Colorado Proposes Changes to General Licensure Rules Concerning Review and Approval of Quality Management Plans for Health Care Entities

The Health Facilities and Emergency Medical Services Division of the Colorado Department of Public Health and Environment (CDPHE) issued proposed amendments to its general licensure rules for health care entities on July 16, 2014.  The division plans to update its rules for the first time since the health facility quality management privilege, C.R.S. § 25-3-109, was enacted in 1988.  A rulemaking hearing is scheduled for Oct. 15, 2014.

The division is amending its regulations to strike language exempting certain health care entities from having a quality management plan, as the statute does not exempt any licensed health care entity from this requirement.  Thus, the proposed rule requires every health care entity licensed or certified by the CDPHE pursuant to C.R.S. § 25-1.5-103(1)(a) to establish a quality management program appropriate to the facility’s size and type that evaluates the quality of patient or resident care and safety.

In addition, the division is amending its rules regarding approval of quality management plans, stating that the current rule language is outdated and is being revised to align with the new health inspection process.  Thus, the proposed rule eliminates the requirement that facilities submit quality management plans for approval.  Instead, every health care entity that must have a quality management plan will be required to develop a quality management plan that shall be available to the CDPHE during the initial licensure survey and each re-licensure survey.  Significantly, the proposed regulations state that the plan for a health care entity’s quality management program shall be considered approved if the CDPHE does not cite any deficient practice related to it.  If the CDPHE finds that a quality management plan does not meet regulatory requirements, it will inform the facility of the specific reasons for disapproval and establish a reasonable date for resubmittal of a revised plan.

On a related note, the Colorado Supreme Court should issue a decision shortly under the former licensing rules.  In Simpson v. Cedar Springs Hospital, Inc., Colo. No. 2013 SA 124, a hospital challenged a trial court’s order to produce documents from its quality management meetings after the trial court found that a hospital had not implemented a quality manage­ment program approved by the CDPHE, such that its quality management materials were subject to the privilege created by C.R.S. § 25-3-109.  The trial court had rejected the hospital’s argument that the evidence that the CDPHE had licensed the hospital and renewed its license established that the hospital had an approved quality management program.

Health care facilities in Colorado should follow the CDPHE’s rulemaking as well as the Colorado Supreme Court’s decision in Simpson as they will provide important information about the scope and requirements of Colorado’s quality management privilege

Key Points to Consider When It Comes to Bed Rail Safety

In recent years, the use of bed rails has received increased scrutiny from the health care community and regulators.  There have been many reports of death and injury, such as entrapment, falls, and asphyxiation, due to bed rail use.  Between Jan. 1, 1985, and Jan. 1, 2013, the Food and Drug Administration (FDA) received 901 incident reports of patients caught, trapped, entangled, or strangled in hospital beds, including 531 deaths.

In January, the FDA, working in conjunction with the Consumer Product Safety Commission (CPSC), developed a new webpage that provides guidance about bed rail use.  The guidance addresses bed rail safety, safety concerns about bed rails, and recommendations for health care providers, consumers, and caregivers about bed rails. Among the information available is clinical guidance to assess an individual patient’s needs when using a bed rail and a bed safety entrapment kit containing information and tools that can be used to assess entrapment risk.

The Colorado Department of Public Health and Environment (CDPHE) also has information on its website to assist nursing homes with bed safety.  The CDPHE has pointed out the risks of using restraints such as bed rails.  The risk of bed rails include falls caused by climbing over the rails, becoming trapped between the bed rail and mattress, which can result in asphyxiation, and fracture from rolling into the transfer rails.

The FDA cautions that health care providers should avoid the routine use of bed rails and that bed rails should not be used as a substitute for proper monitoring, especially for people at high risk of entrapment.  Likewise, the CDPHE encourages the use of alternatives before using bed rails, such as lowered beds, futons, or waterbeds.

Nursing homes often run into conflict with family members who request bed rails.  However, nursing homes cannot use family requests to justify using bed rails.  Surveyor guidance emphasizes that the legal surrogate or representative cannot give permission to use restraints for the sake of discipline or staff convenience when the restraint is not necessary to treat the resident’s medical condition.  In other words, the facility cannot use restraints in violation of 42 C.F.R. § 483.13(a) solely based on a family member’s request or approval.