Article 3 - Basic Services

§ 70201 & § 70203 Medical Service - Medical service means those preventive, diagnostic and therapeutic measures performed by or at the request of members of the organized medical staff.

(a) A committee of the medical staff shall be assigned responsibility for:
(1) Recommending to the governing body the delineation of medical privileges.
(2) Developing, maintaining and implementing written policies and procedures in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.
(3) Developing and instituting, in conjunction with members of the medial staff and other hospital services, a continuing cardiopulmonary resuscitation training program.
(4) Determining what emergency equipment and supplies should be available in all areas of the hospital.

(b) The responsibility and accountability of the medical service to the medical staff and administration shall be defined.

(c) The following shall be available to all patients in the hospital:
(1) Electrocardiographic testing.
(2) Pulmonary function testing.
(3) Intermittent positive pressure breathing apparatus.
(4) Cardiac monitoring capability.
(5) Suction.

(d) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70209 Medical Service Space. There shall be adequate space maintained to meet the needs of the service.

§ 70211 Nursing Service General Requirements

(a) The nursing service shall be organized, staffed, equipped, and supplied, including furnishings and resource materials, to meet the needs of patients and the service.

(b) The nursing service shall be under the direction of an administrator of nursing services who shall be a registered nurse with the following qualifications:
(1) Master's degree in nursing or a related field with at least two years of experience in administration; or
(2) Baccalaureate degree in nursing or a related field with at least two years of experience in nursing administration; or
(3) At least four years of experience in nursing administration or supervision, with evidence of continuing education directly related to the job specifications.

(c) It shall be designated in writing by the hospital administrator that the administrator of nursing services has authority, responsibility and accountability for the nursing service within the facility.

(1) The internal structure and accountability of the nursing service, including identification of nursing service units and committees, shall be defined in writing.

(2) The relationship between the nursing service and administration, organized medical staff and other departments shall be defined in writing. Such definition of relationship shall be developed in cooperation with respective departments. Administrative, medical staff and other hospital committees that address issues affecting nursing care shall include registered nurses, including those who provide direct patient care. Licensed vocational nurses may serve on those committees. Note: Authority cited: Sections 100275(a) and 1275, Health and Safety Code. Reference: Section 1276, Health and Safety Code.

§ 70213 Nursing Service Policies and Procedures.

(a) Written policies and procedures for patient care shall be developed, maintained and implemented by the nursing service.

(1) Policies and procedures which involve the medical staff shall be reviewed and approved by the medical staff prior to implementation.

(2) Policies and procedures of other departments which contain requirements for the nursing service shall be reviewed and approved by the nursing service prior to implementation.

(3) The nursing service shall review and revise policies and procedures every three years, or more often if necessary.

(4) The hospital administration and the governing body shall review and approve all policies and procedures that relate to the nursing service every three years or more often, if necessary.

(b) Policies and procedures shall be based on current standards of nursing practice and shall be consistent with the nursing process which includes: assessment, nursing diagnosis, planning, intervention, evaluation, and, as circumstances require, patient advocacy.

(c) Policies and procedures which contain competency standards for staff performance in the delivery of patient care shall be established, implemented, and updated as needed for each nursing unit, including standards for the application of restraints. Standards shall include the elements of competency validation for patient care personnel other than registered nurses as set forth in Section 70016, and the elements of competency validation for registered nurses as set forth in Section 70016.1. At least annually, patient care personnel shall receive a written performance evaluation. The evaluation shall include, but is not limited to, measuring individual performance against established competency standards.

(d) Policies and procedures that require consistency and continuity in patient care, incorporating the nursing process and the medical treatment plan, shall be developed and implemented in cooperation with the medical staff.

(e) Policies and procedures shall be developed and implemented which establish mechanisms for rapid deployment of personnel when any labor intensive event occurs which prevents nursing staff from providing attention to all assigned patients, such as multiple admissions or discharges, or an emergency health crisis.

Note: Authority cited: Sections 100275(a) and 1275, Health and Safety Code. Reference: Section 1276, Health and Safety Code.

§ 70214 Nursing Staff Development.

(a) There shall be a written, organized in-service education program for all patient care personnel, including temporary staff as described in subsection 70217(m). The program shall include, but shall not be limited to, orientation and the process of competency validation as described in subsection 70213(c).

(1) All patient care personnel, including temporary staff as indicated in subsection 70217(m), shall receive and complete orientation to the hospital and their assigned patient care unit before receiving patient care assignments. Orientation to a specific unit may be modified in order to meet temporary staffing emergencies as described in subsection 70213(e).

(2) All patient care personnel, including temporary staff as described in subsection 70217(m), shall be subject to the process of competency validation for their assigned patient care unit or units. Prior to the completion of validation of the competency standards for a patient care unit, patient care assignments shall be subject to the following restrictions:
(A) Assignments shall include only those duties and responsibilities for which competency has been validated.
(B) A registered nurse who has demonstrated competency for the patient care unit shall be responsible for nursing care as described in subsections 70215(a) and 70217(h)(3), and shall be assigned as a resource nurse for those registered nurses and licensed vocational nurses who have not completed competency validation for that unit.
(C) Registered nurses shall not be assigned total responsibility for patient care, including the duties and responsibilities described in subsections 70215(a) and 70217(h)(3), until all the standards of competency for that unit have been validated.

(3) The duties and responsibilities of patient care personnel who may be temporarily re-directed from their assigned units are subject to the restrictions in (A), (B), and (C) of subsection (a)(2) above.

(4) Orientation and competency validation shall be documented in the employee's file and shall be retained for the duration of the individual's employment.

(5) A rural General Acute Care Hospital, as defined in Health and Safety Code Section 1250(a), may apply for program flexibility pursuant to Section 70129 of this Chapter, to meet the requirements of subsections 70214(a)(1) through (4) above, by alternate means.

(b) The staff education and training program shall be based on current standards of nursing practice, established standards of staff performance as specified in subsection 70213(c) above, individual staff needs and needs identified in the quality assurance process.

(c) The administrator of nursing services shall be responsible for seeing that all nursing staff receive mandated education as specified in subsection (a) of this Section.

(d) All staff development programs shall be documented by:
(1) A record of the title, length of course in hours, and objectives of the education program presented.
(2) Name, title, and qualifications of the instructor or the title and type of other educational media.
(3) A description of the content.
(4) A date, a record of the instructor, process, or media and a list of attendees.
(5) Written evaluation of course content by attendees.

§ 70215 Planning and Implementing Patient Care.

(a) A registered nurse shall directly provide:
(1) Ongoing patient assessments as defined in the Business and Professions Code, section 2725(b)(4). Such assessments shall be performed, and the findings documented in the patient's medical record, for each shift, and upon receipt of the patient when he/she is transferred to another patient care area.
(2) The planning, supervision, implementation, and evaluation of the nursing care provided to each patient. The implementation of nursing care may be delegated by the registered nurse responsible for the patient to other licensed nursing staff, or may be assigned to unlicensed staff, subject to any limitations of their licensure, certification, level of validated competency, and/or regulation.
(3) The assessment, planning, implementation, and evaluation of patient education, including ongoing discharge teaching of each patient. Any assignment of specific patient education tasks to patient care personnel shall be made by the registered nurse responsible for the patient.

(b) The planning and delivery of patient care shall reflect all elements of the nursing process: assessment, nursing diagnosis, planning, intervention, evaluation and, as circumstances require, patient advocacy, and shall be initiated by a registered nurse at the time of admission.

(c) The nursing plan for the patient's care shall be discussed with and developed as a result of coordination with the patient, the patient's family, or other representatives, when appropriate, and staff of other disciplines involved in the care of the patient.

(d) Information related to the patient's initial assessment and reassessments, nursing diagnosis, plan, intervention, evaluation, and patient advocacy shall be permanently recorded in the patient's medical record.

§ 70217 Nursing Service Staff

(a) Hospitals shall provide staffing by licensed nurses, within the scope of their licensure in accordance with the following nurse-to-patient ratios. Licensed nurse means a registered nurse, licensed vocational nurse and, in psychiatric units only, a psychiatric technician. Staffing for care not requiring a licensed nurse is not included within these ratios and shall be determined pursuant to the patient classification system.

No hospital shall assign a licensed nurse to a nursing unit or clinical area unless that hospital determines that the licensed nurse has demonstrated current competence in providing care in that area, and has also received orientation to that hospital's clinical area sufficient to provide competent care to patients in that area. The policies and procedures of the hospital shall contain the hospital's criteria for making this determination.

Licensed nurse-to-patient ratios represent the maximum number of patients that shall be assigned to one licensed nurse at any one time. “Assigned” means the licensed nurse has responsibility for the provision of care to a particular patient within his/her scope of practice. There shall be no averaging of the number of patients and the total number of licensed nurses on the unit during any one shift nor over any period of time. Only licensed nurses providing direct patient care shall be included in the ratios.

Nurse Administrators, Nurse Supervisors, Nurse Managers, and Charge Nurses, and other licensed nurses shall be included in the calculation of the licensed nurse-to-patient ratio only when those licensed nurses are engaged in providing direct patient care. When a Nurse Administrator, Nurse Supervisor, Nurse Manager, Charge Nurse or other licensed nurse is engaged in activities other than direct patient care, that nurse shall not be included in the ratio. Nurse Administrators, Nurse Supervisors, Nurse Managers, and Charge Nurses who have demonstrated current competence to the hospital in providing care on a particular unit may relieve licensed nurses during breaks, meals, and other routine, expected absences from the unit.

Licensed vocational nurses may constitute up to 50 percent of the licensed nurses assigned to patient care on any unit, except where registered nurses are required pursuant to the patient classification system or this section. Only registered nurses shall be assigned to Intensive Care Newborn Nursery Service Units, which specifically require one registered nurse to two or fewer infants. In the Emergency Department, only registered nurses shall be assigned to triage patients and only registered nurses shall be assigned to critical trauma patients.

Nothing in this section shall prohibit a licensed nurse from assisting with specific tasks within the scope of his or her practice for a patient assigned to another nurse. “Assist” means that licensed nurses may provide patient care beyond their patient assignments if the tasks performed are specific and time-limited.

(1) The licensed nurse-to-patient ratio in a critical care unit shall be 1:2 or fewer at all times. “Critical care unit” means a nursing unit of a general acute care hospital which provides one of the following services: an intensive care service, a burn center, a coronary care service, an acute respiratory service, or an intensive care newborn nursery service. In the intensive care newborn nursery service, the ratio shall be 1 registered nurse:2 or fewer patients at all times.

(2) The surgical service operating room shall have at least one registered nurse assigned to the duties of the circulating nurse and a minimum of one additional person serving as scrub assistant for each patient-occupied operating room. The scrub assistant may be a licensed nurse, an operating room technician, or other person who has demonstrated current competence to the hospital as a scrub assistant, but shall not be a physician or other licensed health professional who is assisting in the performance of surgery.

(3) The licensed nurse-to-patient ratio in a labor and delivery suite of the perinatal service shall be 1:2 or fewer active labor patients at all times. When a licensed nurse is caring for antepartum patients who are not in active labor, the licensed nurse-to-patient ratio shall be 1:4 or fewer at all times.

(4) The licensed nurse-to-patient ratio in a postpartum area of the perinatal service shall be 1:4 mother-baby couplets or fewer at all times. In the event of multiple births, the total number of mothers plus infants assigned to a single licensed nurse shall never exceed eight. For postpartum areas in which the licensed nurse's assignment consists of mothers only, the licensed nurse-to-patient ratio shall be 1:6 or fewer at all times.

(5) The licensed nurse-to-patient ratio in a combined Labor/Delivery/Postpartum area of the perinatal service shall be 1:3 or fewer at all times the licensed nurse is caring for a patient combination of one woman in active labor and a postpartum mother and infant The licensed nurse-to-patient ratio for nurses caring for women in active labor only, antepartum patients who are not in active labor only, postpartum women only, or mother-baby couplets only, shall be the same ratios as stated in subsections (3) and (4) above for those categories of patients.

(6) The licensed nurse-to-patient ratio in a pediatric service unit shall be 1:4 or fewer at all times.

(7) The licensed nurse-to-patient ratio in a postanesthesia recovery unit of the anesthesia service shall be 1:2 or fewer at all times, regardless of the type of anesthesia the patient received.

(8) In a hospital providing basic emergency medical services or comprehensive emergency medical services, the licensed nurse-to-patient ratio in an emergency department shall be 1:4 or fewer at all times that patients are receiving treatment. There shall be no fewer than two licensed nurses physically present in the emergency department when a patient is present.

At least one of the licensed nurses shall be a registered nurse assigned to triage patients. The registered nurse assigned to triage patients shall be immediately available at all times to triage patients when they arrive in the emergency department. When there are no patients needing triage, the registered nurse may assist by performing other nursing tasks. The registered nurse assigned to triage patients shall not be counted in the licensed nurse-to-patient ratio.

Hospitals designated by the Local Emergency Medical Services (LEMS) Agency as a “base hospital,” as defined in section 1797.58 of the Health and Safety Code, shall have either a licensed physician or a registered nurse on duty to respond to the base radio 24 hours each day. When the duty of base radio responder is assigned to a registered nurse, that registered nurse may assist by performing other nursing tasks when not responding to radio calls, but shall be immediately available to respond to requests for medical direction on the base radio. The registered nurse assigned as base radio responder shall not be counted in the licensed nurse-to-patient ratios.

When licensed nursing staff are attending critical care patients in the emergency department, the licensed nurse-to-patient ratio shall be 1:2 or fewer critical care patients at all times. A patient in the emergency department shall be considered a critical care patient when the patient meets the criteria for admission to a critical care service area within the hospital.

Only registered nurses shall be assigned to critical trauma patients in the emergency department, and a minimum registered nurse-to-critical trauma patient ratio of 1:1 shall be maintained at all times. A critical trauma patient is a patient who has injuries to an anatomic area that: (1) require life saving interventions, or (2) in conjunction with unstable vital signs, pose an immediate threat to life or limb.

