The health care industry includes health care providers (hospitals, nursing homes, pain management clinics, doctor’s offices, surgical centers, rehab facilities, etc.) and health care professionals (physicians, nurses, dentists, pharmacists, therapists, psychologists, psychiatrists, mental health counselors, medical students, medical interns, hospital administrators, etc.). These health care providers and health care professionals are often the subject of legal issues.

In Brief: Florida Pain Management Clinic Laws

Every health profession has its own set of rules and regulations. This week, we’re examining Florida laws under which pain management clinics operate.

Because Florida has one of the worst drug trafficking problems in the country, law enforcement is making sure that punishments for any violations are severe. For example, if a patient dies of drug overdose and the prescriber is found to be responsible, he or she can be charged with homicide, which was the case for a Palm Beach County pain management physician (see this New York Times article).

The DEA, Florida Department of Health and Florida law enforcement are watching pain management clinics very closely in order to keep Florida’s drug trafficking problem under control. Make sure that your clinic abides by the following legislation, in order to prevent any interference with your practice.

The 2011 Florida Statutes

Section 458.3265, F.S.:

Definition of Pain Management Clinic:

Pain-management clinic” or “clinic” means any publicly or privately owned facility:
(I) That advertises in any medium for any type of pain-management services; or
(II) Where in any month a majority of patients are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic nonmalignant pain.

Registration:

Every pain-management clinic must register with the Florida Department of Health UNLESS:

1. That clinic is licensed as a facility pursuant to chapter 395;

2. The majority of the physicians who provide services in the clinic primarily provide surgical services;

3. The clinic is owned by a publicly held corporation whose shares are traded on a national exchange or on the over-the-counter market and whose total assets at the end of the corporation’s most recent fiscal quarter exceeded $50 million;

4. The clinic is affiliated with an accredited medical school at which training is provided for medical students, residents, or fellows;

5. The clinic does not prescribe controlled substances for the treatment of pain;

6. The clinic is owned by a corporate entity exempt from federal taxation under 26 U.S.C. s. 501(c)(3);

7. The clinic is wholly owned and operated by one or more board-certified anesthesiologists, physiatrists, or neurologists; or

8. The clinic is wholly owned and operated by one or more board-certified medical specialists who have also completed fellowships in pain medicine approved by the Accreditation Council for Graduate Medical Education, or who are also board-certified in pain medicine by a board approved by the American Board of Medical Specialties and perform interventional pain procedures of the type routinely billed using surgical codes.

Physician Responsibilities:

1. A physician may not practice medicine in a pain-management clinic, if the pain-management clinic is not registered with the department. Any physician who qualifies to practice medicine in a pain-management clinic pursuant to rules adopted by the Board of Medicine as of July 1, 2012, may continue to practice medicine in a pain-management clinic as long as the physician continues to meet the qualifications set forth in the board rules. A physician who violates this paragraph is subject to disciplinary action by his or her appropriate medical regulatory board.

2. A person may not dispense any medication on the premises of a registered pain-management clinic unless he or she is a physician licensed under this chapter or chapter 459.

3. A physician, a physician assistant, or an advanced registered nurse practitioner must perform a physical examination of a patient on the same day that the physician prescribes a controlled substance to a patient at a pain-management clinic. If the physician prescribes more than a 72-hour dose of controlled substances for the treatment of chronic nonmalignant pain, the physician must document in the patient’s record the reason for prescribing that quantity.

4. A physician authorized to prescribe controlled substances who practices at a pain-management clinic is responsible for maintaining the control and security of his or her prescription blanks and any other method used for prescribing controlled substance pain medication. The physician shall comply with the requirements for counterfeit-resistant prescription blanks in s. 893.065 and the rules adopted pursuant to that section. The physician shall notify, in writing, the department within 24 hours following any theft or loss of a prescription blank or breach of any other method for prescribing pain medication.

5. The designated physician of a pain-management clinic shall notify the applicable board in writing of the date of termination of employment within 10 days after terminating his or her employment with a pain-management clinic that is required to be registered. Each physician practicing in a pain-management clinic shall advise the Board of Medicine, in writing, within 10 calendar days after beginning or ending his or her practice at a pain-management clinic.

6. Each physician practicing in a pain-management clinic is responsible for ensuring compliance with facility and physical operations requirements

Inspection:

1. The department shall inspect the pain-management clinic annually, including a review of the patient records, to ensure that it complies with this section and the rules of the Board of Medicine.

2. During an onsite inspection, the department shall make a reasonable attempt to discuss each violation with the owner or designated physician of the pain-management clinic before issuing a formal written notification.

3. Any action taken to correct a violation shall be documented in writing by the owner or designated physician of the pain-management clinic and verified by followup visits by departmental personnel.

