Second Regular Session Sixty-fifth General Assembly STATE OF COLORADO INTRODUCED LLS NO. 06-0615.01 Christy Chase SENATE BILL 06-050 SENATE SPONSORSHIP Johnson, HOUSE SPONSORSHIP (None), Senate Committees House Committees Business, Labor and Technology A BILL FOR AN ACT Concerning professional review of health care providers. Bill Summary (Note: This summary applies to this bill as introduced and does not necessarily reflect any amendments that may be subsequently adopted.) Authorizes professional review committees (committees), governing boards (boards), and organizations that perform health care accreditation or certification to share with one another privileged and confidential information concerning health care providers (providers). Gives a provider subject to review by a committee or board the right to reasonable notice of, as well as the right to any documents, records, and evidence pertaining to, a hearing regarding the provider's conduct. States that such information shall be privileged and confidential and shall not be admissible in a civil suit or other legal or administrative proceeding, except as otherwise specified. Directs a committee or board and a provider subject to certain disciplinary actions to report actions taken against the provider, as well as any agreement or understanding made between the provider and the committee or board regarding the conduct of the provider, to the Colorado state board of medical examiners (board of medical examiners). Allows the board of medical examiners to initiate proceedings against a provider in certain instances and to ascertain whether a committee or board is conducting appropriate professional conduct reviews. Clarifies that a person serving on or participating in activities of a committee or board that oversees the conduct of providers shall be immune from a civil suit and liability arising from such participation. Makes legislative findings and declarations. Makes conforming amendments. Be it enacted by the General Assembly of the State of Colorado: SECTION 1. 12-36.5-101, Colorado Revised Statutes, is amended BY THE ADDITION OF THE FOLLOWING NEW SUBSECTIONS to read: 12-36.5-101. Legislative declaration. (4) The general assembly finds, determines, and declares that the protection of public health, safety, and welfare will be further strengthened by a state policy that encourages and protects licensed physicians engaged in the evaluation and review of competence, professional conduct, and quality and appropriateness of patient care provided by other licensed physicians in the state. To encourage and protect professional review activities as described and authorized in this article, the general assembly recognizes that it must provide participants with certain immunities from suit and liability and ensure that such activities are conducted, maintained, and protected as privileged and confidential. Privilege and confidentiality are critical for the effective functioning of professional review processes, which in turn are essential to furthering the overwhelming public interest in continued improvement in patient care and safety through the free, candid, and unfettered flow and exchange of ideas, advice, and professional judgment. Accordingly, it is the intent of the general assembly that professional review activities, records, and other information are privileged and confidential and not subject to discovery so that professional review participants may openly, honestly, and objectively conduct professional evaluations and reviews of their peer physicians without fear that their work will be subject to the litigation and discovery processes. (5) The general assembly recognizes as state policy the importance of the availability and accessibility of professional liability insurance coverage for health care providers as a matter of statewide interest and concern in promotion of access to and quality of health care. The availability and use of information in the professional review context for making underwriting, risk management, and claims decisions contribute to the availability and affordability of professional liability coverage and consumer satisfaction. SECTION 2. 12-36.5-102 (1), (2), and (4), Colorado Revised Statutes, are amended, and the said 12-36.5-102 is further amended BY THE ADDITION OF THE FOLLOWING NEW SUBSECTIONS, to read: 12-36.5-102. Definitions. As used in this article, unless the context otherwise requires: (1) "Board of medical examiners" means the Colorado state board of medical examiners created pursuant to section 12-36-103. "Adversely affects" means reduces, restricts, suspends, revokes, denies, or fails to renew a physician's clinical privileges or membership in any entity that conducts professional review. (1.5) "Board of medical examiners" means the Colorado state board of medical examiners created pursuant to section 12-36-103. (2) "Governing board" means any board, board of trustees, governing board, or other body, or duly authorized subcommittee thereof, of any organization of health care providers, which board or body has final authority pursuant to such organization's written bylaws, organizational documents, policies, or procedures to take final action regarding the recommendations of any authorized professional review committee. (2.5) "Joint commission on accreditation of healthcare organizations" means the nationally recognized nonprofit accreditation organization that establishes and maintains standards for the quality and safety of patient care provided by health care organizations. (4) (a) "Records" means any and all written or verbal oral communications by any person, any member of an investigative body, or any professional review committee or