1. Cady, Rebecca F. RNC, BSN, JD

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The Agency for Healthcare Research and Quality (AHRQ) has released a list of 10 patient safety tips for hospitals, derived from studies performed regarding patient safety over the last 5 years. The full text of the tips, along with references for each, is available at AHRQ's tips:


1. Survey staff to assess and improve the culture of patient safety.


2. Limit medical residents' shift lengths.


3. Eliminate 30-hour shifts for medical interns in the ICU.


4. Adopt changes to reduce ventilator-associated pneumonia in ICU patients.


5. Conduct surgical instrument and sponge counts before and after surgery and use x-rays to verify counts.


6. Maintain appropriate staffing levels in ICUs on all shifts to prevent airway tube complications.


7. Make personal digital assistant-based drug information readily available at the point of care.


8. Use free software tool, the Medication Safety Best Practices Guide, to improve medication safety in ambulatory care.


9. Use a computer-based order entry system to reduce catheter-related urinary tract infections.


10. Minimize interruptions and distractions in nursing staff routines.



A Wisconsin nurse has been charged with criminal neglect of a patient in the medication error-related death of a 16-year-old woman during labor. The nurse, apparently, accidentally gave a bag of epidural analgesia instead of the intended bag of penicillin intravenously. The Wisconsin Hospital Association, Wisconsin Nurses Association, and several other associations have voiced their opposition to criminal charges for medication errors. Watch this column for updates related to this case.


The Centers for Disease Control has released guidelines for preventing the spread of multi-drug-resistant infections in healthcare settings. They are available at


Troubled Alvarado Hospital Medical Center is to be purchased by Plymouth Health, a newly formed physician-owned company based in San Diego, which will continue operating the facility as an acute care facility with 24-hour emergency room services. (San Diego Daily Transcript, October 27, 2006).


According to an article published in Hospitals and Health Networks, some experts believe that as many as 90% of hospital-acquired infections could be prevented if hospitals paid more attention to hygiene and standardized how ICU patients get care. The article makes suggestions for reducing hospital-acquired infections, including the following:


1. Use alcohol-based hand rubs.


2. Keep surgical patients warm during surgery.


3. Clip versus shaving operative site.


4. Give prophylactic antibiotics within 1 hour of surgery start.


5. Provide good oral hygiene to patients on ventilators.


6. Keep head of ventilator patient elevated between 30[degrees] and 45[degrees].


7. Use silver alloy-coated urinary catheters if patient will require catheter for 2 to 3 weeks.


8. Monitor patients for antibiotic resistant bacteria.


9. Vaccinate staff for flu.



(D. Scalise, Save Lives Now, 30 things you can do to eliminate infections. Hospitals and Health Networks 80(9):33-40, September 2006).


A recent study in New York City measured participants' satisfaction with mediation of medical malpractice lawsuits. The data indicate that all parties were satisfied with the process regardless of whether settlement was reached. Of the 19 cases that were mediated, 13 settled, with a median payment of $111,000. Both sides' attorneys estimated that they spent only 1/10th of the time preparing the case for mediation that they would have spent preparing for trial. (Hyman, C. and Schechter, C. Mediating Medical Malpractice Lawsuits Against Hospitals: New York City's Pilot Project. Health Affairs 25(5):1394-1399, 2006).


A hospital at which lethal doses of a drug were given to 3 premature babies has experienced another medication mistake, this time involving a new mother being given a painkiller 10 times faster than intended, making her temporarily unable to walk. The error was caused by an improperly programmed epidural medication pump. The error was made by the anesthesiologist who administered the epidural. (Associated Press, Hospital makes mistake again, October 15, 2006).


The Department of Justice has announced a record $3.1 billion in fraud recoveries for fiscal year 2006. The majority (72%) of these recoveries were healthcare related. (DOJ Press release, November 21, 2006).


The American Hospital Association has issued a regulatory advisory related to the NLRB guidelines for supervisory status discussed below in the Oakwood case. The advisory is available on the organization's Web site,


A panel in New York State has advised the governor to close 9 hospitals across the state and to reconfigure, affiliate, or convert 48 others. The plan will become law unless the Governor or the state legislature rejects the proposal. (AHA News Now, November 28, 2006).