Penalties and Enforcement:

1. The department may impose an administrative fine on the clinic of up to $5,000 per violation for violating the requirements of this section; chapter 499, the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug Abuse Prevention and Control Act; chapter 893, the Florida Comprehensive Drug Abuse Prevention and Control Act; or the rules of the department. In determining whether a penalty is to be imposed, and in fixing the amount of the fine, the department shall consider the following factors:

  • The gravity of the violation, including the probability that death or serious physical or emotional harm to a patient has resulted, or could have resulted, from the pain-management clinic’s actions or the actions of the physician, the severity of the action or potential harm, and the extent to which the provisions of the applicable laws or rules were violated.
  • What actions, if any, the owner or designated physician took to correct the violations.
  • Whether there were any previous violations at the pain-management clinic.
  • The financial benefits that the pain-management clinic derived from committing or continuing to commit the violation.

2. Each day a violation continues after the date fixed for termination of the violation as ordered by the department constitutes an additional, separate, and distinct violation.

3. The department may impose a fine and, in the case of an owner-operated pain-management clinic, revoke or deny a pain-management clinic’s registration, if the clinic’s designated physician knowingly and intentionally misrepresents actions taken to correct a violation.

4. An owner or designated physician of a pain-management clinic who concurrently operates an unregistered pain-management clinic is subject to an administrative fine of $5,000 per day.

5. If the owner of a pain-management clinic that requires registration fails to apply to register the clinic upon a change of ownership and operates the clinic under the new ownership, the owner is subject to a fine of $5,000.

For more information about Florida pain management clinics, visit www.TheHealthLawFirm.com.

More Reasons Not to Voluntarily Relinquish Your Professional License or Fail to Appeal an Exclusion Action

In the past, I have written articles and blogs on why a physician, nurse, dentist, psychologist, pharmacist, mental health counselor or other licensed health professional should never agree to voluntarily relinquish his or her license after any notice of a possible investigation being opened.  This is treated the same as if the state licensing agency had revoked that license for cause.  This applies even if the license is in another state, is inactive, or has expired.

The consequences of this include the action that will surely follow from the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) to exclude that professional from the Medicare Program.  Of course, this exclusion means any federal health care program, including participation in TRICARE/CHAMPUS, Veterans Administration (VA) program, Public Health Service (PHS) programs, Indian Health Service programs, U.S. Postal Service (USPS) health programs, and the state Medicaid program. 

However, 42 C.F.R. § 1001.2006 requires that that the Department of Health and Human Services (HHS) provide notice of a health professional’s exclusion from the Medicare Program to, among others:

 (1)  Medicare beneficiaries;

 (2)  The public;

 (3)  Any entity in which the excluded individual is known to be serving as an employee, administrator, operator, or in which the individual is serving in any other capacity and is receiving payment for providing services;

 (4)  State Medicaid Fraud Control Units;

 (5)  Utilization and Quality Control Quality Improvement Organizations;

 (6)  Hospitals, skilled nursing facilities, home health agencies and health maintenance organizations;

 (7)  Medical societies and other professional organizations;

 (8) Contractors, health care prepayment plans, private insurance companies and other affected agencies and organizations;

 (9)  The National Practitioner Data Bank.

 (10)  Other Departmental operating divisions, Federal agencies, and other agencies or organizations, as appropriate.

One should think not twice but three times before voluntarily relinquishing a health professional license of any kind, medical license, nursing license, psychology license, pharmacy license, social work license, mental health counselor license, or any other, once there is some notice that an investigation has commenced or that a complaint has been received.

For more information please visit our website at www.TheHealthLawFirm.com.

New System for Patients to Report Medical Mistakes in the Works

By Danielle M. Murray, J.D.

According to the New York Times, the government wants to implement a new system that would allow patients to report medical mistakes and unsafe practices by health care providers to a central reporting organization. This includes doctors, hospitals, pharmacists, and all other professionals or entities that provide medical treatment. While it is only an idea at this point, the government envisions patients reporting problems through a website or a phone number by answering a short questionnaire.

Federal officials believe that medical mistakes frequently go unreported and patients could have useful information that could be used to identify health care providers and facilities where errors are made.

A Tool to Help Doctors and Hospitals Learn from Mistakes.

Hospitals and some doctors like the idea. They argue that it would allow them to better understand the prevalence and characteristics of medical errors and learn how to better prevent those errors.

However, some suggest that these reports need to be matched with a patient’s medical records and taken with a grain of salt. Health care providers believe patients may perceive something as an adverse event that is actually not a problem or is common with the procedure they received. The example used in the New York Times article is that a patient with a hip replacement surgery may report a dislocated hip when the patient hears or feels a popping sensation, but this is a normal sensation after this type of procedure.

System Will Monitor Quality.

Health care providers are already under scrutiny by the government through Medicare and Medicaid. This would be another tool used to monitor doctors’ ability to give care. It’s great for patients, but what will the effect be on providers? It’s too soon to say. The American Medical Association did not comment for the New York Times article, stating that it needed to study the details.

To read the New York Times article, click here.

Comments?

As a provider, do you agree with this proposed system? Leave a comment below.

How Patient Complaints Can Impact Your License.

