Chapter IV General Hospitals
Table of Contents
Part 1.	Statutory Authority and Applicability
Part 2.	General Provisions
Part 3.	Governing Board
Part 4.	Administrative Officer
Part 5.	Medical Staff
Part 6.	Nursing Staff
Part 7.	Personnel
Part 8.	Medical Records Department
Part 9.	Anesthesia Services
Part 10.	Laboratory Services
Part 11.	Pregnancy, Labor and Delivery
Part 12.	Dietary Services
Part 13.	Emergency Services
Part 14.	Outpatient Services
Part 15.	Infection Control Services
Part 16.	Respiratory Care Services
Part 17.	Critical Care Services
Part 18.	Occupational and Physical Therapy Services
Part 19.	General Patient Care Services
Part 20.	Pediatric Patient Care Services
Part 21.	Pharmaceutical Services
Part 22.	Psychiatric Patient Care Services
Part 23.	Surgical and Recovery Services
Part 24.	Diagnostic Imaging Services
Part 25.	Nuclear Medicine Services
Part 26.	Central Medical-Surgical Supply Services
Part 27.	Housekeeping Services
Part 28.	Linen and Laundry Services
Part 29.	Maintenance Services
Part 30.	Waste Disposal Services
Part 31.	Physical Plant

CHAPTER IV  GENERAL HOSPITALS
Part 1.  STATUTORY AUTHORITY AND APPLICABILITY 
1.101	Statutory Authority
(1)	Authority to establish minimum standards through regulation and to administer and enforce such regulations is provided by Sections 25-1.5-103 and 25-3-101, C.R.S., et seq.
1.102	Applicability
(1)	All hospitals shall meet applicable federal and state statutes and regulations, including but not limited to:
(a)	6 CCR 1011-1, Chapter II.
(b)	This Chapter IV, except as noted in subparagraphs (i) and (ii), below:
(i)	facilities that are federally certified or are undergoing federal certification under 42 CFR 482 et seq. as long term hospitals shall meet the requirements of this chapter, except that they shall not be required to have an emergency department, obstetric services or anesthesia services.
(ii)	Facilities that have 25 inpatient beds or less and are federally certified or undergoing federal certification under 42 CFR 485.600, et seq., as critical access hospitals shall meet the requirements of this chapter, except that the level of staffing, hours of operation, and quality management requirements shall not exceed the requirements established in the aforementioned federal regulations.  
(2)	Contracted services shall meet the standards established herein.
Part 2.  GENERAL PROVISIONS 
	2.100	Definitions
	2.200	Department Oversight
2.100	Definitions
2.101	General Definitions
(1)	“Department” means the Department of Public Health and Environment.
(2)	“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 offered or provided by a general hospital may be provided directly or by contractual agreement in compliance with the regulations.
(c)	A general hospital may provide services through the use of more than one physical location pursuant to the provisions of Chapter II, sections 2.3, 2.6, and 2.7 of these regulations.
(3)	“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 particularized facilities and services to care for patients who require continuing, acute observation and concentrated, highly proficient care. 
(4)	“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.
(5)	“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 provide adequate nursing care and clinical management of inpatients; and that is thereby planned, organized, operated, and maintained to function as a separate and distinct unit. 
(6)	“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.  
(7)	“Respiratory care” is 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. 
(8)	“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. 
2.200	DEPARTMENT OVERSIGHT
2.201	General.  Reserved.
2.202	Licensure Fees.  Reserved.
2.203	Plan Review and Plan Review Fees.   Plan review and plan review fees are required as listed below in sections (1) through (5), below.  Fees are nonrefundable and shall be submitted prior to the Department initiating a plan review for a facility.
(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)	New Construction.  Applicable to new construction including replacement facilities, structural additions of any size and prefabricated structures.  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.	
(3)	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.	
(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 2.203 (3), the fee in this Section 2.203 (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 subsection 32.2.5, 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 2.203 (3), the fee in this Section 2.203 (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.
Part 3.  GOVERNING BOARD 
3.101	ORGANIZATION & Staffing 
(1)	The governing board shall be organized formally with written constitution or articles of incorporation and by-laws, have meetings at regularly stated intervals, and maintain records of these meetings.
(2)	The governing board shall appoint an administrative officer who is qualified by training and experience in hospital administration and delegate to him or her the executive authority and responsibility for the administration of the hospital.
(3)	The governing board shall appoint the medical staff. Appointments shall be made following consideration of the recommendations by the medical staff. The governing board shall establish formal liaison with; and approve the by-laws, rules, and regulations of the medical staff.
(4)	The governing board shall provide personnel necessary for the welfare and safety of patients.  
3.102	PROGRAMMATIC FUNCTIONS.  The governing board shall:
(1)	provide services and hospital departments necessary for the welfare and safety of patients.  The scope of care shall be defined in writing.
(2)	be responsible for all the functions performed within the hospital.  
(3)	ensure that training programs in the safe management of patients are conducted.
(4)	adopt a written emergency management plan.
(a)	at minimum, the plan shall address the following emergency situations:
(i)	loss of heat or air conditioning.
(ii)	unanticipated interruption of serve of utilities, including water, gas, and electricity either within the facility or within a local widespread area.
(iii)	fire, explosion, or other physical damage to the hospital.
(iv)	local and widespread weather emergencies or natural disaster.
(v)	pandemics or other situations where the community’s need for services exceeds the availability of beds and services regularly offered by the hospital.  The hospital response for emergency epidemics shall be directed by 6 CCR 1009-5, Regulation 2 – Preparations by General or Critical Access Hospitals for an Emergency Epidemic.
(b)	at minimum, the plan shall address the following components of the facility response:
(i)	the responsibilities of those involved in the emergency management activities within the facility, including authority to activate the plan.
(ii)	patient triage, care, and discharge.
(iii)	staff education and training.
3.103	Equipment and Supplies
(1)	The governing board shall provide equipment and supplies necessary for the welfare and safety of patients.
3.104	FACILITIES
(1)	The governing board shall provide facilities necessary for the welfare and safety of patients.
Part 4.  ADMINISTRATIVE OFFICER
4.101	ORGANIZATION and staffing  
(1)	The facility shall have an administrative officer who shall be responsible for the onsite administration of the hospital and shall maintain liaison between the governing board and the medical staff.
(2)	The hospital shall be organized formally to carry out its responsibilities.  The administrative officer shall be responsible for developing and implementing a written plan of organization defining the authority, responsibility, and functions of each category of personnel.
4.102	Programmatic Functions
(1)	The administrative officer shall be responsible for the development of hospital policies and procedures for employee and medical staff use.  
4.103	Equipment and Supplies.  Reserved.  
4.104	FACILITIES.  Reserved.
Part 5.  MEDICAL STAFF
5.101	ORGANIZATION and Staffing 
(1)	All hospitals shall have an organized medical staff with written rules, regulations, and by-laws. The by-laws shall make provision for application, appointment, privileges, discipline, control, right of appeal, attendance at medical staff meetings, committees, and professional conduct in the hospital.
(2)	A physician from the organized medical staff shall be appointed or elected as chief of staff.
(3)	The medical staff shall meet regularly and maintain written records of these meetings.
5.102	PROGRAMMATIC FUNCTIONS
(1)	There shall be a medical committee composed of physicians to review systematically the work of the medical staff with respect to quality of medical care.
(2)	Medical records shall include final diagnosis with completion of medical records within 30 days following discharge.  
(3)	The admitting diagnosis, history, and physical examination shall be completed no more than seven (7) days prior to admission or within twenty-four (24) hours after the patient's admission to the hospital.
(4)	All persons admitted as patients to a hospital shall have benefit of continuing daily care of a medical staff member. Policies shall be provided for coordinating and designating responsibility when more than one member of the medical staff is treating a patient.
5.103	EQUIPMENT AND SUPPLIES.  Reserved.
5.104	FACILITIES.  Reserved.  
Part 6.  NURSING DEPARTMENT
6.101	ORGANIZATION AND STAFFING
(1)	There shall be a nursing department.  The nursing department shall be organized formally to provide complete, effective care to each patient.  
(2)	The nursing service department shall be under the direction of a registered nurse qualified by education and experience to direct effective nursing care.
(3)	There shall be a master plan of nurse staffing for providing continuous registered nurse coverage, for distribution of nursing personnel, for replacement of nursing personnel, and for forecasting future needs.  The nursing care required by different types of patients shall be the major consideration in determining the number, quality, and category of nursing personnel that are needed in any given situation.
(4)	The authority and responsibility of each nurse and nursing personnel shall be defined clearly in written policies.  Licensed practical nurses and auxiliary nursing personnel shall be assigned only those duties for which they are qualified and shall be under the supervision of a registered nurse.
6.102	PROGRAMMATIC FUNCTIONS
(1)	There shall be written nursing procedures that establish the standards of performance for safe, effective nursing care of patients.  These procedures shall be reviewed periodically and revised as necessary.
(2)	There should be a plan for continuous evaluation of nursing care including that of private duty nurses.  The nursing department should periodically evaluate the adequacy of facilities in terms of patient and nursing needs, and participate in planning facilities and services.
6.103	EQUIPMENT.  Reserved.
6.104	FACILITIES.  Reserved.
Part 7.  PERSONNEL
7.101	Organization and Staffing
(1)	Each hospital department or service shall have written organizational policies and procedures that identify the scope of the services to be provided, the lines of authority and accountability and the qualifications of the personnel performing the services.  Such policies and procedures shall be made available to employees. 
(2)	Each department or service of the hospital shall be under the direction of a person qualified by training, experience, and ability to direct the department or service.
(3)	There shall be sufficient qualified personnel in each department or service to properly operate the department or service.
(4)	Facility staff shall be licensed or registered in accordance with applicable state laws and regulations. 
(5)	All persons assigned to the direct care of or service to patients shall be prepared through formal education, as applicable, and on-the-job training in the principles, the policies, the procedures, and the techniques involved so that the welfare of patients will be safeguarded.
7.102	Programmatic Functions
(1)	There shall be personnel records on each person of the hospital staff including employment application and verification of licensure, competencies and credentials for medical staff.
(2)	All personnel shall have a pre-employment physical examination and such interim examinations as may be required by the hospital administration or the health service physician. 
(3)	There shall be library services available to meet the needs of the medical staff and other professional personnel.
7.103 	Equipment and Supplies.  Reserved.
7.104	Facilities.  Reserved.
Part 8.  MEDICAL RECORDS DEPARTMENT
8.101	ORGANIZATION AND STAFFING 
(1)	A complete medical record shall be maintained on every patient from the time of admission through discharge.  In addition, complete medical records shall be maintained for patients receiving emergency and outpatient services.
(2)	A registered record administrator or other trained medical record practitioner shall be responsible for the administration and functions of the medical record department.
(3)	There shall be a sufficient number of regular full-time and part-time employees so that medical record services may be provided as needed.