Health officials in Boston have ordered Children's Hospital Boston to improve its process for informing the city's public health commission of disease outbreaks after the facility failed to quickly notify the agency about a whooping cough outbreak among staff in October 2006. Massachusetts state law requires that infectious disease clusters be reported within 24 hours, but officials did not learn of this outbreak affecting 33 employees until several weeks after the fact. The hospital had, however, acted internally to identify and contain the cluster. (Associated Press, Boston faults Children's for failure to report cough outbreak, November 28, 2006).


A study published in the November issue of the Annals of Emergency Medicine suggests that naps taken by emergency room doctors and nurses in the middle of an all-night shift may improve performance. The physicians and nurses who participated in the study took a 40-minute sleep break in the middle of their all-night shift, and performed substantially better on tests of mood, alertness, and performance than colleagues who did not take a nap. (Scripps Howard News Service, November 13, 2006).


The National Quality Forum has released an updated list of serious reportable events in healthcare. Eleven states, including Minnesota and California, use the report in whole or in part as the basis of their state-based public reporting system. The list presently encompasses 28 serious reportable events. The list is available at


A survey released in October 2006 by Press Ganey indicates that hospital patients' experiences are most influenced by the hospital staff's ability to respond to their concerns and complaints. The top concerns for patients were determined to be:


1. the amount of attention paid to a patient's special or personal needs


2. staff sensitivity to the inconvenience caused by health problems and hospitalization


3. staff efforts to include the patient in decisions about their treatment


4. how well nurses kept them informed.



(Press Ganey, Press Release, October 4, 2006).


A study released in October 2006 in the Annals of Internal Medicine suggests that basic errors made by physicians, including tests ordered too late or not at all and failure to create follow-up plans, played a role in nearly 60% of cases in which patients were allegedly hurt by missed or delayed diagnoses. (Associated Press, Study links doctor errors, bad diagnoses, October 2, 2006).



New Jersey has become the first state to pass a law mandating screening and education for postpartum depression in postpartum care up to 3 months after delivery. (AWHONN News, Fall 2006).



Indiana's state board of health has adopted rules requiring that hospitals in that state disclose their errors to the public. The rules lists 27 mistakes that hospitals and surgery centers must report to the state within 15 days of confirming they were at fault and up to 6 months after a mishap. The list includes things such as wrong-site surgery, deaths from contaminated drugs, and sexual assaults on patients. (Hupp, S. Hospital errors to go public in 2007, Indianapolis Star, September 21, 2006).


The Centers for Medicare and Medicaid Services has finalized a proposal to relax 4 current requirements or conditions for participation in the Medicare and Medicaid programs. The final rule will become effective on January 26, 2007. It gives hospitals up to 30 days before a patient's admission or 24 hours after admission to complete a medical history and physical examination and allows more healthcare professionals to perform the examination. The record of the examination must be entered into the medical record within 24 hours after admission. The rule also indicates that for a 5-year period beginning with the date of publication of the final rule, all orders, including verbal orders, must be dated, timed, and authenticated promptly by the prescribing practitioner or another practitioner responsible for the care of the patient, even if the order did not originate with him or her. After the 5-year period, the requirement will be that all orders, including verbal order, be dated, timed, and authenticated by the prescribing practitioner. In the absence of a state law specifying the time frame for authentication of verbal orders, the rule requires authentication within 46 hours. The regulation will also require hospitals to secure all drugs and biologicals, and will permit any individual who is qualified to administer anesthesia, rather than the person who administered it, to conduct the postanesthesia evaluation. (AHA News Now, November 29, 2006).


The Centers for Medicare and Medicaid Services has issued a final rule regarding how hospitals must notify Medicare beneficiaries who are hospital inpatients about their hospital discharge appeal rights. Notice is required both for original Medicare beneficiaries and for beneficiaries enrolled in Medicare health plans. The final rule requires that hospitals use a revised version of the Important Message from Medicare, an existing statutorily required notice, to explain the discharge rights. Hospitals must issue the notice within 2 days of admission and must obtain the signature of the beneficiary or his or her representative. In cases where the notice is delivered more than 2 days before discharge, hospitals will be required to given the beneficiary a copy of the signed notice before discharge. For beneficiaries who request an appeal, the hospital or health plan will deliver a more detailed notice. The new process will be implemented on July 1, 2007. (CMS-4105-F, Final Rule: Notification of Hospital Discharge Appeal Rights).


