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DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT

Health Facilities Regulation Division

STANDARDS FOR HOSPITALS AND HEALTH FACILITIES

CHAPTER IV - GENERAL HOSPITALS

PART 1. STATUTORY AUTHORITY AND APPLICABILITY

1.102 APPLICABILITY



[Page 19, section 1.102 Remove paragraph 1(a)(i)and replace with the following:]

(i) Notwithstanding 6 CCR 1011-1, Chapter II, Section 2.3.2, hospital services/departments provided for under this Chapter IV shall not require a separate license if they are on the hospital campus. Services that are subject to separate licensure including, but not limited to, assisted living residences, hospices, hospital units, home care agencies, long term care facilities, and end stage renal dialysis treatment centers, shall not be considered part of the hospital campus.


Part 2. DEFINITIONS

2.100

[Page 19, Remove the entire definitions section and replace with the following:]

(1) “Anesthetizing location” means any area of a facility that has been designated to be used for the administration of nonflammable inhalation anesthetic agents in the course of examination or treatment, including the use of such agents for relative analgesia.

(2) “Care plan” means a plan of care, treatment and services designed to meet the needs of the patient.

(3) “Cord blood unit” means neonatal blood collected from the placenta and/or the umbilical cord of a single newborn baby after separation from the baby.

(4) “Critical care unit” means a designated area of the hospital containing a grouping of single bedrooms or enclosures accommodating not more than 6 beds each, and providing specialized facilities and services to care for patients who require continuing, acute observation and concentrated, highly proficient care.

(5) “Department” means the Department of Public Health and Environment.

(6) “Dietary services equipment” means an article used in the operation of dietary services, such as, but not limited to a freezer, grinder, hood, ice maker, oven, mixer, range, slicer, or ware-washing machine. “Dietary services equipment” does not include items used for handling or storing large quantities of packaged foods received from a supplier in a cased or over-wrapped lot, such as forklifts, hand trucks, dollies, pallets, racks and skids.

(7) “Distinct part” means a physically distinguishable portion from the larger hospital institution that is separately certified by the Centers for Medicaid and Medicaid Services as a nursing facility, a skilled nursing facility or a psychiatric or rehabilitation unit for the purposes of exclusion from prospective payment systems.

(8) “Food-contact surfaces” means those surfaces of equipment and utensils with which food normally comes in contact, and those surfaces from which food may drain, drip, or splash back onto surfaces in contact with food. This excludes ventilation hoods.

(9) “General hospital” means a health facility that, under an organized medical staff, offers and provides twenty-four hours per day, seven days per week, inpatient services, emergency medical and surgical care, continuous nursing services, and necessary ancillary services, to individuals for the diagnosis or treatment of injury, illness, pregnancy, or disability.

(a) A general hospital may offer and provide, but is not limited to, outpatient, preventive, therapeutic, surgical, diagnostic, rehabilitative, or any other supportive services for periods of less than twenty-four hours per day.

(b) Services provided by a general hospital may be provided directly or by contractual agreement. Direct inpatient services shall be provided on the licensed premises of the general hospital.

(c) A general hospital may provide services on its campus and on off-campus locations.

(d) Non-direct care services (such as billing functions) necessary for the successful operation of the facility that are not on the hospital campus may be incorporated under the license.

(10) “Governing board” means the board of trustees, directors, or other governing body in whom the ultimate authority and responsibility for the conduct of the hospital is vested.

(11) “Hospital Campus” means the hospital’s main buildings including areas and structures that are not strictly contiguous to the main building excluding parking lots and other parcels dedicated to the public’s use. In order to be part of the hospital campus, any adjoining areas shall be under the same hospital operational control and ownership as described on the hospital’s license application. The campus is considered one licensed facility at one location as opposed to off-campus locations or facilities subject to a separate license.

(12) “Licensed independent practitioner” means an individual permitted by law and the facility to independently diagnose, initiate, alter or terminate health care treatment within the scope of his or her license.