(9) The licensed nurse-to-patient ratio in a step-down unit shall be 1:4 or fewer at all times. Commencing January 1, 2008, the licensed nurse-to-patient ratio in a step-down unit shall be 1:3 or fewer at all times. A “step down unit” is defined as a unit which is organized, operated, and maintained to provide for the monitoring and care of patients with moderate or potentially severe physiologic instability requiring technical support but not necessarily artificial life support. Step-down patients are those patients who require less care than intensive care, but more than that which is available from medical/surgical care. “Artificial life support” is defined as a system that uses medical technology to aid, support, or replace a vital function of the body that has been seriously damaged. “Technical support” is defined as specialized equipment and/or personnel providing for invasive monitoring, telemetry, or mechanical ventilation, for the immediate amelioration or remediation of severe pathology.

(10) The licensed nurse-to-patient ratio in a telemetry unit shall be 1:5 or fewer at all times. Commencing January 1, 2008, the licensed nurse-to-patient ratio in a telemetry unit shall be 1:4 or fewer at all times. “Telemetry unit” is defined as a unit organized, operated, and maintained to provide care for and continuous cardiac monitoring of patients in a stable condition, having or suspected of having a cardiac condition or a disease requiring the electronic monitoring, recording, retrieval, and display of cardiac electrical signals. “Telemetry unit” as defined in these regulations does not include fetal monitoring nor fetal surveillance.

(11) The licensed nurse-to-patient ratio in medical/surgical care units shall be 1:6 or fewer at all times. Commencing January 1, 2005, the licensed nurse-to-patient ratio in medical/surgical care units shall be 1:5 or fewer at all times. A medical/surgical unit is a unit with beds classified as medical/surgical in which patients, who require less care than that which is available in intensive care units, step-down units, or specialty care units receive 24 hour inpatient general medical services, post-surgical services, or both general medical and post-surgical services. These units may include mixed patient populations of diverse diagnoses and diverse age groups who require care appropriate to a medical/surgical unit.

(12) The licensed nurse-to-patient ratio in a specialty care unit shall be 1:5 or fewer at all times. Commencing January 1, 2008, the licensed nurse-to-patient ratio in a specialty care unit shall be 1:4 or fewer at all times. A specialty care unit is defined as a unit which is organized, operated, and maintained to provide care for a specific medical condition or a specific patient population. Services provided in these units are more specialized to meet the needs of patients with the specific condition or disease process than that which is required on medical/surgical units, and is not otherwise covered by subdivision (a).

(13) The licensed nurse-to-patient ratio in a psychiatric unit shall be 1:6 or fewer at all times. For purposes of psychiatric units only, “licensed nurses” also includes psychiatric technicians in addition to licensed vocational nurses and registered nurses. Licensed vocational nurses, psychiatric technicians, or a combination of both, shall not exceed 50 percent of the licensed nurses on the unit.

(14) Identifying a unit by a name or term other than those used in this subsection does not affect the requirement to staff at the ratios identified for the level or type of care described in this subsection.

(b) In addition to the requirements of subsection (a), the hospital shall implement a patient classification system as defined in Section 70053.2 above for determining nursing care needs of individual patients that reflects the assessment, made by a registered nurse as specified at subsection 70215(a)(1), of patient requirements and provides for shift-by-shift staffing based on those requirements. The ratios specified in subsection (a) shall constitute the minimum number of registered nurses, licensed vocational nurses, and in the case of psychiatric units, psychiatric technicians, who shall be assigned to direct patient care. Additional staff in excess of these prescribed ratios, including non-licensed staff, shall be assigned in accordance with the hospital's documented patient classification system for determining nursing care requirements, considering factors that include the severity of the illness, the need for specialized equipment and technology, the complexity of clinical judgment needed to design, implement, and evaluate the patient care plan, the ability for self-care, and the licensure of the personnel required for care.

The system developed by the hospital shall include, but not be limited to, the following elements: (1) Individual patient care requirements. (2) The patient care delivery system. (3) Generally accepted standards of nursing practice, as well as elements reflective of the unique nature of the hospital's patient population.

c) A written staffing plan shall be developed by the administrator of nursing service or a designee, based on patient care needs determined by the patient classification system. The staffing plan shall be developed and implemented for each patient care unit and shall specify patient care requirements and the staffing levels for registered nurses and other licensed and unlicensed personnel. In no case shall the staffing level for licensed nurses fall below the requirements of subsection (a).

The plan shall include the following: (1) Staffing requirements as determined by the patient classification system for each unit, documented on a day-to-day, shift-by-shift basis. (2) The actual staff and staff mix provided, documented on a day-to-day, shift-by-shift basis. (3) The variance between required and actual staffing patterns, documented on a day-to-day, shift-by-shift basis.

(d) In addition to the documentation required in subsections (c) (1) through (3) above, the hospital shall keep a record of the actual registered nurse, licensed vocational nurse and psychiatric technician assignments to individual patients by licensure category, documented on a day-to-day, shift-by-shift basis. The hospital shall retain: (1) The staffing plan required in subsections (c)(1) through (3) for the time period between licensing surveys, which includes the Consolidated Accreditation and Licensing Survey process, and (2) The record of the actual registered nurse, licensed vocational nurse and psychiatric technician assignments by licensure category for a minimum of one year.

(e) The reliability of the patient classification system for validating staffing requirements shall be reviewed at least annually by a committee appointed by the nursing administrator to determine whether or not the system accurately measures patient care needs.

(f) At least half of the members of the review committee shall be registered nurses who provide direct patient care.

(g) If the review reveals that adjustments are necessary in the patient classification system in order to assure accuracy in measuring patient care needs, such adjustments must be implemented within thirty (30) days of that determination.

(h) Hospitals shall develop and document a process by which all interested staff may provide input about the patient classification system, the system's required revisions, and the overall staffing plan.

(i) The administrator of nursing services shall not be designated to serve as a charge nurse or to have direct patient care responsibility, except as described in subsection (a) above.

(j) Registered nursing personnel shall: (1) Assist the administrator of nursing service so that supervision of nursing care occurs on a 24-hour basis. (2) Provide direct patient care. (3) Provide clinical supervision and coordination of the care given by licensed vocational nurses and unlicensed nursing personnel.

(k) Each patient care unit shall have a registered nurse assigned, present and responsible for the patient care in the unit on each shift.

(l) A rural General Acute Care Hospital as defined in Health and Safety Code Section 1250(a), may apply for and be granted program flexibility for the requirements of subsection 70217(i) and for the personnel requirements of subsection (j)(1) above.

(m) Unlicensed personnel may be utilized as needed to assist with simple nursing procedures, subject to the requirements of competency validation. Hospital policies and procedures shall describe the responsibility of unlicensed personnel and limit their duties to tasks that do not require licensure as a registered or vocational nurse.

(n) Nursing personnel from temporary nursing agencies shall not be responsible for a patient care unit without having demonstrated clinical and supervisory competence as defined by the hospital's standards of staff performance pursuant to the requirements of subsection 70213(c) above.

(o) Hospitals which utilize temporary nursing agencies shall have and adhere to a written procedure to orient and evaluate personnel from these sources. Such procedures shall require that personnel from temporary nursing agencies be evaluated as often, or more often, than staff employed directly by the hospital.

(p) All registered and licensed vocational nurses utilized in the hospital shall have current licenses. A method to document current licensure shall be established.

(q) The hospital shall plan for routine fluctuations in patient census. If a healthcare emergency causes a change in the number of patients on a unit, the hospital must demonstrate that prompt efforts were made to maintain required staffing levels. A healthcare emergency is defined for this purpose as an unpredictable or unavoidable occurrence at unscheduled or unpredictable intervals relating to healthcare delivery requiring immediate medical interventions and care.

§ 70219 Nursing Service Space

(a) Space and components for nurses' stations and utility rooms shall comply with the requirements set forth in California Code of Regulations, Title 24, Part 2, Section 420A.14, California Building Code, 1995.

(b) Office space shall be provided for the administrator of nursing services and for the other needs of the service.

§ 70221 Surgical Service Definition. Surgical service means the performance of surgical procedures with the appropriate staff, space, equipment and supplies.

(a) Hospitals shall maintain at least the number of operating rooms in ratio to licensed bed capacity as follows: Licensed bed capacity Number of operating rooms less than 25 One 25 to 99 Two 100 or more Three For each additional 100 beds or major fractions thereof, at least one additional operating room shall be maintained, unless approved to the contrary by the Department.

(1) Required operating rooms are in addition to special operating rooms, cystoscopy rooms and fracture rooms which are provided by the hospital.

(2) Beds in a distinct part skilled nursing service, intermediate care service or psychiatric unit shall be excluded from calculating the number of operating rooms required.

(b) A committee of the medical staff shall be assigned responsibility for: (1) Recommending to the governing body the delineation of surgical privileges for individual members of the medical staff. A current list of such privileges shall be kept in the files of the operating room supervisor.

(2) Development, maintenance and implementation of written policies and procedures in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(3) Determining what emergency equipment and supplies shall be available in the surgery suite.

(4) Determining which operative procedures require an assistant surgeon or assistants to the surgeon.

(c) The responsibility and the accountability of the surgical service to the medical staff and administration shall be defined.

(d) Prior to commencing surgery the person responsible for administering anesthesia, or the surgeon if a general anesthetic is not to be administered, shall verify the patient's identity, the site and side of the body to be operated on, and ascertain that a record of the following appears in the patient's medical record: (1) An interval medical history and physical examination performed and recorded within the previous 24 hours. (2) Appropriate screening tests, based on the needs of the patient, accomplished and recorded within 72 hours prior to surgery. (3) An informed consent, in writing, for the contemplated surgical procedure.

(e) The requirements of (d), above, do not preclude rendering emergency medical or surgical care to a patient in dire circumstances.

(f) A register of operations shall be maintained including the following information for each surgical procedure performed: (1) Name, age, sex and hospital admitting number of the patient. (2) Date and time of the operation and the operating room number . (3) Preoperative and postoperative diagnosis. (4) Name of surgeon, assistants, anesthetists and scrub and circulating assistant. (5) Surgical procedure performed and anesthetic agent used. (6) Complications, if any, during the operation.

(g) All anatomical parts, tissues and foreign objects removed by operation shall be delivered to a pathologist designated by the hospital and a report of his findings shall be filed in the patient's medical record.

(h) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

(i) The requirements in this section do not apply to special hospitals unless the special hospital provides this service.

§ 70225 Surgical Service Staff.

(a) A physician shall have overall responsibility for the surgical service. This physician shall be certified or eligible for certification in surgery by the American Board of Surgery. If such a surgeon is not available, a physician, with additional training and experience in surgery shall be responsible for the service.

(b) One or more surgical teams consisting of physicians, registered nurses and other personnel shall be available at all times.

(c) A registered nurse with training and experience in operating room techniques shall be responsible for the nursing care and nursing management of operating room service.

(d) There shall be sufficient nursing personnel so that one person is not serving as circulating assistant for more than one operating room.

(e) There shall be evidence of continuing education and training programs for the nursing staff.

§ 70227 Surgical Service Equipment and Supplies.

(a) There shall be adequate and appropriate equipment and supplies maintained related to the nature of the needs and the services offered, including at least the following monitoring equipment and supplies: (1) Cardiac monitor, with a pulse rate meter, for each patient receiving a general anesthetic. (2) D. C. defibrillator. (3) Electrocardiographic machine. (4) Oxygen and respiratory rate alarms. (5) Appropriate supplies and drugs for emergency use.

§ 70229 Surgical Service Space.

(a) Hospitals shall maintain operating rooms as follows: (1) Operating rooms shall have a minimum floor dimension of 5.4 meters (18 feet) and shall contain not less than 30 square meters (324 square feet) of floor area. (2) Cast rooms, fracture rooms and cystoscopic rooms, if provided, shall have a minimum floor area of 17 square meters (180 square feet), no dimension of which shall be less than three (3) meters (11 feet) net.

§ 70231 Anesthesia Service Definition. Anesthesia service means the provision of anesthesia of the type and in the manner required by the patient's condition with appropriate staff, space, equipment and supplies. A postanesthesia recovery unit is a specific area in a hospital, staffed and equipped to provide specialized care and supervision of patients during the immediate postanesthesia period.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

The policies and procedures shall include provision for at least: (1) Preanesthesia evaluation of the patient by an individual qualified to administer anesthesia as a licensed practitioner in accordance with his or her scope of licensure. Persons providing preanesthesia evaluations shall appropriately document pertinent information relative to the choice of anesthesia and the surgical or obstetrical procedure anticipated. (2) Review of the patient's condition immediately prior to induction of anesthesia. (3) Safety of the patient during the anesthetic period. (4) Recording of all events taking place during the induction of, maintenance of and emergence from anesthesia, including the amount and duration of all anesthetic agents, other drugs, intravenous fluids and blood or blood fractions. (5) Recording of postanesthetic visits that include at least one note describing the presence or absence of complications related to anesthesia.

(b) The responsibility and the accountability of the anesthesia service to the medical staff and administration shall be defined.

(c) Rules for the safe use of nonflammable and flammable anesthetic agents which conform with the rules of the State Fire Marshal and Section 70849 shall be adopted.

(d) Periodically, an appropriate committee of the medical staff shall evaluate the service provided and make appropriate recommendations to the executive committee of the medical staff and administration.

(e) The requirements in this section do not apply to special hospitals unless the special hospital provides this service.

§ 70235 Anesthesia Service Staff.

(a) A physician shall have overall responsibility for the anesthesia service. His responsibility shall include at least the: (1) Availability of equipment, drugs and parenteral fluids necessary for administering anesthesia and for related resuscitative efforts. (2) Development of regulations concerning anesthetic safety. (3) Operation of the postanesthesia service.