8.102	PROGRAMMATIC FUNCTIONS
(1)	Medical records shall be stored safely to provide protection from loss, damage, and unauthorized use.
(2)	Medical records shall be preserved as original records, on microfilm or electronically:
(a)	for minors, for the period of minority plus 10 years (i.e., until the patient is age 28) or 10 years after the most recent patient usage, whichever is later. 
(b)	for adults, for 10 years after the most recent patient care usage of the medical record.  
(3)	After the required time of record preservation, records may be destroyed at the discretion of the facility.  Facilities shall establish procedures for notification to patients whose records are to be destroyed prior to the destruction of such records.
(4)	If a facility ceases operation, the facility shall make provision for secure, safe storage, and prompt retrieval of all medical records for the period specified in 8.102 (2).  The hospital shall publicize in a widely circulated newspaper(s) in the facility’s service area a notice indicating where medical records can be retrieved.  
(5)	All orders for diagnostic procedures, treatments, and medications shall be signed by the physician or other licensed practitioner as authorized by law submitting them and entered in the medical record in ink or in type. The prompt completion of a medical record shall be the responsibility of the attending physician or other practitioner authorized by law. Authentication may be by written signature, identifiable initials or computer key. The use of rubber stamp signatures is acceptable under the following strict conditions:
(a)	The physician or other practitioner authorized by law whose signature the rubber stamp represents is the only one who has possession of the stamp and is the only one who uses it; and
(b)	The physician or other practitioner authorized by law places in the administrative offices of the hospital a signed statement to the effect that he or she is the only one who has the stamp and is the only one who will use it.
(6)	The content of patient records shall be as follows.  
(a)	All patient records shall include the following:  
(i)	Adequate identification - sociological data (including hospital number assigned to patient.)
(ii)	Chief complaint and present illness.
(iii)	History of disease or injury.
(iv)	Past, family, and personal history.
(v)	Physical examination reports.
(vi)	Reports of any special examinations, including clinical and pathological laboratory findings.  Original copies of all pathology test results shall be posted in the patient's medical record, to include reports of tests referred to another laboratory.
(vii)	A written report of the findings and evaluation of each diagnostic imaging examination signed by the physician or other practitioner authorized by law responsible for the procedure, as applicable. 
(viii)	Reports of consultations by consulting physicians, when applicable.
(ix)	Treatment and progress notes signed by the attending physician or other practitioner authorized by law.
(x)	Findings of clinical or other staff involved in the care of the patient.
(xi)	Nursing notes.
(xii)	All medications administered including the name, strength, dosage, mode of administration of the medication; date, time, and signature of the person administering.
(xiii)	Signed informed consent forms.
(xiv)	Final diagnosis, secondary diagnosis, complications.
(xv)	Disposition of the case and instructions for follow-up care.
(xvi)	Autopsy protocol, if any.
(xvii)	As applicable, physical therapy/occupational therapy treatment records to include a prescription and/or order for treatment signed by the physician, progress notes of the physical/occupational therapist, and results of special tests and measurements.
(b)	Inpatient records shall include the following:
(i)	Date and time of admission and discharge.
(ii)	Admission diagnosis.
(iii)	Discharge summary, with outcome of hospitalization.  If the patient is discharged in less than 24 hours, the discharge summary may be included in the physician’s progress notes.
(c)	Records of all patients undergoing surgery shall include the following:
(i)	History, physical, special examinations, and diagnosis recorded prior to operation.
(ii)	Anesthesia record, including post-anesthetic condition signed by the anesthetist, anesthesiologist, surgeon or licensed practitioner authorized by law to sign the record.
(iii)	Complete description of operative procedures and findings including the provisional diagnosis prior to the operative procedure, and post-operative diagnosis recorded and signed by the attending surgeon promptly following the operation. 
(iv)	The pathologist's report on all tissues removed at the operation.
(d)	Records of all obstetric patients shall include the following:
(i)	Record of previous obstetric history and pre-natal care including blood serology, and RH factor determination.
(ii)	Admission obstetrical examination report describing conditions of mother and fetus.
(iii)	Complete description of progress of labor and delivery, including reasons for induction and operative procedures.
(iv)	Records of anesthesia, analgesia, and medications given in the course of labor and delivery.
(v)	Records of fetal heart rate and vital signs.
(vi)	Signed report of consultants when such services have been obtained.
(vii)	Names of assistants present during delivery.
(viii)	Progress notes including descriptions of involution of uterus, type of lochia, condition of breast and nipples, and report of condition of infant following delivery.
(e)	Records of newborn infants shall be maintained as separate records and shall contain the following:
(i)	Date and time of birth, birth weight and length, period of gestation, sex.
(ii)	Parents' names and addresses.
(iii)	Type of identification placed on infant in delivery room.
(iv)	Description of complications of pregnancy or delivery including premature rupture of membranes; condition at birth including color, quality of cry, method and duration of resuscitation.
(v)	Record of prophylactic instillation into each eye at delivery.
(vi)	Results of newborn screening required by law and regulation.
(vii)	Report of initial physical examination, including any abnormalities, signed by the attending physician.
(viii)	Progress notes including temperature, weight, and feeding charts; number, consistency, and color of stools; condition of eyes and umbilical cord; condition and color of skin; and motor behavior.
(f)	The following hospital records shall be maintained:
(i)	Daily census
(ii)	Admissions and discharges analysis record.
(iii)	Chronological register of all deliveries including live and stillbirths.
(iv)	Register of all surgeries performed (entered daily)
(v)	Diagnostic index.
(vi)	Physician index.
(vii)	Death register.
(viii)	Register of out-patient and emergency room admissions and visits.
8.103	EQUIPMENT AND SUPPLIES
(1)	Each facility shall provide adequate supplies and equipment for the safe storage and prompt retrieval of medical records.
8.104	FACILITIES
(1)	Each hospital shall provide a medical record room or other suitable medical record facilities.
(2)	In the case of new hospital construction or modification of an existing hospital facility the hospital shall have a medical record department with administrative responsibility for medical records and the following shall apply:
(a)	Each hospital shall provide a medical record department and other medical record facilities with supplies and equipment for medical record functions and services. This department shall include:
(i)	Active Record Storage Area.
(ii)	Record Review and Dictating Room for physicians.
(iii)	Work area for sorting, recording, typing, filing and other assigned medical record functions shall be separate from the record review and dictating room. Consideration should be given to isolation of noisy equipment. Accommodations should be provided for conducting medical record business with hospital paramedical personnel or public individuals for legitimate access to medical records.
(iv)	Medical record storage area within the department.
(v)	Inactive medical record storage area. (May be omitted if microfilming used.) Medical record department shall be located in an area of the hospital that is convenient to most of the professional staff.
(b)	Security measures shall be maintained by mechanical means in the absence of medical record supervision, to preserve confidentiality and to provide protection from loss, damage and unauthorized use of the medical records.
Part 9.  ANESTHESIA Services  
9.101	ORGANIZATION AND STAFFING
(1)	The hospital shall provide anesthesia services commensurate with the services provided by the hospital.
(2)	General or regional anesthesia or analgesia shall be administered only by a physician qualified by training, experience, and ability in anesthesiology; or a registered nurse anesthetist graduated from a certified school. In case of dental treatment, dentists may administer local anesthetics.
9.102	PROGRAMMATIC FUNCTIONS
(1)	Patients recovering from anesthesia shall remain under continuous care of a registered nurse. Nurses shall have been instructed in the care of post-anesthetic patients, shall have no other duties during the time they are caring for such patients and shall have facilities for immediate communication with the attending surgeon, anesthesiologist, or qualified substitute present in the hospital.
9.103	EQUIPMENT 
(1)	There shall be equipment for the administration of anesthesia that is commensurate with the clinical procedures and programs conducted within the hospital.
(2)	Anesthesia equipment shall be cleaned properly and sterilized after each use excepting multi-use heat sensitive equipment may be disinfected using a process that is bactericidal, tuberculocidal and virucidal. Hypodermic needles, syringes, and allied equipment shall be sterilized, unless disposed of after use. Written procedures shall be developed for these processes.
9.104	FACILITIES
(1)	There shall be facilities for the administration of anesthesia that are commensurate with the clinical procedures and programs conducted within the hospital.
(2)	Areas used to care for post-anesthetic patients shall have facilities for immediate communication with the attending surgeon, anesthesiologist, or qualified substitute present in the hospital.
Part 10  LABORATORY SERVICES
10.100	Clinical Pathology
10.200	Blood Banking
10.100	Clinical Pathology
10.101	ORGANIZATION AND STAFFING
(1)	Clinical pathology services shall be made available as required by the needs of the medical staff.  Emergency laboratory services shall be made available whenever needed.
(2)	The laboratory shall be under the supervision of a physician, certified in clinical pathology, either on a full-time, part-time, or consulting basis. The pathologist shall provide, at a minimum, monthly consultative visits. 
(3)	There shall be a sufficient number of clinical laboratory technologists, qualified by training and experience, to promptly and proficiently perform the laboratory tests and examinations required of them.
10.102	PROGRAMMATIC FUNCTIONS
(1)	All clinical pathology services shall be ordered by a physician or a person authorized by law to use the results of such findings.
(2)	Clinical pathology services shall comply with the requirements set forth in the Clinical Laboratory Improvement Amendments (CLIA).
(3)	Policies and procedures
(a)	A manual outlining all procedures performed in the laboratory shall be complete and readily available for reference.
(b)	The conditions and procedures for referring specimens to another laboratory be in writing and available in the laboratory.
(c)	Procedures for the adequate precautions for discarding specimens shall be in use -- sterilization, incineration, or both.
(4)	Records
(a)	A record system shall be established which ensures that specimens are adequately identified, properly processed, and permanently recorded.
(b)	Duplicate copies of all reports shall be kept in the laboratory in a manner which permits ready identification and accessibility for two years. 
10.103	EQUIPMENT AND SUPPLIES
(1)	All equipment shall be in good working order, be routinely checked and be precise in terms of calibration.
(2)	If tests are performed in the specialties of mycobacteriology, mycology, and/or virology, the laboratory shall be equipped with a microbiological safety cabinet, with an adequately filtered exhaust system.
(3)	Vacuum breakers must be present on sinks where specimens are handled or discarded to ensure that the water supply is not contaminated.
10.104	FACILITIES.  Reserved.
10.200	Blood Banking
10.201	ORGANIZATION AND STAFFING
(1)	The hospital shall provide for the procurement, storage, and transfusion of blood as needed for routine and emergency cases.
10.202	PROGRAMMATIC FUNCTIONS
(1)	Standards of the American Association of Blood Banks shall be used; or the administrative staff of the hospital must substitute, in writing, alternate standards which are safe and adequate for the collection and administration of blood and blood products.
(2)	Blood and blood products shall only be administered upon order of a physician or other practitioner authorized by law.