(13) “Off-campus location” means a facility whose operations are directly owned by the hospital and under the same governing body that is not located on the hospital’s campus, but which provides services that are organizationally and functionally integrated with the hospital which the hospital chooses to list under its hospital license, and is either:

(a) a distinct part unit providing rehabilitation or psychiatric services in existence prior to January 1, 2011; or

(b) an outpatient facility providing preventive, diagnostic and/or treatment services that is not regulated by a Chapter of 6 CCR 1011-1,Standards for Hospitals and Health Facilities.

(14) “Patient care unit” means a designated area of the hospital that provides a bedroom or a grouping of bedrooms with respective supporting facilities and services to meet the care and clinical management needs of inpatients; and that is thereby planned, organized, operated, and maintained to function as a separate and distinct unit.

(15) “Pharmacist” means a person licensed by the Colorado State Board of Pharmacy as a pharmacist.

(16) “Plan review” means the review by the Department, or its designee, of new construction or remodeling plans to ensure compliance by the facility with the National Fire Protection Association (NFPA) Life Safety Code and with this Chapter IV. Plan review consists of the examination of new construction or remodeling plans and onsite inspections, where warranted. In reference to the National Fire Protection Association requirements, the Department is the authority having jurisdiction for state licensure.

(17) “Public cord blood bank” means a public cord blood bank that has obtained all applicable federal and state licenses, certifications and registrations and is accredited as a public cord blood bank by an accrediting entity recognized or otherwise approved by the Secretary of Health and Human Services under the Public Health Service Act, as such Act may be amended. (42 U.S.C. Section 274k)

(18) “Relative Analgesia” means a state of sedation and partial block of pain perception produced in a patient by the inhalation of concentrations of nitrous oxide insufficient to produce loss of consciousness; i.e., conscious sedation.

(19) “Respiratory care” means that service which is organized to provide facilities, equipment, and personnel who are qualified by training, experience and ability to treat conditions caused by deficiencies or abnormalities associated with respiration.

(20) “Surgical recovery room” means designated room(s) designed, equipped, staffed, and operated to provide close, individual surveillance of patients recovering from acute affects of anesthesia, surgery, and diagnostic procedures.

(21) “Utensil” means any implement used in the storage, preparation, transportation, or service of food.

(22) “Voluntary cord blood donor” means a pregnant woman who has delivered or will deliver a newborn baby and/or such other individual(s) as may be identified by the hospital as required to consent to the voluntary donation of neonatal blood remaining in the placenta and/or the umbilical cord after separation from the newborn baby and who has provided timely informed written consent in accordance with standards established by the hospital pursuant to the provisions of Section 20.152 (1)(d).



Part 3. DEPARTMENT OVERSIGHT

3.101 Submittal of Fees. Fees shall be submitted to the Department as specified below.



[Page 21, Remove paragraph (7) and replace with the following:]

(7) Off-Campus Locations

(a) Addition, Annual Renewal and Termination of Off- Campus Locations. A licensee shall submit a nonrefundable fee of:

(i) $1,000 for the addition of each location to the list of off-campus locations under the license, except that critical access hospitals shall submit a nonrefundable fee of $500.

(ii) $500 for the annual renewal of each off-campus location listed under the license.

(iii) $360 for the removal of each location from the list of off-campus locations under the license.



[Insert the following NEW section after paragraph 7]
3.200 INCREASE IN LICENSED CAPACITY

3.201 Each licensee shall comply with the requirements of 6 CCR 1011-1, Chapter II, section 2.10.5 regarding written notification of changes affecting the licensee’s operation or information, except that the procedure regarding a proposed increase in licensed capacity set forth in Chapter II, section 2.10.5(A)(1) shall be as follows:

(1) Subject to subpart (a), if a licensee notifies the Department in writing at least thirty (30) calendar days in advance of an increase in licensed capacity, an amended license shall be issued upon payment of the appropriate fee. Upon request by the Department, the licensee shall meet with a Department representative prior to implementation to discuss the proposed changes.