As many health professionals are aware, patient complaints are a frequent cause of problems for your license. When a patient complains to the Department of Health (DOH), the DOH will hold a hearing, called a probable cause panel, to determine, based on the complaint, if there is enough information to proceed against your license. If there is, the DOH will file an administrative complaint against your license, and ask you to voluntarily relinquish your license.

When you receive the first correspondence from the DOH that there is a pending investigation, do not sit idly. Call an experienced health law attorney, such as those available at The Health Law Firm, to evaluate your case and let you know what your options are. Do not speak with any investigator or DOH representative, and do not voluntarily relinquish your license. Your career and livelihood are at stake.

For a list of the 25 biggest mistakes health professionals make when notified of a DOH investigation, click here.

Contact Health Law Attorneys Experienced in Representing Health Care Providers in DOH Cases.

The Health Law Firm represents pharmacists, pharmacies, physicians, nurses, and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies.

If you are aware of an investigation of you or your practice, or if you have been contacted by DOH, contact an experienced health law attorney immediately.

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

Source:

Pear, Robert, “New System for Patients to Report Medical Mistakes.” The New York Times, (September 22, 2012). From: ttp://www.nytimes.com/2012/09/23/health/new-system-for-patients-to-report-medical-mistakes.html?emc=tnt&tntemail0=y&_r=1

 

About the Author: Danielle M. Murray is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Medical Negligence – An Accidental Overdose of Prescription Pain Pills Can Lead to Lawsuits

GFI Blog LabelBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Carole C. Schriefer, R.N., J.D., The Health Law Firm

In February 2009, a 30-year-old male patient was prescribed, all together, 180 pills of Dilaudid and Xanax from a South Florida pain clinic. Sometime within the next 24 hours the patient died of what medical examiners ruled an overdose. According to the American Association for Justice, the patient’s family then sued the pain management clinic alleging the clinic’s physician prescribed a lethal overdose of the drugs and the defendant was liable for damages resulting from the patient’s murder. In the lawsuit, the jury awarded the plaintiff more than $5.33 million.

Physicians and Business Owners Liable for Medical Negligence.

According to an article in American Medical News, of the pharmaceutical-related overdoses in 2010, seventy-four percent (74%) were unintentional. As prescription drug overdoses rise across the country, we are seeing some physicians and business owners held liable for medical negligence.

For example, in May 2012, an Alabama jury ruled a widower to receive $500,000 after he sued his wife’s physician. His wife died of an accidental overdose after being prescribed a number of narcotic pain medications. In April 2012, a woman was awarded $1.9 million after she sued her family physician claiming he over prescribed her methadone, which led to brain damage after she stopped breathing, according to American Medical News.

Click here to read the entire article from American Medical News.

Protecting Your Business and License.

Health care professionals need to pay close attention to patients who request pain medication. Being proactive about prescription management can also deter lawsuits or help in doctors’ defense if they are sued. Physicians must make sure their records meet all requirements of state laws and regulations. In cases where a patient has been “doctor-shopping” in order to abuse pain pills, we see state disciplinary investigations initiated against each physician who prescribed that individual medication. In most cases, these physicians were unaware of the other prescribers. Disciplinary actions such as these can often be defended when the physician has taken the proper safeguards.

Click here to read legal tips for physicians to manage pain patients.

Drug Monitoring Programs are Here to Stay.

The growing epidemic has some states developing drug monitoring programs to track drug seekers.

In Florida, a bill that would require doctors to check with the state’s drug database before writing a prescription for addictive medications passed in a House panel on March 19, 2013. Recently, legislators in California, Pennsylvania and Kentucky are contemplating moves to tighten monitoring and prescribing of controlled substances. Click here to read a blog on the possible new actions in these states.

Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

Comments?

Do you think physicians and business owners should be held liable for medical negligence in cases of an accidental overdose? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Thirty-Two Indicted in Broward and Palm Beach Counties in Second Coordinated Pill Mill Takedown.” Department of Justice. (August 23, 2011). From: http://www.justice.gov/usao/fls/PressReleases/110823-04.html

Gallegos, Alicia. “Physician Liability: When an Overdose Brings a Lawsuit.” American Medical News. (March 4, 2013). From: http://www.thehealthlawfirm.com/uploads/AMN_Overdose%20Lawsuits.PDF

LaMendola, Bob. “Pain Clinic Boss Jeffrey George Pleads Guilty to Murder.” Sun Sentinel. (August 29, 2011). From: http://articles.sun-sentinel.com/2011-08-29/health/fl-hk-jeff-george-pleads-guilty-20110829_1_pain-clinic-cynthia-cadet-george-twins

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

Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

 

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Orlando Health’s Restructuring Efforts Might Mean Pay Cuts and Layoffs for Employees

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Many employees at Orlando Health might be getting hit hard in the wallet with pay cuts schedule for later this year. According to the Orlando Sentinel, the eight-hospital health system notified its night-shift workers that their differential pay would be trimmed by several dollars an hour. For some employees that could be a twenty percent (20%) reduction in salary. The differential pay cuts are scheduled to take effect on September 8, 2013.