(3)	Before administering a blood transfusion, the following shall be identified accurately and verified by a registered nurse and a licensed health care professional acting within his or her standard of practice: 1) Patient; 2) Patient's blood specimen; 3) Type, crossmatch, and expiration date of donor blood.  
(4)	Records must be kept which show the complete receipt and disposition of blood.
(5)	Each unit of blood typed and cross-matched for transfusion must be adequately identified by an attached tag which cannot be removed from the unit accidentally.
10.203	EQUIPMENT AND SUPPLIES
(1)	Equipment shall be available which ensures safe storage and transfusion of blood.
(2)	Refrigerators used to store blood overnight shall have a recording thermometer and an adequate alarm system. The refrigerator shall be on the emergency power source.
10.204	FACILITIES
(1)	Facilities shall be available to ensure safe storage and transfusion of blood.
Part 11.  PREGNANCY, LABOR AND DELIVERY 
11.100	Labor and Delivery
11.200	Nurseries
11.100	Labor and Delivery
11.101	ORGANIZATION AND STAFFING
(1)	To the extent the facility provides non-emergent labor and delivery services, the facility shall provide labor and delivery in accordance with the scope of care established pursuant to Section 3.102 (1).  The requirements set forth in this Subpart 11.100 are in addition to those specified in Part 19, General Patient Care Services.
(2)	If a delivery suite is provided, the nursing service of the delivery suite shall be under the supervision of a registered nurse qualified by training and experience to direct obstetric nursing.
11.102	PROGRAMMATIC FUNCTIONS
(1)	Nursing
(a)	A registered nurse qualified by training and experience in delivery room nursing shall be present as a circulating nurse during each delivery. Additional registered and licensed practical nurses, or auxiliary nursing personnel shall be available as necessary. 
(b)	Patients shall be provided with continuous direct care by a registered nurse, either in the delivery room or in an obstetric recovery room, until vital signs are established, shock and hemorrhage are not evidenced, and the patient is awake.
(2)	Policies for the administration of oxytocic drugs, analgesics, and anesthetics shall be written.
(3)	Security measures shall be instituted to safeguard against unauthorized entry and to protect the safety of newborns.  
(4)	Newborn Care
(a)	Identification shall be placed securely on each infant before removal from the delivery room.
(b)	Prophylaxis shall be administered to the eyes of all newborn infants.
(c)	Newborn screening shall be conducted in accordance with 5 CCR 1005-4 Newborn Screening and Second Newborn Screening.
(5)	If an obstetric recovery room is provided, it shall be restricted to obstetric patients only.
11.103	EQUIPMENT AND SUPPLIES
(1)	Each delivery room shall be equipped with the following:  1) Incubator approved by the Underwriters Laboratories; 2) Suction and resuscitation equipment for adults and infants; 3) Anesthesia machines and supplies for inhalation, spinal, and saddle-block anesthesia; 4) Instruments and supplies for management of normal delivery, obstetric emergencies; 5) Emergency drugs, solutions, and supplies; 6) Infant identification.
11.104	FACILITIES
(1)	The obstetric (maternity) patient care unit in the hospital should be isolated from other patient care units, both architecturally and nursing-wise.  However, if necessary, under specific controls, the presence of clean gynecological and surgical cases may be admitted on the obstetric patient care unit.
(2)	The delivery suite and labor room(s) shall be located so as to minimize traffic to patients, visitors, and personnel from other areas of the hospital.
(3)	The design of and equipment in labor room(s) shall meet the requirements for a private bedroom specified in Part 19, General Patient Care Services except that windows need not be provided if mechanical ventilation is installed.
(4)	The delivery suite shall be provided with at least one delivery room should be equipped for major obstetrical operative procedures, including caesarian section. In case of new hospital construction, or modification of an existing hospital facility the following shall apply:
(a)	In hospitals of 30 beds or less, one operating suite may be used for surgical or delivery procedures, providing there is a labor room equipped for emergency delivery adjacent and accessible to the suite and with a minimum area of 180 sq. ft., no dimension to be less than 12'0" except ceiling height. Ventilation of the emergency delivery room must be either a separate system from that in the operating suite, allowing recirculation in each area, or if connected to the same system as the operating Suite, the system must provide 100% exhaust with no recirculation.
(b)	Sub-sterilizing room adjacent; to delivery room(s) will not be required unless major gynecological surgical procedures are performed in the delivery room.
(5)	The requirements specified in Part 23, Surgical and Recovery Services, Section 23.104, with the exception of the requirements for the operating room shall be met.
(6)	In hospitals under 50 beds, separate nurses and doctors locker rooms with toilets and showers for each suite are desirable but not mandatory.
11.200	Nursery Services
11.201	ORGANIZATION AND STAFFING
(1)	The hospital may provide nursery services.  The standards in this subpart shall only apply if the hospital provides such services.  The following requirements are in addition to those specified in Part 19, General Patient Care Services.  
(2)	Nursery services shall be under the supervision of a qualified physician.  
(3)	A registered nurse shall supervise at all times the nursing care of newborn infants. At no time shall an infant be left unattended in the nursery.  Nursing personnel assigned to the care of newborn infants should not care for other patients.
11.202	PROGRAMMATIC FUNCTIONS
(1)	Written policies and procedures shall be established for nursery personnel. 
(2)	Personnel shall wash their hands before and after handling each infant.
(3)	Security measures shall be instituted to safeguard against unauthorized entry and to protect the safety of newborns.  
(4)	Infants shall be held for feedings. Propping bottles is prohibited.
(5)	A common conveyor shall not be used to transport infants to mothers.
(6)	Each infant shall be examined upon admission to the nursery and daily until discharge.
(7)	Isolation of infectious disease cases shall be conducted in accordance with written neonatal standards of practice.  If an infant is isolated with his mother, both shall be isolated in a private room.
11.203	EQUIPMENT AND SUPPLIES
(1)	The following equipment shall be provided in each nursery: 1) Easily cleaned bassinet for each infant, with storage space for the individual infant supplies in a compartment in bassinet or on individual table; 2) Incubator or warmer; 3) Infant emergency equipment and supplies essential to resuscitation; 4) Diaper waste receptacles with foot controls and disposable impervious liners, 5) Soiled linen waste receptacles with foot controls and disposable impervious liners, 6) Accurate easily cleaned scales.
11.204	FACILITIES
(1)	The nursery should be located in the maternity patient care unit as close to the mothers as possible and away from the line of traffic of others than maternity services. The nursery(ies) shall be separated physically and functionally from other hospital services.
(2)	A minimum of twenty-four (24) square feet per infant shall be provided within the nursery. Thirty square feet are recommended.
(3)	A control area shall be provided to serve as a work space and nursery entry for security.
(4)	A fixed view window shall be provided between nursery(ies) and control area or between two nursery(ies). Fixed view windows between the nurseries and corridor shall be wire glass set in steel frames. In the case of new hospital construction or modification of an existing hospital facility, the view windows shall be 1/4 inch thick welded wire glass set in steel frames. Curtains or drapes when used in nurseries shall be laundered frequently and maintained flame-retardant.
(5)	All electrical outlets must have a common ground. One electrical outlet shall be provided for every two bassinets. Some of the outlets shall be connected to an emergency source of power. In the case of new hospital construction, or modification of an existing hospital facility fifty (50) percent of the outlets shall be connected to an emergency source of power. The use of adapters, extension cords, and junction boxes should be discouraged.
(6)	The nursery(ies) shall be well lighted to permit optimal observation and for easy detection of jaundice or cyanosis. In the case of new hospital construction, or modification of an existing hospital facility, shadow-free illumination with at least 100 ft. candle intensity at the infants' level is required and is best provided by fluorescent lamps. A suggested fluorescent tube for illuminations is General Electric's fluorescent tubes F-40-CWX(deluxe cool white) or equal. Light fixtures should be provided with lenses to reduce glare. The number and exact location of fixtures cannot be recommended because ceiling height and windows influence the intensity of the illumination. Spot illumination can be provided by a portable lamp containing two 15 watt fluorescent bulbs which, when held 12” from the infant, will produce about 100 ft. candle intensity of light.
(7)	Wall surfaces shall be washable and non-glare. Acoustical ceiling tile is permissible if it is incombustible and washable.
(8)	A minimum ventilation rate of 12 room volumes of out-door air per hour with no recirculation shall be provided by mechanical supply and exhaust air systems. Filters with a minimum efficiency of 90-99 percent in the retention of particles shall be provided. Positive air pressure relative to the air pressure of adjoining areas should be maintained. A temperature of 75-82° F. and a relative humidity of less than 50% is recommended. In the case of new hospital construction, or modification of an existing hospital facility, access openings in ducts for cleaning purposes shall be provided.
(9)	Facilities shall be available for the immediate isolation of all newborn infants who have or are suspected of having an infectious disease (e.g., infants whose possible infection constitutes a risk or danger to other newborns, including those born outside the delivery suite.)  
(10)	The following shall be provided in each nursery: 1) Lavatory with mixing faucet, knee, foot or automatically operated, soap and sanitary hand-drying accommodations; 2) Piped oxygen with outlets, one for every four bassinets; 3) In the case of new hospital construction, or modification of an existing hospital facility, a nurse call shall be provided.
Part 12.  DIETARY SERVICES 
12.101	ORGANIZATION AND STAFFING
(1)	There shall be an organized food service planned, equipped, and staffed to serve adequate meals to patients according to physicians' orders.
(2)	A dietitian or person qualified by training and experience in food service shall direct the dietary services.
12.102	PROGRAMMATIC FUNCTIONS
(1)	Policies and procedures for dietary practices shall be written.
(2)	Therapeutic Diets
(a)	All diets and nourishments shall be served as prescribed by the attending physician.
(b)	A diet manual shall be available to medical staff and personnel for fulfilling dietary prescriptions.
(3)	Menus
(a)	Menus shall be varied to meet patient needs. Personal tastes, desires, and cultural patterns of patients shall be considered and reasonable menu adjustments made.
(b)	Rotating menus are recommended.
(4)	All food served shall be from approved sources and shall meet the standards of quality as established by applicable laws and regulations. Food prepared outside the hospital shall be from sources that comply with applicable laws and regulations.
(5)	Personal Hygiene
(a)	Employees shall wash their hands thoroughly in an approved hand washing facility before starting work and as often as may be necessary to remove soil and contamination. Each employee shall wash his hands before resuming work after visiting the toilet room.
(b)	All dietary employees shall wear hair nets, head-bands, caps, or other effective hair restraints.
(c)	Employees shall not use tobacco in any form while engaged in food preparation, service, or equipment washing areas.
(6)	Food Storage and Handling
(a)	Unwrapped food on display for service shall be protected against contamination by counter-protector devices. Food being conveyed should be covered, completely wrapped or packaged to protect from contamination.
(b)	Potentially perishable foods shall be maintained at a temperature of 45° F. or below, or 140° F. or above. Other foods should be stored at approximately 50° F.
