary elective angiograms, medically unnecessary elective angioplasties, and medically unnecessary elective stenting procedures. A whistle-blower will receive $760,000 of this settlement under the False Claims Act. (Department of Justice Press Release, August 17, 2006).

 

A South Carolina medical center has agreed to pay the United States $3.75 million to resolve allegations that it paid kickbacks to physicians in return for referrals of Medicare patients and others covered by Federal health insurance programs. United States v. Marion County Medical Center (12 No. 2 Andrews Health Care Fraud Litigation Reporter 10, August 8, 2006).

 

Kaiser Foundation Health Plan has agreed to pay $5 million to resolve state charges that it failed to maintain adequate oversight at its Northern California kidney transplant center. Of that amount, $2 million will satisfy a fine levied by the state's Department of Managed Health Care (the largest ever assessed by that agency) and $3 million will be applied to an organ and tissue registry program to be used for an outreach campaign to bolster organ donation. The DMHC found that the program did not have the administrative resources to take in patients from other programs, was too slow in making specialists available to patients, and failed to adequately oversee its medical group and kidney transplant program. (Press release, Department of Managed Health Care, August 10, 2006).

 

A case against Sutter Health by a class of uninsured patients, alleging that Sutter charged the uninsured excessive and unfair prices for medical treatment and engaged in aggressive and unfair collection practices, has been settled. The agreement entitles class members to make a claim for refunds or deductions of between 25% and 45% from their prior hospital bills. Sutter also agreed to maintain discounted pricing policies for the uninsured for the next 3 years and to implement more compassionate collections policies. (Uninsured settle pricing lawsuit with Sutter Health, Health Lawyers Weekly, August 11, 2006).

 

Tenet Healthcare Corporation has agreed to pay the US Government $21 million as well as sell or close Alvarado Hospital Medical Center, Inc. in exchange for the dismissal of all criminal charges against the hospital, its former chief executive officer, and the Tenet subsidiary that owns the facility as well as an agreement by the government not to pursue civil action. This facility has been the focus of 2 criminal trials against Tenet based on allegations that the hospital paid kickbacks to physician practices in San Diego to induce patient referrals. The 2 criminal trials resulted in mistrials after both juries were unable to reach a verdict.

 

A hospital in New Jersey will pay $265 million to settle a claim that its 8-hospital system overcharged Medicare for outlier cases from 1995 to 2003. Two separate whistle-blower cases alleged that St. Barnabas Health Care System inflated its cost-to-charge ratio, triggering higher outlier payments than the system was entitled to receive. The settlement also includes a 6-year corporate integrity agreement requiring annual audits of hospital diagnosis related group charges, reports to the government and staff training. (Modern Healthcare Alert, N.J. System to pay $265 million in outlier case, June 15, 2006).

 

A hospital in the Chicago area has settled a shoulder dystocia case for $2.9 million. The plaintiff alleged permanent injury to her left arm and hand at birth. Burnett v. Weaver (13 No. 11 Andrews Health Law Litigation Reporter 7, March 22, 2006).

 

Tenet has settled a claim in Florida alleging it falsely inflated its 2000-2003 hospital charges to obtain Medicare reimbursements. This $7 million settlement resolved a civil suit brought last year by the state's attorney general on behalf of 13 county hospital districts within the state. (13 No. 11 Andrews Health Law Litigation Reporter 7, March 22, 2006).

 

In another matter, Tenet has agreed to pay more than $900 million to resolve False Claims Act allegations involving its billing practices consisting of allegations that its hospitals received excessive outlier payments, that it paid kickbacks to physicians to get Medicare patients referred to its facilities, billed Medicare for services that were ordered or referred by physicians with whom it had an improper financial relationship, and engaged in "upcoding" to increase reimbursement. In addition, Tenet agreed to enter into a multiyear corporate integrity agreement, and to retain an independent review organization to evaluate its ongoing compliance with Medicare coding, physician financial relationships, setting of hospital charges, and quality of care. (Department of Justice Press release, June 29, 2006).

