Patient safety and quality improvement — Burden of proving bad faith and malice

Tenn. Code Ann. § 68-11-272, under Regulation of Health and Related Facilities.

Tenn. Code Ann. § 68-11-272

(a) It is the policy of this state to encourage the improvement of patient safety, the quality of patient care and the evaluation of the quality, safety, cost, processes and necessity of healthcare services by hospitals, healthcare facilities and healthcare providers. Tennessee further recognizes that certain protections must be available to these entities to ensure that they are able to effectively pursue these measures.

(b) As used in this section:(1) “Adverse healthcare incident” means an objective and definable outcome arising from or related to patient care that results in the death or injury of a patient;(2) “Healthcare organization” means any:(A) Healthcare facility licensed or regulated under this title and any related system;(B) Hospital licensed under this title and any related hospital system;(C) Hospital licensed under title 33 and any related hospital system;(D) Entity owning, owned by, affiliated with or providing ancillary or allied health services to, or on behalf of, a hospital, hospital system, or healthcare facility licensed or regulated under this title;(E) Entity that contracts with a healthcare organization to perform any of the functions of a quality improvement committee;(F) Entity that maintains a patient safety evaluation system in compliance with the Patient Safety and Quality Improvement Act of 2005 (Pub. L. No. 109-41), as amended, for reporting to a patient safety organization listed as such by the federal secretary of health and human services pursuant to § 924 of the Patient Safety and Quality Improvement Act of 2005;(G) Professional assistance program providing, or attempting to provide, intervention, counseling, referral or other assistance to any healthcare provider or family of a healthcare provider directly related to and including the alcohol or drug impairment of a healthcare provider;(H) Professional healthcare foundation;(I) Health maintenance organization, preferred provider organization, hospital and medical service corporation, or accountable care organization as defined by § 3022 of the federal Patient Protection and Affordable Care Act (Pub. L. No. 111-148), as amended;(J) University medical school or health science center; or(K) Community mental health center as defined in § 33-1-101;(3) “Healthcare provider” means any healthcare professional licensed, authorized, certified or regulated under title 63 or this title, including, but not limited to, medical resident physicians, interns, and fellows participating in a training program of one (1) of the accredited medical schools or of one (1) of such medical school's affiliated teaching hospitals in this state, or any other clinical staff of a healthcare organization;(4) “Hospital system” means two (2) or more hospitals that are subject to the control and direction of one (1) common owner, or an entity under a management contract, responsible for the operational decisions of the entire system or that have integrated administrative functions and medical staff that report to one (1) governing body as the result of a formal legal or contractual obligation;(5) “Open discussion”:(A) Means any communication that is made under this section and includes memoranda, work product, documents, and other materials that are prepared for, or submitted in the course of or in connection with, communications under this section; and(B) Does not include any communications, memoranda, work product, documents, or other materials that are otherwise subject to discovery and that were not prepared specifically for use pursuant to this subdivision (b)(5);(6) “Quality improvement committee” or “QIC” means a committee formed or retained by a healthcare organization, an activity of a healthcare organization, or one (1) or more individuals employed by a healthcare organization performing the types of functions listed in subdivisions (4)(A)-(P), the purpose of which, or one (1) of the purposes of which is to evaluate the safety, quality, processes, costs, appropriateness or necessity of healthcare services by performing functions including, but not limited to:(A) Evaluation and improvement of the quality of healthcare 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 healthcare providers or actions upon matters relating to the discipline of any individual healthcare 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 healthcare providers;(J) Review of professional qualifications or activities of healthcare providers;(K) Evaluation of the quantity, quality and timeliness of healthcare 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 the Health Care Service Utilization Review Act, compiled in 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 healthcare organization's patient safety and risk management activities;(O) Activities to determine the healthcare organization's compliance with state or federal regulations;(P) Participation in patient safety activities as defined at § 921 of the Patient Safety and Quality Improvement Act of 2005; and(7) “Records” means records of interviews and all 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 QIC and any patient safety work product as defined at § 921 of the Patient Safety and Quality Improvement Act of 2005.