(b) Anesthesia care shall be provided by physicians or dentists with anesthesia privileges, nurse anesthetists, or appropriately supervised trainees in an approved educational program.

(c) Anesthesia staff shall be available or on call at all times.

(d) A registered nurse with training and experience in postanesthesia nursing care shall be responsible for the nursing care and nursing management in the postanesthesia recovery unit.

(e) There shall be sufficient licensed nurses assigned to meet the needs of the patients.

(f) Nurses assistants, where provided, shall not be assigned patient care duties unless under the direct supervision of a licensed nurse.

§ 70237 Anesthesia Service Equipment and Supplies.

(a) There shall be adequate and appropriate equipment for the delivery of anesthesia and postanesthesia recovery care.

(1) The anesthetist shall check the readiness, availability, and cleanliness of all equipment used prior to the administration of the anesthetic agents.

(2) At least the following equipment shall be provided in the postanesthesia recovery room: (A) Cardiac monitor, with pulse rate meter, in the ratio of 1 monitor for each two (2) patients. (B) D. C. defibrillator. (C) Mechanical positive pressure breathing apparatus. (D) Stripchart electrocardiographic recorder. (E) Sphygmomanometer. (F) Crash cart, or equivalent, with appropriate supplies and drugs for emergency use.

§ 70239 Anesthesia Service Space.

(a) Postanesthesia recovery unit shall maintain the following spaces as required in Section T 17-314, Title 24, California Administrative Code: (1) Floor area of at least 7.5 square meters (80 square feet) per bed exclusive of the spaces listed below in (2) through (6). (2) Space for a nurses' control desk, charting space, locked medicine cabinet, refrigerator and handwashing lavatory not requiring direct contact of the hands for operation. (3) A utility space including a rim-flush clinic sink and countertop work space at least one meter (3 feet) long. Clean and dirty areas shall be separated. (4) Storage space for clean linen. (5) Storage space for soiled linen. (6) Storage space for supplies and equipment. (7) Air Conditioning.

(b) The postanesthesia recovery unit is classified as an electrically sensitive area and shall meet grounding requirements in Section 70853.

(c) Beds in the postanesthesia recovery unit shall not be included in the licensed bed capacity of the hospital.

§ 70239 Anesthesia Service Space

(a) Postanesthesia recovery unit shall maintain the following spaces as required in Section T 17-314, Title 24, California Administrative Code: (1) Floor area of at least 7.5 square meters (80 square feet) per bed exclusive of the spaces listed below in (2) through (6). (2) Space for a nurses' control desk, charting space, locked medicine cabinet, refrigerator and handwashing lavatory not requiring direct contact of the hands for operation. (3) A utility space including a rim-flush clinic sink and countertop work space at least one meter (3 feet) long. Clean and dirty areas shall be separated. (4) Storage space for clean linen. (5) Storage space for soiled linen. (6) Storage space for supplies and equipment. (7) Air Conditioning.

(b) The postanesthesia recovery unit is classified as an electrically sensitive area and shall meet grounding requirements in Section 70853.

(c) Beds in the postanesthesia recovery unit shall not be included in the licensed bed capacity of the hospital.

§ 70243Clinical Laboratory Service General Requirements.

(a) Clinical laboratories shall be operated in conformance with the California Business and Professions Code, Division 2, Chapter 3 (Sections 1200 to 1322, inclusive) and the California Administrative Code, Title 17, Chapter 2, Subchapter 1, Group 2 (Sections 1030 to 1057, inclusive).

(b) All hospitals shall maintain clinical laboratory services and equipment for routine laboratory work, such as urinalysis, complete blood counts, blood typing, cross matching and such other tests as are required by these regulations.

c) All hospitals shall maintain or make provision for clinical laboratory services for performance of tests in chemistry, microbiology, serology, hematology, pathology and such other tests as are required by these regulations.

(d) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(e) The responsibility and the accountability of the clinical laboratory service to the medical staff and administration shall be defined.

(f) The director of the clinical laboratory shall assure that: (1) Examinations are performed accurately and in a timely fashion. (2) Procedures are established governing the provision of laboratory services for outpatients. (3) Laboratory systems identify the patient, test requested, date and time the specimen was obtained, the time the request reached the laboratory, the time the laboratory completed the test and any special handling which was required. (4) Procedures are established to ensure the satisfactory collection of specimens. (5) A communications system to provide efficient information exchange between the laboratory and related areas of the hospital is established. (6) A quality control system within the laboratory designed to ensure medical reliability of laboratory data is established. The results of control tests shall be readily available in the hospital. (7) Reports of all laboratory examinations are made a part of the patient's medical record as soon as is practical. (8) No laboratory procedures are performed except on the order of a person lawfully authorized to give such an order.

(g) Tissue specimens shall be examined by a physician who is certified or eligible for certification in anatomical and/or clinical pathology by the American Board of Pathology or possesses qualifications which are equivalent to those required for certification. Oral specimens may be examined by a dentist who is certified or eligible for certification as an oral pathologist by the American Board of Oral Pathology. A record of his findings shall become a part of the patient's medical record. (1) A tissue file shall be maintained at the hospital or the principal office of the consulting pathologist.

(h) The use, storage and disposal of radioactive materials shall comply with the California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17, California Administrative Code.

(i) Where the hospital depends on outside blood banks, there shall be a written agreement governing the procurement, transfer and availability of blood.

(j) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Section 1276, Health and Safety Code.

§ 70245 Clinical Laboratory Service Staff

(a) A physician shall have overall responsibility for the clinical laboratory service. This physician shall be certified or eligible for certification in clinical pathology and/or pathologic anatomy by the American Board of Pathology. If such a pathologist is not available on a full-time or regular part-time weekly basis, a physician or a licensed clinical laboratory bioanalyst who is available on a full-time or regular part-time basis may administer the clinical laboratory. In this circumstance, a pathologist, qualified as above, shall provide consultation at suitable intervals to assure high quality service.

(b) There shall be a physician, clinical laboratory bioanalyst or clinical laboratory technologist on duty or on call at all times to assure the availability of emergency laboratory services.

(c) There shall be sufficient staff with adequate training and experience to meet the needs of the service being offered.

§ 70247 Clinical Laboratory Service Equipment and Supplies

(a) There shall be sufficient equipment and supplies maintained to perform the laboratory services being offered.

(b) The hospital shall maintain blood storage facilities in conformance with the provisions of Section 1002(g), Article 10, Group 1, Subchapter 1, Chapter 2, Title 17, California Administrative Code. Such facilities shall be inspected at appropriately short intervals each day of the week to assure these requirements are being fulfilled.

§ 70249 Clinical Laboratory Service Space

(a) Adequate laboratory space as determined by the Department shall be maintained.

(b) If tests on outpatients are to be performed, outpatient access to the laboratory shall not traverse a nursing unit.

§ 70253 Radiological Service General Requirements.

(a) All hospitals shall maintain a diagnostic radiological service.

(b) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(c) The responsibility and the accountability of the radiological service to the medical staff and administration shall be defined.

(d) The use, storage and shielding of all radiation machines and radioactive materials shall comply with the California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17, California Administrative Code.

(e) All persons operating or supervising the operation of X-ray machines shall comply with the requirements of the Radiologic Technology Regulations, Subchapter 4.5, Chapter 5, Title 17, California Administrative Code.

(f) Diagnostic radiological services may be performed on the order of a person lawfully authorized to give such an order.

(g) Reports of radiological service examinations shall be filed in the patient's medical record and maintained in the radiology unit.

(h) X-ray films or reproductions thereof, shall be retained for the same period of time as is required for other parts of the patient's medical record.

(i) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70255 Radiological Service Staff

(a) A physician shall have overall responsibility for the radiological service. This physician shall be certified or eligible for certification by the American Board of Radiology. If such a radiologist is not available on a full-time or regular part-time basis, a physician, with training and experience in radiology, may administer the service. In this circumstance, a radiologist, qualified as above, shall provide consultation services at suitable intervals to assure high quality service.

(b) Sufficient certified radiologic technologists shall be employed to meet the needs of the service being offered.

(c) There shall be at least one person on duty or on call at all times capable of operating radiological equipment.

§ 70257Radiological Service Equipment and Supplies.

(a) There shall be sufficient equipment and supplies maintained to adequately perform the radiological services that are offered in the hospital. As a minimum, the following equipment shall be available: (1) At least one radiographic and fluoroscopic unit. On and after January 1, 1977, fluoroscopic units shall be equipped with image intensifiers. (2) Film processing equipment.

(b) Proper resuscitative and monitoring equipment shall be immediately available.

§ 70259 Radiological Service Space.

(a) There shall be sufficient space maintained to adequately provide radiological services.

This shall include but not be limited to the following: (1) A separate X-ray room large enough to accommodate the necessary radiographic equipment and to allow easy maneuverability of stretchers and wheelchairs. (2) Toilet facilities located adjacent to or in the immediate vicinity. (3) Dressing room facilities for patients. (4) Film processing area. (5) Sufficient storage space for all the necessary X-ray equipment, supplies and for exposed X-ray film and copies of reports. (6) Suitable area for viewing and reporting of radiographic examinations.

(b) If X-ray examinations are to be performed on outpatients, outpatient access to the radiological spaces shall not traverse a nursing unit.

§ 70263 Pharmaceutical Service General Requirements

(a) All hospitals having a licensed bed capacity of 100 or more beds shall have a pharmacy on the premises licensed by the California Board of Pharmacy. Those hospitals having fewer than 100 licensed beds shall have a pharmacy license issued by the Board of Pharmacy pursuant to Section 4029 or 4056 of the Business and Professions Code.

(b) The responsibility and the accountability of the pharmaceutical service to the medical staff and administration shall be defined.

(c) A pharmacy and therapeutics committee, or a committee of equivalent composition, shall be established. The committee shall consist of at least one physician, one pharmacist, the director of nursing service or his or her representative and the administrator or his or her representative.

(1) The committee shall develop written policies and procedures for establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs and chemicals. The pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and implementations of procedures. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(2) The committee shall be responsible for the development and maintenance of a formulary of drugs for use throughout the hospital.

(d) There shall be a system maintained whereby no person other than a pharmacist or an individual under the direct supervision of a pharmacist shall dispense medications for use beyond the immediate needs of the patients.

(e) There shall be a system assuring the availability of prescribed medication 24 hours a day.

(f) Supplies of drugs for use in medical emergencies only shall be immediately available at each nursing unit or service area as required.

(1) Written policies and procedures establishing the contents of the supply procedures for use, restocking and sealing of the emergency drug supply shall be developed.

(2) The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within.

(3) The supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years.

(g) No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish. This shall not preclude the administration of aerosol drugs by respiratory care practitioners. The order shall include the name of the drug, the dosage and the frequency of administration, the route of administration, if other than oral, and the date, time and signature of the prescriber or furnisher. Orders for drugs should be written or transmitted by the prescriber or furnisher. Verbal orders for drugs shall be given only by a person lawfully authorized to prescribe or furnish and shall be recorded promptly in the patient's medical record, noting the name of the person giving the verbal order and the signature of the individual receiving the order. The prescriber or furnisher shall countersign the order within 48 hours.

(1) Verbal orders for administration of medications shall be received and recorded only by those health care professionals whose scope of licensure authorizes them to receive orders for medication.

(2) Medications and treatments shall be administered as ordered.

(h) Standing orders for drugs may be used for specified patents when authorized by a person licensed to prescribe. A copy of standing orders for a specific patient shall be dated, promptly signed by the prescriber and included in the patient's medical record.

These standing orders shall: (1) Specify the circumstances under which the drug is to be administered. (2) Specify the types of medical conditions of patients for whom the standing orders are intended. (3) Be initially approved by the pharmacy and therapeutics committee or its equivalent and be reviewed at least annually by that committee. (4) Be specific as to the drug, dosage, route and frequency of administration.

(i) An individual prescriber may notify the hospital in writing of his or her own standing orders, the use of which is subject to prior approval and periodic review by the pharmacy and therapeutics committee or its equivalent.

(j) The hospital shall develop policies limiting the duration of drug therapy in the absence of the prescriber's specific indication of duration of drug therapy or under other circumstances recommended by the pharmacy and therapeutics committee or its equivalent and approved by the executive committee of the medical staff. The limitations shall be established for classes of drugs and/or individual drug entities.

(k) If drugs are supplied through a pharmacy, orders for drugs shall be transmitted to the pharmacy either by written prescription of the prescriber, by an order form which produces a direct copy of the order or by an electronically reproduced facsimile. When drugs are not supplied through a pharmacy, such information shall be made available to the hospital pharmacist.

(l) Medications shall not be left at the patient's bedside unless the prescriber so orders. Such bedsidemedications shall be kept in a cabinet, drawer or in possession of the patient. Drugs shall not be left at the bedside which are listed in Schedules II, III and IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 as amended. If the hospital permits bedside storage of medications, written policies and procedures shall be established for the dispensing, storage and records of use, of such medications.

(m) Medications brought by or with the patient to the hospital shall not be administered to the patient unless all of the following conditions are met: (1) The drugs have been ordered by a person lawfully authorized to give such an order and the order entered in the patient's medical record. (2) The medication containers are clearly and properly labeled. (3) The contents of the containers have been examined and positively identified, after arrival at the hospital, by the patient's physician or the hospital pharmacist.

(n) The hospital shall establish a supply of medications which is accessible without entering either the pharmacy or drug storage room during hours when the pharmacist is not available. Access to the supply shall be limited to designated registered nurses. Records of drugs taken from the supply shall be maintained and the pharmacist shall be notified of such use. The records shall include the name and strength of the drug, the amount taken, the date and time, the name of the patient to whom the drug was administered and the signature of the registered nurse. The pharmacist shall be responsible for maintenance of the supply and assuring that all drugs are properly labeled and stored. The drug supply shall contain that type and quantity of drugs necessary to meet the immediate needs of patients as determined by the pharmacy and therapeutics committee.

