Statement of Basis and Purpose s3

STATEMENT OF BASIS AND PURPOSE AND SPECIFIC STATUTORY AUTHORITY FOR

6 CCR 1011-1, Standards for Hospitals and Health Facilities

Chapter IX - Community Clinics and Community Clinics and Emergency Centers

Comprehensive Revisions to Community Clinic Requirements

Adopted by State Board of Health November 21, 2012

Basis and Purpose

6 CCR 1011-1, Chapter IX - Community Clinics and Community Clinics and Emergency Centers. The proposed amendments to Chapter IX make comprehensive revisions to regulations that are over 30 years old. The amendments:  comply with legislation passed in 2012 which defines the categories of community clinics subject to licensure (see House Bill 12-1294, § 3 and C.R.S. § 25-3-101(2).  comply with legislation passed in 2011 that exempts Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) from community clinic regulation (see C.R.S. § 25- 3-101 (2)).  Update standards regarding governing body; medical director; emergency evacuation/management plan; licensure fees; plan review; policies and procedures; infection control; emergency care services; service interruptions and seasonal closures of community emergency centers; and inpatient stays.

Table 1 contrasts existing language to the substantive changes of the regulatory proposal.

1 Table 1. Comparison of Substantive Changes between the Existing and Proposed Regulations Existing Regulation Proposed Regulation Clinic categories Establishes two categories of clinics, both of which are Establishes three categories of clinics in accordance with HB 12-1294: required to provide inpatient stays, unless the Department  primary care clinics (including prison clinics and those that opt to waives the inpatient stay requirement. The two categories obtain licensure) are:  clinics that operate inpatient beds  community clinics that provide primary care  clinics that provide emergency services (called community  community clinics and emergency centers that provider emergency centers) emergency services (and are essentially free standing The clinics have tiered requirements, as summarized in Table 2. emergency departments) [§ 1.1] Subchapter IX.A establishes requirements for all community clinics. Subchapter IX.B establishes additional requirements for clinics that operate inpatient beds and community emergency centers. [See respective definitions in IX.A § 2.101] Physician office Exempts physicians' offices from community clinic licensure Exempts facilities that function only as an office for the practice of licensure unless: it holds itself out to the public as a community clinic, medicine or the delivery of primary care services by other licensed or 2) it is operated or used by a person or entity different than certified practitioners in accordance with House Bill 12-1294 – see the physician, 3) patients are charged a fee for the use of C.R.S. § 25-3-101 (2)(a)(III)(C). [IX.A § 2.101(14)] the facility in addition to the physician(s) professional fee. [§ 1.5] Licensure fees Sets the initial and renewal licensure fees ranging from Same. [IX.A § 3.100] $650 to $3,100 depending on the category of community clinic (clinics serving the uninsured or underinsured get a discount ranging from 50-75%.) [6 CCR 1011-1, Chap II, § 13.10] Plan review Requires all community clinics, except prison clinics, to Also exempts school-based clinics subject to plan review by the Division undergo plan review [§ 13.9] of Fire Safety. Makes plan review optional for clinics that opt to obtain licensure [IX.A § 4.101] Governing body Requires all community clinics to have a governing body [§ Only requires clinics with inpatient beds and community emergency 3.1] centers to have a governing body [IX.B § 6.100] Medical director Requires all community clinics to have a medical director [§ Only requires clinics with inpatient beds and community emergency 3.2] centers to have a medical director [IX.B § 6.300] Evacuation/emergency No requirements Requires all clinics to have an emergency evacuation plan [IX.A § 6.202 plan (3)]. Requires clinics with inpatient beds and community emergency centers to have an emergency management plan re: man-made or natural disasters and the facility's role in pandemic or other community- wide emergencies [IX.B § 6.202 (1)] Policies and Includes but is not limited to protocols for: Deletes the two protocols mentioned in the "Existing Regulation" column Procedures (P&Ps) 1) the medical management of health care problems and adds requirements for P&Ps re: 1) preventive services; 2) including those requiring medical consultation and/or patient coordination of care with other facilities; 3) continuing care by the same referral, and 2) medical acts that may be undertaken by a practitioner where possible; 4) prompt follow-up of abnormal and physician assistant, advanced practice nurse, or other physical findings; and 5) how the facility will respond to an individual in provider staff with and without supervision of a physician or need of emergency care who presents in a primary care clinic or a clinic