(1) “Adverse healthcare incident” means an objective and definable outcome arising from or related to patient care that results in the death or injury of a patient;

(2) “Healthcare organization” means any:(A) Healthcare facility licensed or regulated under this title and any related system;(B) Hospital licensed under this title and any related hospital system;(C) Hospital licensed under title 33 and any related hospital system;(D) Entity owning, owned by, affiliated with or providing ancillary or allied health services to, or on behalf of, a hospital, hospital system, or healthcare facility licensed or regulated under this title;(E) Entity that contracts with a healthcare organization to perform any of the functions of a quality improvement committee;(F) Entity that maintains a patient safety evaluation system in compliance with the Patient Safety and Quality Improvement Act of 2005 (Pub. L. No. 109-41), as amended, for reporting to a patient safety organization listed as such by the federal secretary of health and human services pursuant to § 924 of the Patient Safety and Quality Improvement Act of 2005;(G) Professional assistance program providing, or attempting to provide, intervention, counseling, referral or other assistance to any healthcare provider or family of a healthcare provider directly related to and including the alcohol or drug impairment of a healthcare provider;(H) Professional healthcare foundation;(I) Health maintenance organization, preferred provider organization, hospital and medical service corporation, or accountable care organization as defined by § 3022 of the federal Patient Protection and Affordable Care Act (Pub. L. No. 111-148), as amended;(J) University medical school or health science center; or(K) Community mental health center as defined in § 33-1-101;

(A) Healthcare facility licensed or regulated under this title and any related system;

(B) Hospital licensed under this title and any related hospital system;

(C) Hospital licensed under title 33 and any related hospital system;

(D) Entity owning, owned by, affiliated with or providing ancillary or allied health services to, or on behalf of, a hospital, hospital system, or healthcare facility licensed or regulated under this title;

(E) Entity that contracts with a healthcare organization to perform any of the functions of a quality improvement committee;

(F) Entity that maintains a patient safety evaluation system in compliance with the Patient Safety and Quality Improvement Act of 2005 (Pub. L. No. 109-41), as amended, for reporting to a patient safety organization listed as such by the federal secretary of health and human services pursuant to § 924 of the Patient Safety and Quality Improvement Act of 2005;

(G) Professional assistance program providing, or attempting to provide, intervention, counseling, referral or other assistance to any healthcare provider or family of a healthcare provider directly related to and including the alcohol or drug impairment of a healthcare provider;

(H) Professional healthcare foundation;

(I) Health maintenance organization, preferred provider organization, hospital and medical service corporation, or accountable care organization as defined by § 3022 of the federal Patient Protection and Affordable Care Act (Pub. L. No. 111-148), as amended;

(J) University medical school or health science center; or

(K) Community mental health center as defined in § 33-1-101;

(3) “Healthcare provider” means any healthcare professional licensed, authorized, certified or regulated under title 63 or this title, including, but not limited to, medical resident physicians, interns, and fellows participating in a training program of one (1) of the accredited medical schools or of one (1) of such medical school's affiliated teaching hospitals in this state, or any other clinical staff of a healthcare organization;

(4) “Hospital system” means two (2) or more hospitals that are subject to the control and direction of one (1) common owner, or an entity under a management contract, responsible for the operational decisions of the entire system or that have integrated administrative functions and medical staff that report to one (1) governing body as the result of a formal legal or contractual obligation;

(5) “Open discussion”:(A) Means any communication that is made under this section and includes memoranda, work product, documents, and other materials that are prepared for, or submitted in the course of or in connection with, communications under this section; and(B) Does not include any communications, memoranda, work product, documents, or other materials that are otherwise subject to discovery and that were not prepared specifically for use pursuant to this subdivision (b)(5);

(A) Means any communication that is made under this section and includes memoranda, work product, documents, and other materials that are prepared for, or submitted in the course of or in connection with, communications under this section; and

(B) Does not include any communications, memoranda, work product, documents, or other materials that are otherwise subject to discovery and that were not prepared specifically for use pursuant to this subdivision (b)(5);

(6) “Quality improvement committee” or “QIC” means a committee formed or retained by a healthcare organization, an activity of a healthcare organization, or one (1) or more individuals employed by a healthcare organization performing the types of functions listed in subdivisions (4)(A)-(P), the purpose of which, or one (1) of the purposes of which is to evaluate the safety, quality, processes, costs, appropriateness or necessity of healthcare services by performing functions including, but not limited to:(A) Evaluation and improvement of the quality of healthcare 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 healthcare providers or actions upon matters relating to the discipline of any individual healthcare 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 healthcare providers;(J) Review of professional qualifications or activities of healthcare providers;(K) Evaluation of the quantity, quality and timeliness of healthcare 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 the Health Care Service Utilization Review Act, compiled in 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 healthcare organization's patient safety and risk management activities;(O) Activities to determine the healthcare organization's compliance with state or federal regulations;(P) Participation in patient safety activities as defined at § 921 of the Patient Safety and Quality Improvement Act of 2005; and

