Did you know CDPHE changed Chapter 2 regulations??



What YOU need to know about the Chapter 2 changes for 2020

 

In January 2020, CDPHE put out a revised Chapter 2 with updated, and some new, regulations. Chapter 2 is titled “General Licensure Standards” and is the foundational chapter for health care entities in Colorado, including home care. This guide provides home care companies with what they need to know about the changes.

Below is a link to the updated Chapter 2. Also, CDPHE put out a letter outlining all of the changes and the stakeholders involved in the process.

Revised Chapter 2 Regulations (effective 1.14.2020)


Snapshot of the Changes

 

For your agency, you want to know what changes affect YOU. As you know, Chapter 2 and 26 are the chapters regulating home care agencies in Colorado. With the changes to Chapter 2, your agency will need to:


1. Understand what changes are related to your agency

2. Update the related policies and procedures to make sure you are in compliance 

 

Below are the updated policies and procedures that you will need for your agency. I will be sending out emails with each of these updated policies and procedures for you to download and utilize for your agency. 

 

Occurrence Reporting Policy

Quality Management Program

Influenza Immunization of Employees and Director Contractors

 

Next, we will look more closely to understand what regulations changed in Chapter 2.     

 

Quick Background

 

Not to make it too painful, but it is helpful to review briefly how we got here. The Health Department (CDPHE) is required to review the current regulations every five to seven years to ensure they are ‘efficient, effective and essential.’ So, in 2018 CDPHE reviewed Chapter 2. 

 

There were numerous stakeholders involved in the revision process. Monthly meetings were held in 2018/2019 and any healthcare entity was invited to attend. Also, the Department notified healthcare entities through the portal of proposed rule changes and had comment periods to obtain feedback. It was an extensive process to try and obtain consensus on the rule changes.

 

Major Changes

 

There were both technical and substantive changes to the regs. Here I provide an overview of those looking at regulations affecting home care companies. 

 

Below is a breakdown of the different parts of Chapter 2. There was a part added to the chapter. We will go through each section for changes. 

 

Previous Chapter 2 had 10 parts:

 

Part 1: General Building and Fire Safety Provisions

Part 2: Licensure Process

Part 3: Quality Management Program, Occurrence Reporting, Palliative Care

Part 4: Waiver of Regulations for Healthcare Entities

Part 5: Access to Patient Medical Records

Part 6: Patient Rights

Part 7: Medications, Medical Devices, and Medical Supplies

Part 8: Protections of Persons from Involuntary Restraint

Part 9: Hospital-Acquired Infection Reporting

Part 10: Influenza Immunization of Healthcare Workers

 

Revised Chapter 2 (effective date of 1.14.2020): 

 

Part 1: Definitions (NEW!)

Part 2: Licensure Process

Part 3: General Building and Fire Safety Provisions

Part 4: Quality Management Program, Occurrence Reporting, Palliative Care

Part 5: Waives of Regulations for Facilities and Agencies

Part 6: Access to Client Records

Part 7: Client Rights

Part 8: Protection of Clients from Involuntary Restraint or Seclusion 

Part 9: Medications, Medical Devices, and Medical Supplies

Part 10: Healthcare-Associated Infection Reporting

Part 11: Influenza Immunization of Employees and Direct Contractors

 

Let’s take a look at the important changes in each part.

 

Part 1 - Definitions

 

All of the definitions that used to be throughout the chapter were consolidated into Part 1. There are 60 definitions in total included here. 

 

Part 2 - Licensure Process

 

This part provides lengthy regulations on the agency initial and renewal license. The Department is changing the regulation for license renewal, which used to have the agency paying a 100% late fee if the license renewal is not submitted 30 days in advance.  Now there is a tiered late fee based on how late the renewal application is submitted, from to 10% to 75% additional fee for up to 90 days past the renewal due date. Part 2.9.6 adds that a change in scope of services or in a service area of a facility or agency are actions that need to be notified to and approved by the Department thirty (30) days prior to implementation.

 

Also, the agency applicant needs to show compliance with the new CAPS (Colorado Adult Protective Services) Check requirements. The Department provides additional clarification on when a transfer of ownership that equals 50% interest takes place, including a non-profit transfer. Lastly, there are regulations added for the process for agencies to close operations. 

