June 21, 2022

Review the JCAHO Patient Safety Goals provided. Then Go

Review the JCAHO Patient Safety Goals provided. Then Google the 2021 NPSG, and select three and describe how you believe it could potentially contribute to a reduction in hospital medical errors.

Chapter 23

Improving Patient Safety and Quality of Health Care

“These are complicated issues… It is important we resolve them right because there is only one goal here: patient care and doctor power. That’s what has made America’s health care system great. And that’s where we have to end up. And if it takes a day or two longer, if it takes a week or two longer, if it takes a month longer, that is not the issue.”

—Rep. Nancy Johnson

Lecture Overview

Principles and Applications

Malpractice Framework

National Database for Patient Safety Research

Risk-Risk Calculus

Institute of Medicine and Food and Drug Administration Reforms

Prevention of Medical Errors and Adverse Events

Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). Antitrust regulation of health care providers. In Health care management and the law: Principles and applications (pp. 487-497). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.

Principles and Applications

An important development in health law over the last decade has been the growing emphasis on patient safety, quality of health care, and the availability of information about provider safety and quality for consumers.

Most Americans will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences.

Evidence suggests that Americans receive lower quality care than the residents of other developed nations

Malpractice Framework (1 of 2)

Hospital’s quality management committee learns that a medical error or adverse event has occurred, they question:

What are the implications for payment?

What is the appropriate course of action?

Who needs to know?

Trend Toward Enterprise Liability

The malpractice framework, which is primarily designed to apportion blame to individual health care providers, has failed to adequately address patient safety problems.

Some have suggested moving toward an enterprise liability model, in which financial liability is imposed on hospitals as opposed to individuals, although a breach of duty would remain a predicate for liability.

Poorly Designed Systems

There is widespread agreement that the root cause of most medical errors is poorly designed systems.

The tremendous complexity of health care delivery systems makes hospitals highly susceptible to both technological and human error.

Market Competition

The federal government sought to determine how to reconfigure the multiple levels of the health care system so as to improve patient care.

In response, Congress appropriated $50 million annually for patient safety research to be conducted by the federal Agency for Healthcare Research and Quality.

Malpractice Framework

National Database for Patient Safety Research (1 of 5)

The Agency for Healthcare Research and Quality grants funding for research on:

Health info tech

Patient safety

Pharmaceutical outcomes

Prevention and care management.

Health Information Technology

The Joint Commission could implement a system for reporting medical errors. The Joint Commission currently requires reporting of sentinel events, which are not the same as preventable medical errors.

Hospitals that do not comply with accreditation requirements risk losing Medicare insurance funding

National Database for Patient Safety Research (2 of 5)

Health Information Technology (Continued)

Today, more than half the states have some form of mandatory disclosure law for medical errors.

In Pennsylvania, the State Health Care Cost Containment Council Imposes penalties for failures to report medical errors, publishes each hospital’s rate of infection, requires hospitals to disclose specific hospital-acquired infections, and requires reporting of serious events to both the state and to patients directly affected by the medical error.

National Database for Patient Safety Research (3 of 5)

Patient Safety Organizations

Patient safety organizations have arisen to contract with health care providers to review and analyze patient safety reports and make recommendations for improving the quality of health care, which includes:

Collecting and analyzing patient safety work product

Developing and disseminating information to improve patient safety

Maintaining procedures to preserve the confidentiality and security of patient safety work product

Providing feedback and assistance to minimize patient risks and medical errors

Utilizing patient safety work product to encourage a culture of safety by health care providers

National Database for Patient Safety Research (4 of 5)

Payment Incentives

Medicare, as well as several private health insurers, such as Aetna and WellPoint, have moved to end payments to hospitals for treatment that results from serious medical errors.

Providers of other private health insurance are now banning payments for only the gravest of mistakes, such as:

Administration of incompatible blood

Infants discharged to the wrong person

Medication errors that result in death or disability

Surgeries on the wrong limbs

It is most likely only a matter of time before the health insurance industry also stops paying for some of the more common and less clear problems that Medicare insurance is tackling.

National Database for Patient Safety Research (5 of 5)

Pharmaceutical Outcomes

Every 5 to 10 years, major legislation addresses pressing issues concerning the federal Food and Drug Administration.

Sometimes, reform is motivated by the perception that the FDA is not getting new drugs to market as efficiently as possible. Other times, the leading concern is that the FDA is not protecting the public from the risks of drugs as effectively as it might.

Patients make a risk-risk assessment: they decide whether the potential risk of a therapeutic option outweighs the risk of a given disorder.

Risk-Risk Calculus (1 of 3)

This risk-risk proposition was evident when Elan Pharmaceutical withdrew Tysabri, a multiple sclerosis therapy, from the market because of a rare and serious potential side effect. Multiple sclerosis patients with limited therapeutic options organized, made their voices heard, and demanded a return of Tysabri to the market.