(o) Investigational drug use shall be in accordance with applicable state and federal laws and regulations and policies adopted by the hospital. Such drugs shall be used only under the direct supervision of the principal investigator, who shall be a member of the medical staff and be responsible for assuring that informed consent is secured from the patient. Basic information concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of investigational drugs shall be available at the nursing station where such drugs are being administered and in the pharmacy. The pharmacist shall be responsible for the proper labeling, storage and distribution of such drugs pursuant to the written order of the investigator.

(p) No drugs supplied by the hospital shall be taken from the hospital unless a prescription or medical record order has been written for the medication and the medication has been properly labeled and prepared by the pharmacist in accordance with state and federal laws, for use outside of the hospital.

(q) Labeling and storage of drugs shall be accomplished to meet the following requirements:

(1) Individual patient medications, except those that have been left at the patient's bedside, may be returned to the pharmacy for appropriate disposition.

(2) All drug labels must be legible and in compliance with state and federal requirements.

(3) Drugs shall be labeled only by persons legally authorized to prescribe or dispense or under the supervision of a pharmacist.

(4) Test agents, germicides, disinfectants and other household substances shall be stored separately from drugs.

(5) External use drugs in liquid, tablet, capsule or powder form shall be segregated from drugs for internal use.

(6) Drugs shall be stored at appropriate temperatures. Refrigerator temperature shall be between 2.2oC (36oF) and 7.7oC (46oF) and room temperature shall be between 15oC (59oF) and 30oC (86oF).

(7) Drugs shall be stored in an orderly manner in well-lighted cabinets, shelves, drawers or carts of sufficient size to prevent crowding.

(8) Drugs shall be accessible only to responsible personnel designated by the hospital, or to the patient as provided in 70263(l) above.

(9) Drugs shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use.

(10) Drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist. Any irregularities shall be reported to the director of nursing service and as required by hospital policy.

(11) Discontinued individual patient's drugs not supplied by the hospital may be sent home with the patient.

Those which remain in the hospital after discharge that are not identified by lot number shall be destroyed in the following manner: (A) Drugs listed in Schedules II, III or IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended, shall be destroyed in the presence of two pharmacists or a pharmacist and a registered nurse employed by the hospital. The name of the patient, the name and strength of the drug, the prescription number, the amount destroyed, the date of destruction and the signatures of the witnesses required above shall be recorded in the patient's medical record or in a separate log. Such log shall be retained for at least three years. (B) Drugs not listed under Schedules II, III or IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended, shall be destroyed in the presence of a pharmacist.

(r) The pharmacist shall develop and implement written quality control procedures for all drugs which are prepackaged or compounded in the hospital including intravenous solution additives. He or she shall develop and conduct an in-service training program for the professional staff to assure compliance therewith.

(s) The pharmacist shall be consulted on proper methods for repackaging and labeling of bulk cleaning agents, solvents, chemicals and poisons used throughout the hospital.

(t) Periodically, the pharmacy and therapeutics committee, or its equivalent, shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

Note: Authority cited: Sections 1275 and 131200, Health and Safety Code. Reference: Sections 1276, 131050, 131051 and 131052, Health and Safety Code. *See DOM 14-06 Pharmaceutical Service Changes for GACH (Senate Bill 1039) surveyor guidance.

§ 70265 Pharmaceutical Services Staff

A pharmacist shall have overall responsibility for the pharmaceutical service. He shall be responsible for the procurement, storage and distribution of all drugs as well as the development, coordination, supervision and review of pharmaceutical services in the hospital. Hospitals with a limited permit shall employ a pharmacist on at least a consulting basis. Responsibilities shall be set forth in a job description or agreement between the pharmacist and the hospital. The pharmacist shall be responsible to the administrator and shall furnish him written reports and recommendations regarding the pharmaceutical services within the hospital. Such reports shall be provided no less often than quarterly.

§ 70267 Pharmaceutical Service Equipment and Supplies.

(a) There shall be adequate equipment and supplies for the provision of pharmaceutical services within the hospital.

(b) Reference materials containing monographs on all drugs in use in the hospital shall be available in each nursing unit. Such monographs must include information concerning generic and brand names, if applicable, available strengths and dosage forms and pharmacological data including indications, side effects, adverse effects and drug interactions.

§ 70269 Pharmaceutical Service Space.

(a) Adequate space shall be available at each nursing station for the storage of drugs and preparation of medication doses.

(b) All spaces and areas used for the storage of drugs shall be lockable and accessible to authorized personnel only.

§ 70273 Dietetic Service General Requirements.

(a) The dietetic service shall provide food of the quality and quantity to meet the patient's needs in accordance with physicians' orders and, to the extent medically possible, to meet the Recommended Daily Dietary Allowances, 1974 Edition, adopted by the Food and Nutrition Board of the National Research Council of the National Academy of Sciences, 2107 Constitution Avenue, Washington, DC 20418.

(1) Not less than three meals shall be served daily.

(2) Not more than 14 hours shall elapse between the evening meal and breakfast of the following day.

(3) Nourishment or between meal feedings shall be provided as required by the diet prescription and shall be offered to all patients unless counter ordered by the physician.

(4) Patient food preferences shall be respected as much as possible and substitutes shall be offered through use of a selective menu or substitutes from appropriate food groups.

(5) When food is provided by an outside food service, all applicable requirements herein set forth shall be met. The hospital shall maintain adequate space, equipment and staple food supplies to provide patient food service in emergencies.

(b) Policies and procedures shall be developed and maintained in consultation with representatives of the medical staff, nursing staff and administration to govern the provision of dietetic services. Policies shall be approved by the medical staff, administration and governing body. Procedures shall be approved by themedical staff and administration.

(c) The responsibility and the accountability of the dietetic service to the medical staff and administration shall be defined.

(d) A current diet manual approved by the dietitian and the medical staff shall be used as the basis for diet orders and for planning modified diets. Copies of the diet manual shall be available at each nursing station and in the dietetic service area.

(e) Therapeutic diets shall be provided as prescribed by a person lawfully authorized to give such an order and shall be planned, prepared and served with supervision and/or consultation from the dietitian. Persons responsible for therapeutic diets shall have sufficient knowledge of food values to make appropriate substitutions when necessary.

(f) A current profile card shall be maintained for each patient indicating diet, likes, dislikes and other pertinent information concerning the patient's dietary needs.

(g)Menus: (1) Menus for regular and routine modified diets shall be written at least one week in advance, dated and posted in the kitchen at least three days in advance. (2) If any meal served varies from the planned menu, the change shall be noted in writing on the posted menu in the kitchen. (3) Menus shall provide a variety of foods in adequate amounts at each meal. (4) Menus should be planned with consideration for cultural and religious background and food habits of patients. (5) A copy of the menu as served shall be kept on file for at least 30 days. (6) Records of food purchased shall be kept available for one year. (7) Standardized recipes, adjusted to appropriate yield, shall be maintained and used in food preparation.

(h) Food shall be prepared by methods which conserve nutritive value, flavor and appearance. Food shall be served attractively at appropriate temperatures and in a form to meet individual needs.

(i) Nutritional Care. (1) Nutritional care shall be integrated in the patient care plan. (2) Observations and information pertinent to dietetic treatment shall be recorded in patient's medical records by the dietitian. (3) Pertinent dietary records shall be included in patient's transfer discharge record to ensure continuity of nutritional care.

(j) In-service training shall be provided for all dietetic service personnel and a record of subject areas covered, date and duration of each session and attendance lists shall be maintained.

(k) Food Storage: (1) Food storage areas shall be clean at all times. (2) Dry or staple items shall be stored at least 30 cm (12 inches) above the floor, in a ventilated room, (not subject to sewage or waste water backflow, or contamination by condensation, leakage, rodents or vermin). (3) All readily perishable foods or beverages capable of supporting rapid and progressive growth of microorganisms which can cause food infections or food intoxication shall be maintained at temperatures of 7 degrees C (45 degrees F) or below, or at 60 degrees C (140 degrees F) or above, at all times, except during necessary periods of preparation and service. Frozen food shall be stored at -18 degrees C (0 degrees F) or below. (4) There shall be a reliable thermometer in each refrigerator and in storerooms used for perishable food. (5) Pesticides, other toxic substances and drugs shall not be stored in the kitchen area or in storerooms for food and/or food preparation equipment and utensils. (6) Soaps, detergents, cleaning compounds or similar substances shall not be stored in food storerooms or food storage areas.

(l) Sanitation. (1) All kitchens and kitchen areas shall be kept clean, free from litter and rubbish and protected from rodents, roaches, flies and other insects. (2) All utensils, counters, shelves and equipment shall be kept clean, maintained in good repair and shall be free from breaks, corrosions, open seams, cracks and chipped areas. (3) Plasticware, china and glassware that is unsightly, unsanitary or hazardous because of chips, cracks or loss of glaze shall be discarded. (4) Ice which is used in connection with food or drink shall be from a sanitary source and shall be handled and dispensed in a sanitary manner. (5) Kitchen wastes that are not disposed of by mechanical means shall be kept in leakproof, nonabsorbent, tightly closed containers and shall be disposed of as frequently as necessary.

(m) All utensils used for eating, drinking and in the preparation and serving of food and drink shall be cleaned and disinfected or discarded after each usage. (1) Gross food particles shall be removed by scraping and prerinsing in running water. (2) The utensils shall be thoroughly washed in hot water with a minimum temperature of 43 degrees C (110 degrees F), using soap or detergent, rinsed in hot water to remove soap or detergent and disinfected by one of the following methods or an equivalent method approved by the Department: (A) Immersion for at least two minutes in clean water at 77 degrees C (170.6 degrees F).(B) Immersion for at least 30 seconds in clean water at 82 degrees C (180 degrees F). (C) Immersion in water containing bactericidal chemical as approved by the Department. (3) After disinfection the utensils shall be allowed to drain and dry in racks or baskets on nonabsorbent surfaces. Drying cloths shall not be used. (4) Results obtained with dishwashing machines shall be equal to those obtained by the methods outlined above and all dishwashing machines shall meet the requirements contained in Standard No. 3 as amended in April 1965 of the National Sanitation Foundation, P.O. Box 1468, Ann Arbor, MI 48106.

Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Section 1276, Health and Safety Code.

§ 70275 Dietetic Service Staff.

(a) A registered dietitian shall be employed on a full-time, part-time or consulting basis. Part-time or consultant services shall be provided on the premises at appropriate times on a regularly scheduled basis and of sufficient duration and frequency to provide continuing liaison with medical and nursing staffs, advice to the administrator, patient counseling, guidance to the supervisor and staff of the dietetic service, approval of all menus and participation in development or revision of dietetic policies and procedures and in planning and conducting in-service education programs.

(b) If a registered dietitian is not employed full-time, a full-time person who meets the training requirements to be a dietetic services supervisor specified in section 1265.4(b) of the Health and Safety Code shall be employed to be responsible for the operation of the food service.

(c) Sufficient dietetic service personnel shall be employed, oriented, trained and their working hours scheduled to provide for the nutritional needs of the patients and to maintain the dietetic service areas. If dietetic service employees are assigned duties in other service areas, those duties shall not interfere with the sanitation, safety or time required for dietetic work assignments.

(d) Current work schedules by job titles and weekly duty schedules shall be posted in the dietetic service area.

(e) A record shall be maintained of the number of persons by job title employed full or part-time in dietetic services and the number of hours each works weekly.

(f) Hygiene of Dietetic Service Staff. (1) Dietetic service personnel shall be trained in basic food sanitation techniques, shall be clean, wear clean clothing, including a cap and/or a hair net and shall be excluded from duty when affected by skin infection or communicable diseases. Beards and mustaches which are not closely cropped and neatly trimmed shall be covered. (2) Employee's street clothing stored in the kitchen area shall be in a closed area. (3) Kitchen sinks shall not be used for handwashing. Separate handwashing facilities with soap, running water and individual towels shall be provided. (4) Persons other than dietetic personnel shall not be allowed in the kitchen area unless required to do so in the performance of their duties.

HSC §1265.4 Qualifications of Dietary Supervisor

(a) A licensed health facility, as defined in subdivision (a), (b), (c), (d), (f), or (k) of Section 1250, shall employ a full-time, part-time, or consulting dietitian. A health facility that employs a registered dietitian less than full time, shall also employ a full-time dietetic services supervisor who meets the requirements of subdivision (b) To supervise dietetic service operations. The dietetic services supervisor shall receive frequently scheduled consultation from a qualified dietitian.

(b) The dietetic services supervisor shall have completed at least one of the following educational requirements: (1) A baccalaureate degree with major studies in food and nutrition, dietetics, or food management and has one year of experience in the dietetic service of a licensed health facility. (2) A graduate of a dietetic technician training program approved by the American Dietetic Association, accredited by the Commission on Accreditation for Dietetics Education, or currently registered by the Commission on Dietetic Registration. (3) A graduate of a dietetic assistant training program approved by the American Dietetic Association. (4) Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility. (5) Is a graduate of a college degree program with major studies in food and nutrition, dietetics, food management, culinary arts, or hotel and restaurant management and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility. (6) A graduate of a state approved program that provides 90 or more hours of classroom instruction in dietetic service supervision, or 90 hours or more of combined classroom instruction and instructor led interactive Web-based instruction in dietetic service supervision. (7) Received training experience in food service supervision and management in the military equivalent in content to paragraph (2), (3), or (6).

§ 70277 Dietetic Service Equipment and Supplies.

(a) Equipment of the type and in the amount necessary for the proper preparation, serving and storing of food and for proper dishwashing shall be provided and maintained in good working order. (1) The dietetic service area shall be ventilated in a manner that will maintain comfortable working conditions, remove objectionable odors and fumes and prevent excessive condensation. (2) Equipment necessary for preparation and maintenance of menus, records and references shall be provided. (3) Fixed and mobile equipment in the dietetic service area shall be located to assure sanitary and safe operation and shall be of sufficient size to handle the needs of the hospital.