2 Existing Regulation Proposed Regulation other authorized licensed practitioner [§ 6.2] with inpatient beds [IX.A § 11.102(3)]. Additionally, facilities that provide inpatient care or emergency services must have P&Ps regarding patient assessment, evaluation, treatment, monitoring as well as patient isolation [IX.B, 11.102 (2)] Infection control Requires community clinics to have an infection control plan Requires P&Ps re: staff training; clean environment; hand hygiene; to prevent the transmission of infections and communicable decontamination of equipment and exam tables; safe injection practices diseases, including a surveillance system. [§ 11.1] and sharps management; and respiratory hygiene and cough etiquette. In addition, requires disease reporting in compliance with rules under the Disease Control and Environmental Epidemiology Division. [IX.A § 9.102] For clinics with inpatient beds and community emergency centers, requires individual trained in infection control to be employed or regularly available to the facility [IX.B, § 9.101] Freestanding EDs: Allows facilities to temporarily interrupt operations during Authorizes service interruptions only in facilities that are in non- service interruptions any part of a 24-hour period. Requires services to be made metropolitan areas that do not have demand to support 24-hour services available within 30 minutes to patients who need them if and if such interruptions are on a routinely scheduled basis. Requires they present when the facility is closed. [§ 9.2] such facilities to report changes in hours of operation to the Department, post signage visible from adjacent major roadways indicating hours of operation, and alert emergency medical services traffic about the periods when the facility is closed. [IX.B § 6.102 (2)(b)(i)] Freestanding EDs: Allows facilities to conduct seasonal closures. Requires Authorizes seasonal closures only in facilities that are in a non- seasonal closures signage indicating service availability to be removed and a metropolitan area that experiences seasonal population influx (such as process for summoning assistance for persons who present ski areas). Requires the facility to have signage visible from adjacent when the facility is closed. [§ 9.2] roadways indicating the facility is closed for the season; report closure and resumption of services to the Department; and alert emergency medical services traffic about the periods when the facility is closed. Also requires fire drills to be conducted upon resumption of services [IX.B § 6.102 (2)(b)(ii)] Freestanding ED: Lists equipment requirements [§ 7,1] and requires the facility Establishes staffing requirements; requires additional policies and emergency care to have triage and transfer protocols [§ 7.2] procedures regarding care delivery including but not limited to screening, requirements assessment, monitoring, and notification of personal physician; and adds to the list of required equipment and supplies [IX.B Part18] In addition, the requirements for the transfer protocols have been increased and require coordination with the local emergency medical services system and licensed ambulance services [IX.B § 6.102 (3)] Inpatient beds Requires all community clinics to have accommodations for Prohibits clinics that only provide primary care services and opt to obtain "inpatient care." [§ 1.1] Defines inpatient care to mean an licensure (rather than being required to be licensed) from providing overnight stay or a continuous period of care of more than inpatient beds. Defines "inpatient beds" to mean the care of medically 24 hrs but not to exceed 72 hours. [§ 1.3] Establishes stable patients who would benefit from monitoring by nurses and admissions, nutrition, and discharge planning requirements physicians for a period between 12-72 hours. [§ 2.101 (7)] Adds for inpatient services [§ 10] staffing and care planning requirements [IX.B Part 19 §§ 19.101 & 19.102]