The Centers for Medicare and Medicaid Services has published a final rule regarding patients' rights in use of restraints and seclusion. Under this rule, healthcare workers who employ physical restraints and seclusion must undergo new, more rigorous training to assure the appropriateness of the treatment and to protect patient rights. The rule specifies components of the training and expands the category of practitioners who may conduct patient evaluations when a restrain or seclusion tactic has been implemented. The rule requires that a patient be evaluated face to face within an hour of being restrained or secluded for the management of violent or self-destructive behavior by a physician, trained registered nurse, or physician assistant. However, if an RN or PA performs the 1-hour evaluation, the physician or other licensed independent practitioner must be consulted as soon as possible. The patient rights included in this rule consist of notification of the patient's rights in regard to their care, privacy and safety, confidentiality of their records, and freedom from the inappropriate use of all restraints and seclusion in all hospital settings. Hospitals must provide the patient or family member with a formal notice of their rights at the time of admission, to include freedom from restraints and seclusion in any form when used as a means of coercion, discipline, convenience of the staff, or retaliation. The rule also adopts stricter standards for when a facility must report the death of a patient associated with the use of restraints and seclusion. The rule becomes effective February 6, 2007.


CMS has revised existing EMTALA regulation. These revisions adopt the definition of "labor" as set forth in the proposed rules issued in April 2006. The modified definition expands the scope of healthcare providers who can certify that a woman is in false labor to include nurse midwives and other qualified medical personnel operating under his or her scope of practice as defined in hospital medical staff bylaws and state law. The rule also clarifies that all Medicare participating hospitals with specialized capabilities, including specialty hospitals, must accept appropriate transfers of unstable individuals, regardless of whether they have an emergency department. (CMS 2007 IPPS Final Rule, August 1, 2006).



JCAHO has revised its contracts with the organizations that report hospital performance data to require additional patient-level data that will not identify the hospital. The changes will take place beginning with the second quarter 2007 core measure data. At that time, performance measurement systems will be expected to report hospital-specific aggregate data for 3 measure sets plus a 100% sample of anonymous patient-level data for all performance measures in the measure sets. Currently, JCAHO requires organizations to report hospital-specific aggregate data for 3 measure sets plus a 20% sample of de-identified patient-level data for 4 outcome measures. (AHA News Now, November 29, 2006).


JCAHO has released the 2007 Medical Staff Standards for Hospitals. The revised standards include a concept of general competencies developed by the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties. The competencies include patient care, medical/clinical knowledge, practice-based learning and improvement, interpersonal and communication skills, professionalism, and systems-based practice. The standards also include a new concept of focused processional practice evaluation, a process that permits organized medical staffs to concentrate assessment on a particular facet of a practitioner's performance. This model is intended to be used when a practitioner has credentials demonstrating competence, but additional data or another evaluation period is needed to corroborate competence in that hospital's particular setting. This model is also intended to be used if questions develop about a provider's professional practice during the ongoing professional practice evaluation. This evaluation is a change from a cyclical model of credentialing and privileging to an ongoing process, which mandates the continuous assessment of every provider's professional performance. The rationale is that this ongoing process will permit earlier detection and resolution of possible performance issues, as well as promote a more effective, evidence-based privilege renewal procedure.



A Miami hospital, along with its current and former owners, has agreed to pay $15.4 million to resolve fraud claims involving kickbacks and medically unnecessary treatments. This settlement resolves the civil case filed by the government in 2004, entitled U.S. v Jack Jacobo Michel, M.D. et. al. (DOJ Press Release, November 30, 2006).


A psychiatric hospital in California has asked a federal judge to vacate the $23 million Medicare fraud judgment awarded against it or alternatively to reduce the amount to $30,000. The facility asserts that the judge failed to adjudicate key issues in the underlying case. U.S. v Bourseau (12 No. 5 Andrews Health Care Fraud Litigation Reporter 2, November 8, 2006).