(b) Food Supplies.

(1) At least one week's supply of staple foods and at least two (2) days supply of perishable foods shall be maintained on the premises. Supplies shall be appropriate to meet the requirements of the menu.

(2) All food shall be of good quality and procured from sources approved or considered satisfactory by federal, state and local authorities. Food in unlabeled, rusty, leaking, broken containers or cans with side seam dents, rim dents or swells shall not be accepted or retained.

(3) Milk, milk products and products resembling milk shall be processed or manufactured in milk product plants meeting the requirements of Division 15 of the California Food and Agricultural Code.

(4) Milk may be served in individual containers, the cap or seal of which shall not be removed except in the presence of the patient. Milk may be served from a dispensing device which has been approved for such use. Milk served from an approved device shall be dispensed directly into the glass or other container from which the patient drinks.

(5) Catered foods and beverages from a source outside the hospital shall be prepared, packed, properly identified, stored and transported in compliance with these regulations and other applicable federal, state and local codes as determined by the Department.

(6) Foods held in refrigerated or other storage areas shall be appropriately covered. Food which was prepared and not served shall be stored appropriately, clearly labeled, and dated.

(7) Hermetically sealed foods or beverages served in the hospital shall have been processed in compliance with applicable federal, state, and local codes.

§70279 Dietetic Service Space

(a) Adequate space for the preparation and serving of food shall be provided. Equipment shall be placed so as to provide aisles of sufficient width to permit easy movement of personnel, mobile equipment and supplies.

(b) Well ventilated food storage areas of adequate size shall be provided.

(c) A minimum of .057 cubic meters (two cubic feet) of usable refrigerated space per bed shall be maintained for the storage of frozen and chilled foods.

(d) Adequate space shall be maintained to accommodate equipment, personnel and procedures necessary for proper cleaning and sanitizing of dishes and other utensils.

(e) Where employee dining space is provided, a minimum of 1.4 square meters (15 square feet) of floor area per person served, including serving area, shall be maintained.

(f) Office or other suitable space shall be provided for the dietitian or dietetic service supervisor for privacy in interviewing personnel, conducting other business related to dietetic service and for the preparation and maintenance of menus and other necessary reports and records.

Article 6 - Supplemental Services

§70403 Acute Respiratory Care Service General Requirements.

§ 70401 Acute Respiratory Care Service Definition Acute Respiratory Care Service means an intensive care unit in which there are specially trained nursing and supportive personnel and the necessary diagnostic, monitoring and therapeutic equipment to provide specialized medical and nursing care to patients with acute respiratory problems.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and accountability of the acute respiratory care service to the medical staff and administration shall be defined.

(c) The unit shall be used primarily for the care of patients with acute respiratory failure. The unit should contain at least four (4) beds and should treat 100 or more patients per year.

(d) Data relating to admissions, mortality and morbidity shall be kept and reviewed by an appropriate committee of the medical staff at least quarterly

(e) The hospital shall have the capability to perform blood gas analysis and electrolyte determinations at all times.

(f) The unit shall be located to prevent through traffic.

(g) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§70405 Acute Respiratory Care Service Staff.

(a) A physician shall have overall responsibility for the acute respiratory care service. When possible this physician shall be certified or eligible for certification in pulmonary disease by the American Board of Internal Medicine or eligible for certification by the American Board of Anesthesiology.

(b) A minimum of one other physician experienced in acute respiratory care shall be available to the unit.

(c) Consultants in the specialties of medicine and surgery shall be available to the unit.

(d) A registered nurse with at least six months of nursing experience in the care of acute respiratory care nursing shall be responsible for the nursing care and management of the unit.

(e) A registered nurse:patient ratio shall be 1:4 or fewer on all shifts.

(f) Sufficient other licensed nursing personnel who have experience in acute respiratory care nursing shall provide additional support in a total nurse:patient ratio of 1:2 or fewer on each shift.

(g) Sufficient respiratory care practitioners and/or respiratory care technicians shall provide support for resuscitation and maintenance of the mechanical ventilators in a ratio of 1:4 or fewer on each shift.

(h) A physical therapist and a social worker should be available on a regular basis.

§70407 Acute Respiratory Care Service Equipment and Supplies.
(a) Equipment and supplies shall include at least: (1) Vertically adjustable beds with immediately removable headboards with trendelenburg position capability. (2) Bed scales. (3) One pressure cycle respirator for each bed and one volume-cycle respirator for each four beds. (4) Endotracheal tubes and tracheostomy sets. (5) Patient lift. (6) Respiratory and cardiac monitoring for each bed. (7) Crash cart or equivalent. (8) Spirometry equipment. (9) Resuscitative equipment. (10) DC defibrillator. (11) Self-inflating bag and attached mask at each bed. (b) An acute respiratory care unit is classified as an electrically sensitive area and shall meet the requirements of Section 70853 of these regulations.

(b) An acute respiratory care unit is classified as an electrically sensitive area and shall meet the requirements of Section 70853 of these regulations.

§ 70409 Acute Respiratory Care Service Space.
(a) In addition to the construction requirements in Section T17-316, Title 24, California Administrative Code, the following shall be met:
§ 70413 Basic Emergency Medical Service, Physician on Duty, General Requirements.

§ 70411 Basic Emergency Medical Service, Physician on Duty, Definition. Basic emergency medical service, physician on duty, means the provision of emergency medical care in a specifically designated area of the hospital which is staffed and equipped at all times to provide prompt care for any patient presenting urgent medical problems.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staffwhere such is appropriate.

(b) The responsibility and the accountability of the emergency medical service to the medical staff and administration shall be defined.

(c) The emergency medical service shall be so located in the hospital as to have ready access to all necessary services.

(d) A communications system employing telephone, radiotelephone or similar means shall be in use to establish and maintain contact with the police department, rescue squads and other emergency services of the community.

(e) The emergency medical service shall have a defined emergency and mass casualty plan in concert with the parent hospital's capabilities and the capabilities of the community served.

(f) The hospital shall require continuing education of all emergency medical service personnel.

(g) Medical records shall be maintained on all patients presenting themselves for emergency medical care. These shall become part of the patient's hospital medical record. Past hospital records shall be available to the emergency medical service.

(h) An emergency room log shall be maintained and shall contain at least the following information related to the patient: name, date, time and means of arrival, age, sex, record number, nature of complaint, disposition and time of departure. The name of those dead on arrival shall be entered in the log.

(i) All medications furnished to patients through the emergency service shall be provided by a pharmacist or an individual lawfully authorized to prescribe. Such medications shall be properly labeled and all required records shall be maintained in accordance with state and federal laws.

(j) Each Basic Emergency Medical Service shall be identified to the public by an exterior sign, clearly visible from public thoroughfares. The wording of such signs shall state: BASIC EMERGENCY MEDICAL SERVICE, PHYSICIAN ON DUTY.

(k) Standardized emergency nursing procedures shall be developed by an appropriate committee of the medical staff.

(l) A list of referral services shall be available in the basic emergency service. This list shall include the name, address and telephone number of the following: (1) Police department. (2) Antivenin service. (3) Burn center. (4) Drug abuse center. (5) Poison control information center. (6) Suicide prevention center. (7) Director of the State Department of Health or his designee.(8) Local health department. (9) Clergy. (10) Emergency psychiatric service. (11) Chronic dialysis service. (12) Renal transplant center. (13) Intensive care newborn nursery. (14) Emergency maternity service. (15) Radiation accident management service. (16) Ambulance transport and rescue service. (17) County coroner or medical examiner.

(m) The hospital shall have the following service capabilities: (1) Intensive care service with adequate monitoring and therapeutic equipment. (2) Laboratory service with the capability of performing blood gas analysis and electrolyte determinations. (3) Radiological service shall be capable of providing the necessary support for the emergency service. (4) Surgical services shall be immediately available for life-threatening situations. (5) Postanesthesia recovery service. (6) The hospital shall have readily available the services of a blood bank containing common types of blood and blood derivatives. Blood storage facilities shall be in or adjacent to the emergency service.

(n) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70415 Basic Emergency Medical Service, Physician on Duty, Staff.

(a) A physician trained and experienced in emergency medical services, shall have overall responsibility for the service. He or his designee shall be responsible for: (1) Implementation of established policies and procedures. (2) Providing physician staffing for the emergency services 24 hours a day who are experienced in emergency care. (3) Development of a roster of specialty physicians available for consultation at all times.

(b) All physicians, dentists and podiatrists providing services in the emergency room shall be members of the organized medical staff.

(c) A registered nurse qualified by education/or training shall be responsible for the nursing care within the service.

(d) A registered nurse trained and experienced in emergency nursing care shall be on duty at all times.

(e) There shall be sufficient other licensed nurses and skilled personnel as required to support the services offered.

§ 70417 Basic Emergency Medical Service, Physician on Duty, Equipment and Supplies.

All equipment and supplies necessary for life support shall be available , including but not limited to, airway control and ventilation equipment, suction devices, cardiac monitor defibrillator , pacemaker capability, apparatus to establish central venous pressure monitoring, intravenous fluids and administration devices.

§ 70419 Basic Emergency Medical Service, Physician on Duty, Space.

(a) The following space provisions and designations shall be provided:

(1) Treatment room.

(2) Cast room.

(3) Nursing station.

(4) Medication room.

(5) Public toilets.

(6) Observation room.

(7) Staff support rooms including toilets, showers, and lounge.

(8) Waiting room.

(9) Reception area.

(b) Observation beds in the emergency medical service shall not be counted in the total licensed bed capacity of the hospital.

§ 70423 Burn Center General Requirements.

§ 70421 Burn Center Definition. Burn center means an intensive care unit in which there are specially trained physicians, nursing and supportive personnel and the necessary monitoring and therapeutic equipment needed to provide specialized medical and nursing care to burned patients.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the burn center service to the medical staff and administration shall be defined.

(c) The burn center shall be used solely for the care of patients with burns or similar and related conditions. The center shall contain at least four (4) beds and should treat fifty (50) or more patients per year.

(d) If clinical or laboratory research projects are conducted, they shall be reviewed annually by an appropriate research committee.

(e) Data relating to admission, morbidity and mortality shall be kept and reviewed by an appropriate committee of the medical staff at least quarterly.

(f) The hospital shall have the capability to perform necessary laboratory studies including blood gas analysis and electrolyte determinations twenty-four (24) hours a day.

(g) A photograph shall be taken of all burns upon admission and upon discharge of the patient.

(h) The center shall be located to prevent through traffic.

(i) Respiratory care service and rehabilitation service shall be available to and associated with the burn center.

(j) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70425 Burn Center Staff.

(a) A physician shall have responsibility for the burn service. This physician shall be certified or eligible for certification by the American Board of Surgery or American Board of Plastic Surgery and should be a member of the American Burn Association.

(b) At least two (2) surgeons, experienced in burn therapy and certified or eligible for certification by the American Board of Surgery or the American Board of Plastic Surgery shall be responsible for the supervision and performance of burn care.

(c) Continuous in-house physician coverage shall be provided.

(d) Consultants in the specialties of medicine and surgery shall be available to the center. These specialties shall include, but not be limited to: anesthesia, dermatology, pediatrics, psychiatry, orthopedics, otolaryngology, ophthalmology, nephrology, pulmonary medicine and pathology.

(e) A registered nurse with at least six months' nursing experience in the treatment of burn patients in a burn center, and with evidence of continuing education in burn care, shall be responsible for the nursing care and nursing management of the burn center.

(f) A registered nurse with at least three months' nursing experience in the treatment of burn patients in a burn center shall be on duty on each shift.

(g) Sufficient other nursing personnel shall be provided.

(h) Psychiatrists, physical therapists, occupational therapists and social workers shall be available on a regular basis to provide needed care and consultation.

§ 70427 Burn Center Equipment and Supplies. (a)Equipment and supplies available to the burn center shall include at least:

(1) Vertically adjustable beds.

(2) Circular rotating electric beds or equivalent.

(3) A suitable patient weighing device.

(4) Ventilators.

(5) Respiratory and cardiac monitoring equipment.

(6) Cardiopulmonary resuscitation cart.

§ 70429 Burn Center Space.

(a) The following spaces, services and equipment shall be provided:

(1) Nurses' station as defined in Title 24, California Administrative Code, Section T17-306.

(2) Utility rooms as defined in Title 24, California Administrative Code, Section T17-308.

(3) Storage space for clean linen.

(4) Storage space for soiled linen.

(5) Air conditioning system as required in Section T17-104.

(6) A piped air/oxygen system and a piped suction system providing outlets at each bed.

(7) Window area sufficient to provide patients with an awareness of the outdoors.

(8) Cubicle curtains or other means of assuring visual privacy for each patient.

(9) A treatment room.

(10) A fully equipped operating room within the hospital.

(11) Bathing facilities for patients.

(12) Storage space for equipment and supplies.

(13) Waiting area adjacent to the center.

(b) Beds located in the burn center shall be included in the total licensed bed capacity of the hospital.

§ 70433 Cardiovascular Surgery Service General Requirements.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate. These policies and procedures shall include provision for at least: (1) Definitions of qualifications of physicians for privileges to perform cardiovascular laboratory catheterization procedures and/or surgery. (2) Regular review of case management, both preoperatively and postoperatively. (3) Collection, processing and retrieval of data on all patients to include at least: diagnosis, procedure performed, pathophysiologic, angiographic, morbidity and mortality data. (4) Recommendations regarding equipment used, procedures performed and staffing patterns in the catheterization laboratory and cardiovascular surgery units.

(b) The responsibility and the accountability of the service to the medical staff and administration shall be defined.

(c) An adequate service base shall support the provision of these services. Recommended minimums are: (1) 260 cardiac catheterizations per year. (2) 150 cardiovascular procedures requiring extra corporeal bypass per year.