governing board, or the staff thereof of such committee or board, including nonprofessional staff, arising from any activities of a professional review committee authorized by this article, including the complaint, response, correspondence related thereto, recordings or transcripts of proceedings, minutes, formal recommendations, decisions, exhibits, and other similar items or documents typically constituting the records of administrative proceedings. (b) "Records" includes, but is not limited to, all information, interviews, reports, statements, memoranda, credentials applications, recommendations, letters of reference, or other third-party confidential assessments of a physician's competence or professional conduct submitted to or obtained or maintained by a professional review committee, governing board, entity authorized to establish professional review committees, or any subdivision or committee of such a professional review committee, governing board, or entity. "Records" also includes, but is not limited to, all communications, information, and documents used in the course of internal quality control, medical study for the purpose of reducing morbidity or mortality, evaluating and improving the quality of patient care, evaluating claims, and engaging in underwriting and risk management activities in connection with professional liability insurance coverage for physicians, or granting, limiting, or revoking staff privileges or agreements for services, and reports made to the board of medical examiners pursuant to this article. SECTION 3. 12-36.5-103 (3) (b), Colorado Revised Statutes, is amended to read: 12-36.5-103. Use of professional review committees. (3) (b) Professional review committees, the members who constitute such committees, governing boards, and persons who participate directly or indirectly in professional review proceedings are granted certain immunities from suit and liability arising from actions which that are within the scope of their activities and taken in good faith as provided in section 12-36.5-105. Such grants of immunity from suit and liability are declared to be necessary to ensure that professional review committees and governing boards can exercise their professional knowledge and judgment. SECTION 4. 12-36.5-104 (4), Colorado Revised Statutes, is amended BY THE ADDITION OF A NEW PARAGRAPH to read: 12-36.5-104. Establishment of professional review committees - function. (4) Any professional review committee established by any of the following organizations, entities, or professional societies shall be an approved professional review committee under this article if it operates pursuant to written bylaws, policies, or procedures which are in compliance with this article and which have been approved by its governing board: (j) Any other entity that is eligible to be licensed as a health care facility under state law or eligible to participate as a medicare provider or supplier. SECTION 5. 12-36.5-104 (7) (c), (7) (d), (8) (b), (10) (a), and (13), Colorado Revised Statutes, are amended to read: 12-36.5-104. Establishment of professional review committees - function. (7) The written bylaws, policies, or procedures of any professional review committee shall provide for at least the following: (c) The physician who is the subject of any investigation shall be given reasonable notice of such hearing and shall have a right to be present, to be represented by legal counsel at such hearing, and to offer evidence in his or her own behalf. For purposes of this paragraph (c), "reasonable notice" includes, but is not limited to, providing the physician with copies of documents or other evidence as is fair to the physician under the circumstances so that he or she may adequately confront the evidence at the hearing. Providing copies to a physician pursuant to this paragraph (c) for the limited purpose of addressing the evidence at the hearing is not prohibited by the privileges and confidentiality of records described in subsections (10) and (13) of this section and is not a waiver of those privileges or the confidentiality of the records. The health care facility may impose reasonable conditions, consistent with law, on the release to the physician of copies of the documents and evidence necessary to ensure their continued confidentiality and privileged status outside the hearing process. (d) After such hearing, the professional review committee shall make any recommendations it deems necessary to the governing board unless otherwise provided by federal law or regulation. (8) (b) The bylaws, policies, or procedures may provide that a committee of not fewer than three members of the governing board may hear the appeal. Such bylaws, policies, or procedures may also allow for an appeal to be heard by an independent third party designated by the board. (10) (a) The records of a professional review committee, a governing board, or the committee on anticompetitive conduct and all other records defined in section 12-36.5-102 (4) shall be privileged and confidential, shall not be subject to subpoena or discovery, and shall not be admissible in any civil suit brought against a physician who is the subject of such records or other legal or administrative proceeding except proceedings before the board of medical examiners or the department of public health and environment as described in subparagraph (V) of paragraph (b) of this subsection (10). The legal privilege created by this paragraph (a) is available to the professional review committee, governing board, or other committee or entity authorized to conduct the professional review activity. (13) All proceedings, recommendations, records, and reports involving professional review committees or governing boards shall be privileged and confidential, shall not be subject to subpoena or discovery, and shall not be admissible in any civil suit or other legal or administrative proceeding except proceedings before the board of medical examiners or the department of public health and environment as described in subparagraph (V) of paragraph (b) of subsection (10) of this section. The legal privilege created by paragraph (a) of subsection (10) of this section is available to the professional review committee, governing board, or other committee or entity authorized to conduct the professional review activity. SECTION 6. 