 

In September 2006, Tenet and the Office of Inspector General for the Department of Health and Human Services executed the corporate integrity agreement referred to in the above settlement. The agreement, lasting 5 years, will require the compliance of Tenet, its wholly owned subsidiaries and affiliates, and all hospitals and other healthcare facilities managed or controlled by Tenet. The agreement requires Tenet to implement a comprehensive compliance program, including corporate, regional, and hospital compliance officers; compliance policies and training; an employee hotline and reporting mechanism; and mandatory reporting and repayment of overpayments. The system is also required to hire independent review organizations to review its DRG claims, outlier payments, physician relationships, and clinical quality management. The agreement also includes provisions which are noted to be unprecedented, and which require the Quality, Compliance, and Ethics Committee of its Board of Directors to undertake a review of the effectiveness of its compliance program and to adopt resolutions regarding this review. Tenet must submit annual reports to OIG, including certifications by its officers that the company is in compliance with the requirements of the Federal healthcare programs. In exchange, the OIG will release and refrain from instituting any administrative action seeking Tenet's exclusion from participation in Medicare, Medicaid, and other Federal healthcare programs for the investigated conduct. (OIG Press Release: OIG executes Tenet corporate integrity agreement unprecedented provisions include board of directors review, September 28, 2006).

 

The New Hampshire Supreme Court has reversed a jury verdict of $2.3 million in damages awarded by a jury to parents in a wrongful birth case against Dartmouth Hitchcock Medical Center. The court found that the evidence overwhelmingly supported the conclusion that the hospital did not negligently fail to warn the parents of an increased possibility of birth defects. Hall v. Dartmouth Hitchcock Medical Center (No. 2004-708, NH, April 25, 2006).

 

Beverly Enterprises, Inc. has agreed to pay the federal government and the State of California $20 million to settle claims that its former subsidiary, MK Medical, violated the False Claims Act. The government claimed that MK Medical submitted false claims for payment to Medicare and Medi-Cal from 1998 to 2002, billing for durable medical equipment without obtaining proper claims and medical documentation. (Department of Justice Press release, August 18, 2006).

 

Harlem Hospital Center in New York City has agreed to pay $2.3 million to settle a civil billing fraud suit. The suit alleged the hospital was double billing Medicare for outpatient services, and that the hospital's managers knew this as early as July 1997 but failed to take substantial action to correct the problem. United States v. Harlem Hospital Center (11 No. 12 Andrews Health Care Fraud Litigation Reporter 5, June 13, 2006).

 

A nursing home chain in Michigan has agreed to pay $78,000 to settle a civil lawsuit brought by that state's attorney general alleging that its facilities had been providing inadequate care to residents. Cox v. Miko Enterprises (11 No. 12 Andrews Health Care Fraud Litigation Reporter 5, June 13, 2006).

LEGISLATION

 

Legislation (SB 1204) has been sent to California's governor which would require hospitals to have a "zero-lift" policy. The bill, intended to prevent workplace injuries among caregivers, would require hospitals to have specialized equipment to move patients and provide special training to workers on "lift teams." Similar past legislation has been vetoed. Watch this column for updates on whether this bill is signed into law.

 

The state of Colorado has passed legislation to join the nurse licensure compact, and will begin the rule writing process to work toward implementation of the compact in 2007. Colorado becomes the 23rd state to join this compact. (AONE Voice of Nursing Leadership, July 2006).

 

The Comprehensive Immigration Reform Act (S. 2611), which includes several provisions to address healthcare workforce shortages, has passed the Senate. The bill would extend permanently the State 30 J-1 visa program, which allows foreign workers training in a US residency program under a J-1 visa to remain in the country after completing their studies if they agree to practice in an underserved rural community for 3 years. The bill would also allow more qualified internationally trained nurses to work in the United States. Currently, 140,000 employment-based visas are available each year for skilled professionals, subject to per-country caps. The bill would exempt nurses and physical therapists from the caps through 2017. During that period, the Department of Health and Human Services and Institute of Medicine would study staffing issues and recommend to Congress ways to increase the domestic supply of nurses and physical therapists. The Senate version will need to be reconciled with the House bill on the same issue which was passed last December. (AHA News Now, May 26, 2006).

 

Two bills (S. 1337 and HR 1546) are currently pending in Congress that would create specialty health courts or tribunals to hear and decide medical malpractice claims. The bills would also impose damages caps for certain types of claims. These bills are being opposed by the American Bar Association. Watch this column for updates on the status of this legislation.