(d) The cardiovascular surgical service shall be available at all times for emergencies. (e) Supportive diagnostic services with trained personnel shall be available and include, where appropriate, electrocardiography, vectorcardiography, exercise stress testing, cardiac pacemaker station, echocardiography, phonocardiography and pulse tracings.

(f) An intensive care service with respiratory care capabilities shall be provided by the hospital.

(g) An animal laboratory is recommended as support for the cardiovascular surgery service.

(h) A cardiac rehabilitation program should be integrated with the cardiovascular surgery service for early identification of the patient who can profit thereby.

(i) All persons operating or supervising the operation of X-ray machines shall comply with the requirements of the Radiologic Technology Regulations, Subchapter 4.5, Chapter 5, Title 17, California Administrative Code.

(j) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration. Interview either the nursing director of the surgical service or the physician director. Ask for and review the list for physicianswho have been granted surgical privileges. Is the list current and kept on file and accessible to staff.

INFORMED CONSENT:

Hospitals must assure that the practitioner(s) responsible for the surgery obtain informed consent from patients in a manner consistent with the hospital’s policies governing the informed consent process. The primary purpose of the informed consent process for surgical services is to ensure that the patient, or the patient’s representative, is provided information necessary to enable him/her to evaluate a proposed surgery before agreeing to the surgery. Typically, this information would include potential short-and longer-term risks and benefits to the patient of the proposed intervention, including the likelihood of each, based on the available clinical evidence, as informed by the responsible practitioner’s professional judgment. Informed consent must be obtained, and the informed consent form must be placed in the patient’s medical record, prior to surgery, except in the case of emergency surgery.

§ 70435 Cardiovascular Surgery Service Staff.

(a) Cardiovascular catheterization laboratory.

(1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification in cardiology by either the American Board of Internal Medicine or the American Board of Pediatrics or have equivalent experience and training. He shall be responsible for:

(A) Implementing established policies and procedures.

(B) Supervision and training of all personnel, including in-service training and continuing education.

(C) Assuring proper safety, function, maintenance and calibration of all equipment.

(D) Maintaining a record of all angiographic procedures performed.

(2) A physician who is certified or eligible for certification by the American Board of Radiology with special training or experience in cardiovascular radiology shall be available to the cardiovascular surgery service staff.

(3) Two persons (registered nurses or cardiovascular technicians) shall assist during the performance of all cardiac catheterization procedures. These personnel shall be trained in the use of all instrumentsand equipment and shall be supervised by a physician.

(4) A biomedical engineer shall be available for consultation as required.

(5) An electronic technician shall be available where required.

(b) Cardiovascular operative service.

(1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery. He shall be responsible for:

(A) Implementing established policies and procedures.

(B) Training and supervising the nurses and technicians in special techniques.

(C) Training and supervising the clinical perfusionists.

(2) A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph

(b) (1) above.

(3) Anesthesia for cardiovascular procedures shall be administered by a physician who is certified or eligible for certification by the American Board of Anesthesiology.

(4) A physician who is certified or eligible for certification in cardiology by the American Board of Internal Medicine should be a member of the surgical team and should assist in monitoring the patient.

(5) Clinical perfusionists shall operate the extracorporeal equipment under the immediate supervision of the cardiovascular surgeon or cardiologist.

Is the cardiovascular surgeon board eligible or certified thoracic surgeon? The appropriately credentialed surgeon will be responsible for policy and procedure, training of nursing and technician staff, training and supervision of perfusionists.

§ 70437 Cardiovascular Surgery Service Equipment and Supplies.

(a) Cardiovascular catheterization laboratory equipment and supplies shall include but not be limited to: (1) X-ray machine (2) Image intensifier. (3) Pulse generator. (4) Camera. (5) Spot film device. (6) Videotape viewing equipment of fluoroscopic procedures. (7) Magnetic tape recording and playback equipment. (8) Motor driven cardiac table. (9) Cinefluorography and radiography equipment. (10) Monitoring and recording equipment. (11) Pressure transducers. (12) Equipment for determining cardiac output. (13) Equipment for exercising patients during procedures. (14) Equipment for determining oxygen saturation, hemoglobin, blood gas analysis and pH. (15) Appropriate cardiac catheters and accessory equipment. (16) Resuscitation equipment.

(b) Cardiovascular operating room equipment and supplies shall include but not be limited to: (1) Monitoring and recording equipment for: (A) Electrocardiograms. (B) Pressures. (C) Coronary blood flow. (D) Cardiac output. (E) Patient temperature. (2) Blood gas analyzer. (3) Heart-lung machine with oxygenator.(4) Device for rapid cooling and heating of the patient.(5) DC or defibrillator. (6)Magnetic tape recording equipment. (7)Suction outlets piped in air and oxygen and tanks of gas including mixtures of oxygen and carbon dioxide. (8) All other necessary equipment and supplies as required in an operation room.

§70438.1 Cardiac Catheterization Laboratory Service -General Requirements. The cardiac catheterization laboratory service may be approved in a general acute care hospital which does not provide cardiac surgery provided the following requirements are met:

§ 70438
Cardiac Catheterization Laboratory Service. Cardiac catheterization laboratory service shall be organized to perform laboratory procedures for obtaining physiologic, pathologic and angiographic data on patients with cardiovascular disease. Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Sections 1255 and 1255.5, Health and Safety Code.

(a) The hospital shall maintain a current written transfer agreement as specified in Section 1255 of the Health and Safety Code, which shall include all of the following: (1) Provisions for emergency and routine transfer of patients. (2) Provisions which specify that cardiac surgery staff and facilities shall be immediately available to the patient upon notification of an emergency. (3) Provisions which specify that the cardiac catheterization laboratory staff shall have responsibility for arranging transportation to the receiving hospitals.

(b) Only the following diagnostic procedures shall be performed in the catheterization laboratory: (1) Right heart catheterization and angiography. (2) Right and left heart catheterization and angiography. (3) Left heart catheterization and angiography. (4) Coronary angiography. (5) Electrophysiology studies. (6) Myocardial biopsy.

(c) The hospital shall comply with all of the requirements of Sections 70433(a), (b), (c)(1), (e), (i), (j), 70435a) and 70437(a).

Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Sections 1255 and 1255.5, Health and Safety Code.

§70438.2 Cardiac Catheterization Laboratory Service -Expanded. (a) As used in this article, the following definition applies: (1) “Expanded cardiac catheterization laboratory space” means a catheterization laboratory space, as provided for in Section 70439(a), that is located in a building connected to a general acute care hospital, as described in subdivision (b) below.

(b) General acute care hospitals that qualify, pursuant to Section 1255(d)(3) of the Health and Safety Code, to provide cardiac catheterization laboratory service in expanded cardiac catheterization laboratory space, may do so, provided that: (1) There exists an enclosed all-weather passageway that connects the general acute care hospital and the structure in which the expanded cardiac catheterization space is located.

Such a passageway shall: (A) be short enough to allow a patient that is undergoing a cardiac catheterization procedure in the expanded cardiac catheterization laboratory space and who needs emergent care to arrive in the appropriate definitive care option in the general acute care hospital within 10 minutes of the time the physician deems that the patient needs to be transported to the definitive care option within the general acute care hospital. The actual transport time of the patient to the definitive care option from the cardiac catheterization laboratory space shall not exceed 5 minutes.

(B) have lighting and emergency lighting and power in accordance with Sections 70851 and 70841, respectively;

(C) have installed heating, air conditioning and ventilating systems;

(D) be equipped with an emergency call feature at each end of the enclosed all-weather passageway. For the purposes of this subdivision, “emergency call feature” is defined as a telephonic connection, or any other means of communication, permanently located within the enclosed all-weather passageway, that allows the medical staff members to communicate with medical staff members in the general acute care hospital;

(E) have access that is restricted to authorized staff and to patients accompanied by authorizedstaff. Authorized staff shall be determined by the policies and procedures developed, maintained, and implemented by the general acute care hospital; and

(F) be secured by electronic means in accordance with the security policies and procedures developed, maintained, and implemented by the general acute care hospital. (2) Policies and procedures for expanded cardiac catheterization laboratory space care for both inpatients and outpatients shall be developed, maintained and implemented by the general acute care hospital. (A) Inpatient care policies and procedures for the expanded cardiac catheterization laboratory space shall include consideration of the acuity of the inpatient and the type of procedure needed by the patient. (3) Inpatients shall have priority for placement on the general acute care hospital's cardiac catheterization laboratory schedule. Inpatients in need of cardiac catheterization laboratory procedures shall not have such procedures performed in the expanded cardiac catheterization laboratory space, unless all of the general acute care hospital cardiac catheterization laboratory space is actively in use. (4) Pediatric cardiac catheterization, as defined in Health and Safety Code Section 1255.5(e), services shall not be performed in an expanded cardiac catheterization laboratory space, in accordance with Sections 1255.5(d) and (e) of the Health and Safety Code.

(c) Not more than 25 percent of the general acute care hospital's inpatients in need of cardiac catheterization laboratory service may have such procedures performed in the expanded cardiac catheterization laboratory space. The general acute care hospital shall maintain records that provide the number of cardiac catheterization procedures performed in the expanded cardiac catheterization laboratory space, and the patient's status as an inpatient or outpatient. (d) The hospital shall comply with all of the requirements of Sections 70433(a), (b), (c)(1), (e), (i), (j), 70435(a) and 70437(a). Note: Authority cited: Sections 1255, 131050, 131051 and 131200, Health and Safety Code. Reference: Section 1255, Health and Safety Code.

§70439 Cardiovascular Surgery Service Space.

(a) Catheterization laboratory space shall include: (1) A minimum floor area of 40 square meters (450 square feet) for the procedure room. (2) A minimum floor area of 9 square meters (100 square feet) for each of the following: (A) Control, monitoring and recording equipment. (B) X-ray power and controls. (C) Work room. (D) Dressing rooms for doctors and nurses.

(b) Cardiovascular surgery space shall include: (1) Operating rooms that comfortably accommodate 12 persons and all necessary equipment with a minimum floor area of 60 square meters (650 square feet). (2) Work room. (3) Pump work room. (4) Adequate storeroom

§ 70443 Chronic Dialysis Service General Requirements.

§ 70441 Chronic Dialysis Service Definition. Chronic dialysis service means a specialized unit of a hospital for the treatment of patients with end-stage renal disease who manifest the accumulation of excessive nitrogenous waste products. The scope of services includes hemodialysis per se and may include peritoneal dialysis or other means for removing toxic or excessive waste products from the blood. The service includes supervision of patients undergoing home dialysis.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and the administration. Policiesshall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is app

(b) The responsibility and the accountability of the chronic dialysis service to the medical staff and administration shall be defined.

(c) The hospital shall: (1) Have two or more dialysis stations. A minimum of five dialysis sessions per week should be performed at each station. (2) Work in cooperation with other facilities providing care for patients with end-stage renal disease. (3) Make chronic dialysis services available to patients with end-stage renal disease referred from other facilities which do not provide chronic dialysis serviced. (4) Participate in the development and use of a registry of prospective recipient patients. (5) Participate in kidney procurement, preservation and transport program. (6) Review all patients with end-state renal disease to determine the appropriateness of their treatment modality, including self-dialysis, home dialysis and renal transplantation and cooperate with other facilities for the timely transfer of medical data.

(d) The hospital shall provide directly: (1) Respiratory therapy. (2) Twenty-four hour laboratory capability of performing, as a minimum, the following determinations: C.B.C., B.U.N., creatinine, platelet count, blood typing and cross matching, blood gas analysis, blood pH, serum glucose, electrolytes, coagulation tests, spinal fluid examination and urinalysis. (3) Chronic dialysis on an outpatient basis. (4) Angiography.

(e) The hospital shall provide directly or by arrangement: (1) Immunofluorescence studies. (2) Electron microscopy. (3) Microbiological studies for rickettsiae, fungi, bacteria and viruses. (4) Tissue culture. (5) Outpatient services. (6) Self-dialysis training program. (7) Home-dialysis training program. (8) Transplantation evaluation of patients with end-stage renal disease. (9) Renal transplantation. (10) Nuclear medicine service.

(f) There shall be a separate designated area as needed for patients undergoing chronic dialysis who are known to be hepatitis B surface antigen positive.

(g) The particular requirements for patients on chronic dialysis shall be accommodated in the disaster and fire plans of the hospital.

(h) There shall be inservice training and continuing education for all medical, nursing and other personnel.

(i) There shall be a written hepatitis control program.

(j) Periodically, a committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration. Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Section 1276, Health and Safety Code.

§ 70445 Chronic Dialysis Service Staff.

(a) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Internal Medicine or the American Board of Pediatrics and shall have a minimum of one year's training or experience in the care of patients with end-stage renal disease.

(b) Surgeons performing the vascular access procedures shall be certified or eligible for certification by the American Board of Surgery and shall have a minimum of one year's training or experience in vascular surgery.

(c) Children being treated for end-stage renal disease shall be under the care of a physician who is certified or eligible for certification by the American Board of Pediatrics.

(d) Where appropriate, the hospital shall provide timely evaluation and consultation by the following specialists: (1) Physicians certified or eligible for certification in cardiology, endocrinology, infectious disease or hematology by the American Board of Internal Medicine. (2) A physician certified or eligible for certification in neurology by the American Board of Psychiatry and Neurology. (3) A physician certified or eligible for certification in psychiatry by the American Board of Psychiatry and Neurology. (4) A physician certified or eligible for certification in orthopaedic surgery by the American Board of Orthopaedic Surgery. (5) A physician certified or eligible for certification by the American Board of Pathology. (6) A physician certified or eligible for certification by the American Board of Urology.

(e) There shall be a registered nurse responsible for the nursing service who has had at least 12 months' general nursing experience or six months' experience in the care of patients with end-stage renal disease.

(f) There shall be sufficient other licensed nurses and skilled personnel to provide the required patient care.

(g) A dietitian shall provide diet management and counseling to meet the needs of patients with end-stage renal disease.