(A) Evaluation and improvement of the quality of healthcare 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 healthcare providers or actions upon matters relating to the discipline of any individual healthcare 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 healthcare providers;

(J) Review of professional qualifications or activities of healthcare providers;

(K) Evaluation of the quantity, quality and timeliness of healthcare 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 the Health Care Service Utilization Review Act, compiled in 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 healthcare organization's patient safety and risk management activities;

(O) Activities to determine the healthcare organization's compliance with state or federal regulations;

(P) Participation in patient safety activities as defined at § 921 of the Patient Safety and Quality Improvement Act of 2005; and

(7) “Records” means records of interviews and all 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 QIC and any patient safety work product as defined at § 921 of the Patient Safety and Quality Improvement Act of 2005.

(c) (1) Records of a QIC and testimony or statements by a healthcare organization's officers, directors, trustees, healthcare providers, administrative staff, employees or other committee members or attendees relating to activities of the QIC shall be confidential and privileged and shall be protected from direct or indirect means of discovery, subpoena or admission into evidence in any judicial or administrative proceeding. Any person who supplies information, testifies or makes statements as part of a QIC may not be required to provide information as to the information, testimony or statements provided to or made before such a committee or opinions formed by such person as a result of committee participation.(2) Any information, documents or records, which are not produced for use by a QIC or which are not produced by persons acting on behalf of a QIC, and are otherwise available from original sources, shall not be construed as immune from discovery or use in any judicial or administrative proceeding merely because such information, documents or records were presented during proceedings of such committee.(3) A QIC may share information and documents, including complaints, incident reports, and testimony and statements by any person to the QIC, with one (1) or more other QICs as defined under this section or under § 63-1-150. Information and documents disclosed by one QIC to another QIC, and any information and documents created or maintained as a result of the sharing of such information and documents, shall be confidential, privileged and protected from direct or indirect means of discovery, subpoena or admission into evidence, to the same extent as provided in subdivision (c)(1). The QIC sharing such information with another QIC shall determine the manner and process by which it will share such information and documents, which process may include requiring a written agreement between QICs regarding the sharing of practitioner information. The QIC and its sponsoring healthcare organization shall not be held liable and are immune from suit for any disclosure or sharing of information in compliance with this section.(4) A good faith disclosure of information related to an activity of a QIC made by a healthcare provider or healthcare organization to a patient or family member of a patient in an open discussion is not a waiver of the privilege and confidentiality protections provided under this section. Such disclosures are considered separate and apart from a QIC proceeding and do not affect the privilege attributed to the QIC documentation.(5) (A) A healthcare provider and healthcare organization are not required to disclose findings, determinations, or conclusions of a QIC during a legal, administrative, or other proceeding.(B) The outcomes from the QIC review must remain confidential and privileged unless otherwise provided by state or federal law, in which case, the disclosure of any QIC proceeding materials, findings, or conclusions made solely to comply with state or federal law does not waive the confidentiality, privilege, or the restricted use of QIC materials, findings, or conclusions as prohibited in this section.(6) (A) A healthcare provider or healthcare organization may voluntarily engage in an open discussion. Any communications during an open discussion are not an admission of liability and are protected from discovery, as described in subdivision (c)(1).(B) A healthcare provider or healthcare organization may engage in voluntary communications, as described in subdivision (c)(6)(A), and is immune from liability as a result of the open discussion as long as the communication is undertaken in good faith and in compliance with subdivision (c)(7).(7) (A) If an adverse healthcare incident occurs, then a healthcare provider or healthcare organization may elect to engage in an open discussion with a patient or invite a patient to participate in the open discussion with the purpose of addressing the incident and proposing resolutions. In a situation where the patient is incapacitated or deceased, a healthcare provider or a healthcare organization may engage in an open discussion with a patient's family member or legal representative. For a minor patient, the open discussion must include the patient's guardian.(B) The following conditions apply to an open discussion pursuant to subdivision (c)(7)(A):(i) Any communication made during the open discussion process is:(a) Privileged and confidential; and(b) Not subject to discovery, subpoena, or use as evidence in any judicial, administrative, or arbitration proceeding;(ii) An individual with whom a healthcare provider or healthcare organization engages in the open discussion process following an adverse healthcare incident, including a patient and any other affected person, must sign a written acknowledgment after an adverse healthcare incident occurs before an open discussion takes place; and(iii) Unless otherwise agreed upon by the patient, only a party involved in the adverse healthcare incident and the party's representatives, including legal counsel, may participate in the open discussion process.

