Monday, January 5, 2015

Effective, December 31, 2015, all assisted living residences, including those with 19 or fewer residents, and all group homes for persons with intellectual and developmental disabilities, will be required to have a quality management program (or QMP) in place. A quality management program is a documented process for evaluating performance to ensure care and services are provided at a level appropriate for the clients served, detect areas where improvement is needed, and implement corrective actions as necessary.

These changes were adopted by the Board of Health on October 15, 2014.

Background (What is not new): In 1988, Colorado's General Assembly declared that implementing a quality management program was essential to operating health care facilities licensed or certified by the Department. The legislature enacted Section 25-3-109, C.R.S., included language requiring licensed health facilities to develop and implement quality management programs approved by the department. In developing regulations, however, the division exempted certain licensed health care entities from the requirement of having a quality management program including assisted living residences with 19 or fewer residents and group homes for persons with developmental and intellectual disabilities.

What has changed: All licensed assisted living residences, including those with 19 or fewer residents, and all licensed group homes for persons with intellectual and developmental disabilities will have to develop and implement a Quality Management Program that is available for the department to review during the initial license survey and each relicense survey.

When does this change take effect: All licensed assisted living residences, including any with 19 or fewer residents, and group homes for persons with intellectual and developmental disabilities have until December 31, 2015 to achieve full compliance with the regulations.

What prompted this change: In 2012, Governor Hickenlooper issued Executive Order D2012-002 calling for regulatory efficiency reviews. The division undertook a review of quality management functions under general licensure requirements, because the statute had not been updated since 1988. The division determined that changes were necessary.
- Since the statute in Section 25-3-109, C.R.S. does not exempt any licensed health care entity from the requirement of having a quality management program, the existing rule exempting certain health care entities was stricken. 
- The existing rule language regarding submission of written quality management plans for division approval was not effective and efficient. It was revised to align with the division's desire to (1)reduce the burden of licensed facilities to submit documents unnecessarily and to (2) improve oversight of the quality management programs by reviewing the program during relicense surveys to evaluate whether the program meets the goal of improving the quality of care and services provided to the resident.

Where to find changes: The revised sections, approved by the Board of Health on October 15, 2014, can be found later in this document. Also, you may go to 6 CCR 1011-1, Standards for Hospitals and Health Facilities, General Licensure Standards, Chapter 2, Part 3. Quality Management, Occurrence Reporting, Palliative Care; conforming changes can be found in Chapter 8, Facilities for Persons with Intellectual and Developmental Disabilities.

Training will be provided: In the near future, the division will offer QMP training around the state for assisted living residences and group homes for persons with intellectual and developmental disabilities. More information on the schedule will be sent via portal message in early 2015. The training will include: what is a quality management program, how to develop a program, as well as implementation and documentation. The training is voluntary; however, a representative from each licensed facility is strongly encouraged to attend one of the scheduled training events. The training will be conducted by the Education and Technical Assistance Branch, with a representative from the assisted living or group home for persons with intellectual and developmental disabilities survey group in attendance. The department will begin inspecting facilities for the implementation of its Quality Management Program, after December 2015.

The published rule is printed below.

DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT, Health Facilities and Emergency Medical Services Division
Adopted by the Board of Health on October 15, 2014
3.1 QUALITY MANAGEMENT PROGRAM. Every health care entity licensed or certified by the Department pursuant to Section 25-1.5-103(1)(a), C.R.S., shall establish a quality management program appropriate to the size and type of facility that evaluates the quality of patient or resident care and safety, and that complies with this Part 3. Assisted living residences and community residential homes shall have until December 31, 2015, to achieve full compliance with this regulation.

3.1.1 Every health care entity identified in section 3.1 shall develop a quality management program that shall be available for Department review during the initial licensure survey and each re-licensure survey. Each program shall include the following elements:
(1) A general description of the types of cases, problems, or risks to be reviewed and criteria for identifying potential risks, including without limitation any incidents that may be required by Department regulations to be reported to the Department;

(2) Identification of the personnel or committees responsible for coordinating quality management activities and the means of reporting to the administrator or governing body of the facility;

(3) A description of the method for systematically reporting information to a person designated by the facility within a prescribed time;

(4) A description of the method for investigating and analyzing the frequency and causes of individual problems and patterns of problems;

(5) A description of the methods for taking corrective action to address the problems, including prevention and minimizing problems or risks;

(6) A description of the method for the follow-up of corrective action to determine the effectiveness of such action;

(7) A description of the method for coordinating all pertinent case, problem, or risk review information with other applicable quality assurance and/or risk management activities, such as procedures for granting staff or clinical privileges; review of patient or resident care; review of staff or employee conduct; the patient grievance system; and education and training programs;

(8) Documentation of required quality management activities, including cases, problems, or risks identified for review; findings of investigations; and any actions taken to address problems or risks; and

(9) A schedule for program implementation not to exceed 90 days after the date of the initial survey.

3.1.2 A health care entity's quality management program shall be considered approved if the Department does not cite any deficient practice related to it. If the Department finds that a quality management program does not meet the requirements of these regulations, the Department shall inform the facility in writing of the deficiency of the quality management program and request or direct a plan of correction in accordance with Section 2.11.4(B) of this Chapter 2. A finding of deficient practice and submittal of a plan of correction will not affect the confidentiality and immunity applicable to quality management activities under Section 25-3-109, C.R.S

3.1.3 If a health care entity 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 Section 3.1.1.

3.1.4 The Department may audit a licensee's quality management program to determine its compliance with this Section 3.1.
(1) If the Department determines that an investigation of any incident or patient or resident outcome is necessary, it may, unless otherwise prohibited by law, investigate and review relevant documents to determine actions taken by the facility.