(a) If a licensee requesting an increase in licensed capacity has, within 12 months prior to giving notice thereof, been subject to conditions imposed upon its license pursuant to § 2.9.4 or been subject to a plan of correction pursuant to § 2.11.3(B), the licensee shall submit to the Department satisfactory evidence that the noted condition(s) have been met or the plan of correction implemented, as applicable, in connection with the notice of increased capacity.

Part 4. FIRE SAFETY AND PHYSICAL PLANT STANDARDS

[Page 23, Remove sections 4.101 and 4.102 and replace with the following. Section 4.103 remains unchanged.]

4.101 PLAN REVIEW AND PLAN REVIEW FEES. Both plan review and plan review fees are required as listed below in sections (A) and (B). Fees are nonrefundable and shall be submitted prior to the Department initiating a plan review for a facility.

4.101A. Plan Review Procedure

Due to the expansive and complex nature of many hospital projects, the items delineated below shall be applied in conjunction with 6 CCR, 1011-1, Chapter II, Part 1 Submission of Construction Plans/Documents and Completion of the Plan Review Process.

(1) Package Assessment

(a) Upon receipt of a request for plan review, the Department shall assess the package to determine if it is complete; the construction documents are in the correct format; if the plan review is required; and if the appropriate plan review fee is included.

(b) If the plan review packet meets the criteria in subsection (1)(a), the Department shall, within fourteen (14) calendar days of determining the submittal package is complete, provide the primary contact for the project (as indicated in the project submittal) a written or electronic communication good faith estimate of when it will issue the written preliminary review findings.

(2) Preliminary Review

(a) Upon receipt of the Department’s written preliminary review findings, the hospital may agree with them and revise its construction documents to include the Department’s review findings, or challenge the preliminary findings as provided for in paragraph (5)(a) of this section 4.101A.

(b) The issuance of written preliminary review findings triggers the 24 month period for completion of the project.

(3) Deferred Submittals and/or Change Orders

(a) The hospital shall submit deferred submittals or change orders related to Life Safety Code or adopted Department standards to the Department for review.

(b) Within fourteen (14) calendar days of receipt of a complete change order package as defined by the Department, the Department shall provide the facility a written good faith estimate of when it will issue written comments/approvals regarding such change order. If the Department requires an extension, it shall notify the facility within seven (7) calendar days.

(c) If the Department determines that any further design consideration is needed for code compliance, it shall provide the primary contact for the project with written findings to that effect. The hospital shall have thirty (30) calendar days from the date of such findings to submit all required documentation to the Department regarding the corrections.

(4) Final Inspection

(a) Prior to requesting a final inspection, the hospital shall provide the Department with local building, zoning and fire department approvals; the certificate of occupancy reflecting the proposed use; and a statement (in the format prescribed by the Department) that the hospital is ready for a final life safety code inspection.

(i) The Department may accept a temporary certificate of occupancy and schedule a final inspection upon receipt of a statement from the issuing entity that outlines the conditions preventing issuance of a final certificate of occupancy, and a determination by the Department that the final certificate of occupancy has been delayed for reasons that do not impact life safety or other regulatory issues.

(b) The Department shall conduct the final review/inspection of the completed project within thirty (30) calendar days of receiving all the required documentation specified in subsection (4)(a).

(5) Dispute Resolution

(a) Within 30 days of issuance of written findings from the Department regarding plan review, a project’s primary contact may challenge the Department’s written findings. Such challenge shall consist of a written request for a meeting (to be conducted in person, telephonically or electronically) with the assigned inspector and Life Safety Code Manager or designee to discuss the findings and attempt to reach an agreement. Such request shall outline the issue being challenged, the facility’s position on the issue, and the code basis for its position. Such meeting shall occur within a reasonable timeframe. If, after meeting with the assigned inspector, the hospital continues to object to the plan review findings and an agreement has not been achieved, it may pursue the options in paragraph (i) and/or paragraph (ii) as set forth below.



(i) Request review by the Plan Review Technical Advisory Panel (PRTAP) for consideration regarding interpretation of the applicable regulatory requirements. This review shall be scheduled no later than 14 calendar days following submission of such request unless a quorum cannot be convened, in which case the meeting shall be convened at the earliest practicable time.