Meanwhile the hospital allegedly raised prices in the cafeteria, reduced the tuition reimbursement benefit, cut some workers hours and made a number of layoffs, according to the Orlando Sentinel. According to Orlando Health officials, this is all part of a restructuring effort that began in November 2012. The cutbacks will affect all eight hospitals and all departments.

Anyone who has eaten in the cafeteria at Orlando Regional knows what a bargain the food was. Now this will be the subject of reminiscence as when us old codgers fondly think back on 5 cent Coca Colas and 10 cent loaves of bread.

To read the Orlando Sentinel article, click here.

Night-Shift Workers Feel Under Paid and Under Appreciated.

Some Orlando Hospital employees spoke to the Orlando Sentinel about the pay cuts. According to the Orlando Sentinel, night-shift workers receive incentive pay on top of their base salary for their willingness to work night shifts. One worker interviewed explained the incentive pay is given to them because no one wants to work the overnight shift. Workers also get differential pay for weekend and holiday hours.

On top of the pay cuts, workers are seeing their hours drop, as well as layoffs around the hospital. In the November 2012, restructuring announcement, Orlando Health said 300 to 400 employees’ jobs were on the chopping block, according to WFTV. Some people were previously let go, while more layoffs will be coming. Hospital officials would not say how many people have been laid off so far.

To read more from WFTV, click here.

Orlando Health’s Statement.

Orlando Health reported an $8.1 million loss last quarter. That’s on top of losing money for the last four out of five quarters, according to the Orlando Sentinel. Hospital officials said the change in differential pay puts Orlando Health in line with the pay of other hospitals in the Southeast. On August 13, 2013, Orlando Health sent out an official statement, click here to read the full statement.

Petition to Block Pay Cuts Gaining Momentum.

A petition filed on August 9, 2013, on Change.org, is requesting the Orlando Health CEO block the pay cuts to the night shift workers. The petition was started by a registered nurse at Winnie Palmer Hospital for Women and Babies and is quickly picking up steam. As of August 15, 2013, the petition had more than 2,700 signatures, although not all are local. To view the petition, click here.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

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

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

Comments?

What do you think of the cutbacks at Orlando Health? Are these steps necessary? If you are an Orlando Health employee, how will these changes affect you? Please leave any thoughtful comments below.

Sources:

Jameson, Marni. “Orlando Health Workers Concerned by Cutbacks in Hours and Pay.” Orlando Sentinel. (August 9, 2013). From: http://www.orlandosentinel.com/health/os-orlando-health-cutbacks-20130809,0,5234963.story?dssReturn

Hughes, Ryan. “Orlando Health Confirms Second Round of Layoffs.” WFTV. (August 2, 2013). From: http://www.wftv.com/news/news/local/orlando-health-confirms-second-round-layoffs/nZCjC/

Lewis, Kena. Orlando Health Statement. Orlando Business Journal. (August 13, 2013). From: http://www.bizjournals.com/orlando/blog/2013/08/orlando-health-pay-cuts-to-save-18m.html?page=all

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

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Open for Registration: Telemedicine Association Begins Telemedicine Accreditation

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

The American Telemedicine Association (ATA) recently announced that it was accepting a limited number of applications for its telemedicine provider accreditation program. According to the ATA the purpose of the accreditation is to recognize organizations that provide top-notch online health care services. The ATA calls the service its “Accreditation Program for Online Patient Consultations.”

Details on ATA’s Accreditation Program.

Eligibility to register and apply for accreditation is aimed at any United States based organization that provides real-time interactive doctor-patient interactions via live online video services. Currently the ATA is not certifying so-called “store-and-forward” providers. However, this may be a possibility in the future as this technology becomes more widely used.

The ATA’s standards for the accreditation program are modeled after those found in state and federal laws and regulations, industry best practices, and input from the community. The primary focus is on robust policies and procedures, appropriate areas of practice (i.e. online treatment is appropriate for the illness), and patient health and safety.

Telemedicine Laws Different in Every State.

As with any health care good or service, the rules and regulations differ widely from state to state and with federal payors like Medicare. It is important to check your state medical board’s rules and opinions on telemedicine to avoid disciplinary action for inadvertently violating the medical practice act or some other applicable regulation.

Also note some states that permit telemedicine still require the physician to be licensed in the state in which the patient resides. Before engaging in telemedicine services, you should also look at the regulations in the states in which your patients are located to see if you need to have a license. Being accredited, while certainly a step in the right direction, will not necessarily exempt you from compliance with the law.

There has been a recent push to expand the scope of telemedicine services that are payable by Medicare. If these efforts are successful, there will undoubtedly be a spike in the number of providers offering remote services. Additionally, many private insurers have been piloting programs to see if the purported savings offered by telemedicine actually reduce the cost of claims.

Comments?