(1) Records of a QIC and testimony or statements by a healthcare organization's officers, directors, trustees, healthcare providers, administrative staff, employees or other committee members or attendees relating to activities of the QIC shall be confidential and privileged and shall be protected from direct or indirect means of discovery, subpoena or admission into evidence in any judicial or administrative proceeding. Any person who supplies information, testifies or makes statements as part of a QIC may not be required to provide information as to the information, testimony or statements provided to or made before such a committee or opinions formed by such person as a result of committee participation.

(2) Any information, documents or records, which are not produced for use by a QIC or which are not produced by persons acting on behalf of a QIC, and are otherwise available from original sources, shall not be construed as immune from discovery or use in any judicial or administrative proceeding merely because such information, documents or records were presented during proceedings of such committee.

(3) A QIC may share information and documents, including complaints, incident reports, and testimony and statements by any person to the QIC, with one (1) or more other QICs as defined under this section or under § 63-1-150. Information and documents disclosed by one QIC to another QIC, and any information and documents created or maintained as a result of the sharing of such information and documents, shall be confidential, privileged and protected from direct or indirect means of discovery, subpoena or admission into evidence, to the same extent as provided in subdivision (c)(1). The QIC sharing such information with another QIC shall determine the manner and process by which it will share such information and documents, which process may include requiring a written agreement between QICs regarding the sharing of practitioner information. The QIC and its sponsoring healthcare organization shall not be held liable and are immune from suit for any disclosure or sharing of information in compliance with this section.

(4) A good faith disclosure of information related to an activity of a QIC made by a healthcare provider or healthcare organization to a patient or family member of a patient in an open discussion is not a waiver of the privilege and confidentiality protections provided under this section. Such disclosures are considered separate and apart from a QIC proceeding and do not affect the privilege attributed to the QIC documentation.

(5) (A) A healthcare provider and healthcare organization are not required to disclose findings, determinations, or conclusions of a QIC during a legal, administrative, or other proceeding.(B) The outcomes from the QIC review must remain confidential and privileged unless otherwise provided by state or federal law, in which case, the disclosure of any QIC proceeding materials, findings, or conclusions made solely to comply with state or federal law does not waive the confidentiality, privilege, or the restricted use of QIC materials, findings, or conclusions as prohibited in this section.

(A) A healthcare provider and healthcare organization are not required to disclose findings, determinations, or conclusions of a QIC during a legal, administrative, or other proceeding.

(B) The outcomes from the QIC review must remain confidential and privileged unless otherwise provided by state or federal law, in which case, the disclosure of any QIC proceeding materials, findings, or conclusions made solely to comply with state or federal law does not waive the confidentiality, privilege, or the restricted use of QIC materials, findings, or conclusions as prohibited in this section.

(6) (A) A healthcare provider or healthcare organization may voluntarily engage in an open discussion. Any communications during an open discussion are not an admission of liability and are protected from discovery, as described in subdivision (c)(1).(B) A healthcare provider or healthcare organization may engage in voluntary communications, as described in subdivision (c)(6)(A), and is immune from liability as a result of the open discussion as long as the communication is undertaken in good faith and in compliance with subdivision (c)(7).

(A) A healthcare provider or healthcare organization may voluntarily engage in an open discussion. Any communications during an open discussion are not an admission of liability and are protected from discovery, as described in subdivision (c)(1).

(B) A healthcare provider or healthcare organization may engage in voluntary communications, as described in subdivision (c)(6)(A), and is immune from liability as a result of the open discussion as long as the communication is undertaken in good faith and in compliance with subdivision (c)(7).