(h) A social worker shall provide social service and counseling to meet the needs of patients with end-stage renal disease.

§70447 Chronic Dialysis Service Equipment and Supplies.

(a) Equipment and supplies shall include at least: (1) A dialysis machine or equivalent (with appropriate monitoring equipment) for each bed or station. (2) Dialysis equipment appropriate for pediatric patients, if treated.

§ 70449 Chronic Dialysis Service Space.

(a) There shall be a minimum of 10 square meters (110 square feet) of floorspace per bed or station.

(b) The following areas shall be provided and maintained: (1) Patient waiting area. (2) Conference room. (3) Nurses' station. (4) Segregated area for home dialysis training, if provided. (5) Machine storage room. (6) Supplies storage room. (7) Utility room.

(c) Beds in the chronic dialysis service, unless used for stay of over 24 hours, shall not be included in the total licensed bed capacity of the hospital.

§ 70453 Comprehensive Emergency Medical Service General Requirements.

§ 70451 Comprehensive Emergency Medical Service Definition. Comprehensive Emergency medical service means the provision of diagnostic and therapeutic services for unforeseen physical and mental disorders which, if not promptly treated, would lead to marked suffering, disability or death. The scope of services is comprehensive with in -house capabilities for managing all medical situations on a definitive and continuing basis.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the emergency medical service to the medical staff and administration shall be defined.

(c) The emergency medical service shall be so located in the hospital as to have ready access to all necessary services.

(d) A communications system employing telephone, radiotelephone or similar means shall be in use to establish and maintain contact with the police department, rescue squads and other emergency services of the community.

(e) The emergency medical service shall have a defined emergency and mass casualty plan in concert with the hospital's capabilities and the capabilities of the community served.

(f) The hospital shall require continuing education of all emergency medical service personnel.

(g) Medical records shall be maintained on all patients presenting themselves for emergency medical care. These shall become part of the patient's hospital medical record. Past hospital records shall be available to the emergency medical service.

(h) An emergency room log shall be maintained and shall contain at least the following information relating to the patient: name, date, time and means of arrival, age, sex, record number, nature of complaint, disposition and time of departure. The name of those dead on arrival shall also be entered in the log.

(i) All medications furnished to patients through the emergency service shall be provided by a pharmacist or an individual lawfully authorized to prescribe. Such medications shall be properly labeled and all required records shall be maintained in accordance with state and federal laws.

(j) Each comprehensive emergency medical service shall be identified to the public by an exterior sign, clearly visible from public thoroughfares. The wording of such signs shall state: COMPREHENSIVE EMERGENCY MEDICAL SERVICE PHYSICIAN ON DUTY.

(k) Standardized emergency nursing procedures shall be developed by an appropriate committee of the medical staff.

(l) A list of referral services shall be available in the emergency center. This list shall include the name, address and telephone number of the following: (1) Police department. (2) Antivenin service. (3) Drug abuse center. (4) Poison control information center. (5) Suicide prevention center. (6) Director of State Department of Health or his designee. (7) Local health department.(8) Clergy. (9) County coroner or medical examiner.

(m) The hospital shall have the following additional services which shall be continuously staffed in a manner that permits the performance of all required functions: (1) Chronic dialysis service. (2) Burn center. (3) Respiratory care service. (4) Intensive care newborn nursery. (5) Coronary care service. (6) Intensive care service. (7) Pediatric service. (8) Psychiatric unit. (9) Cardiovascular surgery service. (10) Postanesthesia recovery unit.

(n) The radiological service shall have the capability of performing contrast studies including angiography in addition to its usual capabilities.

(o) The clinical laboratory shall be capable of performing blood gas analysis, pH, serum electrolytes and other procedures appropriate for emergency medical care.

(p) Surgical services shall be immediately available for life-threatening situations.

(q) The hospital shall have readily available the service of a blood bank containing common types of blood and blood derivatives. Blood storage facilities shall be in or adjacent to the emergency service.

(r) There shall be affiliation of the emergency medical service with a medical school.

(s) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70455 Comprehensive Emergency Medical Service Staff.

(a) A full-time physician trained and experienced in emergency medical service shall have overall responsibility for the service. The physician or her or his designee shall be responsible for: (1) Implementation of established policies and procedures. (2) Providing continuous staffing with physicians trained and experienced in emergency medical service. Such physicians shall be assigned to and be located in the emergency service area 24 hours a day. (3) Providing experienced physicians in specialty categories to be available in-house 24 hours a day. Such specialties include but are not limited to medicine, surgery, anesthesiology, orthopedics, neurosurgery, pediatrics and obstetrics-gynecology. (A) The most senior resident in any of the specialties may be considered an experienced physician. (4) Maintenance of a roster of specialty physicians immediately available for consultation and/or assistance. (5) Assurance of continuing education for all emergency service staff including physicians, nurses and other personnel.

(b) All physicians, dentists and podiatrists providing services in the emergency room shall be members of the organized medical staff.

(c) A registered nurse qualified by education and/or training shall be responsible for nursing care within the service.

(d) All registered nurses shall have training and experience in emergency lifesaving and life support procedures.

(e) A registered nurse trained and experienced in emergency nursing care shall be on duty at all times.

(f) There shall be sufficient licensed nurses and other skilled personnel on duty as required to support the services.

Note: Authority cited: Sections 1252, 1255(c), 1275, 1276.4 and 100275(a), Health and Safety Code. Reference: Section 1250(a), Health and Safety Code.

§ 70457 Comprehensive Emergency Medical Service Equipment and Supplies.

All equipment and supplies necessary for life support shall be available, including but not limited to: airway control and ventilation equipment, suction devices, cardiac monitor, defibrillators, pacemaker capability, apparatus to establish central nervous system monitoring and administration devices.

§ 70459 Comprehensive Emergency Medical Service Space.

(a) The following space provisions and designations shall be provided: (1) Treatment rooms. (2) Cast rooms. (3) Operating room fully equipped. (4) Intensive care in or adjoining the emergency medical service area. (5) Nursing station. (6) Medication room. (7) Clean and dirty utility room. (8) X-ray spaces. (9) Laboratory facilities. (10) Staff support rooms including toilets, showers, lounge and sleeping area. (11) Public toilets. (12) Observation room. (13) Police and press room. (14) Waiting room. (15) Reception area.

(b) Observation beds in the emergency medical service shall not be counted in the total licensed bed capacity of the hospital.

§ 70463 Coronary Care Service General Requirements.

§ 70461 Coronary Care Service Definition. Coronary care service means an intensive care unit in which there are specially trained nursing and supportive personnel with necessary diagnostic, monitoring and therapeutic equipment needed to provide specialized medical and nursing care to patients suspected of or having significant coronary artery disease, heart failure or dysrhythmia.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate. The policies and procedures shall include but not be limited to: (1) Admission, transfer and discharge policies. (2) Staffing requirements. (3) Routine procedures. (4) Emergency procedures.

(b) The responsibility and the accountability of the coronary care service to the medical staff and administration shall be defined.

(c) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Section 1276, Health and Safety Code.

§ 70465 Coronary Care Service Staff.

(a) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification in cardiovascular disease by the American Board of Internal Medicine. If such a cardiologist is not available, a physician certified or eligible for certification in internal medicine by the American Board of Internal Medicine, with training and experience in cardiovascular disease, may administer the service. In this circumstance, a cardiologist, qualified as above, shall provide consultation at such frequency as to assure high quality service. The physician in charge shall be responsible for: (1) Implementation of established policies and procedures.(2) Development of a system for assuring physician coverage. (3) Conducting education programs in coronary care for physicians. (4) Assuring there is a continuing education program for nursing personnel in coronary care. (5) Final decision regarding admissions to and discharges from unit.

(b) A registered nurse with training and experience in coronary care nursing shall be responsible for the nursing care and nursing management of the service.

(c) All licensed nurses shall have had training and experience in coronary care nursing.

(d) There shall not be less than two nursing personal physically present in the coronary unit when a patient is present. At least one of the personal shall be a registered nurse.

(e) The licensed nurse: patient ratio shall be 1:2 or fewer at all times. Licensed vocational nurses may constitute up to 50 percent of the licensed nurses.

§ 70467 Coronary Care Service Equipment and Supplies.

The equipment and supplies required in Section 70497 for intensive care units shall be provided.

§ 70469 Coronary Care Service Space.

The space requirements in Section 70499 for intensive care units shall be provided.

§ 70473 Dental Service General Requirements.

§ 70471 Dental Service Definition. Dental services means the provision of diagnostic, preventive or corrective procedures performed by dentists with appropriate staff, space, equipment and supplies.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the dental service to the medical staff and administration shall be defined.

(c) A physician member of the medical staff shall be responsible for the care of any medical problem arising during the hospitalization of dental patients.

(d) There shall be a well-defined plan for oral health care, based on patient need, the size of the hospital and the type of service provided.

(e) There shall be a well-organized plan for emergency dental care.

(f) There shall be a record of all dental services provided to the patient and this shall be made a part of the patient's medical record.

(g) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70475 Dental Service Staff.

(a) A dentist shall have overall responsibility for the dental service.

(b) The dental service shall be staffed by a sufficient number of dentist members of the medical staff along with auxiliary personnel to render proper dental care.

(c) If dental hygienists, dental assistants or dental laboratory technicians are employed, they shall work under the supervision of the director of the dental service.

§ 70477 Dental Service Equipment and Supplies

(a) There shall be sufficient equipment, instruments and supplies maintained to meet the needs of the services offered.

(b) There shall be equipment for sterilization of instruments and supplies.

(c) The following materials shall be available for immediate use wherever dental treatment is provided:(1) Oxygen. (2) appropriate drugs. (3) Resuscitation equipment.

(d) The hospital library shall contain an adequate selection of dental texts, periodicals and the “Index to Dental Literature.”

(e) Radiographic equipment shall meet the requirements of Chapter 5, Part 1, Title 17, California Administrative Code.

§ 70479 Dental Service Space.

(a) There shall be adequate space maintained for the dental service.

(b) There shall be facilities for dental radiography.

§ 70481Intensive Care Newborn Nursery Service Definition. An intensive care newborn nursery service means the provision of comprehensive and intensive care for all contingencies of the newborn infant. Infant transport services are an indispensable part of an intensive care newborn nursery service. Guidance to Surveyors: The NICU can be categorized into different levels depending on the level of care offered. Below are references from the American Academy of Pediatrics (AAP), GUIDELINES FOR PERINATAL CARE 7th Edition. The references are not the entire text and additional research may be required based on your observations of care. Additional information can be found under CALIFORNIA CHILDREN'S SERVICES -ICNN (Intensive Care Newborn Nursery) levels of care and are termed as Regional, Community and Intermediate. Level I (basic) AAP:  Provide neonatal resuscitation at every delivery, as needed Provide care for infants born at 35-37 weeks who are physiologically stable  Stabilize infants born <35 weeks or who are ill until transfer to a higher level of care facility Level II (Specialty Care) AAP:  Provide care for infants ≥32 weeks or ≥1500 grams who have physiological immaturity (e.g. apnea, inability to feed orally) or who are moderately ill with problems that are expected resolve rapidly and are not anticipated to need subspecialty services on an urgent basis.  Provide convalescent care after intensive care Level III (Subspecialty Care) AAP  Provide sustained life support and comprehensive care for infants <32 wk and <1500 g, and all critically ill infants  Prompt and readily available access to a full range of pediatric medical subspecialists, pediatric surgical specialists, pediatric anesthesiologists and pediatric ophthalmologists on site or at a closely related institution by pre-arranged consultative agreement  Capability to perform advanced imaging with interpretation on an urgent basis, including computed tomography, magnetic resonance imaging and echocardiography Level IV (Subspecialty Care) AAP  Located within an institution with the capability to provide surgical repair of complex congenital or acquired conditions.  Immediate on-site access to pediatric medical and surgical subspecialists, and pediatric anesthesiologists
§ 70483 Intensive Care Newborn Nursery Service General Requirements.

(a) An intensive care newborn nursery service shall provide: (1) Comprehensive care for all life-threatening or disability-producing situations.

(2) Consultation service to referring perinatal units.

(3) Infant transport services between perinatal units and the intensive care newborn nursery.

(4) A transport team consisting of at least a physician and registered nurse or respiratory care practitioner.

(5) Continuing education for staff of the intensive care newborn nursery as well as referring perinatal units.

(6) Review and evaluation of service programs of perinatal units.

(b) There shall be written policies and procedures developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Procedures shall be approved by the medical staff and administration where such is appropriate. Such policies and procedures shall include but not be limited to: (1) Relationships to other services in the hospital.

(2) Admission to the intensive care newborn nursery.

(3) Consultation to perinatal units.

(4) Infection control and relationship to the hospital infection committee.

(5) Transfer of infants to and from perinatal units.

(6) Provision for family-centered infant care by parent or surrogate.

(7) Prevention and treatment of neonatal hemorrhagic disease.

(8) Visiting privileges.

(9) Resuscitation of the newborn.

(10) Administering and monitoring of oxygen and respiratory therapy.

(11) Transfusion.

(12) PKU screening

(13) Rhesus (Rh) hemolytic disease identification, reporting and prevention.

(14) Management of hyperbilirubinemia.

(15) Discharge and continuity of care with referral to community supportive services.

(16) Pediatric-pathologic-radiologic conferences.

(17) Routine and special care of the infant.

(18) Handwashing technique.

(19)Individual Bassinet technique.

(20)Gavage feedings.

(21) Intravenous therapy.

(22) Formula preparation and storage.

(23) Respiratory care procedures.

(c) The responsibility and the accountability of the intensive care newborn nursery service to the medical staff and administration shall be defined.

(d) The hospital laboratory shall have the capability of performing blood gas analyses, pH and microtechniques.

(e) Infants with diarrhea of the newborn as defined in section 2564, Title 17, California Code of Regulations, or who have draining lesions shall be isolated.