(c)	Convenient and suitable utensils, including self-service, such as forks, knives, tongs, and spoons shall be used to handle food at all points where food is prepared and served.
(7)	Poisonous and toxic materials shall be labeled, stored separately from food, and used only in such ways that they will neither contaminate food nor be hazardous to employees.
(8)	Storage and Handling of Utensils
(a)	Clean cups and glasses shall be handled so that fingers do not contact inside or lip-contact surfaces.
(b)	Portable equipment and utensils shall be cleaned, disinfected, and stored above the floor in a clean, dry location.  Utensils shall be air-dried before storing. Stored containers and utensils shall be covered or inverted.
(c)	Disposable serving utensils shall be stored, handled, and dispensed to prevent contamination; and shall be used only once.
(9)	Food served to patients in isolation, because of infectious diseases, shall be in disposable utensils or in utensils that shall be sterilized.
(10)	Ware Washing and Storage
(a)	If washable dishes are used, commercial-type mechanical dishwashing equipment shall be provided equipped with an easily readable thermometer in each tank. In case of new hospital construction, or modification of an existing hospital facility this equipment shall be physically separated from food preparation and service areas. Equipment and utensils shall be prescraped and, when necessary, presoaked to remove soil. A suitable detergent in effective concentration shall be used. Wash water shall be kept reasonably clean, and washing cycle properly timed. The wash water temperature shall be compatible with the detergent used. The final rinse water shall be unused water at temperature not less than 180° F. manifold temperature, 170° F. on the surface of the dishes. Rinsing cycles shall be timed accurately. In case of new hospital construction, or modification of an existing hospital facility, the dishwash room must be arranged such that clean dishes are discharged from the dish machine onto a clean dish table outside of the dishwash room. Only air drying shall be employed after washing and rinsing. All dishes and utensils shall be stored in clean, dry areas free of contamination.
(b)	Utility ware, pots, pans, and similar utensils shall be cleaned in an area separated from the dishwashing operation. 
(c)	Separate drainboards shall be used for soiled utensils prior to washing and for clean utensils following disinfecting.
(11)	Garbage and refuse shall be placed in impervious containers equipped with tightly fitting covers. Containers shall be stored in a safe area or refrigerated space pending removal and shall be removed from the premises and cleaned at frequent intervals.
(12)	Storage rooms, loading docks, and premises shall be free from rodent and insect infestation, odors, dust, and other sources of contamination.
12.103	EQUIPMENT AND SUPPLIES
(1)	A minimum of two units of refrigeration shall be provided to protect foods kept on hand. Refrigerators and storerooms used for perishable foods shall be equipped with reliable thermometers.
(2)	Walk-in refrigerators and freezers shall have inside lighting and inside lock releases, or an audiovisual signal system as a suitable safety device.
(3)	Adequate equipment shall be provided for efficient preparation of meals.  Equipment and utensils should be resistant to denting, pitting, chipping, and excessive wear; should withstand repeated scrubbing, scouring, and corrosive action of cleaning and disinfecting agents; and should be in good repair.
(4)	Food-contact surfaces of equipment and utensils shall be smooth; free from breaks, open seams, cracks, chips, and similar imperfections; and free of difficult-to-clean internal corners and crevices.
(5)	Cutting blocks, boards, and table tops should be of hard material which is non-toxic; smooth; and free of cracks, crevices, and open seams.
(6)	Equipment on tables or counters, unless readily movable, shall be installed so as to facilitate cleaning and safety.
(7)	Floor-mounted equipment, unless readily movable shall be sealed to the floor to prevent liquids or debris from settling under the equipment. Lubricated bearings and gears shall be constructed so that lubricants cannot get into the food.
(8)	Food waste grinders shall be installed in compliance with applicable laws and regulations.
12.104	FACILITIES
(1)	Adequate space shall be provided to allow for fixed and movable equipment and employee functions for receiving and storage, refrigeration, food preparation, and dishwashing and scullery.
(2)	Clean, well ventilated food storerooms shall be provided. Food when being stored, prepared, displayed, served, or sold shall be protected from contamination.
(3)	Containers of food shall be stored above the floor on clean racks, dollies, or other clean surfaces to protect them from contamination.
(4)	Facilities and systems for storage of silverware shall be designed and maintained to prevent contamination.
(5)	Areas for preparing food, and storing and cleaning utensils shall be adequately lighted.
(6)	Rooms for preparing and serving food and washing utensils shall be well ventilated. Filters shall be readily removable for cleaning or replacement.
(7)	Adequate, clean toilet facilities shall be provided.
(8)	Approved handwashing facilities with soap and sanitary hand-drying accommodations shall be conveniently provided. In the case of new hospital construction, or modification of an existing hospital facility, this must be provided within the kitchen area.
(9)	In case of new hospital construction, or modification of an existing hospital facility, this area the area for the manual washing of utility ware, pots, pans and similar utensils must be physically separated from the dishwashing operation. Separate two-compartment sinks are required for manual washing operations, and they shall be of such length, width, and depth to permit complete immersion of equipment and utensils. In the case of new hospital construction, or modification of an existing hospital facility, each compartment shall be supplied with hot and cold water under pressure through a mixing faucet.
(10)	In the case of new hospital construction, or modification of an existing hospital facility, the following shall apply:
(a)	Cart washing space must be provided, preferably in the dishwashing area. Hot water and a floor drain must be provided in this area.
(b)	A lounge, complete with lockers and toilet facilities for the dietary staff shall be provided near the kitchen.
(c)	Dining area(s) must be provided for staff, visitors and patients.
Part 13.  EMERGENCY SERVICES
13.101	ORGANIZATION AND STAFFING
(1)	Each general hospital shall be organized and equipped to provide emergency treatment at any hour to persons presenting or presented for this purpose. Such treatment shall be rendered in an area specifically designated for this service, and hereafter referred to as the “emergency department”.
(2)	Each hospital shall have a well defined plan for the provision of emergency care. This plan shall relate to community need and the capability of the hospital. If the hospital elects to transfer patients, the referring hospital shall institute essential life saving measures and provide emergency procedures.
(3)	The emergency department shall be organized formally as a department or service of the organized medical staff.
(4)	Provision shall be made for medical staff coverage at any hour.
(5)	A registered nurse qualified by training and experience in emergency procedures shall be available at all times to supervise nursing care in the emergency unit. Nursing staff shall be available to cover average utilization. Provision shall be made for additional nursing personnel during unusual circumstances.
13.102	PROGRAMMATIC FUNCTIONS
(1)	Emergency patient care shall be guided by written policies, and shall be supported by appropriate procedure manuals and reference material.
(2)	Each patient shall be discharged from the emergency department only upon a physician’s recorded authorization including instructions given to the patient for follow-up care.
(3)	A poison control chart and the location and telephone number of the nearest poison control center shall be posted prominently in the emergency department.
13.103	EQUIPMENT and SUPPLIES
(1)	Equipment, supplies and drugs shall be provided commensurate with the scope of operation. 
(2)	The equipment and supplies shall include but not be limited to the administration of blood, plasma, plasma expanders, parenteral solutions; the administration of oxygen; tracheotomy; the control of bleeding; emergency splinting of fractures; and gastric lavage. X-Ray permeable stretchers intended for use as examining tables should be provided.
13.104	FACILITIES
(1)	Emergency facilities should be conveniently located with respect to radiological and laboratory services. Emergency facilities shall be separate and removed from surgical and obstetrical suites and shall consist, as a minimum of the following:
(a)	A well-marked ENTRANCE, separate from the main hospital entrance, at grade level and sheltered from the weather with provisions for ambulance and pedestrian service.
(b)	A RECEPTION AND CONTROL AREA with visual control of the entrance, waiting room and treatment area. (Required for hospitals of 50 beds or more).*
(c)	COMMUNICATIONS with appropriate nursing stations outside the emergency unit and connected to emergency power source.
(d)	PUBLIC WAITING SPACE with toilet facilities, telephone, drinking fountain, stretcher and wheelchair storage.*
(e)	EMERGENCY ROOM equipped with clinical sink and handwashing facilities.*
(f)	NURSES STATION which may be combined with reception and control area, or it may be within the emergency room.*
(g)	STORAGE FOR CLEAN SUPPLIES.*
* Required only in case of new hospital construction, or modification of an existing hospital facility.
(2)	If provided, operating rooms located within the emergency unit shall meet the requirements specified in Part 23 surgical suite and recovery room(s).
(3)	The following physically separated areas must be provided: 1) An adequate waiting room, 2) public toilet facilities, 3) public phone, 4) drinking fountain, 5) patient preparation area with adjacent toilet room, handwashing and provision for storing patient's clothing, 6) provisions within the patient preparation area for medication storage and preparation, 7) recovery room equipped as specified in Part 33, Section 11. 
Part 14.  OUTPATIENT SERVICES
14.101	ORGANIZATION AND STAFFING
(1)	Hospitals shall provide outpatient services.
(2)	There shall be specific written policies for admissions and discharge of patients, physician responsibility, staffing, and procedures for individual patient care, and equipment and supplies.
(3)	The nursing service shall be under the supervision of a registered nurse qualified by training, experience and ability. There shall be such professional and non-professional personnel as required for efficient operation.
14.102	PROGRAMMATIC FUNCTIONS.  Reserved.
14.103	EQUIPMENT AND SUPPLIES.  Reserved.
14.104	FACILITIES 
(1)	The following physically separated areas shall be provided: 1) An adequate waiting room, 2) public toilet facilities, 3) public phone, 4) drinking fountain, 5) patient preparation area with adjacent toilet room, handwashing and provision for storing patient's clothing, 6) ' provisions within the patient preparation area for medication storage and preparation, 7) recovery room equipped as specified in Part 23, Surgical and Recovery Services.
Part 15.  INFECTION CONTROL SERVICES
15.101	ORGANIZATION AND STAFFING
(1)	The facility shall have an infection control program responsible for reducing the risk of acquiring and transmitting nosocomial infections and infectious diseases in the facility.
(2)	There shall be a multi-disciplinary infections control committee charged with:
(a)	developing written policies and procedures regarding prevention, surveillance and control of nosocomial infections and infectious diseases. 
(b)	making findings and recommendations to prevent and control nosocomial infections and infectious diseases.
(3)	Infection control officer(s) shall implement the policies and procedures and the recommendations of the infection control committee. 
15.102	PROGRAMMATIC FUNCTIONS
(1)	There shall be written policies and procedures regarding infection control consistent with the following guidelines of the Centers for Disease Control and Prevention (CDC):  Guideline for Isolation Precautions:  Preventing Transmission of Infectious Agents in Healthcare Settings, 2007 and Guidelines for Environmental Infection Control in Health-Care Facilities, 2003.  Policies and procedures shall include, but not be limited to:
(a)	the admission and isolation of patients with specific infectious diseases; 
(b)	the control of routine use of antibiotics and adrenocorticosteroids; 
(c)	the inservice education programs on the control of nosocomial and infectious diseases, including but not limited to universal precautions;
(d)	standards for sterilization of equipment used for direct patient care;
(e)	standards for cleaning and disinfecting all areas of the hospital;
(f)	standards for linen and laundry services;
(g)	the implementation of infection control measures during hospital renovations;
(h)	the reporting of diseases as required by laws and regulations pertaining to disease control.