What do you think about the ATA’s accreditation program? Where do you think telemedicine will be in five years? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings. To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

About the Author: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

Nurses Rx: Medication Administration

From George Indest’s Nursing Law Manual

Nurses face a busy schedule often including a long list of patients and extensive work hours. As a result, they can become overworked and overtired, which may lead to mistakes when carrying out essential job duties like administering medication. An Institute of Medicine (IOM) report titled To Err is Human: Building a Safer Health System (IOM, Dec. 1999) states the deaths from medication errors that take place both in and out of hospitals, more than 7,000 annually, exceed those from workplace injuries. In a separate report, investigation by the Chicago-Tribune states that since 1995, at least 1,720 hospital patients have died and 9,548 others have been injured because of mistakes made by RN’s across the country (Associated Press, Sept. 10, 2000).

Because nurses are usually the front-line health care providers who are required to administer medications prescribed by physicians (and often the most potent medications to critically ill patients), they must be especially careful in their procedures and practices to avoid one of the many types of common medication errors. The most common types of medication errors include:

1. similar sounding medication name;

2. administration without a prescription;

3. the wrong medication;

4. the wrong dosage;

5. negligent injection;

6. failure to note an order change;

7. failure to administer medication;

8. failure to discontinue medication;

9. use of an unsterile needle;

10. the wrong patient;

11. allergic reactions; and

12. failure to assure patient taking medications.

Nurses are required to handle and administer a vast variety of drugs that are prescribed by physicians and dispensed by an organization’s pharmacy. Medications may range from aspirin to esoteric drugs that are administered through intravenous solutions. These medications must be administered in the prescribed manner and dose to prevent serious harm to patients.

There are a variety of ways to ensure that, as a nurse, you are helping to prevent medication errors within your facility. Use this checklist from George Indest’s Nursing Law Manual in order to maintain safe administration procedures.

Nurses are exempted from the various pharmacy statutes when administering a medication on the oral or written order of a physician. However, the improper administration of medications can lead to malpractice suits.

ADMINISTRATION OF CONTROLLED MEDICATIONS WITHOUT A PRESCRIPTION

A nurse should never administer prescription medications without a valid prescription or order from a physician. In effect, doing that constitutes practicing medicine without a medical license and is beyond the scope of a nurse’s license. Administering medications without approval may give rise to legal liability and disciplinary action against the nurse.

ADMINISTERING THE WRONG MEDICATION

The injection of the wrong medication into a patient can lead to civil liability or to a charge of substandard nursing care made to the Department of Health. A nurse who prepares medication for a physician is liable for the preparation of that medication. A physician can blame a nurse who fails to prepare the medication properly in order to escape liability.

In the case of Ambercrombie v. Roof, a solution was prepared by a nurse employee and injected into the patient by a physician, 28 N.E. 2d 772 (Ohio 1940). The physician made no examination of the fluid, and the patient suffered permanent injuries as a result of the infection. An action was brought against the physician for malpractice. The patient claimed that the fluid injected into her was alcohol and that the physician should have recognized its distinctive odor. The court, in finding for the physician, stated that the physician was not responsible for the misuse of drugs prepared by the hospital, unless the ordinarily prudent use of his faculties would have prevented injury to the patient.

GIVING THE WRONG DOSAGE

A nurse is responsible for making an inquiry if there is uncertainty about the accuracy of a physician’s medication order in a patient’s record. A nurse who is in doubt about a physician’s orders should contact that physician and seek clarification of their order.

WRONG ROUTE

The nurse in Fleming v Baptist General Convention, 742 P.2d 1087 (Okla. 1987), negligently injected the patient with a solution of Talwin and Atarax subcutaneously, rather than intramuscularly. The patient suffered tissue necrosis as a result of the improper injection. The suit against the hospital was successful. On appeal, the court held that the jury’s verdict for the plaintiff found adequate support in the testimony of the plaintiff’s expert witness on the issues of nursing negligence and causation.

FAILURE TO NOTE AN ORDER CHANGE

A nurse’s failure to review a patient’s record before administering a medication, to ascertain whether an order has been modified, may render a nurse liable for negligence.

FAILURE TO ADMINISTER MEDICATION

In Kallenberg v. Beth Israel Hospital, 357 N.Y. S.2d 508 (N.Y. App. Div. 1974), a patient died after her third cerebral hemorrhage because of the failure of the physicians and staff to administer necessary medications. When the patient was admitted to the hospital, her physician determined that she should be given a ceratin drug to reduce her blood pressure and make her condition operable. For some unexplained reason, the drug was not administered. The patient’s blood pressure rose, and after a hemorrhage, she died. The jury found the hospital and physicians negligent in failing to administer the drug and ruled that the negligence had caused the patient’s death. The appellate court found that the jury had sufficient evidence to decide that the negligent treatment had been the cause of the patient’s death.

FAILURE TO DISCONTINUE A MEDICATION

A health care organization will be held liable if a nurse continues to inject a solution into a patient after noticing its ill effects. Once something is observed to be wrong with the administration of the medication, the nurse has a duty to discontinue its use.