3 Existing Regulation Proposed Regulation FQHCs and RHCs Does not exempt either Federally Qualified Health Centers Both FQHCs and RHCs are exempted (While 72 FQHCS were licensed (FQHCs) or Rural Health Clinics (RHCs) as community clinics, no RHC were licensed.) [IX.A § 2.101 (3)]

4 Table 2. Summary of Requirements and Applicability The table below indicates the requirements common to all community clinics (items 1-16) incorporated in Subchapter IX.A and the additional requirements applicable to clinics with inpatient beds and community emergency centers (items 17-24) incorporated in Subchapter IX.B. Issue Area Primary Care Clinics with Inpatient Beds and Location & Clinics Community Emergency Centers Applicability of Provisions 1 Liability insurance (statutory requirement) Yes Same 2 Occurrence reporting1 (statutory requirement) Yes [Chap II § 3.2] Same 3 Plan review regarding compliance with the Life Safety Optional Yes Code 4 Clean environment Yes Same 5 Building & equipment maintenance Yes Same 6 Emergency management plan Yes Higher standards [IX.B p.16 ln 31] 7 Quality management plan Yes [Chap II § 3.1] Same Higher standards for the medical director, Personnel (credentials and training) Yes IX.A (unless 8 emergency care services and inpatient stay otherwise specified) 9 Medical records (organized, right to access) Yes Same 10 Infection control Yes Higher standards Requirements 11 Patient rights2 Yes Same for all 12 General patient care requirements (e.g., policies & Community Clinics procedures re: prevention, coordination with specialists, Yes Higher standards continuity of care) 13 Waste disposal (proxy requirement -Haz Mat Division regs) Yes Same 14 Pharmacy (proxy requirement -DORA regs) Yes Same 15 Lab (proxy requirement -CLIA regs) Yes Same 16 Radiology (proxy requirement -Haz Mat Division regs Yes] Same 17 Linen and laundry No Yes 18 Governance & leadership No Yes IX.B 19 Nursing No Yes 20 Dietary No Yes Additional 21 Anesthesia No Yes Requirements 22 Emergency care No Yes for Inpatient 23 & Emergency Inpatient beds No Yes Care

1 Reporting abuse, neglect, misappropriation of property, diversion of drugs, equipment malfunction, unexplained death, serious injuries (brain and spinal cord injuries, life- threatening anesthesia & transfusion errors, 2nd and 3rd degree burns) 2 Participate in all decisions, informed consent, free of abuse and neglect, free of inappropriate use of restraints, complaints, itemized bill, disclosure as to whether providers have financial interest in referred providers, etc 5 24 Obstetrics No Yes

6 Specific Statutory Authority

These rules are promulgated pursuant to Section 25-1.5-103, C.R.S.

Major Factual and Policy Issues Encountered

 Life Safety Code Compliance - Applicable Occupancy Type: The specific occupancy chapter that each facility type must meet has been omitted in Subchapter IX.A, Section 4.102(1). Generally, the following occupancy requirements will apply: o primary care clinics: business occupancy. o clinics that operate inpatient beds and community emergency centers: ambulatory health care occupancy. However, not specifying an occupancy chapter means there is more flexibility in applying the most relevant code chapter in a multi-storey building. For example, a three-storey building could meet differing occupancy standards for each storey depending on the services provided - with the proviso that there is a 1-hour separation between each floor. If the 1st floor has anesthetizing services, that floor must meet ambulatory health care. If the 2nd floor just has exam rooms it can meet business occupancy. If the third floor is used for storage, it can meet the storage occupancy requirements. Again, between each storey there would need to be a 1- hour horizontal separation.

 Infection Control: The majority of provisions under Subchapter IX.A Part 9- Infection Control were derived from the Centers for Disease Control's Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care.

 Inpatient Beds: The provisions regarding inpatient beds are based on a model of care being provided by the Children's Hospital North Campus Community Clinic in Broomfield. It is being used for children with respiratory ailments who are medically stable but are held for observation in case they decompensate.