(2)	The committee shall make findings and recommendations available promptly to the infection control officer for action.
(3)	The committee shall meet at least monthly and maintain minutes of the meetings.
15.103	EQUIPMENT AND SUPPLIES.  Reserved.
15.104	FACILITIES
(1)	Rooms used for isolation of patients with infectious diseases should be: 1) Equipped with private toilet facilities; 2) Provided with an air supply and exhaust system that neither recirculates nor redistributes air from a central air system; 3) Designed to provide a negative or positive pressure in relation to adjacent areas.
	In the case of new hospital construction, or modification of an existing hospital facility isolation room(s) shall be provided on the basis of one for each thirty (30) beds or major fraction thereof, if the hospital does not have a separate contagious disease unit. Each isolation room shall have:  
(a)	Handwashing facilities as required in Part 19 General Patient Care Services. 
(b)	Separate toilet room with bath or shower
(c)	Mechanical ventilation shall be provided at the rate of six air changes per hour with no recirculation. Supply air shall be filtered using 80% efficient filters.  Rooms to be of negative pressure relative to adjacent areas.
(d)	An anteroom with lavatory should be provided (One anteroom may serve more than one isolation room.)
Part 16.  RESPIRATORY CARE SERVICES 
16.101	ORGANIZATION AND STAFFING
(1)	The hospital may provide respiratory care services.  The following standards shall apply only if the hospital provides such services.  
(2)	The respiratory care service should be under the direct supervision of a committee of the organized medical staff or a physician who has had special training in respiratory diseases and therapy. 
16.102	PROGRAMMATIC FUNCTIONS
(1)	Respiratory care services shall be administered only by persons qualified by training, experience, and ability in respiratory therapy.
16.103	EQUIPMENT AND SUPPLIES
(1)	The equipment for respiratory care services shall be commensurate with the clinical procedures and programs of the hospital.
(2)	Respiratory care equipment shall be cleaned properly and disinfected after each use in accordance with written procedures. The disinfection process shall be bactericidal, tuberculocidal, and virucidal. 
16.104	FACILITIES
(1)	The facilities for respiratory care services shall be commensurate with the clinical procedures and programs of the hospital.
Part 17.  CRITICAL CARE SERVICES 
17.101	ORGANIZATION AND STAFFING
(1)	The hospital may provide critical care services in a critical care unit.  The following standards shall apply only if the hospital provides such services.  
17.102	PROGRAMMATIC FUNCTIONS
(1)	There shall be specific written policies for admission and discharge of patients, physician responsibility, staffing, and procedures for individual patient care. 
(2)	The nursing service shall be under the supervision of a registered nurse qualified by training, experience, and ability. At least a minimum of one registered nurse shall be on duty at all times to give direct patient care. Additional nursing personnel shall be available, consistent with the nursing care required by the different types of patients.
17.103	EQUIPMENT AND SUPPLIES
(1)	There shall be written policies regarding equipment and supplies.
(2)	The equipment shall include: 1) Variable height beds with safety sides; 2) Bedside cabinets; 3) Sphygnomannometers; 4) Resuscitation apparatus; 5) Additional equipment as oxygen tents, pacemaker, defibrillator, and electrocaridiography apparatus.
17.104	FACILITIES

(1)	A system shall be established for calling selected emergency personnel to the unit.
(2)	The critical unit shall have: 1) Intravenous rods installed in ceilings or walls, or attached to beds; 2) Piped oxygen; 3) Suction outlets; 4) Emergency signal system at each bed and nurses station, 5) In case of new hospital construction or modification of an existing hospital facility, an emergency call from unit to outside the unit where additional personnel are available shall be provided.
(3)	The area shall be sufficient in size to allow movable equipment to be placed on either side of the bed(s) and provide-at least 80 square feet per bed in multiple bedrooms and 100 square feet in single bedrooms. Space for storage of commonly used equipment and supplies shall be provided. (Storage carts are recommended). A patient care control center (nurses station), medicine preparation area, clean and soiled holding areas, and janitor's closet conforming to the requirements of Section 19, Patient Care Unit, shall be provided in proximity to the bedrooms or within the enclosures.  When more than one enclosure is provided within room, the size of these areas should be increased.
(4)	A toilet complete with flushing attachments shall be provided in each room. In case of new hospital construction or modification of an existing hospital facility the door to the toilet room shall be 2'8” wide, 3'0” recommended.
(5)	A lavatory complete with mixing faucet, blade controls, soap, and sanitary hand-drying accommodations shall be provided within each room.
(6)	Two duplex convenience outlets shall be installed in proximity to the head of each bed. General lighting shall be uniform throughout the room and controlled by a dimmer. The electrical system shall be connected to the emergency power system. In the case of new hospital construction, or modification of an existing hospital facility, four duplex convenience outlets shall be installed in proximity to the head of each bed.
(7)	A waiting room shall be provided. This may be shared with as adjacent patient care unit.
Part 18.  OCCUPATIONAL AND PHYSICAL THERAPY SERVICES 
18.100	Occupational Therapy
18.200	Physical Therapy
18.100	Occupational Therapy
18.100	ORGANIZATION AND STAFFING
(1)	The hospital may provide occupational therapy services.  The following standards shall apply only if the hospital provides such services.  
(2)	Occupational therapy services shall be rendered only by individuals qualified by training and experience.
18.101	PROGRAMMATIC FUNCTIONS
(1)	There shall be written policies identifying the organization, administration, performance standards, and direction and supervision of patient care rendered. 
18.102	EQUIPMENT AND SUPPLIES
(1)	There shall be appropriate equipment as determined by the professional staff to be essential to the requirements of care and treatment of referred patients.
18.103	FACILITIES
(1)	There shall be adequate facilities, space, and storage areas as determined by the professional staff to be essential to the requirements of care and treatment of referred patients.
18.200	Physical Therapy
18.201	ORGANIZATION AND STAFFING
(1)	The hospital may provide physical therapy services.  The following standards shall apply only if the hospital provides such services.  
(2)	The physical therapy services shall be under medical direction. This may be 1) A committee of the organized medical staff, or 2) A designated physician qualified by training and experience.
(3)	Physical therapy shall be rendered only by a physical therapist licensed to practice in the State of Colorado. All personnel assisting with the physical therapy of patients must be under the direct supervision of a licensed physical therapist.
18.202	PROGRAMMATIC FUNCTIONS
(1)	There shall be written policies governing physical therapy services.
18.203	EQUIPMENT AND SUPPLIES
(1)	There shall be appropriate equipment as determined by the professional staff, to be essential to the requirements of care and treatment of referred patients.
18.204	FACILITIES
(1)	The physical therapy services shall be located in an area convenient for in and out patients.
(2)	There shall be adequate facilities, space, appropriate equipment, and storage areas as determined by the professional staff to be essential to the requirements of care and treatment of referred patients.
Part 19.  GENERAL PATIENT CARE SERVICES 
19.101	ORGANIZATION AND STAFFING
(1)	There shall be patient care services commensurate with the services provided by the facility.
(2)	The nursing care required by different types of patients shall be the major consideration in determining the number, quality, and category of nursing personnel that are needed in any given situation.
19.102	PROGRAMMATIC FUNCTIONS
(1)	Admissions
(a)	Each patient admitted to the hospital shall have a visible means of identification placed on his person.
(b)	No patient shall be admitted for inpatient care to any room or area other than one regularly designated as a patient bedroom. There shall be no more patients admitted to a patient bedroom than the number for which the room is designed and equipped.  Emergencies are exceptions.
(2)	Patient Care Unit
(a)	At least one registered nurse shall be on duty at all times in each patient care unit. One registered nurse shall be designated in charge and shall be delegated the authority and responsibility for the nursing services on that patient care unit. Additional registered nurses, licensed practical nurses, or other auxiliary personnel shall be available.
(b)	Written policies for patient care shall be established.
(3)	A nursing care plan shall be prepared for each patient. The plan shall be reviewed and revised as needed.
(4)	Medications
(a)	Medications shall be identified with at least the name, strength, dosage, and frequency and mode of administration of the medication; and the name of the patient for whom the medication is prescribed.  This identification shall be verified not only when the medicine is prepared but also when it is administered.
(5)	Orders
(a)	Medications and treatments shall be given only on the order of a physician or other practitioner authorized by law. 
(b)	Orders shall be received by a house physician or registered nurse; shall be written; and shall include the date, time, and specifications of the order. 
(c)	Physician orders for treatment may be received by members of the appropriate discipline as specified and approved by the medical staff, nursing services, and the governing board. 
(d)	Orders shall be transferred to the medical record by a member of the specific discipline responsible for implementing the order. 
(e)	Orders prescribing dangerous drugs, i.e., narcotics, sedatives, anticoagulants, antibiotics, etc., shall include a time limit. Such time limit shall be agreed upon by the medical staff and shall be so recorded in the rules and regulations of the organized medical staff.  
19.103	EQUIPMENT/FURNITURE AND SUPPLIES
(1)	The following shall be readily available at all times: 1) Oxygen; 2) Suction; 3) Portable emergency equipment, supplies and medications; 4) Compatible supplies and equipment for immediate intravenous therapy.
(2)	Patient bedrooms shall be equipped with movable furniture and equipment with the following for each patient: 1) Adjustable, washable bed with side rails; 2) Cabinet or bedside table; 3) Overbed table; 4) Complete personal care equipment that is sterile including water carafe, mouth wash cups, emesis basin, wash basin, bedpan and urinal (when necessary).
19.104	FACILITIES 
(1)	Patient Rooms
(a)	There shall be provisions for private and multiple bedrooms to meet the needs of patients and programs of the hospital. There shall be no more than four beds per patient bedroom. There should be no more than approximately 40 patient beds in a patient care unit.
(b)	Each one-bed room shall contain a minimum floor area of 100 square feet. Each multiple-bed room shall contain a minimum floor area of 80 square feet per bed. This minimum floor area, may include built-ins not exceeding four feet in height.
(c)	Privacy shall be provided for each patient in a multiple-bed room by the installation of approved cubicle curtains or partitions. 
(d)	Each patient bedroom shall have a minimum window area equal to 1/8 of the floor area. The ground level shall be maintained at or below the window sill for a distance of at least 8 feet measured perpendicular to the window.  Privacy for the patient and control of light shall be provided at each window.
(e)	Each patient bedroom shall have direct entry from a corridor. In the case of new hospital construction, or modification of an existing hospital facility, the door to each patient room may be no more than 120 feet from the nursing station or from the clean or soiled holding rooms.
