6 Colo. Code Regs. § 1011-1 Chapter 02 Part 4

Current through Register Vol. 47, No. 11, June 10, 2024

Part 4 - QUALITY MANAGEMENT PROGRAM, OCCURRENCE REPORTING, PALLIATIVE CARE

4.1Quality Management Program, Occurrence Reporting, Palliative Care

4.1.1 Every facility or agency shall have a quality management program (QMP) designed to improve client safety and well-being. The client safety component of the program shall implement improvements in response to patterns and trends associated with service delivery errors and potential for error. The client well-being component of the program shall implement improvements that are not necessarily tied to errors or potential for error but instead to the continuous quality improvement principle that opportunities always exist to enhance service delivery.

4.1.2 The program shall be implemented in accordance with a quality management plan that is reviewed and approved annually by the governing body, or if the facility or agency is not required to have a governing body, by the administrator or the administrator's designee(s). The plan shall have the following elements:

(A) Identification of quality management projects

(1) For the client safety component of the program, the plan shall identify:

(a) The types of service delivery errors and potential for error that will be monitored, which may shall be based, at minimum, on a review of negative client outcomes that are unanticipated, client grievances, deficiencies cited by regulatory agencies, occurrences and/or errors, and potential for errors reported by staff.

(b) A process for staff to report service delivery error and potential for error within a prescribed period of time and a plan for how staff will be trained regarding such reporting.

(c) The methods used to collect and analyze data in order to find patterns and trends. The plan shall also include how the governing body, if applicable, and the administrator will be informed of such patterns and trends.

(d) The method(s) used to select quality management projects.

(e) The method(s) for selecting the service delivery practice(s) that will be reviewed.

(B) Implementation of improvement strategies

(1) The plan shall include how improvement strategies will be developed. This may include identifying the personnel that will be involved in designing the intervention, opportunities for client input, and the administrative approvals needed to finalize the intervention design.

(2) There shall be documentation for each improvement strategy that includes:

(a) A description of the intervention design. For client safety improvements, this shall include how information about patterns and trends will be shared with staff and how the underlying systemic problem(s) that led to the pattern or trend will be addressed.

(b) How staff will be allocated and/or trained to implement the strategy.

(c) How the strategy will be evaluated for effectiveness.

(d) Timelines for implementation and evaluation of the strategy and how the facility or agency is tracking the meeting of these milestones.

4.1.3 If a licensee has a quality management program that complies with the quality standards of a Medicare deemed status accrediting organization, Medicare conditions of participation or Medicare conditions for coverage, as applicable, it shall not be required to develop a separate state quality management program as long as the entity can show that its program includes the elements in Part 4.1.2.

4.1.4 The Department may audit a licensee's quality management program to determine its compliance with this Part 4.1.

(A) If the Department determines that an investigation of any incident or client outcome is necessary, it may, unless otherwise prohibited by law, investigate and review relevant documents to determine actions taken by the licensee.

4.1.5 Any records, reports, and other information of a licensee that is part of the quality management program shall not be subject to subpoena or discoverable or admissible in evidence in any civil or administrative proceeding, so long as the quality management program meets the definition and standards as put forth in section 25-3-109, C.R.S. and these rules.

(A) The Department or any other appropriate regulatory agency having jurisdiction for disciplinary or licensing sanctions shall have access to any records, reports, and other information of the quality management program.

4.2Occurrence Reporting

4.2.1 Notwithstanding any other reporting required by state statute or regulation, each facility or agency licensed pursuant to section 25-1.5-103, C.R.S. shall report to the Department the occurrences specified at section 25-1-124(2), C.R.S.

4.2.2 The following occurrences shall be reported to the Department within one business day after the occurrence or when the licensee becomes aware of the occurrence, in the format required by the Department:

(A) Any occurrence that results in the death of a client of the facility or agency and is required to be reported to the coroner pursuant to section 30-10-606, C.R.S., as arising from an unexplained cause or under suspicious circumstances;

(B) Any occurrence that results in any of the following serious injuries to a client:

(1) Brain or spinal cord injuries;

(2) Life-threatening complications of anesthesia or life-threatening transfusion errors or reactions;

(3) Second or third degree burns involving twenty percent (20%) or more of the body surface area of an adult client or fifteen percent (15%) or more of the body surface area of a child client;

(C) Any time that a client of the facility or agency cannot be located following a search of the facility or agency, its grounds, and the area surrounding facility or agency, and there are circumstances that place the client's health, safety, or welfare at risk or, regardless of whether such circumstances exist, the client has been missing for eight hours;

(D) Any occurrence involving physical, sexual, or verbal abuse of a client, as described in sections 18-3-202, 18-3-203, 18-3-204, 18-3-206, 18-3-402, 18-3-403, as it existed prior to July 1, 2000, 18-3-404, or 18-3-405, C.R.S., by another client, an employee of the licensee or a visitor to the facility or agency;

(E) Any occurrence involving neglect of a client, as described in section 26-3.1-101 (2.3),(7)(b) C.R.S.