A court has sentenced the former owner of 2 large California home health agencies to nearly 4 years in prison for her part in a $40 million Medicare fraud case involving kickbacks to physicians and patients under the terms of a plea agreement the owner reached with the U.S. Attorney's office. U.S. v Perez (12 No. 5 Andrews Health Care Fraud Litigation Reporter 6, November 8, 2006).


Defendants in a Missouri fraud case have pled guilty to charges of conspiring to defraud the US government by chronically understaffing 3 nursing homes, leading to substandard and neglectful care for which they billed Medicare and Medicaid. U.S. v Wachter (12 No. 5 Andrews Health Care Fraud Litigation Reporter 9, November 8, 2006).


The operators of 5 Massachusetts nursing homes have been indicted on charges of diverting funds from the facilities for their own use while residents suffered from widespread neglect. Massachusetts Nursing Home's ex-operators indicted for fraud, neglect (12 No. 5 Andrews Health Care Fraud Litigation Reporter 10, November 8, 2006).


The Supreme Court of Virginia has upheld a medical malpractice damages award of $1.6 million to the mother of a severely neurologically impaired child for her own injuries suffered during the birth. Her injuries were alleged to include physical injuries, mental anguish, and lost income. The court found that it was not error for the trial court to allow a jury instruction indicating that injury to an unborn child is physical injury to the mother. The court also found that evidence related to the extent of the child's impairments and the nature of the care the mother has to provide to him were relevant to the issue of her continuing mental anguish over the child's impairments. Castle v Lester (No. 052679, Virginia, November 3, 2006).


The Supreme Court of Virginia has also upheld a $1 million judgment against a hospital for failing to institute sufficient fall prevention measures for an elderly patient who suffered a fractured hip after falling. The patient had been admitted for weakness, disorientation, and dehydration, all related to lymphoma, with which she had been diagnosed 10 years prior. On admission, the intake form completed by hospital staff did not identify the patient as a high fall-risk patient and therefore no fall prevention procedures were initiated for her. Plaintiff claimed that the hospital was aware of numerous patient falls at its facility and negligently failed to implement restraint, a bed alarm, or other precautions for plaintiff. The hospital asserted that it was an error for the trial court to admit statistical evidence about patient falls in the general hospital population as well as information in a report by the hospital regarding other falls at the facility. The Supreme Court rejected that contention based on the hospital's failure to object at the time of trial. The court also determined that it was appropriate to admit into evidence certain internal quality control reports of a factual nature about patient care incidents kept in the normal course of business of the treatment facility. The court rejected the hospital's argument that these reports qualified as privileged material exempt from disclosure under the state's peer review statutes. The court did not feel that these reports were reports of a quality assurance or quality of care committee entitled to privileged status under state law. The court felt these documents were more appropriately characterized as incident reports made and kept in the normal course of the operation of the hospital, and therefore, fell within an explicit statutory exception to the privilege provided by state law. Riverside Hospital, Inc. v Johnson (No. 060392, Virginia, November 3, 2006).



The Eighth Circuit has affirmed a preliminary injunction against implementing a 2005 South Dakota law setting forth specific elements of informed consent discussions by physicians regarding abortions in that state. Among other things, the law requires physicians to inform their patients that an abortion will "terminate the life of a whole, separate, unique, living human being." Planned Parenthood v Rounds (No. 05-3093, 8th Cir., October 30, 2006).


A lawsuit filed in Illinois in November 2006 claims that state's caps on noneconomic damages unconstitutionally limit what an injured child and her family should receive in their medical malpractice case against a hospital and physician as a result of injuries she sustained from the alleged mismanagement of her mother's labor and delivery. (Associated Press, Malpractice caps face big challenge, November 21, 2006).


An appeals court in Florida has ruled that the parents of a newborn who suffered permanent brain damage after the hospital's on-call neonatologist allegedly failed to order tests and resuscitative measures in a timely fashion may pursue medical malpractice claims against the hospital despite the fact that the physician was an independent contractor. The court held that the hospital could not escape its duty to provide care by hiring independent contractors to perform that care. Pope v Winter Park Healthcare Group, Ltd. (No. 5D04-3284, Fla. Dist. Ct. App., October 6, 2006).


