While Tennessee has had a Peer Review law for decades, recent Tennessee Supreme Court cases have called into question the protections of this law and how they apply. In response, the Tennessee General Assembly recently enacted legislation to clarify and strengthen the law. This newsletter examines the reasons for enacting this new law, the "Tennessee Patient Safety and Quality Improvement Act of 2011," and explains its provisions.

Tennessee Supreme Court Limits Peer Review

In 2010, the Tennessee Supreme Court decided two cases that significantly limited, if not eliminated, the protections for many health care facility records under the Tennessee Peer Review Statute.1 The Powell v. Community Health Systems case analyzed the peer review statute and determined that records made in the ordinary course of business are not protected.2 The second case, Lee Medical v. Beecher, essentially eliminated the peer review protection for health care facility quality assurance, and limited the statute to matters only involving the review of a specific physician's professional conduct.3

Legislative Reaction to Powell and Lee

In the 2011 legislative session, provider organizations developed a legislative proposal designed to restore the protections that most providers had assumed existed under the Tennessee Peer Review Statute. The Tennessee Legislature recognized the need to enact new protection for health care facilities, and introduced the legislation as SB484/HB1158. Known as the "Tennessee Patient Safety and Quality Improvement Act of 2011" (TPSQIA), the legislation passed both the Tennessee Senate and House, and became law as of April 12, 2011 as Public Chapter 67.4

The Legislature's response recognized that it is the policy of the state of Tennessee to encourage the improvement of patient safety, the quality of patient care, and the evaluation of the quality, safety, cost, processes, and necessity of health care services by hospitals, health care facilities, and health care providers. Tennessee further recognizes that certain protections must be available to these entities to ensure that they are able to effectively pursue these measures.

The TPSQIA also restores those protections that existed under the Peer Review Statute, and in many ways strengthens those protections.

Explanation of the Act

The specifics of the act revolve around three questions: Who is protected? What records are protected? And how does the protection work?

Who is protected?

The TPSQIA establishes three important definitions that control the application of the

legal protections - "health care organization," "health care provider," and a "Quality Improvement Committee." The protections apply only to health care providers and health care organizations. However, those definitions are broadly drafted to include most of the people, entities, and organizations involved in quality improvement. All health care facilities regulated under Title 68 and all health care professionals licensed under Title 63 are covered by the definitions. Also covered are affiliates, contracted entities, patient safety organizations, and peer assistance programs that have connections or business relationships with either a health care facility or a health care provider. Additionally, any entities within "a hospital and any related health system" or related contractors with a health system fall within the definition of a "health care organization."

The operative entity that receives the protection is called a "Quality Improvement Committee" or QIC. The Committee moves away from the physician-centric concept of "peer review" to a broader concept of "health care quality improvement privilege." A QIC must be either a committee formed or retained by a health care organization, or one or more individuals employed by a health care organization. Secondly, at least one of the purposes of the committee or group of employees must be to evaluate the safety, quality, processes, costs, appropriateness, or necessity of health care services. The statute which includes a non-exclusive list of functions that meet this test is as follows:

a) evaluation and improvement of the quality of health care services rendered;

b) determination that health services rendered were professionally indicated or were performed in compliance with the applicable standards of care;

c) determination that the cost of health care rendered was reasonable;

d) evaluation of the qualifications, credentials, competence, and performance of health care providers or actions upon matters relating to the discipline of any individual health care provider;

e) reduction of morbidity or mortality;

f) establishment and enforcement of guidelines designed to keep the cost of health care within reasonable bounds;

g) research;

h) evaluation of whether facilities are being properly utilized;

i) supervision, education, discipline, admission, and the determination of privileges of health care providers;

j) review of professional qualifications or activities of health care providers;

k) evaluation of the quantity, quality, and timeliness of health care services rendered to patients;

l) evaluation, review, or improvement of methods, procedures, or treatments being utilized;

m) participation in utilization review activities, including participation in review activities within the facility or hospital system and activities in conjunction with an insurer or utilization review agent under title 56, chapter 6, part 7;

n) the evaluation of reports made pursuant to § 68-11-211 and any internal reports related thereto or in the course of a health care organization's patient safety and risk management activities;

o) activities to determine the health care organization's compliance with state or federal regulations; and

p) participation in patient safety activities as defined at § 921 of the Patient Safety and Quality Improvement Act of 2005, P.L. 109-41, as amended.