12-36.5-104 (10) (b), Colorado Revised Statutes, is amended BY THE ADDITION OF A NEW SUBPARAGRAPH to read: 12-36.5-104. Establishment of professional review committees - function. (10) (b) Notwithstanding the provisions of paragraph (a) of this subsection (10), such records shall be subject to subpoena and available for use: (V) By the department of public health and environment for purposes of a regulatory or administrative inspection, investigation, or proceeding as otherwise provided by law. SECTION 7. 12-36.5-104.4 (2) (b), Colorado Revised Statutes, is amended to read: 12-36.5-104.4. Hospital professional review committees. (2) (b) All matters considered in collaboration with or referred to a committee pursuant to this subsection (2) and all records, information, and proceedings related thereto shall remain privileged and confidential. and The committee members, governing board, witnesses, and complainants shall be subject entitled to the immunities and privileges as set forth in this article, and the records, information, and proceedings shall be privileged and confidential as set forth in this article. SECTION 8. Part 1 of article 36.5 of title 12, Colorado Revised Statutes, is amended BY THE ADDITION OF THE FOLLOWING NEW SECTIONS to read: 12-36.5-104.7. Exchange and sharing of information - privilege and confidentiality not waived. (1) Professional review committees and governing boards may exchange and share privileged and confidential records and other information with each other without waiving the privilege or confidentiality established by this article. The privilege and confidentiality shall not be impaired, waived, or otherwise affected solely by reason of the exchange or sharing of records or information authorized by this section. The privilege and confidentiality shall be extended and applied on the same terms and conditions to all professional review committees and governing boards engaged in the exchange or sharing of records and information. This subsection (1) shall not be construed to require the exchange or sharing of records or information if not otherwise required by law. (2) Records and other privileged and confidential information may be released to an organization that performs health care accreditation or certification services, including, without limitation, the joint commission on accreditation of healthcare organizations, without waiving the privilege and confidentiality established by this article. Records or other information released under this subsection (2) shall be limited to those reasonably necessary and relevant to the organization's determination to grant, continue, or deny accreditation or certification. Any records or information released pursuant to this subsection (2) shall remain confidential and privileged, and the accreditation or certification organization shall maintain the confidentiality of the records and information as required by this article. This subsection (2) shall not be construed to require the release of records or information to an accreditation or certification organization if not otherwise required by law. 12-36.5-104.9. Reports to board of medical examiners. (1) (a) A professional review committee or governing board shall report the following actions or occurrences to the board of medical examiners within forty-eight hours after the action or occurrence, in a form determined by the board: (I) A professional review action that adversely affects the clinical privileges of a physician for more than fourteen days; or (II) Acceptance by the committee or board of the surrender of clinical privileges of a physician while investigating the physician for possible incompetence or improper professional conduct or in return for not conducting an investigation of the physician. (b) A physician who is the subject of an action or occurrence described in paragraph (a) of this subsection (1) shall make an independent report of the action or occurrence to the board of medical examiners within forty-eight hours after the action or occurrence in a form determined by the board. (2) (a) A professional review committee or governing board shall report to the board of medical examiners, in a form determined by the board, any voluntary agreement or understanding between a licensed physician or physician assistant and the professional review committee or governing board if the agreement or understanding is based on allegations of unprofessional conduct as defined in section 12-36-117. The professional review committee or governing board shall submit the report within five days after the effective date of the agreement or understanding. (b) The physician or physician assistant who enters a voluntary agreement or understanding with a professional review committee or governing board shall make an independent report of the agreement or understanding to the board within five days after the effective date of the agreement or understanding, in a form determined by the board. (c) The board of medical examiners may confirm that the licensed physician or physician assistant complies