The Need for Confidentiality in Peer-Reviewed Organ Transplant Documents

company formation documentsOver time, organ transplants or sharing in the United States has saved many lives. According to preliminary data from United Network for Organ Sharing (UNOS), there were over 40000 organ transplants in 2021. It is a record-breaking number of organ transplants in the United States in a calendar year.

“One of the organizations that help UNOS achieve their aim is the Organ Procurement Organizations (OPO),” says Russell J. Berkowitz from Berkowitz Hanna Malpractice & Injury Lawyers. While OPOs assist in saving lives, the lawsuit against the organization in South Carolina raises concern about its credibility. Additionally, it raises concerns about the peer review privilege law.

The Organ Procurement Organization (OPO) in South Carolina

Organ Procurement Organizations (OPOs) are nonprofit organizations backed by the federal government that carries out the responsibility of obtaining organs from deceased donors for transplantation. They are the only organizations with this responsibility. OPOs offer a wide range of services, including:

  • Facilitating the donation process according to federal laws
  • Medical suitability evaluation and clinical management of organ donors
  • Offer families compassionate care and grief support before, during, and after donations
  • Educating the public to enable informed donation decisions
  • Policy and procedure creation for hospital donations and healthcare professional education

Furthermore, there are more than 50 Organ Procurement Organizations (OPOs) in the United States, each covering a distinct geographic region. South Carolina is one of the states in the US that has OPO, known as We Are Sharing Hope. We Are Sharing Hope SC (SHSC) facilitates life-enhancing tissue and life-saving organ donation throughout the state.

The Peer-Review Privilege Law

The Peer-review privilege is a privilege that shields from disclosing the proceedings and reports of the peer-review committee of a medical facility. These reports and proceedings examine and monitor the patient care and medical services that medical staff provide.

Due to this privilege, hospital records created in connection with quality review proceedings are not accessible to patient plaintiffs. Privilege laws that shield the peer-review records of medical staff members are present in all 50 states in the US and the District of Columbia.

Some states like Georgia and California also grant statutory immunity from the discovery of the peer-review record. Records containing peer evaluations and performance reviews of doctors (concerning their practices at hospitals) are not subject to discovery under this protection.

Concern Over OPO Credibility in South Carolina

We Are Sharing Hope SC faces three lawsuits because doctors unknowingly transplanted organs with incompatible blood types into three patients. Two recipients, Ykeiah Lawrence and Joe Patterson, survived following second transplants. Sadly, Allen Holliman, who received the incorrect lungs at the Medical University of South Carolina in Charleston, passed.

Consequently, the wife of Mr. Holliman, Mr. Patterson, and Ms. Lawrence all sued We Are Sharing Hope SC. The lawsuits contend that before matching donor organs to patients and shipping them, the organization failed to conduct the two necessary tests to verify donor blood type.

OPOs recover organs and distribute them to waiting patients; part of their job is to secure blood tests to ensure that patients and organs are compatible. The wrongful death lawsuit by the deceased wife demands the documents created or obtained by We Are Sharing Hope or UNOS through a peer-review process.

The Court Ruling in this Case

The documents created during the peer-review process of the Human Organ Transplant Network are protected. However, the South Carolina court ruling concerning the medical liability lawsuit seems to create an exemption on the peer review privilege law.

The ruling mandates the handover of the document created by the state OPO during a federally required peer-review process to the estate suing for wrongful death. Following this ruling, the South Carolina Medical Association (SCMA) and the American Medical Association (AMA) Litigation Center briefly Support Transplant Organizations. In their brief, they ask the South Carolina Court of Appeals to revert its decision and rule that documents are privileged.

Why Peer-review Documents for Organ Transplants Must Remain Confidential

In the absence of protection, some doctors might even feel compelled to criticize their peers in reports. But many will likely do otherwise unless there is a guarantee of no reports disclosure. The reason is fear of retaliation, conflict, or being held accountable.

Additionally, keeping the document confidential is vital when it involves any investigations conducted during root cause analysis meetings. In addition, it is essential to protect it because of morbidity and mortality conferences, which are vital in preventing future harm.

Thus, the reviewing-court refusal to enforce peer-review actions in the best possible way would make their efforts less effective. Patient safety would be compromised, which is not what the General Assembly intended.

CMS Strategy to Improve OPO performance and Patient Safety

In November 2020, the Centers for Medicare and Medicaid Services (CMS) provided some metrics to assess the success of OPOs. However, the new measures will go into effect on August 1st, 2022, and full enforcement will start in 2026. Some of these measures are as follows:

#1. Donation and Transplantation Rate Measure

The donation rate measure is the first to be changed. The modifications encourage OPOs to seek out all potential donors, including those who can only give one organ. According to CMS, we could have about 5,600 more organs available for transplantation yearly if every OPO meets or exceeds this donation rate measure.

With the transplantation rate measure, OPOs will no longer receive credit for merely obtaining an organ. Instead, the organ must be transplanted to be credited. As a result, this gives OPOs an incentive to find all viable organs and match them with recipients.

Additionally, as part of the transplantation measure, CMS has stopped accepting OPOs self-reported data. Instead, CMS will use death certificate data, a more trusted and verifiable data source, to calculate the outcome measures for OPO.

#2. Performance Benchmark

To increase transparency, CMS makes outcome measure performance available to the public. Publicizing this will draw attention to OPOs with donation and transplantation rates below the top 25 percent and help them determine areas for improvement.

It will also allow them to act quickly to save more lives. OPOs will be required to participate in a Quality Assurance and Performance Improvement (QAPI) program to improve their performance rates if they fall below the top 25 percent.

#3. 12-Month Review Periods

During the four-year recertification cycle, CMS will evaluate OPO performance yearly to ensure a few wastages of viable organs and transplants happen more quickly. The 12-month review period would enable CMS to promptly spot OPOs that require improvement, allowing quicker implementation of the necessary changes.

According to CMS, monitoring the improvement efforts and conducting more frequent reviews of OPOs will encourage best practices. It will also boost the number of organs available for transplant.

If an OPO does not meet the outcome measures before the recertification cycle is over, it may be de-certified. In addition, the OPO may lose its Donation Service Area (DSA).

Bottom Line

There is a need to keep peer review documents and materials in South Carolina confidential. Protecting these documents will help promote the public interest in improving the standard of healthcare in the state.

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