By Justin Miller Attorney Colorado lawmakers continue to craft new regulations that govern the way…
The House and Senate both passed Senate Bill 19-234 and it is awaiting Governor Polis’s signature. Assuming the governor signs the bill, it will re-enact Colorado’s Professional Review Act, C.R.S. § 12-36.5-101, et seq. If signed, the revised statute with take effect August 2, 2019, and it will sunset again on September 1, 2030.
Entities conducting professional review need to consider these revisions in evaluating the confidentiality of documents contained in professional review files. Currently, in Colorado, the “records” of an authorized entity, its professional review committee, and its governing board are not subject to subpoena or discovery and are not admissible in any civil suit. C.R.S. § 12-36.5-104 (10)(a). This general grant of confidentiality to professional review records remains unaltered with respect to most records “arising from any activities of a professional review committee.” C.R.S. § 12-36.5-102(7)(a). Nevertheless, the revised Professional Review Act contains five significant changes.
First, the revised statute defines a category of documents that are designated as “original source materials.” Original source materials are defined as:
- materials that are prepared in the ordinary course of business
- are not otherwise privileged or confidential; and
- contain “factual information relating solely to the individual patient in interest in a civil action”
C.R.S. § 12-36.5-102 (5.5). The statute excludes certain documents from the definition of “records arising from professional review activity”, specifically “incident reports prepared in the ordinary course of business” and “relevant hospital or facility policies, procedures and protocols, or other original source documents”. C.R.S. § 12-36.5-102 (7)(b). These documents will therefore need to be considered in the process of identification of original source materials, as described below.
Second, original source materials may be subject to discovery or subpoena from a hospital or other entity engaged in professional review activities provided that the materials are relevant to an individual patient whose care is the subject of a civil lawsuit and the documents are otherwise not available. Specifically, the bill provides:
- upon request or subpoena for original source documents, the entity shall “provide a log of all original source documents contained in its professional review files”;
- “original source documents” are generally subject to subpoena or discovery only from the original sources, however,
- if the “original source documents” are not produced by the original source, then an “individual patient in interest in a civil action” may subpoena or seek discovery of the original source documents directly from an authorized entity’s professional review committee, and
- “original source documents” are not protected from subpoena, discovery or use in any civil action merely because they were considered by or presented to a professional review committee.
Third, the bill revises registration and reporting requirements for professional review committees, making changes to C.R.S. § 12-36.5-104.6. The new statute:
- requires an annual update, to the Colorado Division of Professions and Occupations, by each governing board that establishes or uses one or more professional review committees;
- requires a report as to whether the governing board is currently engaged in professional review activity, or intends to engage in professional review activity in the future;
- clarifies that even though the Division issues reports where the reporting governing board will remain anonymous, the identity of the governing board may be known to the division; and
- requires the Division to adopt rules to determine the de-identified information which must be reported and to establish a process to remove entities from the registry if the reporting is no longer required.
Fourth, the bill contains a provision encouraging hospitals to “appoint a consumer to serve as a nonvoting member” of the hospital’s professional review committee. This is a recommendation and not a requirement. If a hospital elects to appoint a consumer in this role, the individual is subject to the hospital’s conflict of interest policies and must enter into a confidentiality agreement that complies with HIPAA nondisclosure requirements. C.R.S. § 12-36.5-104.
Fifth, the bill disposes of a prior requirement that after a fair hearing, a professional review committee must report its recommendations to the state licensing board. This revision eliminates pre-existing confusion regarding when an entity, and who within the entity, should report any final adverse action taken against a provider’s privileges to the appropriate licensing board.
Keeping these changes in mind, professional review committees should review their procedures as well as the way they maintain their professional review files. The re-enactment should prompt professional review committees to adopt policies regarding how to identify and label “original source materials”.
Please don’t hesitate to call us should you have any questions or need assistance developing new policies and procedures to remain in compliance with the Act’s requirements.