In October 2006, the National Labor Relations Board (NLRB) released guidelines for determining whether a charge nurse is a supervisor under the National Labor Relations Act, and therefore, exempt from collective bargaining. The NLRB also ruled that permanent charge nurses employed by Oakwood Heritage Hospital in Taylor, Michigan, exercised supervisory authority in assigning employees, concluding that the charge nurses regularly assigned nursing personnel to care for specific patients during their shifts. The Board found that such assignments, which consisted of giving "significant overall duties" to an employee, showed that the charge nurses exercised independent judgment in making such assignments. The Board also found that the hospital failed to establish that the rotating charge nurses exercised supervisory authority for a substantial part of their work time. Therefore, the Board found that only the permanent charge nurses were supervisors, rather than employees, under the National Labor Relations Act. The Board also defined several important terms related to these issues. The Board has now defined "assign" as the act of "designating an employee to a place (such as a location, department or wing), appointing an individual to a time (such as a shift or overtime period), or giving significant overall duties, ie, tasks, to an employee." The Board also indicated that to "assign" for purposes of the Act means the designation of significant overall duties to an employee, not to the ad hoc instruction that the employee perform a discrete task. The board has defined "responsibility to direct" as "if a person on the shop floor has men under him, and if that person decides what job shall be undertaken next or who shall do it, that person is a supervisor, provided that the direction is both 'responsible' and carried out with independent judgment." The element of "responsible" direction involves a finding of accountability so that it must be shown that the employer delegated to the supervisor the authority to direct the work and the authority to take corrective action if needed, and that there is the potential of adverse consequences for the supervisor arising from his or her direction of other employees. Lastly, the Board adopted an interpretation of the term "independent judgment" that applies whether or not the supervisory function is implicated, and regardless of whether the judgment is exercised using professional or technical expertise. The definition of "independent judgment" is defined relative to 2 concepts. First, to be independent, the judgment exercised must not be effectively controlled by another authority. Thus, where a judgment is dictated or controlled by detailed instructions or regulations, the judgment would not be found to be sufficiently independent under the Act. Second, the Board has indicated that the degree of discretion exercised must rise above the routine or clerical in order to be an independent judgment. This decision followed a 2001 Supreme Court ruling in the case of NLRB v Kentucky River Community Care that nurses who use independent judgment in directing employees are supervisors. In another decision released at the same time, the Board found that charge nurses at another facility, Golden Crest Healthcare Center, did not exercise supervisory authority under the Act. The Board found that these charge nurses lacked authority to assign other employees under the Act, had no authority to require other employees to stay past the end of their shifts, to require them to come in from off-duty status, or to shift selection assignments. The charge nurses also lacked authority to responsibly direct other employees under the Act because the charge nurses were not actually held accountable for the job performance of other employees. (NLRB Press Release October 3, 2006).


The Illinois Department of Revenue has upheld the decision of the Champaign County Board of Review that Provena Covenant Medical Center was not entitled to a real estate tax exemption on some of its properties for the 2002 tax year. The Department's reasons for doing so included the following:


1. The hospital reduced payments by those meeting certain percentages of the federal poverty level on a sliding scale, but the reduction was based on usual and customary charges as opposed to charges to third-party payors and insurers. In addition, there was no relationship between the gross amount of the bill and the patient's ability to pay, and the hospital widely used collection agencies to collect unpaid portions of these bills. This practice was felt to be inconsistent with charitable activities.


2. The hospital's cost of providing charity care for the tax year in question (2002) was only 0.7% of its total net patient revenues, and was less than the amount of property tax at issue. The director suggested that an exemption request in excess of the cost of the charity care actually provided was inconsistent with state law as well as the hospital's stated policy regarding charity care. The Director rejected the hospital's assertion that the amount of unreimbursed Medicare and Medicaid costs should be included in its total of charity care provided for the year, as well as the assertion that certain community activities and contributions constituted charity care, given that these were common to both for profit and not-for-profit hospitals.


3. The hospital received 97.7% of its income from that year from payments for patient services, and virtually no funds from public and private donations.