(f)	Artificial light shall be provided and include: 1) General illumination; 2) Other sources of sufficient illumination for reading, observations, examinations, and treatments; 3) Night light controlled at the door of the bedroom; 4) Quiet operating switches (not required in existing buildings.)
(g)	A lavatory complete with mixing faucet, blade controls, soap and sanitary hand drying accommodations shall be provided in each patient bedroom, except that the lavatory may be installed within the toilet room in private bedrooms.
(h)	Toilet facilities shall be provided immediately adjacent to private or multiple-bed rooms in the ratio of one facility for not more than four patient beds and shall include: 1) Toilet with bedpan flushing equipment; 2) Incombustible waste paper receptacle, either seamless or with removable impervious liner; 3) Approved grab bars convenient for the safety of patients; 4) Nurse-call signal system. In new construction the door to the toilet shall be at least 2'8” in width and shall not swing into the toilet room unless provided with rescue hardware. Recommend 3'0” door.
(i)	Each patient shall be provided with separate closet space or locker. In the case of new hospital construction or modification of an existing hospital facility, the closet space or locker must open into the patient room.
(j)	Each patient shall be furnished with a nurse-call signal system that registers a signal from the patient, at the corridor bedroom door, at the patient care control center (nurses station), and in service areas of the patient care unit.  A duplex unit may be used for 2 patients in multi-bed rooms, but a light should be provided to indicate the patient placing the call.
(2)	Service Areas
(a)	The following service areas shall be provided and located conveniently for patient care: 1) Patient care control center (nurses station) accommodating a nurse call signal system from patients, a communication system with other hospital departments, and the outside; 2) Medical record recording facilities; 3) Medicine preparation area; 4) Clean holding area: 5) Soiled holding area; 6) Janitor's closet; 7) Stretcher and wheelchair storage area, 8) Nourishment station shall be provided in the case of new hospital construction, or modification of an existing hospital facility; 9) Clinical examination and treatment room: 10) Bathing facilities.
(b)	The patient care control center (nurses station)** shall be adequately designed and equipped.
(c)	The medication preparation area** shall be equipped with: 1) Cabinets with suitable locking devices to protect drugs stored therein; 2) Refrigerator equipped with thermometer and used exclusively for pharmaceutical storage; 3) Counter work space; 4) Sink with approved handwashing facilities; 5) Antidote, incompatibility, and metri-apothecary conversion charts. Only medications, equipment, and supplies for their preparation and administration shall be stored in the medication preparation area. Test reagents, general disinfectants, cleaning agents, and other similar products shall not be stored in the medication area.
**	Other approved facilities for patient services may be substituted to meet the requirements specified in 19.13 through 19.18
(3)	Linen and Laundry
(a)	(Not required in hospitals of 25 beds or less if the CSR is conveniently located on the same floor). The clean supply holding room*** shall be equipped with: 1) Suitable counter sink with mixing faucet, blade controls, soap, and sanitary band drying facility; 2) Waste container with cover (foot controlled recommended), and impervious, disposable liner; 3) Cupboards or carts for supplies. In the case of new hospital construction, or modification of an existing hospital facility, 4) Mechanical fresh air supply to maintain positive pressure; and 5) Nurse call utility station must also be provided.
(b)	There shall be a separate closed area in the clean supply holding room, on a cart, or in a separate closet for clean linen supplies.***
(c)	(Not required in hospitals of 25 beds or less if there is a CSR, and a soiled linen holding room or soiled linen chute conveniently located on the same floor). The soiled holding room*** shall be equipped with: 1) Suitable counter sink with mixing faucet, blade controls, soap, and sanitary hand-drying facility. In the case of new hospital construction, or modification of an existing hospital facility the sink must be 2-compartment. 2) Waste container with cover (foot controlled recommended) and impervious, disposable liner; 3) Soiled linen cart or hamper with impervious liner; 4) Accommodations and provisions for enclosed soiled articles; 5) Space for short-time holding of specimens awaiting delivery to laboratory; 6) Adequate shelf and counter space; and in the case of new hospital construction, or modification of an existing hospital facility, 7) Nurse call utility station; 8) A clinical flushing sink; and 9) Continuous mechanical exhaust ventilation to the outside.
(4)	The janitor's closet*** shall be equipped with: 1) Sink, preferably a floor receptor, with mixing faucets; 2) Hook strip for mop handles from which soiled mopheads have been removed; 3) Shelving for cleaning materials; 4) Approved handwashing facilities, in the case of new hospital construction, or modification of an existing hospital facility, the handwashing facility must be separate if a floor receptor is used; 5) Waste receptacle with impervious liner.
The floor area should be adequate to store mop buckets on a roller carriage, wet and dry vacuum machine, and floor scrubbing machine.
(5)	In new construction, recessed storage space or rooms shall be provided for extra equipment, stretchers, and wheelchairs.
(6)	In new construction, the nourishment station shall contain a sink equipped for handwashing, equipment for serving nourishments between scheduled meals, refrigerator, and storage cabinets. Ice for patient service and treatment shall be provided only by ice maker - dispenser units.
***Other approved facilities for patient services may be substituted to meet the requirements specified in 19.13 through 19.18.
(7)	Patient bathing facilities shall be provided in the ratio of one tub or shower for each ten patients. Approved grab bars, and in the case of new hospital construction, or modification of an existing hospital facility, a nurse call, shall be installed at each tub or shower convenient for the safety of patients using the tub or shower. The room shall be sufficiently large to provide space for wheelchair movement and provision for privacy. In the case of new hospital construction or modification of an existing hospital facility, on each patient floor at least one shower shall be provided which will accommodate a wheelchair.
There should be toilet and lavatory facilities in the bathroom with mixing faucet, blade controls, soap, and sanitary hand-drying accommodations.
(8)	Toilet facilities shall be provided for personnel on each patient care unit.
Part 20.  PEDIATRIC PATIENT CARE SERVICES 
20.101	ORGANIZATION AND STAFFING
(1)	The hospital shall provide pediatric patient care in accordance with the scope of care established pursuant to Section 3.102 (1).  The following requirements are in addition to those specified in Part 19, General Patient Care Services.
(2)	A medical staff member with special training in pediatrics should be appointed chief of pediatric service.
(3)	Pediatric nursing care shall be under the direction of a registered nurse qualified by training, experience, and ability to direct effective pediatric nursing. All nursing personnel, assigned to care for children, shall be oriented to the special care of children.
20.102	PROGRAMMATIC FUNCTIONS
(1)	The hospital shall not routinely admit children to patient bedrooms where accommodations are shared with adults.
20.103	EQUIPMENT AND SUPPLIES
(1)	When a pediatric patient care unit is established it shall provide: 1) equipment and supplies appropriate for the care of children; 2) Cubicle partitions, when used, that permit visibility of patients by nurses and by patients in the same room and that are of shatterproof materials; 3) washable tables and chairs of various sizes, and appropriate entertainment materials.
20.104	FACILITIES
(1)	A separate pediatric patient care unit is recommended when the annual average pediatric daily census requires 10-14 beds. The unit should contain no more than 24 beds.
(2)	When a pediatric patient care unit is established it shall provide; 1) A playroom with washable tables and chairs of various sizes, storage for equipment and supplies, and appropriate entertainment materials; 2) An examination and treatment room with equipment and supplies appropriate for the care of children; 3) Rooms designed and furnished to facilitate grouping patients according to condition and age groups; 4) Cubicle partitions, when used, that permit visibility of patients by nurses and by patients in the same room and that are of shatterproof materials; 5) Space with adequate facilities for safe storing and warming of food.
(3)	Nursery facilities shall be provided for sick newborn infants transferred from the newborn nursery and admitted from outside.  The facility shall include: 1) A minimum of 30 square feet of space for each bassinet or incubator; 2) At least one incubator approved by the Underwriters Laboratories; 3) Diaper containers with foot-controlled covers and impervious, disposable liners; 4) Baby scales and stand.
(4)	Reasonable privacy, without limiting necessary observation, shall be available for adolescents.
Part 21.  PHARMACEUTICAL SERVICES
21.101	ORGANIZATION AND STAFFING
(1)	The pharmaceutical services of the hospital shall be organized and maintained primarily for the benefit of the hospital patients, and shall be operated in accordance with federal and state laws and regulations. 
(2)	The pharmacy service shall be under the direction or supervision of a pharmacist licensed to practice pharmacy in the State of Colorado. 
21.102	PROGRAMMATIC FUNCTIONS
(1)	Written policies shall be developed by the hospital and the supervising pharmacist to indicate the pharmacist’s responsibility for periodic inspection of medications, dispensing, inventory control, and establishment of necessary records.
(2)	The pharmacist shall initiate and develop policies of the service. There should be a hospital pharmacy and therapeutic committee to assist in the formulation of broad professional policies regarding the evaluation, selection, procurement, distribution, use, safety procedures, and other matters relating to drugs in hospitals. It is recommended that a formulary be adopted and operations be under the formulary system.
(3)	Unused prepared medications shall be disposed of in accordance with documented procedures.
(4)	A pharmacist's responsibilities shall include: 1) Preparation of pharmaceuticals; 2) Filling and labeling of all drug containers from which medications are to be administered; 3) Dispensing of drugs, antibiotics, biological, and pharmaceutical preparations which shall meet the standards established by the United States Pharmacopeia, National Formulary, or New and Non-official Drugs: 4) Dispensing of narcotics, hypnotics, amphetamines, alcohol preparations, and the maintenance of a perpetual inventory of them; 5) Maintenance of an approved stock of antidotes and emergency drugs; 6) Periodic inspection of all pharmaceuticals and biological supplies on all services; 7) Distribution of information concerning medications to physicians, dentists, and nurses; 8) Preparation, sterilization, and analysis of injectable medications when compounded in the pharmacy; 9) Establishment and maintenance of a system of records and accounting in accordance with hospital policies.
(5)	Only physicians, who are so authorized under the laws of the State of Colorado, and are registered with the Director of Internal Revenue, shall prescribe narcotics.
21.103	EQUIPMENT.  Reserved.
21.104	FACILITIES
(1)	Facilities shall be provided for the storage, safe-guarding, preparation, and dispensing of drugs with proper lighting, temperature control, ventilation, and sanitation facilities. In addition to adequate safeguards for all drugs, special safety precautions should be given to the storage of alcohol.
(2)	A refrigerator with thermometer and freezing compartment shall be provided for the proper storage of thermolabile products.
Part 22.  PSYCHIATRIC PATIENT CARE SERVICES
22.101	ORGANIZATION AND STAFFING
(1)	The hospital may provide psychiatric patient care services.  The standards in this subpart shall apply only if the hospital provides such services.  The following requirements are in addition to those specified in Part 19, General Patient Care Services.
(2)	A medical staff member with special training in psychiatry, preferably a Diplomate of the American Board of Psychiatry and Neurology, should be appointed chief of the psychiatric service.