Although not every negative care outcome is a result of negligence, or even an entirely preventable error, providers of health insurance maintain that the no-pay policies will help improve patient safety and reduce health care costs.

While patients want to be warned of known risks, they also understand their disease and want, even demand, the right to choose their own therapies.

Risk-Risk Calculus (2 of 3)

Evidence-Based Guidelines

The lack of standardized, universally accepted treatment guidelines, firmly supported by scientific evidence, is a significant obstacle to the prevention of medical errors.

Moreover, nearly all of these adverse events could be prevented with simple clinical processes in place.

Example: Evidence suggests that using chlorhexidine to clean the skin prior to placing a central venous catheter can cut the risk of catheter related bloodstream infections in half with minimal, if any, increase in costs.

Risk-Risk Calculus (3 of 3)

Evidence-Based Guidelines (Continued)

The tools available for learning about drugs and their effectiveness include:

Drug coverage, including tiered benefits by the health care industry based on proven effectiveness.

Drug utilization management programs that influence prescribing

Electronic data on prescription use and patient outcomes

Internet resources for consumers of health care to understand their use of prescription drugs

Institute of Medicine and Food and Drug Administration Reforms (1 of 5)

The reforms recommended by the Institute of Medicine and proposed by the FDA fall into four main categories:

Balancing drug safety against access to innovative treatments

More effective use of prescribed drugs

Need to balance industry user fees and federal appropriations

Post-marketing drug surveillance

Need to Balance Industry User Fees and Federal Appropriations

Total user fees exceed $2.2 billion per year, accounting for more than half of the FDA resources for drug regulation.

While FDA critics claim this has affected drug safety, the rate at which drugs have been withdrawn from the market has not increased since user fees were implemented.

The increase in FDA resources has resulted in important public health benefits, including a reduction in drug review time, which is estimated to save 180,000 to 210,000 lives year.

Institute of Medicine and Food and Drug Administration Reforms (2 of 5)

Balancing Drug Safety with Access to Innovative Treatments

The FDA has authority to help assure drug safety, including the ability to:

Impose special requirements for prescribers, such as documentation of laboratory testing that would be monitored by the FDA

Limit direct-to-consumer marketing

Mandate post-marketing drug surveillance

Require special medication guides for patients

Restrict which physicians can prescribe a drug, for instance, restricting certain therapeutic classes to oncologist or cardiologist prescribers.

Critics believe such steps strengthen the FDA’s enforcement authority.

Institute of Medicine and Food and Drug Administration Reforms (3 of 5)

Post-Marketing Drug Surveillance

A fundamentally better system for post-marketing drug surveillance could help avoid increased costs and reduced access due to drug-by-drug regulation, with the development of better risk information based on actual experience with every new drug.

While the United States obtains innovative drugs two to three years ahead of its European counterparts, Europe has a compulsory drug surveillance system.

The FDA relies on its Adverse Event Reporting System, which involves the investigation of voluntary adverse event reports from health care providers, pharmaceutical firms, and consumers of health care.

Institute of Medicine and Food and Drug Administration Reforms (4 of 5)

More Effective Use of Prescribed Drugs

While it has been proposed that a regulatory entity be formed that is separate from the FDA pre-marketing review process, this possibility has generally been rejected.

Achieving a balanced approach to the assessment of risks and benefits would be greatly complicated, or even compromised, if two separate agencies were working in isolation from one another.

More effective use of drugs could be promoted by augmenting FDA resources with the rapidly growing array of electronic resources related to drug use.

Institute of Medicine and Food and Drug Administration Reforms (5 of 5)

Prevention of Medical Errors and Adverse Events

While some still claim adverse events are an inherent risk in receiving health care, the consensus is that medical errors should not be tolerated.

States are increasingly requiring health care professionals to report adverse events, with harsh penalties for non-reporting.

Transparency and public disclosure of medical errors are gradually becoming mandatory.

The financial disincentives for medical errors also are becoming more significant, as Medicare insurance and the health insurance industry refuse to compensate care associated with adverse events.

Management and Law Issues

Should the federal government support the states and begin mandating the use of generally accepted clinical procedures approved by the Agency for Healthcare Research and Quality in all acute-care hospitals, not just those receiving Medicare insurance funding, in an effort to decrease health care costs?

Chapt24

Human Body Parts Industry

Lecture Overview

Principles and Applications

Misconduct in the Human Remains Market

General Unawareness of Corruption

Commodification of Human Materials

Medical Research and Development of Medical Products

Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). .Human body parts industry. In Health care management and the law: Principles and applications (pp. 501-516). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.

Principles and Applications

Human material is used to develop medical devices and cosmetic products as well as in most surgeries.