with the terms of a voluntary agreement or understanding reported pursuant to this subsection (2) and may enter into discussion with the professional review committee or governing board regarding the terms of the agreement or understanding. However, the board of medical examiners may initiate proceedings pursuant to section 12-36-118 for conduct resulting in the voluntary agreement or understanding only under the following circumstances: (I) The board of medical examiners receives a complaint from the public involving the same conduct that is the subject of the voluntary agreement or understanding; (II) The licensed physician or physician assistant does not comply with the voluntary agreement or understanding; or (III) The board of medical examiners receives three or more reports of voluntary agreements or understandings entered into by the same physician or physician assistant within three years that involve separate incidents or sets of incidents. (3) To assure that appropriate professional review is being conducted, the board of medical examiners may request, and shall be provided with, general professional review information and proceedings from a professional review committee or governing board if the board of medical examiners has not received a report pursuant to subsection (1) or (2) of this section for three years. The information requested pursuant to this subsection (3) shall be provided in a form determined by the board of medical examiners by rule. (4) An individual physician reviewing another physician as part of a professional review process is not obligated under section 12-36-118 (3) (a) to report to the board of medical examiners any information about the physician who is the subject of the professional review process if the reviewing physician became aware of the information only through participation in the professional review process. Nothing in this subsection (4) shall be construed to limit or negate the responsibility of a physician under section 12-36-118 (3) (a) to report to the board of medical examiners any information reportable under said section that the physician became aware of by any means other than a professional review activity. SECTION 9. 12-36.5-105, Colorado Revised Statutes, is amended to read: 12-36.5-105. Immunity from suit and liability. (1) A member of a professional review committee, a witness before a professional review committee, or any person who files a complaint or otherwise participates in the professional review process shall be immune from suit and liability in any civil or criminal action, including antitrust actions, brought by a physician who is the subject of the review by such professional review committee, if such member made a reasonable effort to obtain the facts of the matter as to which he or she acted, acted in the reasonable belief that the action taken by him or her was warranted by the facts, and otherwise acted in good faith within the scope of such professional review committee process and if such witness or participant acted in good faith within the scope of such professional review committee process. (2) The governing board, the individual members of such board and the entity that has established a peer review committee pursuant to section 12-36.5-104, the board's staff, any person acting as a witness or consultant to the board, any witness testifying in a proceeding authorized under this article, and any person who lodges a complaint pursuant to this article shall be immune from suit and liability in any civil action brought against him or her for acts occurring while acting in his or her capacity as board member, staff, consultant, or witness, respectively, if such individual was acting in good faith within the scope of his or her respective capacity, made a reasonable effort to obtain the facts of the matter as to which he or she acted, and acted in the reasonable belief that the action taken by him or her was warranted by the facts. Any person participating in good faith in lodging a complaint or participating in any investigative or administrative proceeding pursuant to this article shall be immune from any civil or criminal liability that may result from such participation. SECTION 10. 25-3-109 (1), (2), (3), (4), (5), (5.5), and (6), Colorado Revised Statutes, are amended, and the said 25-3-109 is further amended BY THE ADDITION OF THE FOLLOWING NEW SUBSECTIONS, to read: 25-3-109. Quality management and patient safety - privilege, confidentiality, and immunity - definitions. (1) The general assembly hereby finds and declares that the implementation of quality management, functions to evaluate and improve patient and resident care is essential to the operation of performance improvement, and patient safety processes at Colorado hospitals and other health care facilities licensed or certified by the department of public health and environment pursuant to section 25-1.5-103 (1) (a) For this purpose, it is necessary that the collection of information and data by such licensed or certified health care facilities be reasonably unfettered so a complete and thorough evaluation and improvement of the quality of patient and resident care can be accomplished. To this end, quality management information relating to the evaluation or improvement of the quality of health care services shall be confidential, subject to the provisions of subsection (4) of this section, and persons performing such functions shall be granted qualified immunity. It is the intent of the general assembly that nothing in this section revise, amend, or alter article 36 or part 1 of article 36.5 of title 12, C.R.S. are essential to the continuous improvement of patient care and safety in this state. The