(3)	A qualified psychiatric staff shall provide diagnostic and consultation services for the care and treatment of patients admitted for psychiatric disorders and for those patients who in the course of hospitalization experience a psychiatric illness.
(4)	The nursing care shall be under the direction of a registered nurse qualified by training, experience, and ability to direct effective psychiatric nursing.
22.102	PROGRAMMATIC FUNCTIONS
(1)	Confinement of patients in psychiatrically secure rooms and physical restraints shall be used only when necessary to prevent injury to the patient or others, and only when other measures are not sufficient to accomplish the purpose. Written policies shall be established relative to the use of psychiatrically secure rooms and restraints.
22.103	EQUIPMENT.  Reserved. 
22.104	FACILITIES 
(1)	When a psychiatric patient care unit is established, the unit shall provide; 1) A day-room or solarium; 2) A dining room; 3) An occupational therapy and recreation room with storage facilities; 4) A conference and interview room; 5) two or more psychiatrically secure rooms.
Part 23.  SURGICAL AND RECOVERY SERVICES 
23.101	ORGANIZATION AND STAFFING
(1)	The hospital shall provide emergency surgical care in accordance with the scope of care established pursuant to Section 3.102 (1), and may provide other surgical services.  
(2)	The nursing service of the surgical suite shall be under the supervision of a registered nurse qualified by training and experience to direct operating room nursing. 
(3)	A registered nurse qualified by training and experience in operating room nursing shall be present as a circulating nurse during operative procedures.
(4)	At least one registered nurse shall be on duty at all times in the surgical recovery room when patients are present. Nurses shall have been instructed in the care of post-anesthetic and post-surgical patients, shall have no other duties during the time they are caring for such patients. Additional registered and licensed practical nurses, and auxiliary nursing personnel shall be available. The nursing care required by different types of patients shall be the major consideration in determining the number, quality, and category of nursing personnel that are needed in any given situation.
23.102	PROGRAMMATIC FUNCTIONS
(1)	Policies related to the surgical suite shall be written and available for staff use. Policies shall include the admission of patients, personnel, and visitors.
(2)	Policies governing the authority and responsibilities of nursing personnel and the admission and length of stay of patients in the surgical recovery room shall be written.
23.103	EQUIPMENT
(1)	Equipment in anesthetizing areas shall be constructed of metal or other electrically conductive material and equipped with rubber pads, leg tips, casters, or equivalent devices which are conductive.
(2)	Only approved portable X-ray equipment shall be used in anesthetizing locations. 
(3)	At least one pressurized steam sterilizer or equivalent shall be installed in the sub-sterilizing room, and provided with indirect waste connections and recording thermometer that indicates temperature in discharge line of sterilizer. In the case of new hospital construction, or modification of an existing hospital facility pressurized steam sterilizer or equivalent, shall be installed in each sub-sterilizing facility, and provided with an indirect waste connection and a recording thermometer that indicates temperature in the discharge line of the sterilizer.
23.104	FACILITIES
(1)	Signs identifying the surgical suite shall be posted at each entrance to the suite.
(2)	Interior finishes in the surgical suite shall be smooth, unbroken, and shall facilitate and withstand frequent cleaning and disinfecting.
(3)	The surgical suite shall be located so that traffic will not pass through the suite to any other part of the hospital and shall be separated physically from the delivery suite and emergency department.  However, in hospitals of 30 beds or less, one operating suite may be used for surgical and delivery procedures, providing there is a labor room equipped for emergency delivery adjacent and accessible to the suite and with a minimum area of 180 sq. ft. See Section 9.3.1.
(4)	Operating Room
(a)	The surgical suite shall be provided with at least one operating room.  There should be one operating room for each 50 beds or major fraction thereof up to and including 200 beds. Above 200 beds the number of operating rooms will be based on the expected average of daily operations.  
(b)	The operating room design, equipment, and functional layout should be commensurate to the surgical procedures performed.
(c)	Each operating room should not be less than 18 feet in any one dimension.
(d)	Operating room(s) shall be provided with an approved electrical nurse call system. In the case of new hospital construction, or modification of an existing hospital facility, this system must be to the operations and control station or nurses station where additional help is available.
(e)	General and spot illumination shall be provided in each operating room.
(f)	The ceiling height shall not be less than 9 feet in operating rooms.****
(g)	Each operating room shall be provided with piped oxygen.  Nitrous oxide and vacuum are recommended.
	In addition to operating room(s) the following physically separated areas shall be provided within the suite. In the case of new hospital construction or modification of an existing hospital facility these areas shall be separated by doors and/or walls: 1) Sub-sterilizing facilities; 2) Scrubup area; 3) Cleanup room: 4) Instrument and supply storage; 5) Anesthesia storage; 6) Janitor's facilities: 7) Doctors' locker and dressing room; 8) Nurses' locker and dressing room; 9) Stretcher alcove. In the case of new hospital construction, or modification of an existing hospital facility, an anesthesia workroom must also be provided. Stretcher space must also be provided in the surgery suite.
**** Not required in existing buildings.
(5)	The sub-sterilizing room shall be physically separated from but adjacent to the operating room for service to the room without passing through contaminated areas. In the case of new hospital construction, or modification of an existing hospital facility, sub-sterilizing facilities shall be located to serve each operating room conveniently. More than one sub-sterilizing facility shall be provided if a suite of operating rooms is not compactly arranged
(6)	The scrubup area shall be adjacent to the operating room to permit immediate access to the room after scrubbing. Surgeon scrub sink(s) with knee or foot controls shall be installed in the scrubup area.
(7)	A clinical sink with an integral fresh water trap seal, and a sink with wrist-blade or foot-action valves shall be installed in each cleanup room.
(8)	Toilet, shower, and lavatory facilities shall be provided in the doctors' locker rooms and in the nurses' locker rooms.
(9)	In the case of new hospital construction, or modification of an existing hospital facility, at least one anesthesia equipment workroom for the cleaning, testing and storage of anesthesia equipment shall be provided. It shall contain a work counter and sink. In hospitals of 30 beds or less, the anesthesia workroom may be combined with other spaces provided that the resulting plan will not compromise the best standards of safety and of medical and nursing practices.
(10)	Ventilation
(a)	Operating rooms shall be provided with a minimum ventilation rate of 8 room volumes of outdoor air per hour with no recirculation, except when not in use, by mechanical supply and exhaust air systems. In the case of new hospital construction or modification of an existing hospital facility, operating rooms shall be provided with a minimum ventilation rate of twenty-five room volumes of air per hour by mechanical supply and exhaust air systems. (a) Outdoor air intakes shall be located as far as practical but not less than 25 feet from the exhausts from any ventilating system, combustion equipment, medical-surgical vacuum system, or plumbing vent or areas which may collect noxious fumes. The bottom of outdoor air intakes shall be located as high as practical but not less than three feet above ground level, or if installed through the roof, 3 feet above the roof level. (b) All air supplied to sensitive areas such as operating and delivery rooms and nurseries shall be delivered at or near the ceiling of the area served.
(b)	Filters shall be installed down draft from blower and provide a minimum efficiency of 90% of 1-5 micron size particles. In the case of new hospital construction, or modification of an existing hospital facility: 1) All ventilation or air conditioning systems serving surgery and delivery suites shall have a minimum of two filter beds. Filter Bed No. 1 shall be located upstream of the air conditioning equipment and shall have a minimum efficiency of 25%. 2) Filter Bed No. 2 shall be downstream of the supply fan and air conditioning equipment and humidifying equipment. Filter Bed No. 2 shall have a minimum efficiency of 90% of 1-5 micron size particles. 3) Each filter bed serving sensitive areas shall have a manometer installed across each filter bed.
(c)	Exhaust outlets, at least two (2), shall be provided, not less than 4 inches above the floor. In the case of new hospital construction, or modification of an existing hospital facility, exhaust outlets, at least two (2), shall be provided in each operating room, not less than 4 inches above the floor.
(d)	The entire surgical suite shall have a balanced air pressure. The surgical suite shall be maintained at a positive air pressure relative to the air pressures of adjacent areas within the hospital. In the case of new hospital construction, or modification of an existing hospital facility, operating rooms shall have a positive air pressure relative to the air pressures of adjacent rooms within the suite. The surgical suite shall be maintained at a positive air pressure relative to the air pressures of adjacent areas within the hospital.
(11)	Surgical Recovery Room
(a)	The design and equipment shall conform generally to the critical care unit. In the case of new hospital construction, or modification of an existing hospital facility, the surgical recovery room must provide for the visual observation of all patients, medicine dispensing facilities, charting facilities, clinical sink with a bedpan washer attachment, and storage space for supplies and equipment.
(b)	The surgical recovery room(s) shall be located in the surgical suite or adjacent thereto.
(c)	The surgical recovery room shall have facilities for immediate communications with the attending surgeon, anesthesiologist, or qualified substitute present in the hospital.
Part 24.  DIAGNOSTIC IMAGING SERVICES
24.101	ORGANIZATION AND STAFFING
(1)	The hospital shall provide diagnostic radiology services in accordance with the scope of care established pursuant to Section 3.102 (1).  Radiological imaging shall be available at all times.  The hospital may provide other diagnostic imaging services, such as ultrasound and magnetic resonance imaging. 
(2)	Imaging services shall be under the direction of a qualified physician.  Radiology services shall be under the supervision of a full-time or consulting radiologist whose professional competence has been determined by the organized medical staff.  
24.102	PROGRAMMATIC FUNCTIONS
(1)	Radiological services involving the use of machines that produce ionizing radiation or the use of radioactive materials for diagnostic purposes shall be in compliance with 6 CCR 1007-1, Rules and Regulations Pertaining to Radiation Control.
(2)	The hospital shall be responsible for the formulation, implementation and periodic review of written policies and procedures governing the services offered and in addition include the management of patients with infectious diseases, critical care patients, and patients who experience medical emergencies.
(3)	Diagnostic imaging services shall be ordered by a physician or other practitioner authorized by law.  The order shall include the name of the patient, the name of the ordering individual, and the radiological procedure ordered.  Services shall be provided in accordance with the order.
24.103	EQUIPMENT AND SUPPLIES.  Reserved.
24.104	FACILITIES
(1)	The facilities used to provide diagnostic imaging services shall have adequate space, storage (including storage for radiological images), lighting and ventilation.
Part 25.  Nuclear Medicine Services
25.101	ORGANIZATION AND STAFFING
(1)	The hospital may provide nuclear medicine services.  The following standards shall apply only if the hospital provides such services.
(2)	Nuclear medicine services shall be under the direction of a qualified physician.  
25.102	PROGRAMMATIC FUNCTIONS
(1)	Nuclear medicine services shall be in compliance with 6 CCR 1007-1, Rules and Regulations Pertaining to Radiation Control.
(2)	There shall be written policies and procedures for all services offered which shall additionally include:
(a)	steps to take in the event of an adverse reaction.