Physicians and dentists use human body parts to:

Plump up lips and eliminate wrinkles

Repair bones

Replace heart valves

Treat burn victims

It is estimated that the human body parts industry in the United States generates $500 million annually in the organ procurement side of the industry alone.

Misconduct in the Human Remains Market (1 of 4)

Since the late 18th century, when dissection became an essential component of medical training, the demand for cadavers has far exceeded the supply.

Back then, the solution was the robbing of graves. Entrepreneurs could make a tidy profit digging up freshly interred bodies and delivering them, under cover of night, to medical men willing to pay handsomely for them.

In Re: Human Tissue Products Liability Litigation

Are organs and tissue from human corpses being harvested without obtaining proper consents?

Holding and Decision: Yes. While litigation is ongoing, this case demonstrates one way the courts are attempting to hold the human body parts industry accountable for illegitimate body harvesting

Misconduct in the Human Remains Market (2 of 4)

Billion Dollar Global Industry

With one harvested corpse worth $200,000 on the black market, the temptations are great and the oversight almost nonexistent.

As multidistrict litigation proceeds in the federal courts on an international human body parts operation involving Medical Tissue Services and Mastromarino, the global pervasiveness of the illegal harvesting of human body parts may be brought to light.

Some commentators think about 15% of the multibillion dollar global human body parts industry could be illegitimate or as high as $1.2 billion.

Misconduct in the Human Remains Market (3 of 4)

The Underground Market in Human Body Parts

Since his death, Alistair Cooke has become the symbol of underground market in the United States that illegally sells corpses and human body parts. Unbeknownst to his family, the bones of Cooke were cut out of his body before he was cremated and his bones were sold for $7,000.

The Cooke scandal raised concerns about the marketing and commoditization of human bodies, property rights, and the implications for medical research that are arising from publicizing this illicit sale and resale of human body parts.

Misconduct in the Human Remains Market (4 of 4)

Fraud and Negligence in the Illicit Sale of Human Body Parts

Liability for the fraudulent receipt of stolen goods is a factual issue determined by the courts after considering all relevant evidence.

The Uniform Anatomical Gift Act of 2006 (UAGA) prohibits the sale of human body parts and was adopted by the states in order to protect corpses.

Congress subsequently set a minimum standard of care for the procurement of organs and transplantable tissue when it passed the National Organ Transplant Act of 1984 (NOTA), but it does not regulate human remains.

General Unawareness of Corruption

There is no political consensus on whether:

A legalized market for buying and selling cadavers would decrease illicit transactions

More explicit rules and regulations should be adopted for the sale of human body parts

Society is so opposed to the commoditization of the human body that such a market would be incomprehensible

Graves v. Biomedical Tissue Services, Ltd

Issue: Did the tissue banks fail in their duty to obtain consents, and did they willfully disregard regulations regarding the procedures for harvesting human organs?

Holding and Decision: The issue of consent was never addressed in this part of the lawsuit. Summary judgment was granted and the complaint was dismissed without prejudice against one of the five tissue banks that had no records of receiving any human organs or tissue from the funeral home that handled the cremation; the remaining four tissue banks remain involved in this ongoing class-action litigation.

Commodification of Human Materials (1 of 11)

The human body parts industry could thrive if cadaveric human body parts could be permitted to enter an open marketplace and the sale of cadavers could be properly regulated.

Washington University v. Catalona

Issue: Once patients sign an informed consent form donating their tissue, blood, DNA, or other human body parts for research purposes to a university, who has the right of ownership?

Holding and Decision: Patients surrender all rights of ownership to direct the use and transfer of their human body parts once they consent to donate; they cannot come back later and direct a new use or ownership.

Commodification of Human Materials (2 of 11)

Limited Property Interest in Human Material

Corpses and human material have characteristics similar to property in the law. Most courts refuse to overturn traditional notions of a limited property interest in the human body.

The growth in the tissue processing market has raised concerns about the transfer of disease during orthopedic and neurosurgical operations.

In practice, the loopholes in the Uniform Anatomical Gift Act and National Organ Transplant Act mean that bones, tissue, organs, joints, limbs, heads, and even entire torsos are scarce commodities in an international marketplace where the demands of medical researchers, product developers, and physicians far exceed the supply.

Commodification of Human Materials (3 of 11)

Illegal Procurement and Sale of Human Body Parts

The first form of misconduct in this arena is the illegal procurement and sale of human body parts. The lawful as well as the unlawful procurement and sale of human body parts is a complex and confusing interplay of:

Economic opportunity

Legal loopholes

Moral limits

Scientific innovation

Commodification of Human Materials (4 of 11)

Illegal Procurement and Sale of Human Body Parts

In the absence of medical and moral clarity about the interchange of human biological material, people are left with the corrupting promise of unlimited economic opportunity in exchanging superfluous human body parts, and a legal system that is ill equipped to cope with the kind of ethical dilemmas being raised by scientific innovation.