NONSTERILE NEEDLE

The blood donor in Brown v. Shannon West Texas Memorial Hospital, 222 S.W. 2d 248 (Tex. 1949), sought to recover from a serious injury allegedly caused by the use of a nonsterile needle. The court held that the burden of proof was on the plaintiff to show, by competent evidence, that the needle was contaminated when used and that it was the proximate cause of the alleged injury. The mere proof, said the court, that infection followed the use of the needle or that the infection possible could be attributed to the use of an unsterile needle was insufficient. If the plaintiff had been able to prove the needle was not sterile, then the plaintiff would have recovered damages.

WRONG PATIENT

It is of utmost importance to check each patient’s name bracelet before administering any medication. To ensure that the patient’s identity corresponds to the name on the patient’s bracelet, the nurse should address the patient by name when approaching the patient’s bedside to administer any medication. Especially in nursing homes and hospitals where there may be more than one patient in a room, this is exceptionally important. Should the nurse unwittingly administer one patient’s medication to a different patient, the attending physician should be notified and appropriate documentation placed on the patient’s chart.

ALLERGIC REACTIONS

Any adverse reactions to a medication should be charted on the patient’s medical record. The attending physician and the facility’s pharmacy should be advised as to the patient’s allergic reaction.

FAILURE TO MONITOR AND ENSURE PATIENT TAKING MEDICATIONS

A nurse normally has a duty to monitor and ensure that a patient is taking their medications. A failure to perform this act can lead to nursing negligence on the part of the nurse.

THE “SEVEN RIGHTS” OF PATIENT MEDICATION

There is a checklist every nurse should learn called the “Seven Rights of Medication.” If this checklist is memorized and followed in every case, medication errors would be significantly reduced or eliminated altogether. Every nurse and nursing student should memorize this list and go through it in her mind every time a patient is administered a medication by the nurse.

Always check for and confirm:

1. The right medication;

2. The right patient;

3. The right dose;

4. The right time;

5. The right route;

6. The right reason; and

7. The right documentation;

The nurse may be the last wall of defense to protect a patient from a medication error. The nurse should avoid at all costs, being rushed, tired, inattentive, sloppy, or lazy. Guard at every turn against medication errors. For more information about nursing law, or to read more from the Nursing Law Manual, visit www.TheHealthLawFirm.com.

By |2024-03-14T10:00:26-04:00June 1, 2018|Categories: Health Care Industry, Nurses, Pharmacy, The Health Law Firm Blog|Tags: , , , |Comments Off on Nurses Rx: Medication Administration

What Physicians Need to Know About Clinical Privileges and Peer Review Actions From the Meyers Case

If you are a physician with hospital privileges or have ever been called a “disruptive physician” make sure you are familiar with  Meyers v. Columbia/HCA Healthcare Corp., which was finally decided in 2003. In ruling on disruptive physician cases, courts almost always rely on Meyers, and it has been cited repeatedly in other disruptive physician cases to justify a hospital or medical staff’s peer review actions disciplining the physician.

In this case, Dr. Meyers, an orthopedic surgeon, received provisional medical staff privileges at a hospital. A year later, the credentials committee at his hospital, comprised of three board members, re-evaluated Dr. Meyers for advancement to active staff privileges. He was denied active staff privileges by the committee for reasons that included his alleged temper tantrums, condescending remarks towards women, refusal to speak to a member of his surgical team during surgical procedures, and several instances of throwing a scalpel during surgical procedures.

Dr. Meyers was granted a hearing by the hospital. The hospital’s bylaws provided for a fair hearing committee comprised of three members of the medical staff, who would have been Dr. Meyers’ peers. However, the fair hearing committee in Dr. Meyers’ case was different. It was comprised of a retired judge, an attorney, a bank president, an industrialist and a dentist. The fair hearing committee met eleven times and 35 witnesses testified during the course of the hearing. After the hearing, the fair hearing committee recommended not appointing Dr. Meyers. It cited his failure to meet the hospital’s ethical standards, as well as his inability to work cooperatively with others. This recommendation was adopted by the hospital’s governing board.

Dr. Meyers sued the hospital and the fair hearing participants. His claims included breach of contract, antitrust, violations of the Emergency Medical Treatment and Active Labor Act (EMTALA), tortious interference, and defamation.

The hospital moved for a summary judgment, claiming immunity under the Health Care Quality Improvement Act of 1986 (HCQIA), which provides immunity if a professional review action is taken under a combination of four circumstances: (1) in the reasonable belief that the action would further quality healthcare; (2) after a reasonable investigation; (3) with adequate notice and hearing procedures; and (4) the reasonable belief that the action was warranted by the facts and the process.

The trial court granted summary judgment in favor of the hospital and the hearing panel’s members. The court’s analysis of the summary judgment standard in the Meyers case for HCQIA has been relied upon regularly since this. Meyers indicated that the professional review actions that were followed satisfied the HCQIA’s immunity requirements. The district court’s action was later affirmed on appeal by the Sixth Circuit.

Because of Meyers, physicians have a much higher standard to overcome, in order to get a similar case before a jury. The physician must demonstrate 1) that a genuine issue of fact exists and 2) that a reasonable jury, viewing the facts in the best light for the plaintiff, might conclude that he has shown by a preponderance of the evidence that the actions of the hospital and committee are outside the scope of HCQIA.