(7) (A) If an adverse healthcare incident occurs, then a healthcare provider or healthcare organization may elect to engage in an open discussion with a patient or invite a patient to participate in the open discussion with the purpose of addressing the incident and proposing resolutions. In a situation where the patient is incapacitated or deceased, a healthcare provider or a healthcare organization may engage in an open discussion with a patient's family member or legal representative. For a minor patient, the open discussion must include the patient's guardian.(B) The following conditions apply to an open discussion pursuant to subdivision (c)(7)(A):(i) Any communication made during the open discussion process is:(a) Privileged and confidential; and(b) Not subject to discovery, subpoena, or use as evidence in any judicial, administrative, or arbitration proceeding;(ii) An individual with whom a healthcare provider or healthcare organization engages in the open discussion process following an adverse healthcare incident, including a patient and any other affected person, must sign a written acknowledgment after an adverse healthcare incident occurs before an open discussion takes place; and(iii) Unless otherwise agreed upon by the patient, only a party involved in the adverse healthcare incident and the party's representatives, including legal counsel, may participate in the open discussion process.

(A) If an adverse healthcare incident occurs, then a healthcare provider or healthcare organization may elect to engage in an open discussion with a patient or invite a patient to participate in the open discussion with the purpose of addressing the incident and proposing resolutions. In a situation where the patient is incapacitated or deceased, a healthcare provider or a healthcare organization may engage in an open discussion with a patient's family member or legal representative. For a minor patient, the open discussion must include the patient's guardian.

(B) The following conditions apply to an open discussion pursuant to subdivision (c)(7)(A):(i) Any communication made during the open discussion process is:(a) Privileged and confidential; and(b) Not subject to discovery, subpoena, or use as evidence in any judicial, administrative, or arbitration proceeding;(ii) An individual with whom a healthcare provider or healthcare organization engages in the open discussion process following an adverse healthcare incident, including a patient and any other affected person, must sign a written acknowledgment after an adverse healthcare incident occurs before an open discussion takes place; and(iii) Unless otherwise agreed upon by the patient, only a party involved in the adverse healthcare incident and the party's representatives, including legal counsel, may participate in the open discussion process.

(i) Any communication made during the open discussion process is:(a) Privileged and confidential; and(b) Not subject to discovery, subpoena, or use as evidence in any judicial, administrative, or arbitration proceeding;

(a) Privileged and confidential; and

(b) Not subject to discovery, subpoena, or use as evidence in any judicial, administrative, or arbitration proceeding;

(ii) An individual with whom a healthcare provider or healthcare organization engages in the open discussion process following an adverse healthcare incident, including a patient and any other affected person, must sign a written acknowledgment after an adverse healthcare incident occurs before an open discussion takes place; and

(iii) Unless otherwise agreed upon by the patient, only a party involved in the adverse healthcare incident and the party's representatives, including legal counsel, may participate in the open discussion process.

(d) No healthcare organization or its officers, trustees, directors, healthcare providers, administrative staff, employees, other committee members or attendees, or any person providing information to a QIC shall be held liable:(1) In any action for damages or other relief arising from the provision of information to a QIC or in any judicial or administrative proceeding if the information is provided to the QIC in good faith and without malice and on the basis of facts reasonably known or reasonably believed to exist; or(2) For damages resulting from any decisions, opinions, actions, and proceedings rendered, entered or acted upon by a QIC undertaken or performed within the scope or function of the duties of such committees or in any judicial or administrative proceeding, if made or taken in good faith and without malice and on the basis of facts reasonably known or reasonably believed to exist.

(1) In any action for damages or other relief arising from the provision of information to a QIC or in any judicial or administrative proceeding if the information is provided to the QIC in good faith and without malice and on the basis of facts reasonably known or reasonably believed to exist; or

(2) For damages resulting from any decisions, opinions, actions, and proceedings rendered, entered or acted upon by a QIC undertaken or performed within the scope or function of the duties of such committees or in any judicial or administrative proceeding, if made or taken in good faith and without malice and on the basis of facts reasonably known or reasonably believed to exist.

(e) Nothing in this section shall conflict with any federal protection of records provided under the federal Health Care Quality Improvement Act (42 U.S.C. § 11101 et seq.), or the federal Patient Safety Act.

(f) Any person providing information to a QIC is presumed to have acted in good faith and without malice. Any person alleging lack of good faith has the burden of proving bad faith and malice.

(g) All decisions, opinions, actions and proceedings rendered, entered or acted upon by a QIC are presumed to have been completed in good faith and without malice. Any person alleging lack of good faith has the burden of proving bad faith and malice.