When corpses are cremated, it eliminates the possibility of police, coroners, or other investigatory agencies finding out what drugs were in the body at the time of death.

Often morticians replace the stolen human body parts with pieces of plastic or metal pipe as was done to with the body of Alistair Cooke, in order to cover the damage for open casket funerals.

Commodification of Human Materials (5 of 11)

Illegal Sale of Cadavers Through University Willed Body Programs

The second, more complicated, form of misconduct involves the trade in corpses from university willed body programs. Donors will their corpses to science, expecting that their cadavers (as most do) will be delivered to the anatomy laboratories of medical schools, and that, in being dissected, they will help train the next generation of physicians.

Louisiana State University, Tulane University, and the University of California at Los Angeles (UCLA) were all implicated in the underground traffic of cadavers. They were caught selling human body parts to brokers and suppliers who then resold them to independent buyers.

For years, military researchers bought corpses through this market to use in research involving explosive devices.

Commodification of Human Materials (6 of 11)

Illegal Sale of Cadavers Through University Willed Body Programs

Gudo v. Administrators of the Tulane Education Fund

Tulane University sold cadavers to the U.S. military to be used in explosives testing

Issue: Can donated cadavers be used in a manner not authorized by the surviving family members?

Holding and Decision: Yes. The statutory definition of what encompasses an action for the unauthorized desecration and mutilation of a cadaver is broad enough to cover cadavers being blown up in landmine experiments.

Commodification of Human Materials (7 of 11)

Sale and Transplantation of Contaminated Body Tissue

Cases of contaminated tissue are rare, but they are making headlines more often. Tissue from one contaminated donor can go to dozens of patients.

The UAGA bans the sale of transplant tissue and the FDA forbids the transplanting of cancerous tissue. The FDA Center for Biologics Evaluation and Research has a regulatory framework for human tissue and cellular and tissue based products that is designed to prevent the introduction, transmission, or spread of communicable diseases by tissue products.

Commodification of Human Materials (8 of 11)

Sale and Transplantation of Contaminated Body Tissue

Commercial human tissue recovery firms are required to screen and test donors for relevant communicable diseases and to ensure that tissues are processed in a way that prevents communicable disease contamination and cross contamination.

The reality is that the regulations governing donor screening and record keeping practices are seldom enforced:

Death certificates maintained by human tissue recovery firms often do not match state death certificates regarding the cause of death

Donors are not always screened for risk factors or clinical evidence of disease agents and diseases

Human tissues are often recovered in a manner that causes contamination

Commodification of Human Materials (9 of 11)

Laundering of Corpses

When corpses have been sold and resold, it is unclear when the charge of receipt of stolen human body parts may be dropped, or if such charges should ever be dropped.

The legal principle of caveat emptor states that buyers must be aware that what they purchase may be accompanied with legal baggage, but the principle of good faith also excuses those who, even with due diligence, claim ignorance to the stolen nature of their purchase.

Commodification of Human Materials (10 of 11)

Criminal and Civil RICO Liabilities

The RICO legislation, originally passed to control organized crime, may create both criminal and civil liabilities against individual health care providers and medical research corporations involved in the underground human body parts industry.

Hypothetically, it could be argued that RICO prohibits using two or more racketeering acts to accomplish:

Acquiring legitimate human body parts that were stolen from donated cadavers

Maintaining human tissue processing organizations and medical research organizations through acceptance of stolen human body parts

Operating a human body parts business with resold human body parts that never should have been commoditized

Commodification of Human Materials (11 of 11)

A two-step process could be used to prove that individuals and corporations violated RICO, whether it would be a criminal prosecution or a civil lawsuit.

First, it would have to be shown that two or more racketeering acts were committed, which would be any of a list of specified criminal acts, including fraud, sales and receipt of stolen property, and theft.

Second, it must be shown that the racketeering acts were used to accomplish one or more of the aforementioned three purposes.

Medical Research and Development of Medical Products (1 of 2)

Several class action lawsuits are focusing on those that deal in cadavers and human body parts:

Body brokers who supply human materials to the medical products industry

Medical research centers that accept the human body parts from the brokers

Tissue banks and other health care providers who act as middlemen

Tissue processing industry that processes tissue and body parts for sale

Hospitals that do business with all these players

There is no oversight of hospitals involved in the human body parts industry; it remains to be seen what, if any, sanctions will be imposed on hospitals involved in the Human Tissue Products Liability Litigation case.

Medical Research and Development of Medical Products (2 of 2)

Although cadavers are bought and sold as commodities, this commodity market is used for the benefit of the living.

Cadavers and human body parts, though they may be illegally bought and sold, are often ultimately used in medical research.

As new medical products are continually developed, more and more human tissues are being stored and distributed for therapeutic and research purposes in a hidden market with few regulations and great opportunities for financial gain.

2013 National Patient Safety Goals