In both Meyers and in subsequent cases, physicians have attempted to challenge this summary judgment standard by various legal arguments. One used is that the action taken against the physician was not “fair” because the hearing committee did not include a physician of the same specialty. Another is that the hearing panel did not include a physician, a “peer.” Therefore, how could it truly be “peer review.”

In Meyers, both the Sixth Circuit and the district court looked to the hospital’s medical staff bylaws which stated that medical staff members (other physicians) would be appointed to the fair hearing committee only “when feasible.” The hospital presented evidence that no medical staff member could serve on the committee at the time when the hearing was scheduled in Dr. Meyers’ case. Furthermore, the district court stated that the bylaws of a hospital concerning peer review actions are inconsequential, as long as the HCQIA’s fair hearing requirements are met. In the HCQIA, there is no requirement that a physician must serve on a fair hearing committee.

Meyers also provided grounds for justifying professional review actions based a physician’s “general behavior and ethical conduct.” Disruptive behavior is also enough to justify suspension or termination of privileges, because, according to the district court, “Quality patient care demands that doctors possess at least a reasonable ability to work with others.”

Although the Meyers case has been the precedent for disruptive physician cases since 2003, physicians must also be aware of The Joint Commission’s standard on disruptive behavior, issued in 2008. This standard affirms that disruptive behavior is enough to justify a hospital’s action against a physician, including termination. Physicians can now expect to see even more actions initiated by hospitals and their staffs against any physician deemed uncooperative or disruptive. You can read The Joint Commission’s sentinel alert on disruptive behavior here.

If you find yourself at the center of a peer review hearing due to reasons of disruptive behavior, make sure that you contact an experienced healthcare attorney to help you navigate the peer review process. See this article on clinical privileges and peer review hearings for more information or visit our website at www.TheHealthLawFirm.com.

By |2024-03-14T10:00:28-04:00June 1, 2018|Categories: Health Care Industry, The Health Law Firm Blog|Tags: , , , , , , , |Comments Off on What Physicians Need to Know About Clinical Privileges and Peer Review Actions From the Meyers Case

CVS Possibly Under Investigation for Medicare Fraud

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

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has reportedly launched an investigation into CVS’ practice for refilling prescriptions. According to an article in the Los Angeles Times, authorities are looking into reports that CVS has been refilling prescriptions and submitting insurance claims without patients’ permission. The Los Angeles Times article, released October 12, 2012, names an official with knowledge of this matter as the source.

We want to emphasize that this is from an unconfirmed news story. The government rarely announces investigations of specific subjects ahead of time.

Click here to read the entire article from the Los Angeles Times.

CVS Has Not Been Contacted By the Government About an Investigation.

A related article in Reuters states that CVS said it has not been contacted by the government about the investigation. The pharmacy also said, as a policy, the company does not condone unauthorized refills. Officials said to allow unauthorized prescription refills could be considered insurance fraud, especially if insurers were not refunded for any drugs rejected by patients.

The probe might be, in part, related to the programs offered by many drugstores that allows a pharmacy to refill prescriptions even before a refill request has been made by the patient.

Click here to read the entire article from Reuters.

So far there is no news from the OIG for the HHS officially confirming this investigation.

Cause for Investigation?

It is unclear to me why there would be any cause to investigate CVS, if Medicare was not being billed until the customer actually picked up the prescription. If the customer fails to pickup the prescription, every drug store I know of restocks the medication after a short period and no one is ever billed for it. It seems that it would be a quick and simple matter for the OIG to check this.

Furthermore, it could also be argued that CVS  is actually promoting good health by this practice. Patients may forget to renew or refill their prescriptions or may fail to notice they are running low.

Two Sanford, Fla., CVS Stores Make Headlines.

On September 12, 2012, the U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida. The two pharmacies are no longer able to fill prescriptions for drugs such as oxycodone, Dilaudid, Vicodin, Ritalin and Xanax. This decision was in response to a government crackdown on the distribution of painkillers. Click here to read a blog on this story.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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

Comments?

What do you think of this story? Do you think CVS is doing anything wrong? How is this any different from the practice of many managed care plans mailing out 90 days of medications to its patients at a time? Please leave any thoughtful comments below.

Sources:

Lazarus, David. “CVS Caremark Prescription Refills Under Scrutiny, Source Says.” Los Angeles Times. (October 12, 2012). From: http://www.latimes.com/business/la-fi-lazarus-20121012,0,1032269.column

Alawadhi, Neha, Wohl, Jessica, and Morgan, David. “CVS Unaware of Any Government Prescription Refill Probe.” Reuters. (October 12, 2012). From: http://www.reuters.com/assets/print?aid=USBRE89B19520121012

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

 
“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Colorado Surgeon Accused of Botching Multiple Robotic Arm Surgeries

CCS Blog LabelBy Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A Colorado surgeon allegedly faces 14 counts of unprofessional conduct associated with the use a robotic arm used during surgeries, according to the formal administrative complaint. The Colorado Medical Board filed the complaint on April 2, 2013, alleging that from 2008 until 2010, the surgeon cut and tore blood vessels, left sponges and other instruments inside of patients, injured patients through padding and positioning, subjected some patients to overly long surgeries and had to abort kidney donation procedures because of mistakes. The surgeon is also accused of not documenting the mistakes in patient charts.