Based on the above facts, the Department determined that the property in question was not exclusively used for charitable purposes as required by state law to obtain the charitable real estate tax exemption. The Department of Revenue of the State of Illinois v Provena Covenant Medical Center, Illinois Department of Revenue Office of Administrative Hearings, No. 04-PT-0014 (Tax Year 2002).


An appeals court in Louisiana has found the $500,000 damages cap for medical malpractice cases to be unconstitutional because it does not provide an adequate remedy for injured plaintiffs. Arrington v ER Physicians Group (No. 04-1235, La. Ct. App., September 2006).


The Superior Court of Connecticut has held that a physician is not qualified to provide expert testimony regarding the standard of care required of a nurse. The court found that the physician expert in question did not have extensive contact with nurses in a setting of day-to-day care of postoperative patients such as the plaintiff, had not attended nursing school, and was not licensed to practice nursing. The court also found that doctors and nurses are not "similar healthcare providers" as defined by Connecticut law. Markland v Abrams (41 Conn L. Rptr No. 8, 303, July 3, 2006).


A federal court in Florida has ruled that an uninsured patient who claimed a hospital charged her 600% more for services than its insured patients could proceed with a lawsuit against the hospital for unreasonable pricing. Colomar v Mercy Hospital, Inc. (No. 05-22409-CIV-SEITZ, S.D. Fla., November 17, 2006).


An appeals court in Indiana has found that a psychiatric patient's claims of injuries received during an altercation with another resident while both were inpatients at a psychiatric hospital were properly based on premises liability, in that the claim involved allegations that the hospital failed to keep its property in a reasonable and safe condition. The court held that the claims were not subject to the state's medical malpractice statutes, and noted that the injuries were not caused by any services that the hospital provided or failed to provide to the plaintiff as a patient, rather they were caused by another resident whom the hospital failed to medicate, restrain, or confine. As such, the claim did not arise from the hospital's treatment of the plaintiff, but from his presence on the hospital's premises. Thus, the duty owed to the plaintiff by the hospital would be the same as what would be owed to any third-party visitor to the hospital. Madison Center Inc. v R.R.K. (No. 71A03-0602-CV-52, Ind. Ct. App., September 21, 2006).


An appeals court in Indiana has affirmed the dismissal of a case against a hospital alleging that the facility violated the state's consumer fraud and deceptive business practices law by charging excessive prices and failing to disclose billing policies. The court found that the patients had failed to allege the hospital knew what other area hospitals charged for the same services, that its rates were greater than the usual and customary charges in the industry, or that their insurance carrier would not fully cover the charges. In addition, the patients did not support their contention that the hospital's failure to volunteer its service rates before rendering treatment amounted to a deceptive practice under the Act. The court notes that charging unconscionably high prices is not, by itself, unfair under the Act. Rockford Memorial Hospital v Havrilesko (No. 04-AR-915, Ill. App. Ct., October 20, 2006).


A federal court in Nebraska has ruled that a physician cannot sue the hospital where he worked based on allegations that the facility violated HIPAA and a specific state law in disclosing to a potential employer his past participation in a drug and alcohol treatment program. The court made this ruling based on the fact that neither HIPAA nor the state law in question provided for a private right of action. Diering v Regional West Medical Center (No. 7:06CV5010, D. Neb., September 15, 2006).


The Montana Supreme Court has affirmed the dismissal of a negligence claim against a clinic by individuals injured in a car accident caused by one of the clinic's patients. The court noted that the law of Montana provides that a physician may voluntarily report to the department of justice when a patient has a physical or mental condition that will significantly impair the patient's ability to safely drive a car. The court held that this law grants immunity as a matter of law to a physician who does not make such a report. Sikorski v Johnson (No. 04-735, Montana, September 12, 2006).




Thrall T. Stopping ED violence before it happens. Hosp Health Netw. 2006;80:57-60.


Calloway S. Consideration of standards and guidance related to informed consent. ASHRM J. 2006;26:39-45.


Zhan C, Friedman B, Mosso A, Pronovost P. Medicare payment for selected adverse events: building the business case for investing in patient safety. Health Aff. 2006;25:1386-1393.

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.