general assembly further recognizes that confidentiality and immunity from liability are critical to the effective and successful functioning of those processes because the collection, analysis, and effective use of quality management, performance improvement, and patient safety information must be candid, objective, and unfettered by fear of disclosure in discovery or personal liability in litigation. Opening such proceedings or information to the litigation or discovery process would unreasonably discourage and inhibit the quality and safety discussion and activities that are so important to health care improvement, patient safety, and the public interest. To that end, it is the purpose of this section to encourage a culture of safety and quality in the Colorado health care system by providing immunity from suit and liability for participants in the quality management, performance improvement, and patient safety processes and by providing confidentiality and other legal protection for information reported, analyzed, or used in those processes. (2) For purposes of this section, a "quality management program" means a program which includes quality assurance and risk management activities, the peer review of licensed health care professionals not otherwise provided for in part 1 of article 36.5 of title 12, C.R.S., and other quality management functions which are described by a facility in a quality management program approved by the department of public health and environment. Nothing in this section shall revise, amend, or alter article 36 or part 1 of article 36.5 of title 12, C.R.S. A patient safety committee at a hospital or other licensed or certified health care facility, including a health carrier, as defined in section 10-16-102 (8), C.R.S., and a licensed physician practice group, shall: (a) Receive reports concerning patient safety at or by the hospital, facility, carrier, or group; (b) Evaluate patient safety actions taken in connection with all reports of sentinel events alleged to have occurred at or by the hospital, facility, carrier, or group; (c) Review and evaluate the quality measures carried out by the hospital, facility, carrier, or group to improve the safety of patients who receive treatment; (d) Make recommendations to the governing board of the hospital or facility to reduce the number and severity of sentinel events that occur at the hospital or facility; (e) Report the following to the governing board of the hospital or facility at least quarterly: (I) The number of sentinel events that occurred at the hospital or facility during the preceding quarter; and (II) Any recommendations to reduce the number and severity of sentinel events that occur at the hospital or facility. (3) Except as otherwise provided in this section, any records, reports, or other information of a licensed or certified health care facility that are part of a quality management program designed to identify, evaluate, and reduce the risk of patient or resident injury associated with care or to improve the quality of patient care shall be confidential information; except that such information shall be subject to the provisions of subsection (4) of this section. Except as otherwise provided in subsection (4): (a) The proceedings, records, and other information collected, analyzed, or used by or reported to any of the following shall be privileged and confidential and shall not be subject to subpoena or discovery in any civil suit or other legal or administrative proceeding: (I) A patient safety committee; (II) An organized committee of a hospital or other health care facility responsible for the evaluation and improvement of the quality of care rendered at the hospital or facility; and (III) A quality improvement or review committee of a medical or dental society. (b) A person who attends a meeting of a committee described in paragraph (a) of this subsection (3) or who participates in the reporting, collection, evaluation, or use of information by or to such committee may be required to testify concerning the information as part of the proceedings at the meeting. (c) The legal privilege created by this subsection (3) is available to a committee described in paragraph (a) of this subsection (3), and the committee has the right to assert, enforce, or waive the privilege. (4) The records, reports, and other information described in subsection (3) and subsection (5.5) of this section shall not be subject to subpoena or discoverable or admissible as evidence in any civil or administrative proceeding. No person who participates in the reporting, collection, evaluation, or use of such quality management information with regard to a specific circumstance shall testify thereon in any civil or administrative proceeding. However, this subsection (4) The privilege and confidentiality required by subsection (3) of this section shall not apply to: (a) Any civil or administrative proceeding, inspection, or investigation as otherwise provided by law by the department of public health and environment or other appropriate regulatory agency having jurisdiction for disciplinary or licensing sanctions; (b) Persons giving testimony concerning facts of which they have personal knowledge acquired independently of the quality management, information program or function performance improvement, or patient safety processes; (c) The availability, as provided by law or the rules of civil procedure, of factual information relating solely to the individual in interest in a civil suit by such person, next friend or legal representative. In no event shall such factual information include opinions or evaluations performed as a part of the quality management program. (d) Persons