(b)	protection from non-therapeutic radiation exposure for patients and visitors while in the hospital.
(c)	information to be provided to patients who receive nuclear medicine therapy and still have radioactive particles in their bodies regarding how to prevent/minimize radiation exposure of others.
25.103	EQUIPMENT.  Reserved.  
25.104	FACILITIES.  Reserved.
Part 26.  CENTRAL MEDICAL-SURGICAL SUPPLY SERVICES 
26.101	ORGANIZATION AND STAFFING
(1)	All hospitals shall provide central medical-surgical supply services with facilities for processing, sterilizing, storing, and dispensing supplies and equipment for all departments/services of the hospital.
(2)	The central medical-surgical supply services shall be organized as a service under the immediate supervision of a person who is competent in management, asepsis, supply processing, and control methods. 
(3)	Sufficient supporting personnel shall be assigned to the service and properly trained in central medical-surgical supply services.
26.102	PROGRAMMATIC FUNCTIONS
(1)	Continuous supervision shall be maintained throughout receiving, cleaning, processing, sterilizing, and storing. A combination of controls or indicators shall be used to determine the effectiveness of the sterilization process. Bacteriological methods shall be used to evaluate the effectiveness of sterilization, by at least monthly cultures with records maintained.
(2)	Written policies and procedures shall be established for all functions of central medical-surgical supply services. Such written procedures shall include, but not be limited to, obtaining, cleaning, processing, sterilizing, storing and issuing supplies.  These policies and procedures shall be periodically reviewed by the Infection Control Committee, as applicable.
(3)	Policies shall be established to provide supervision and training programs for all personnel involved in central medical-surgical supply operations and services.
(4)	Water used for sterile solutions shall be distilled and sterilized in flasks which are resistant to heat, chemical, and electrical action.
(5)	Dry heat and special chemical methods are available and acceptable for sterilization of materials which would be damaged by pressurized steam.
26.103	EQUIPMENT
(1)	Pressurized steam sterilizers, or equivalent, and water stills, of approved type and necessary capacity for adequate sterilization, shall be provided and maintained.  Pressurized steam sterilizers shall be installed and provided with arecording thermometer that indicates temperature in discharge line of the sterilizer. 
26.104	FACILITIES
(1)	This service shall be separated physically from other areas of the hospital and shall include areas designated for the following: 1) Receiving; 2) Cleaning and processing; 3) Sterilizing; 4) Storing clean and sterile supplies; 5) Storing bulk supplies and equipment.
(2)	A two-compartment sink, with counter or drainboard and knee-or-wrist action valves, shall be provided in the cleaning area.
(3)	Adequate cabinets, cupboards, and other suitable equipment shall be provided for the processing of materials and for the storage of equipment and supplies in a clean and orderly manner.
(4)	Pressurized steam sterilizers shall be installed and provided with indirect waste connections.  Vents used for sterilizers that emit steam exhaust shall be installed in such a manner as to avoid recirculation.
(5)	Ventilation
(a)	Ventilation to this area may be supplied from the general ventilation system, if properly filtered.
(b)	The flow of air should be from the clean areas toward the exhaust in the soiled area. In the case of new hospital construction or the modification of a hospital facility, the flow of air shall be from the clean areas toward the exhaust in the soiled area. 
(c)	Exhausts shall be installed over sterilizers to prevent condensation on walls and ceilings.
Part 27.  HOUSEKEEPING SERVICES  
27.101	ORGANIZATION AND STAFFING
(1)	Each hospital shall establish organized housekeeping services.  The hospital environment shall be clean and sanitary.
(2)	The services shall be under the supervision of a person competent in environmental sanitation and management.
27.102	PROGRAMMATIC FUNCTIONS
(1)	Written policies and procedures shall be established and implemented for cleaning the physical plant and equipment.  The policies and procedures shall be designed to prevent and control infection.  At minimum, the policies and procedures shall address:  cleaning schedules, cleaning methods, the proper use and storage of cleaning supplies, hand washing, and the supervision and training of housekeeping personnel. These policies and procedures shall be periodically reviewed by the Infection Control Committee, as applicable. 
(2)	Dry dusting and sweeping are prohibited.
(3)	All personnel shall wash their hands thoroughly after handling waste products.
(4)	Accumulated waste material shall be removed at least daily.
27.103	EQUIPMENT AND SUPPLIES
(1)	Suitable equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition.
(2)	Selection of germicides shall be under the supervision of competent individual(s).
(3)	Solutions, cleaning compounds, and hazardous substances shall be labeled properly and stored in safe places. Paper towels, tissues, and other supplies shall be stored in a manner to prevent their contamination prior to use.
(4)	All rubbish and refuse containers shall be impervious and tightly covered.
(5)	Carts used to transport rubbish and refuse shall be constructed of impervious materials, shall be enclosed, and shall be used solely for this purpose. 
27.104	FACILITIES.  Reserved.
Part 28.  LINEN AND LAUNDRY SERVICES
28.101	ORGANIZATION AND STAFFING
(1)	The hospital shall provide linen and laundry services.  There shall be proper laundering of washable goods and a sufficient supply of clean linen.  
(2)	Linen and laundry services shall be under the supervision of a person qualified by education, training or experience.
28.102	PROGRAMMATIC FUNCTIONS
(1)	There shall be written policies and procedures for the collection, processing, distribution and storage of linen.  These policies and procedures shall be reviewed periodically by the infection control committee, as applicable.
(2)	Clean linen shall be stored and distributed to the point of use in a way that minimizes microbial contamination from surface contact or airborne particles.
(3)	Soiled linen shall be collected at the point of use and transported to the soiled linen holding room in a manner that minimizes microbial dissemination.
28.103	EQUIPMENT
(1)	The hospital shall use only commercial laundry equipment to process hospital linen and laundry.
28.104	FACILITIES
(1)	Laundry Area.  Handwashing facilities and a toilet should be available in the laundry area.  The general air movement shall be from the cleanest areas to the most contaminated areas.  A minimum ventilation rate of ten room volumes of outside air per hour with no recirculation is recommended for the laundry proper.  Laundry exhaust should be carried to a point above the roof or 50 feet away from any window and shall not discharge near any fresh air inlet.
(2)	Soiled Linen Storage and Sorting Area
(a)	If a laundry is not provided in the hospital, a soiled linen storage room shall be provided. 
(b)	Soiled linen storage room shall be enclosed, designed and used solely for that purpose, and provided with exhaust ventilation direct to the outside.  Recirculation of air from this room shall not be permitted.  The room shall have negative pressures relative to adjacent areas.  Eight room volumes of outside air per hour is recommended for the sorting area.  In the case of new hospital construction, or modification of an existing hospital facility, the room shall also be mechanically ventilated to the outside air.  
(3)	Clean Linen Storage
(a)	A clean linen storage and sewing room shall be provided separate from the laundry room.
(b)	Clean linen stored on patient care units shall be in closets, shelves, conveyances, or rooms used only for clean linen storage.
Part 29.  MAINTENANCE SERVICES
29.101	ORGANIZATION AND STAFFING
(1)	The hospital shall provide facility maintenance services which shall be responsible for the upkeep of the hospital’s grounds, physical plant, equipment and furnishings.  The grounds, physical plant, equipment and furnishings shall be hazard free and in good repair.
(2)	The building and mechanical programs shall be under the direction of a qualified person informed in the operations of the facility and in the building structures, their component parts and facilities.
(3)	Only properly trained responsible personnel shall be allowed to apply insecticides and rodentcides.  
29.102	PROGRAMMATIC FUNCTIONS
(1)	The hospital shall implement written policies and procedures to keep the entire facility in good repair and to provide for the safety, welfare, and comfort of the occupants of the building(s).
(2)	Physical Plant Maintenance
(a)	Inspections and maintenance shall be conducted, in accordance with written maintenance schedules, of physical plant systems including but not limited to the electrical system, emergency power generators, water supply, and ventilation.  
(b)	Records shall be maintained showing the date of maintenance and action taken to correct any deficiencies.
(3)	Equipment Maintenance
(a)	Inspections and preventive maintenance shall be conducted in accordance with written maintenance schedules of equipment, including equipment used for direct patient care, to ensure that it is in good working order.  Preventive maintenance includes, but is not limited to, routine inspections, cleaning, testing and calibrating in accordance with manufacturer’s instructions or if there are not manufacturers’ instructions, as specified by the hospital’s written policies and procedures.
(b)	Records shall be maintained showing the date of maintenance and action taken to correct any deficiencies.
(4)	Insect, Pest, and Rodent Control
(a)	The facility shall develop and implement written policies and procedures for the effective control and eradication of insects, pests, and rodents. 
(b)	Pesticides shall not be stored in patient or food areas and shall be kept under lock. 
29.103	EQUIPMENT.  Reserved.
29.104	FACILITIES
(1)	Screens or other effective methods shall be provided on all exterior openings and the structure so maintained as to prevent entry of rats or mice through cracks in foundations, holes in walls, around service pipes, etc.  
Part 30.  WASTE DISPOSAL SERVICES 
30.101	ORGANIZATION AND STAFFING
(1)	The hospital shall provide for the safe disposal of all types of waste products.  
(2)	Infectious waste disposal shall be directed by a person qualified by education, training, or experience in the principles of infectious waste management.  
30.102	PROGRAMMATIC FUNCTIONS
(1)	The hospital shall implement written policies and procedures to ensure the safe disposal of waste products.  The policies and procedures shall address:
(a)	sewage.  All sewage shall be discharged into a public sewer system.
(b)	garbage and refuse.  All garbage and refuse, not treated as sewage, shall be collected in and stored in covered containers and shall be removed from the hospital premises as frequently as necessary to prevent nuisance or health hazards or incinerated once a day.
(c)	infectious waste.  Infectious waste shall be handled and disposed of in accordance with the requirements of C.R.S. 25-15-401, et seq.
(d)	biological non-infectious waste.
(2)	Refuse or garbage shall not be burned on the premises except in an incinerator.  Incinerators shall comply with federal, state and local air pollution regulations. 
30.103	EQUIPMENT
(1)	Incinerators shall be so constructed as to prevent insect and rodent breeding and harborage.
(2)	A sufficient number of sound water-tight containers with tight fitting lids, to hold all refuse that accumulates between collections, shall be provided. Lids must be kept on the containers. Garbage containers shall be cleaned each time emptied. (Single service container liners are recommended).
30.104	FACILITIES
(1)	No exposed sewer line shall be located directly above working, storing, or eating surfaces in kitchens, dining rooms, pantries, or food storage rooms, or where medical or surgical supplies are prepared, processed, or stored.
(2)	Racks or stands for garbage containers shall be kept in good repair. A paved storage area for the containers should be provided.
Part 31.  Physical Plant
31.101 	Compliance with the Life Safety Code
(1)	Facilities shall be compliant with the National Fire Protection Association (NFPA) 101, Life Safety Code (2000).
(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).