 

Part 3 - General Building and Fire Safety Provisions

 

One of the major changes in Chapter 2 is here in Part 3. Previously, each chapter contained regulations about general building and fire safety provisions. Now, they are all contained in Part 3 and also updated to incorporate the 2018 edition of the Facilities Guidelines Institute (FGI). Part 3 typically applies more to hospitals, nursing facilities and other buildings that have patients inside of a facility. If there is new construction, renovations or additions, there is a process for review of FGI compliance to ensure the building meets the 2018 regulations. 

 

Part 4 - Quality Management Program, Occurrence Reporting, Palliative Care

 

For home care agencies, this part perhaps is the most referenced in Chapter 2 regarding the Quality Management Program and Occurrence Reporting. It has been modified to emphasize a client focus, instead of about the agency. There are enough changes in this section that each agency will need to revise their QMP and Occurrence Reporting policy. 

 

Quality Management Program

 

For example, for Quality Management Program it used to read that the agency “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.” Now it reads that the agency “shall have a Quality Management Program (QMP) designed to improve client safety and well-being.”  The regulation further explains the agency needs to identify ways to ‘enhance service delivery’ through ‘continuous quality improvement.’ 

 

The program is now to be centered around (Chapter 2, Part 4, 4.1.2(A)(1)(a):

 

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

 

A new list of items that need to be included in the QMP are provided. They are similar to the previous list in the regulations but discuss ‘service delivery errors’ and ‘potential for error’ rather than the old verbiage of the ‘types of cases, problems or risks to be reviewed and the criteria for identifying potential risks.’ 

 

Here is the updated 4.1.2. describing what needs to be included in the QMP:

 

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.

 

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.

 

Occurrence Reporting

 

The words “patient or resident” and “health care entity” and been updated to “client” and “facility or agency.” The Occurrence Reporting Manual will likely be updated to reflect the most inclusive language for all the entities that are regulated by the Department. 

 

Part 5 - Waiver of Regulations for Facilities and Agencies

 

Here CDPHE reduced the verbiage of the section because it was redundant with Part 3 describing the waiver process. An agency can submit a waiver regarding certain regulations when the agency first obtains certification.

 

Part 6 - Access to Client Records

 

The changes here are mostly of inclusive language, replacing “patient”, “resident” and “health care entity” with “client” and “facility or agency”.

 

Part 6.1.3 outlines a timeline to be followed when requests are received for medical records. 

 

Part 6.1.8 provides clarification that HIPPA guidelines need to be followed for client records. 

 

Part 7 - Client Rights

 

The changes here are mostly of inclusive language, replacing “patient”, “resident” and “health care entity” with “client” and “facility or agency”.

 

Part 8 - Protection of Clients from Involuntary Restraint or Seclusions

 

This section did have changes as a result in changes to statutes. Most notably, protections are included for involuntary seclusion, in addition to the existing protections for involuntary restraint. If any agency uses restraint or seclusion, they must develop and implement policies and procedures that are consistent with Part 8. 

 

Part 9 - Medications, Medical Devices, and Medical Supplies

 

This updated part provides more clarification for how both used and unused medications, medical devices and medical supplies can be donated or accepted. This can be an area a surveyor looks out while doing an inspection and provides some regulations on the process of donation or accepting. If your agency does either, it is a good idea to review and potentially revise your policy or procedure. 

 

Part 10 - Healthcare-Associated Infection Reporting

 

This part has been updated to clarify that the Disease Control and Environmental Epidemiology Division within the Department is responsible for collection of data and reporting of infection reporting. Health Facilities and Emergency Medical Services Division is the enforcement arm and can impose consequences if an agency does not comply with regulations. 

 

Part 11 - Influenza Immunization of Employees and Direct Contractors

 

This last part updates the language to remove the phase in approach to seasonal vaccination rates that concluded in 2014. Since 2014, all agencies must meet the 90% seasonal vaccination rate. There is now included language for agencies to demonstrate vaccinations for ‘direct contractors’ in addition to employees. This will need to be reflected in an updated policy and procedure for the agency. 

 

In summary, there were notable changes to Chapter 2 during this latest revision. Surveyors will be looking for how your agency has responded to the changes.  Depending on when you see their smiling faces this year or next, they may not be expecting full compliance with all the updates, but you can count on an inspector wanting to see that you are aware of the changes and taking steps to follow. 

 

Start with the updated Policies and Procedures in this article. Edit them to fit your agency and look to implement as soon as possible. These also would be great to then put on the agenda to review with the Governing Body at the next scheduled meeting.