giving testimony concerning an act or omission which they have observed or in which they participated, notwithstanding any participation by them in the quality management program; (e) Persons giving testimony concerning facts they have recorded in a medical record relating solely to the individual in interest in a civil suit by such person. (5) Nothing in this section shall affect the voluntary release of any quality management, performance improvement, or patient safety record or information by a hospital or other health care facility. except that no patient-identifying information shall be released without the patient's consent. (5.5) (a) The privilege and confidentiality of information provided for in this section shall in no way be impaired or otherwise adversely affected solely by reason of the submission of the information to a nongovernmental entity to conduct studies that evaluate, develop, and analyze information about health care operations, practices, or any other function of health care facilities. The records, reports, and other information collected or developed by a nongovernmental entity shall remain protected as provided in subsections (3) and (4) subsection (3) of this section. In order to adequately protect the confidentiality of such information, no findings, conclusions, or recommendations contained in such studies conducted by any such nongovernmental entity shall be deemed to establish a standard of care for hospitals or other health care facilities. (b) For purposes of this subsection (5.5), "health care facility" includes a health carrier as defined in section 10-16-102 (8), C.R.S., and a health care practitioner licensed or certified pursuant to title 12, C.R.S. (5.6) Patient safety committees and organized committees of hospitals or other health care facilities whose records and proceedings are privileged and confidential under subsection (3) of this section may exchange and share such records and other related information with each other without waiving the privilege and confidentiality of the records and information. The protections provided by said subsection (3) shall not be impaired, waived, or otherwise affected solely by reason of the exchange or sharing of the records or other information, and the privilege and confidentiality shall be extended and applied on the same terms and conditions to all patient safety committees and other organized hospital or health care facility committees engaged in such exchange or sharing. Nothing in this subsection (5.6) shall be construed to require a patient safety committee or other organized hospital or health care facility committee to exchange or share records or information if not otherwise required by law. (5.7) Records and other privileged and confidential information may be released to an organization that performs health care accreditation or certification services, including, without limitation, the joint commission on accreditation of healthcare organizations, without waiving the privilege and confidentiality established by this section. Records or other information released under this subsection (5.7) shall be limited to those reasonably necessary and relevant to the organization's determination to grant, continue, or deny accreditation or certification. Any records or information released pursuant to this subsection (5.7) shall remain confidential and privileged, and the accreditation or certification organization shall maintain the confidentiality of the records and information as required by this section. This subsection (5.7) shall not be construed to require the release of records or information to an accreditation or certification organization if not otherwise required by law. (6) Any person who in good faith and within the scope of the functions of a quality management, program performance improvement, or patient safety process participates in the reporting, collection, evaluation, or use, exchange, or sharing of quality management, performance improvement, or patient safety information or performs other functions as part of a quality management, program performance improvement, or patient safety process with regard to a specific circumstance shall be immune from suit in any civil action based on such activities and functions brought by a health care provider or person to whom the quality, performance, or safety information pertains. In no event shall this immunity apply to any negligent or intentional act or omission in the provision of care. (12) As used in this section: (a) "Joint commission on accreditation of healthcare organizations" means the nationally recognized nonprofit accreditation organization that establishes and maintains standards for the quality and safety of patient care provided by health care organizations. (b) "Sentinel event" means a sentinel event as defined by the joint commission on accreditation of healthcare organizations. SECTION 11. Effective date - applicability. (1) This act shall take effect at 12:01 a.m. on the day following the expiration of the ninety-day period after final adjournment of the general assembly that is allowed for submitting a referendum petition pursuant to article V, section 1 (3) of the state constitution (August 9, 2006, if adjournment sine die is on May 10, 2006); except that, if a referendum petition is filed against this act or an item, section, or part of this act within such period, then the act, item, section, or part, if approved by the people, shall take effect on the date of the official declaration of the vote thereon by proclamation of the governor. (2) The provisions of this act shall apply to professional review of health care providers on or after the applicable effective date of this act.