(F) Any occurrence involving misappropriation of a client's property. For purposes of this paragraph, "misappropriation of a client's property" means a pattern of or deliberately misplacing, exploiting, or wrongfully using, either temporarily or permanently, a client's belongings or money without the client's consent;

(G) Any occurrence in which drugs intended for use by clients are diverted to use by other persons. If the diverted drugs are injectable, the licensee shall also report the full name and date of birth of any individual who diverted the injectable drugs; and

(H) Any occurrence involving the malfunction or intentional or accidental misuse of client equipment that occurs during treatment or diagnosis of a client and that significantly adversely affects or if not averted would have significantly adversely affected a client of the facility or agency.

4.2.3 Any reports submitted shall be strictly confidential in accordance with and pursuant to section 25-1-124(4),(5), and (6) C.R.S.

4.2.4 The Department may request further oral reports or a written report of the occurrence if it determines a report is necessary for the Department's further investigation.

4.2.5 Every licensee shall have a policy that defines the deaths reportable to the local county coroner under section 30-10-606(1), C.R.S. and that is consistent with the local coroner's reporting policy.

4.2.6 Every licensee shall have a policy for requiring its employees to report occurrences to it.

4.2.7 No licensee, nor any employee, officer, or any other person with controlling interest in the facility or agency, shall discharge, discriminate, or retaliate against any individual because the individual has made or is about to a make a good faith report pursuant to this Part 4.2, or has provided or is about to provide evidence in any proceeding or investigation relating to any occurrences required to be reported to the Department. Such individuals include clients and employees or contractors of the facility or agency, as well as their relatives, sponsors, or legal representatives.

(A) A licensee cannot discharge, discriminate, or retaliate against a client or employee or contractor due to the reporting or the provision of evidence by a third party who is related, sponsoring, or is a legal representative of the client or employee or contractor.

4.2.8 The Department shall investigate all reports made to it under this part, and make a summary report.

(A) The report shall include:

(1) A summary of finding(s) including the department's conclusion(s),

(2) Whether any violation of licensing standards was noted or whether a deficiency notice was issued,

(3) Whether the licensee acted appropriately in response to the occurrence, and

(4) If the investigation was not conducted on site, how the investigation was conducted.

(B) A summary report shall not identify a client or health care professional.

(C) In response to an inquiry, the Department may confirm that it has obtained a report concerning the occurrence and that an investigation is pending.

(d) Prior to releasing a summary report that identifies a facility or agency, the Department shall notify the licensee and provide it with a copy of the summary report. The licensee shall be allowed seven (7) days to review, comment, and verify the report. If immediate release of information is necessary and the Department cannot provide at least prior oral notice to the licensee, the Department shall provide notice as soon as reasonably possible with an explanation of why it could not provide prior notice.

4.2.9 Nothing in this Part 4 shall be construed to limit or modify any statutory or common law right, privilege, confidentiality, or immunity.

4.2.10 Nothing in this Part 4 shall affect a person's access to their own medical record(s) as provided in section 25-1-801, C.R.S., nor shall it affect the right of a family member or any other person to obtain medical record information upon the consent of the client or the client's designated representative.

4.3Palliative Care Standards

4.3.1 If palliative care is provided within or by a facility or agency, the licensee shall have written policies and procedures for the comprehensive delivery of these services. For each client receiving palliative care, there shall be documentation in the plan of care regarding evaluation of the client and what services will be provided. The licensee's policies and procedures shall address the following elements of palliative care and how they will be provided and documented:

(A) Assessment and management of the client's pain and other distressing symptoms,

(B) Goals of care and advance care planning,

(C) Provision of, or access to, services to meet the psychosocial and spiritual needs of the client and the individuals who are identified as the client's personal support system,

(D) Provision of, or access to, a support system to help the individuals who are identified as the client's personal support system cope during the client's illness, and

(E) As indicated, the need for bereavement support for individuals who are identified as the client's personal support system by providing resources or referrals.

6 CCR 1011-1 Chapter 02 Part 4