(A) The panel shall consist of no more than seven members, four of whom shall be qualified by experience and/or education regarding Life Safety Code or other building requirements and not be employed by the Department.

(B) Members shall be appointed by the Division Director who shall consider the recommendations of professional organizations such as the American Institute of Architects (AIA), the Colorado Association of Healthcare Engineers and Directors (CAHED) or other relevant professional organizations;

(C) Members may have a designated/appointed alternative who may serve when the appointed member has a conflict of interest in the matter before the panel.

(D) A quorum of the panel shall be no less than three members, of which at least two shall not be Department employees.

(E) The panel shall determine the process and procedures for the rendering of recommendations to the Division Director or designee.


(F) The Division Director or designee shall consider the recommendations of the panel and issue an agency action within ten (10) calendar days.

(ii) Submit a waiver request consistent with 6 CCR 1011-1, Chapter II, Part 4.

(b) Appeal of the Department’s action shall be made pursuant to the State Administrative Procedure Act, Section 24-4-101,et seq., C.R.S.

4.101B. Plan Review Fees

(1) Initial licensure Applicable to applications for an initial license, when such initial license is not a change of ownership. This includes new facility construction and existing structures. The requirement for plan review and the fee applies to initial license applications submitted on or after January 1, 2008. Fee: See table below.



Square Footage

Cost per square foot

Explanatory Note

0-35,000 sq ft

$0.37

This is the cost for the first 35,000 sq ft of any plan submitted.

35,001-200,000

$0.03

This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft.

200,001+

$0.01

This cost is applicable to the additional square footage over 200,000 sq ft.

(2) Additions and Relocations

(a) Applicable to additions of previously uninspected or unlicensed square footage under the license to an existing occupancy, the addition of an off-campus location, and relocations of a currently licensed facility in whole or in part to another physical plant, except as exempted in Section 4.101(2)(b), below. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after January 1, 2008. However, facilities for which the application for the building permit from the local authority having jurisdiction is dated prior to January 1, 2008 may request a partial plan review. The partial plan review is subject to a ten (10) to twenty-five (25) percent reduction of the fee, as determined by the Department, dependent on the phase of facility construction; except that the fee shall not be below the minimum fee established by this subsection. Fee: See table below. Minimum fee: $2,000.




Square Footage

Cost per square foot

Explanatory Note

0-35,000

$0.37

This is the cost for the first 35,000 sq ft of any plan submitted.

35,001-200,000

$0.03

This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft.

200,001+

$0.01

This cost is applicable to the additional square footage over 200,000 sq ft.

(b) An off-campus location in operation prior to January 1, 2011 is not subject to the plan review required under Section 4.101 (2) (a), if it is added:

(i) to the license of a hospital licensed prior to January 1, 2011;

(ii) through the renewal licensure application process; and

(iii) at the first licensure renewal that occurs on or after April 1, 2011.

(3) Remodeling – General and Phased

(a) Remodeling - General. Applicable to relocation, removal or installation of walls resulting in 50% or more of a smoke compartment being reconfigured. The cost per square footage listed in the table below is to be assessed for the entire smoke compartment(s) being reconfigured. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after January 1, 2008. Fee: See table below. Minimum fee: $2,000.




Square Footage

Cost per square foot

Explanatory note

0-35,000

$0.25

This is cost for the first 35,000 sq ft of any plan submitted.

35,001-200,000

$0.03

This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft.

200,001+

$0.01

This cost is applicable to the additional square footage over 200,000 sq ft.

(b) Remodeling - Phased. Applicable to projects whereby one area is remodeled and occupied by personnel vacated from another area within the licensed facility and such vacated space is subsequently remodeled. In addition to the general remodeling fee established in subsection (3)(a), the facility shall also submit a fee of $2,500 per separate area being remodeled and occupied; with the exception of critical access hospitals, for which the fee shall be $750 per separate area. Prior to being occupied, the remodeled area is subject to inspection for compliance with the LSC requirements in effect at the time of the construction plan submittal. In order to be considered a phased project all aspects of the entire project (all phases) must be submitted at the inception of the project. Phases submitted at a later date will be considered separate projects and will be subject to the plan review requirements and fees applicable at that later date.