According to the Colorado Board of Medicine’s administrative complaint, the surgeon was using the da Vinci robot, manufactured by Intuitive Surgical, Inc., for surgeries.

Click here to read the formal complaint from the Colorado Medical Board.

This complaint was filed around the same time as the U.S. Food and Drug Administration (FDA) launched a review of the robotic procedures.

A Number of Patients Speak Out On Surgeries.

The complaint lists 11 patient cases allegedly mishandled by the surgeon.

In one case, a 22-year-old woman wanted to donate a kidney to her brother. She was informed by the surgeon that the robot was the “gold standard” for kidney removals and transplants. During the surgery, the surgeon allegedly injured the patient’s aorta. To stop the bleeding, the surgeon allegedly converted to an open surgery, then aborted the kidney removal. After the attempted surgery, the patient allegedly went into post-operative distress and an X-ray showed a sponge that had been left inside the patient. The patient also alleges she was left with nerve damage after being improperly padded.

In another case, the surgeon allegedly used the robot on an 86-year-old man with metastatic cancer. The surgeon allegedly injured the patient’s aorta, and the robot arm moved when it should not have, causing another tear. The patient suffered kidney failure after the operation, and the family withdrew the patient’s life support.

Surgeon Suspended for Performing Robotic Surgeries.

In the complaint, the Colorado Medical Board is asking an administrative law judge to discipline the surgeon’s license to practice medicine. An article in The Denver Post states that the surgeon had his robotic-surgery privileges suspended for three months in 2010. The hospital would not say whether or not the surgeon received new training before allowing him to use the robotic arm after his suspension.

To read the entire article from The Denver Post, click here.

FDA and Other Medical Societies Leery of Robotic Procedures.

In March 2013, the FDA began interviewing surgeons about issues with the robotic surgery units, according to Fierce Health IT. The agency is allegedly trying to figure out why there has been an uptick in adverse event reports, including damaged organs and device failures, and whether these are a result of error or design problems.

For a list of other sources discussing possible adverse outcomes from robotic surgery, please see “references” below.

The American Congress of Obstetricians and Gynecologists and the Massachusetts Quality and Patient Safety Division are also warning health care professionals about the risks associated with robotic surgeries, according to Fierce Health IT. The American Congress of Obstetricians and Gynecologists said that these types of surgeries should not be the first or second choice for women undergoing routine hysterectomies. The Massachusetts Quality and Patient Safety Division sent a letter advising doctors of the safety concerns regarding robotic surgery.

Click here to read the entire article from Fierce Health IT.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

Comments?

As a health care professional, does your facility use robotic arm surgeries? Do you believe they are the safer option? Do you think the FDA should take a closer look at these machines? Please leave any thoughtful comments below.

Sources:

Booth, Michael. “Colorado Charges Doctor in Problem-Plagued Robo-Surgeries at Porter.” The Denver Post. (April 10, 2013). From: http://www.denverpost.com/breakingnews/ci_22998041/colorado-charges-doctor-botched-robo-surgeries-at-porter

Hall, Susan. “Robo-Surgery Mistakes Land Physician in Hot Water.” Fierce Health IT. (April 15, 2013). From: http://www.fiercehealthit.com/story/robo-surgery-mistakes-land-physician-hot-water/2013-04-15

Colorado Medical Board v. Warren J. Kortz, M.D. Case Number ME 2013. Formal Complaint (April 2, 2013). From:http://www.thehealthlawfirm.com/uploads/Colo%20v.%20Warren%20Kortz%20MD.pdf

Gold, Ashley. “Health Officials Warn Complications Robotic Surgeries.” Fierce Health IT. (March 26, 2013). From: http://www.fiercehealthit.com/story/health-officials-warn-complications-robotic-surgeries/2013-03-26

Hall, Susan. “OBGYN Group: Robotic Surgeries Not Best Choice for Routine Hysterectomies.” (March 15, 2013). From: http://www.fiercehealthit.com/story/obgyn-group-robotic-surgery-not-best-choice-routine-hysterectomies/2013-03-15

Garde, Damian. “FDA Echoes Questions Over Intuitives’s Surgical Robot.” Fierce Medical Devices. (March 1, 2013). From: http://www.fiercemedicaldevices.com/story/fda-echoes-questions-over-intuitives-surgical-robot/2013-03-01

Bird, Julie. Much of Robo-Surgery Marketing ‘Unsubstantiated.’” Fierce Health IT. (July, 24, 2012). From”
http://www.fiercehealthit.com/story/much-robotic-surgery-marketing-unsubstantiated/2012-07-24

About the Authors: Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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