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.

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 required to provide inpatient stays, unless the Department waives the inpatient stay requirement. The two categories are:
- community clinics that provide primary care
- community clinics and emergency centers that provider emergency services (and are essentially free standing emergency departments) [§ 1.1] / Establishes three categories of clinics in accordance with HB 12-1294:
- primary care clinics (including prison clinics and those that opt to obtain licensure)
- clinics that operate inpatient beds
- clinics that provide emergency services (called community emergency centers)
The clinics have tiered requirements, as summarized in Table 2. 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 licensure / Exempts physicians' offices from community clinic licensure unless: it holds itself out to the public as a community clinic, 2) it is operated or used by a person or entity different than the physician, 3) patients are charged a fee for the use of the facility in addition to the physician(s) professional fee. [§ 1.5] / Exempts facilities that function only as an office for the practice of medicine or the delivery of primary care services by other licensed or certified practitioners in accordance with House Bill 12-1294 – see C.R.S. § 25-3-101 (2)(a)(III)(C). [IX.A § 2.101(14)]
Licensure fees / Sets the initial and renewal licensure fees ranging from $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] / Same. [IX.A § 3.100]
Plan review / Requires all community clinics, except prison clinics, to undergo plan review [§ 13.9] / Also exempts school-based clinics subject to plan review by the Division 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 [§ 3.1] / Only requires clinics with inpatient beds and community emergency centers to have a governing body [IX.B § 6.100]
Medical director / Requires all community clinics to have a medical director [§ 3.2] / Only requires clinics with inpatient beds and community emergency centers to have a medical director [IX.B § 6.300]
Evacuation/emergency plan / No requirements / Requires all clinics to have an emergency evacuation plan [IX.A § 6.202 (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 Procedures (P&Ps) / Includes but is not limited to protocols for:
1) the medical management of health care problems including those requiring medical consultation and/or patient referral, and 2) medical acts that may be undertaken by a physician assistant, advanced practice nurse, or other provider staff with and without supervision of a physician or other authorized licensed practitioner [§ 6.2] / Deletes the two protocols mentioned in the "Existing Regulation" column and adds requirements for P&Ps re: 1) preventive services; 2) coordination of care with other facilities; 3) continuing care by the same practitioner where possible; 4) prompt follow-up of abnormal and physical findings; and 5) how the facility will respond to an individual in need of emergency care who presents in a primary care clinic or a clinic 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 to prevent the transmission of infections and communicable diseases, including a surveillance system. [§ 11.1] / Requires P&Ps re: staff training; clean environment; hand hygiene; decontamination of equipment and exam tables; safe injection practices 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: service interruptions / Allows facilities to temporarily interrupt operations during any part of a 24-hour period. Requires services to be made available within 30 minutes to patients who need them if they present when the facility is closed. [§ 9.2] / Authorizes service interruptions only in facilities that are in non-metropolitan areas that do not have demand to support 24-hour services and if such interruptions are on a routinely scheduled basis. Requires 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: seasonal closures / Allows facilities to conduct seasonal closures. Requires signage indicating service availability to be removed and a process for summoning assistance for persons who present when the facility is closed. [§ 9.2] / Authorizes seasonal closures only in facilities that are in a non-metropolitan area that experiences seasonal population influx (such as ski areas). Requires the facility to have signage visible from adjacent 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: emergency care requirements / Lists equipment requirements [§ 7,1] and requires the facility to have triage and transfer protocols [§ 7.2] / Establishes staffing requirements; requires additional policies and procedures regarding care delivery including but not limited to screening, 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 "inpatient care." [§ 1.1] Defines inpatient care to mean an overnight stay or a continuous period of care of more than 24 hrs but not to exceed 72 hours. [§ 1.3] Establishes admissions, nutrition, and discharge planning requirements for inpatient services [§ 10] / Prohibits clinics that only provide primary care services and opt to obtain licensure (rather than being required to be licensed) from providing inpatient beds. Defines "inpatient beds" to mean the care of medically stable patients who would benefit from monitoring by nurses and physicians for a period between 12-72 hours. [§ 2.101 (7)] Adds staffing and care planning requirements [IX.B Part 19 §§ 19.101 & 19.102]
FQHCs and RHCs / Does not exempt either Federally Qualified Health Centers (FQHCs) or Rural Health Clinics (RHCs) / Both FQHCs and RHCs are exempted (While 72 FQHCS were licensed as community clinics, no RHC were licensed.) [IX.A § 2.101 (3)]

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 / Clinics with Inpatient Beds and
Community Emergency Centers / Location & Applicability of Provisions
1 / Liability insurance (statutory requirement) / Yes / Same
2 / Occurrence reporting[1] (statutory requirement) / Yes [Chap II § 3.2] / Same
3 / Plan review regarding compliance with the Life Safety Code / Optional / Yes
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
8 / Personnel (credentials and training) / Yes / Higher standards for the medical director, emergency care services and inpatient stay / IX.A (unless
otherwise specified)
9 / Medical records (organized, right to access) / Yes / Same
10 / Infection control / Yes / Higher standards / Requirements
11 / Patient rights[2] / Yes / Same / for all
12 / General patient care requirements (e.g., policies & procedures re: prevention, coordination with specialists, continuity of care) / Yes / Higher standards / Community Clinics
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 / Inpatient beds / No / Yes / & Emergency Care
24 / Obstetrics / No / Yes

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.

[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