(4) Remodeling – Egress Components. Applicable to the relocation, removal, or addition of any egress component, including but not limited to corridors, stairwells, exit enclosures, or points of refuge. (Widening of an egress component is not relocation.) The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after January 1, 2008. Fee: $2,000. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in Section 4.101 (3), the fee in this Section 1.101 (4) shall not apply.

(5) Remodeling – Specific Systems. Applicable to significant modifications to the following systems: fire sprinkler, fire alarm, medical gas, kitchen exhaust/suppression system, and essential electrical system. The requirement for plan review and the fee applies to significant modifications where construction is initiated on or after July 1, 2008. For the purposes of this Section 4.101 (5), construction of significant modifications is deemed initiated when there is an alteration associated with the remodeling to an existing structure that results in a physical change. Fee: $2,000 for up to four smoke compartments, plus $500 for each additional compartment. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in Section 4.101 (3), the fee in this Section 4.101 (5) shall not apply. Significant modifications include:

(a) Fire sprinkler: 100 or more sprinklers. Notwithstanding the other provisions in this Section 2.203 (5), the extension of a sprinkler system involving the installation of 25 to 99 sprinkler heads for an area previously unsprinklered is subject to a partial plan review consisting of the review of the remodeling plans and a fee of $500.

(b) Fire alarm: any modification to the fire alarm system that involves the replacement of the main fire alarm control unit (panel).

(c) Medical gas: modifications that affect 50% or more of a smoke compartment.

(d) Kitchen exhaust/suppression system: replacement of the suppression or hood exhaust/duct system.

(e) Essential electrical system: replacement or addition of a generator or transfer switch.



4.102 COMPLIANCE WITH THE LIFE SAFETY CODE

(1) Facilities shall be compliant with the National Fire Protection Association (NFPA) 101, Life Safety Code (2000). This section incorporates by reference the NFPA 101, Life Safety Code (2000). Such incorporation by reference, as provided for in 6 CCR 1011-1, Chapter II, excludes later amendments to or editions of referenced material.

(a) Facilities licensed on or before September 30, 2003 shall meet Chapter 19, Existing Health Care Occupancies, NFPA 101 (2000).

(b) Facilities licensed on or after October 1, 2003 or portions of facilities that undergo remodeling on or after October 1, 2003 shall meet Chapter 18, New Health Care Occupancies, NFPA 101 (2000). In addition, if the remodel represents a modification of more than 50 percent, or more than 4,500 square feet of the smoke compartment, the entire smoke compartment shall be renovated to meet Chapter 18, New Health Care Occupancies, NFPA 101 (2000).

(c) An off-campus location in operation prior to January 1, 2011 may meet either the existing or the new occupancy Life Safety Code requirements, if it is added to the hospital license at the first renewal licensure that occurs on or after April 1, 2011.

(d) Notwithstanding 6 CCR 1011-1, Chapter II, Part 2.3.5(A), an off-campus location that contains an anesthetizing location shall have an intact, two-hour fire rated separation wall, floor or ceiling assembly under the following circumstances:



(i) For each applicant seeking an initial license on or after January 1, 2011, except for a health care entity that has submitted building plans to the Department and obtained a building permit prior to January 1, 2011,from the local authority having jurisdiction.

(ii) For each licensee that submits building plans to the Department or obtains a building permit on or after January 1, 2011, for relocations in whole or in part to another physical structure.



(iii) For each licensee that submits building plans to the Department or obtains a building permit on or after January 1, 2011, to add previously un-inspected or unlicensed square footage to an existing license. For the purposes of compliance with this section, the two-hour fire rated separation shall be around either the entire perimeter of the added square footage or the entire perimeter of the facility.

(iv) For each licensee that creates a new anesthetizing location on or after January 1, 2011, within an existing off-campus location.


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