 

A new law in Vermont requires hospitals to make information on patient and staff levels publicly available. The law gives patients the right to know staffing levels for registered nurses, licensed practical nurses, and licensed nurse assistants as well as the maximum number of patients on those units during each shift. Hospitals will also be required to post nurse staffing levels and maximum patient census by nursing unit and by shift at least once daily. (AHA News Now, May 23, 2006).

JCAHO

 

JCAHO has released its 2007 National Patient Safety Goals and related requirements. Major changes include extension of a requirement that accredited organizations define and communicate the means for patients and their families to report concerns about safety. A new requirement indicates that behavioral healthcare organizations, psychiatric hospitals, and patients being treated for emotional or behavioral disorders in general acute care hospitals must identify patients at risk for suicide. Home care organizations will be required to identify risks associated with long-term oxygen therapy, and all organizations will be required to provide a complete list of current medications to each patient on discharge from care. (JCAHO Press Release, June 12, 2006).

 

A study released by JCAHO in August 2006 indicates that there are many hospitals across the country where patients can receive quality heart care. The study found that this care was widely available outside of hospitals ranked as the best for heart care by U.S. News & World Report. The hospitals were compared using measures based on clinical treatment guidelines from the American College of Cardiology and the American Heart Association. Researchers found that 13 hospitals not on the magazine's list of 50 best heart and heart surgery hospitals actually did better than any of the top 41 ranked hospitals in adhering to the treatment guidelines, and that of 774 hospitals evaluated in this study, 313 nonranked hospitals did as well as the top half of ranked hospitals. (JCAHO News Release, August 18, 2006).

BIBLIOGRAPHY

 

Reece RL. Managing malpractice risk. Hosp Health Netw Online. August 22, 2006.

 

Shepherd J. A hospital risk manager's story: surviving Hurricane Katrina. ASHRM J. 2006;26:15-21.

 

Bate A. After disaster: using Katrina's lessons to manage future risk. ASHRM J. 2006;26:22-25.

 

Lyndon A. Communication and teamwork in patient care: how much can we learn from aviation? JOGN Nurs. 2006;35:538-546.

 

Simpson K, James D, Knox E. Nurse-physician communication during labor and birth: implications for patient safety. JOGN Nurs. 2006;35:547-556.

 

Harris K, Treanor C, Salisbury M. Improving patient safety with team coordination: challenges and strategies of implementation. JOGN Nurs. 2006;25:557-566.

 

Wolfson H, Gilbert E. Statutory Immunity for Reports Filed with the National Practitioner Data Bank-what is "accurate" reporting for purposes of immunity. The Health Lawyer. August 2006;18:24-27.

 

Larkin H. 12-step disaster plan, what every hospital needs to know before trouble starts. Hosp Health Netw. May 2006;80:46-48.

 

Thorman K, Capitulo K, Dubow J, Hanold K, et al. Perinatal patient safety from the perspective of nurse executives: a round table discussion. JOGN Nurs. May/June 2006;35:409-416.

 

Will S, Hennicke K, Jacobs L, et al. The perinatal patient safety nurse: a new role to promote safe care for mothers and babies. JOGN Nurs. May/June 2006;35:417-423.

 

McCartney P. Using technology to promote perinatal patient safety. JOGN Nurs. May/June 2006;35:424-431.

 

Simpson K. Measuring perinatal patient safety: review of current methods. JOGN Nurs. May/June 2006;35:432-442.

 

Huff C. Emotional debriefing: hospitals give staff new ways to cope with stress and sadness at work. Hosp Health Netw. August 2006;80:39-42.

 

Veltman L. Vaginal birth after cesarean section (VBAC): issues for the risk manager. ASHRM J. 2006;26:9-13.

 

West J. Surgical "never events:" how common are adverse occurrences? ASHRM J. 2006;26:15-21.

 

Cherouny P, Federico F, et al. Idealized design of perinatal care. ASHRM J Suppl. 2006;26:9-17.

Section Description

 

This column provides executive summaries of developments in legal and regulatory issues related to healthcare, lists a bibliography of pertinent healthcare law-related articles, and discusses interesting health law court decisions.