As the reader will note, the addition of specific quality improvement functions is an important revision to the former peer review. Note that certain of the provisions listed above focus on the compliance function of the various health care entity committees, as well as the evaluation of the care provided, protecting those deliberations and records in a very specific way.

What Records Are Protected?

Even under the previous peer review privilege, not every record within a health care facility was protected. Records that are not made as part of the peer review process do not become privileged merely because they are presented to the peer review committee. The law specifically excluded "records made in the regular course of business by a hospital or other provider of health care and information." Documents or records otherwise available from original sources also were not protected from discovery or production merely because they were presented during proceedings of a peer review committee.

The new law provides a wide, but not unlimited, protection for facility records and information. "Records" is defined in the law, and includes "reports, incident reports, statements, minutes, memoranda, charts, statistics, evaluations, critiques, test results, corrective actions, disciplinary actions, and any and all other documentation generated by or in connection with activities of a QlC." The law also covers Patient Safety Organization work product, which would also be protected under the federal Patient Safety and Quality Improvement Act of 2005. The law further protects testimony or statements by individuals that are part of the QIC activities. Third parties cannot compel a health care organization's officers, directors, trustees, health care providers, administrative staff, employees, or other committee members or attendees to testify or discuss information about or activities relating to the QIC.

The law does retain the "ordinary business records" exception from the former peer review law. The new act does not extend protection to any information, documents, or records that:

  1. are not produced for or used by a QIC;
  2. are not produced by persons acting on behalf of a QIC; or
  3. are otherwise available from original sources.

Just as they were treated under the former law, those documents are not protected from discovery or use in any judicial or administrative proceeding simply because such information, documents, or records were presented during proceedings of such committee. A document that is not protected does not get protection simply because the QIC reviews it. In short, if the information is created during or at the direction of the QIC it is protected. If it was created before the QIC meetings and is otherwise a facility business record, it does not gain QIC protection because someone gives it to the QIC.

How does the Protection Work?

The new TPSQIA protects good faith efforts by health care providers to evaluate health care quality and health care compliance. In that way, it is similar to the former peer review law in that it does not provide a QIC with the ability to extend protection to non-protectable records simply because they are provided to a QIC. In short the law protects QIC records, and makes them confidential and privileged. All QIC records are protected from direct or indirect means of discovery, subpoena, or admission into evidence in any judicial or administrative proceeding.

Health care facilities should follow a few simple tips from the new law:

  1. It makes sense to ensure that any of a health care organization's committees performing protected functions are identified as a QIC under the new Tennessee law. That can be done either by renaming the committee or by a simple reference in the facility's policies and procedures to its function being performed under the new law.
  2. In most cases, the Corporate Compliance Committee should be designated as a QIC.
  3. As part of the QIC's policies and procedures, the facility should broadly list any applicable functions from the TPSQIA that the committee is performing. This sort of list will make it clear that the committee is performing functions of a QIC protected under the new law.
  4. Documentation, data, or other information ought to be marked "Quality Improvement Committee Record" or "QIC Record" to clearly establish that the documents are protected under the new law. Because of the uncertainty of the protections under the old Peer Review Statute, facilities should shift from the term "Peer Review" to the new terminology of "Quality Improvement Privilege."
  5. While a formal committee is clearly a QIC under the TPSQIA, sub-groups of one or more employees may also be protected as a QIC if they are performing one or more of the noted functions. Health care facilities should consider this as they review their quality improvement activities, as full QIC committee meetings are not required to create the protection.
  6. Facilities should understand the protection. Stamping every document "QIC Protected" is not helpful. As explained above, the information needs to be legitimately a QIC record for the protections to apply.

Implemented and used properly, the new Tennessee Patient Safety and Quality Improvement Act of 2011 should provide the appropriate protection for health care facilities to perform the quality improvement activities required to help advance the quality of care for Tennessee patients.

Footnotes

1 T.C.A. § 63-6-219

2 Powell v. Community Health System, 312 S.W.3d 496 (Tenn. 2010).

3 Lee Medical, Inc. v. Beecher, 312 S.W.3d 515 (Tenn. 2010).

4 http://www.tn.gov/sos/acts/107/pub/pc0067.pdf

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.