(f) Infants suspected of having airborne infections shall be separated from other infants in the nursery.

(g) All infections shall be reported to the hospital infection control committee promptly.

(h) Social services shall be available.

(i) There shall be discharge planning and provisions for follow-up care.

(j) Oxygen shall be administered to newborn infants only on the written order of a physician. The order shall include the concentration (volume percent) or desired arterial partial pressure of oxygen and be reviewed, modified or discontinued after 24 hours.

(k) The intensive care newborn nursery is considered an electrically sensitive area and shall meet the requirements of section 70853 of these regulations.

(l) An air-conditioned transport vehicle shall be provided which has an intercommunication system between the driver and the transport team and radio communication between the transport team and the intensive care newborn nursery.

(m) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

Note: Authority cited: Sections 1275 and 13200, Health and Safety Code. Reference: Sections 1276, 131050, 131051 and 131052, Health and Safety Code.

§ 70485 Intensive Care Newborn Nursery Service Staff.

(a) A physician shall have overall responsibility for the service. The physician shall be certified or eligible for certification by the American Board of Pediatrics and have additional training and experience in neonatology. (1) The pediatrician shall be responsible for: (A) Providing in-hospital pediatric service. (B) Maintaining working relationships with referring perinatal units. (C) Providing for joint staff conferences and continuing education of respective medical specialties. (D) Providing transport team availability at all times. (2) A physician who is certified or eligible for certification by the American Board of Anesthesiology shall be available to the service. (3) A surgeon experienced in neonatal surgery and a pediatric cardiologist shall be available to the service.

(b) A registered nurse who has had training and experience in intensive care of the newborn shall be responsible for the nursing care in the intensive care newborn nursery.

(c) A registered nurse trained in intensive care of the newborn shall be on duty on each shift.

(d) A ratio of one registered nurse to two or fewer intensive care infants shall be maintained.

(e) There shall be evidence of continuing education and training programs for the nursing staff in intensive care newborn nursing.

(f) A registered nurse trained in intensive care of the newborn shall be available to serve on the transport team.

(g) A respiratory care practitioner trained in the respiratory care of the newborn shall be available to the service.

§ 70487 Intensive Care Newborn Nursery Service Equipment and Supplies. (a) The intensive care newborn nursery shall include at least the following:

(1) A separate bassinet or equivalent for each infant.

(2) Enclosed storage unit for clean supplies.

(3) Diaper receptacles with a cover, foot control and disposable liner.

(4) A hamper with a disposable liner for soiled linen.

(5) A wall thermometer and hygrometer.

(6) Accurate beam scales or the equivalent.

(7) Thermostatically controlled incubators or radiant heating devices to maintain proper ambient temperature.

(8) Two oxygen and one compressed air outlets per infant station with regulating devices andadministration equipment.

(9) Resuscitation equipment and supplies to include at least:

(A) Glass trap suction device with catheter or a device which serves this function.

(B) Pharyngeal airways, assorted sizes.

(C) Laryngoscope, including a blade for premature infants.

(D) Endotracheal catheters, assorted sizes with malleable stylets.

(E) Arterial catheters, assorted sizes.

(F) Ventilatory assistance bag and infant mask.

(G) Bulb syringe.

(H) Stethoscope.

(I) Syringes, needles and appropriate drugs.

(10) Suction equipment.

(11) DC defibrillator (within the hospital).

(12) Cardiac monitor.

(13) Blanket warmer.

(14) Blood gas analyzer (within the hospital).

(15) Umbilical blood vessel catheterization tray.

(16) Portable incubator with power pack to provide continuous temperature control and monitoring.

(17) Ventilatory equipment designed for the care of newborn infants.

(18) Ten or more electrical outlets for each infant bed equivalent. (19) One handwashing sink with controls not requiring direct contact of the hand for operation (wrist or elbow blade handle are not acceptable) for each four bassinets.

(b) Infant transport equipment shall include at least the following: (1) Infant transport incubator with self-contained power supply to maintain a neutral thermal environment.

(2) Oxygen supply with fail-safe monitor humidifier.

(3) Oxygen analyzer.

(4) Compressed air supply.

(5) Temperature monitoring equipment.

(6) Cardiopulmonary monitoring equipment.

(7) Suction device.

(8) Infusion pump.

(9) Resuscitation equipment and supplies.

(10) Intravenous fluids and supplies.

§ 70489 Intensive Care Newborn Nursery Service Space.

(a) Sufficient floor area shall be provided so that there is at least 7.2 square meters (80 square feet) per bassinet.

(b) A work room or control station shall be maintained which shall provide for handwashing, gowning and charting.

(c) There shall be 100 foot candles of light at each bassinet.

(d) A waiting room shall be maintained adjacent to the intensive care newborn nursery.

(e) A treatment area with temperature control.

(f) Bassinets in the intensive care newborn nursery shall be included in the total licensed bed capacity of the hospital.

§ 70493 Intensive Care Service General Requirements.

§ 70491 Intensive Care Service Definition. An intensive care service is a nursing unit in which there are specially trained nursing and supportive personnel and diagnostic, monitoring and therapeutic equipment necessary to provide specialized medical and nursing care to critically ill patients

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate. Policies and procedures shall include, but not be limited to: (1) Admission, discharge and transfer policies. (2) Staffing requirements. (3) Routine procedures. (4) Emergency procedures.

(b) The responsibility and the accountability of the intensive care service to the medical staff and administration shall be defined.

(c) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

(d) Intensive care units are classified as electrically sensitive areas and shall meet the requirements of section 70853 of these regulations.

§ 70495 Intensive Care Service Staff.

(a) A physician with training in critical care medicine shall have overall responsibility for the intensive care service. This physician or his designated alternate shall be responsible for: (1) Implementation of established policies and procedures.

(2) Development of a system for assuring physician coverage.

(3) Final decision regarding admissions to and discharges from the unit.

(4) Assuring there is continuing education for the medical staff and nursing personnel.

(b) A registered nurse with training and experience in intensive care nursing shall be responsible for the nursing care and nursing management of the intensive care unit when a patient is present.

(c) All licensed nurses shall have training and experience in intensive care nursing.

(d) There shall be not less than two nursing personnel physically present in the intensive care unit when a patient is present. At least one of the nursing personnel shall be a registered nurse.

(e) The nurse:patient ratio shall be 1:2 or fewer at all times. Licensed vocational nurses may constitute up to 50 percent of the licensed nurses.

(f) An inhalation therapist, physical therapist and other supportive service staff shall be available depending upon the requirements of the service.

§ 70497 Intensive Care Service Equipment and Supplies. (a) In addition to the construction requirements of Section T17-316, Title 24, California Administrative Code, the following requirements shall be met:

(1) Individual bed area lighting which is controlled by a dimmer in the patient care unit shall be provided. Special lights should be provided for patient examinations.

(2) Isolated power systems, if installed, shall be provided with a continuously operating line isolation monitor to warn of possible leakage or faulty current. The monitor shall contain a red signal lamp and audible warning signal activated when total current reaches a value of two (2) milliamperes. All other receptacles shall be located at least 2.4 meters (8 feet) away.

(3) A minimum of four (4) duplex or eight (8) single receptacles shall be provided at the head of each bed and served by at least two separate circuits used for no other purpose.

(b) General equipment shall include but not be limited to: (1) Electrocardiographic oscilloscopic monitor with writer at each bed. If a central nurses' station is equipped with a writer, a writer is not required at each bedside.

(2) DC defibrillator.

(3) Positive pressure breathing apparatus.

(4) Oxygen mask with accessory equipment.

(5) Transvenous cardiac pacemaker.

(6) Emergency cart containing drugs and emergency supplies.

(7) Sterile trays for parenteral therapy.

(8) Tracheostomy tray.

(9) Thoracentesis tray.

(10) Venesection tray.

(11) Irrigation equipment.

(12) Intravenous fluids and plasma expanders or plasma.

(13) Refrigerated storage for drugs and biologicals.

(14) Laryngoscope and cuffed endotracheal tubes.

(15) Equipment for blood gas analysis, immediately available.

(c) Other equipment that is to be provided at each bed unless otherwise indicated: (1) Devices for holding intravenous solutions.

(2) Wall clock with sweep second hand visible to each patient.

(3) Wall-mounted interval clock with sweep second hand which may be activated at time of cardiac arrest.

(4) A sphygmomanometer.

(5) Two oxygen outlets or a single outlet with a “Y” connection with sufficient oxygen delivery capability.

(6) One air outlet.

(7) Two piped suction inlets or a single inlet with a “Y” connection with sufficient suction capability.

(d) An intercommunication system shall be provided which includes the following: (1) A call outlet at each bed which communicates to the nurses' control desk.

(2) An intercommunication system connected to the nearest continuously staffed nurses' station, which will enable the nurse or physician to contact the nearby unit without leaving the intensive care unit.

(3) An alarm system or other method for summoning physicians or cardiac arrest teams.

§ 70499 Intensive Care Service Space. (a) In addition to the construction requirements in Section T17-316, Title 24, the following requirement shall be met:

(1) An intensive care unit shall consist of not less than four (4) nor more than twelve (12) patient beds, including at least one isolation room. Multiple, interconnected units may be approved by the Department.

(2) Beds in the intensive care unit shall be included in the total licensed bed capacity.

(3) Each patient bed area shall contain at least 11.9 square meters (132 square feet) with no dimension less than 3.3 meters (11 feet) and with 1.2 meters (4 feet) of clearance at each side and the foot of the bed and with a minimum 2.4 meters (8 feet) between beds.

(4) 1.2 meters (4 feet) shall be provided around the nurses' desk.

(5) All beds shall be placed in relation to the nurses' station or work area to obtain maximum observation of patients.

(6) A visitor's waiting area nearby to the unit shall be provided.

§ 70503 Intermediate Care Service General Requirements. (a) The regulations for Intermediate Care Facilities, Chapter 4, Division 5, Title 22, California Administrative Code, shall be met with the following exceptions:

§ 70501Intermediate Care Service Definition. Intermediate care service means the provision of inpatient care to patients who have need for skilled nursing supervision and supportive care but who do not require continuous skilled nursing care. Generally you will not see this in the hospital setting, but follow below if the unit is encountered.

(1) The administrator of the hospital does not need to possess a license as a nursing home administrator and his services may be shared between the hospital and the intermediate care service.

(2) The functions of the director of nurses may be shared between the hospital and the intermediate care service. The registered nurse requirement, referred to as the director of the nursing service in Section 73323 of the regulations for Intermediate Care Facilities, shall be met.

(b) There shall be written policies and procedures relating to the transfer of patients between the hospital and intermediate care service that are approved by the medical staff.

(c) The intermediate care services shall be provided in a distinct part.

§ 70507 Nuclear Medicine General Requirements.

§ 70505 Nuclear Medicine Service Definition. Nuclear medicine service means those measures using internal radionuclides for the diagnosis and treatment of patients, employing specially trained personnel and providing appropriate space, equipment and supplies.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the nuclear medicine service to the medical staff and administration shall be defined.

(c) The storage, use and disposal of radionuclides shall meet the safety standards of California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17, California Administrative Code.

(d) Nuclear medicine patients shall be subject to periodic follow-up on completion of their treatment in coordination with the referring physician.

(e) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make recommendations to the executive committee of the medical staff and administration.

§ 70509 Nuclear Medicine Service Staff.

(a) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the appropriate specialty board, as follows: the conjoint American Board of Nuclear Medicine or one of its parent boards: American Board of Radiology, American Board of Pathology or American Board of Internal Medicine.

(b) Where appropriate, technologists with training and experience in handling radionuclides in either of the three disciplines of radiology, nuclear medicine or pathology shall be employed in sufficient number to accomplish the mission of the service.

(c) A radiological physicist should be available to the nuclear medicine service.

§ 70511 Nuclear Medicine Equipment and Supplies.

Equipment and supplies shall be sufficient to meet the needs of the patients and the scope of services offered.

§ 70513 Nuclear Medicine Space.

The space required will be dependent upon services offered. Where radiotherapy is provided from a radionuclide source, construction requirements shall meet the standards of Subchapter 4, Chapter 5, Title 17, California Administrative Code and Part 6, Division T17, Part 6, Subchapter 4, Chapter 5, Title 24, California Administrative Code.

§ 70517 Occupational Therapy Service General Requirements.

§ 70515 Occupational Therapy Service Definition. (a) Occupational therapy services means those services provided to a patient by or under the supervision of an occupational therapist with appropriate staff, space, equipment and supplies. These services are used to restore the functional capacity of those individuals whose abilities to cope with tasks of daily living are threatened or impaired by developmental deficits, the aging process, physical illness or injury or psychosocial disabilities. Occupational therapy services include but are not limited to:
(1) Providing the physician with an initial evaluation of the patient's level of function by diagnostic and prognostic testing.
(2) Intervention in acute stages of illness or injury to minimize or prevent dysfunction.
(3) Use of professionally selected self-care skills, daily living tasks and tests and therapeutic exercises to improve function.
(4) Training in the performance of tasks modified to the patient's level of physical and emotional tolerance.
(5) Provision of preventive and corrective equipment to promote function and to prevent deformity.
(6) Reevaluating the patient as changes occur and modifying treatment goals consistent with these changes.
(7) Psychological conditioning of the patient to prepare him for reentry and integration into his community.
(8) Use of tests to determine patient's ability in areas of concentration, attention, thought organization, perception and problem solving.
(9) Prevocational evaluation through the use of specific tasks to determine the patient's potential for vocational performance.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the occupational therapy service to the medical staff and administration shall be defined.

(c) Occupational therapy shall be given only on the signed order of a person lawfully authorized to give such an order.

(d) Patients shall be evaluated by the occupational therapist and a treatment program shall be established to include the modalities, the frequency and duration of treatments. This program and any modifications shall be approved in writing by the referring physician.

(e) Signed notes shall be entered into the record each time occupational therapy service has been performed.

(f) Progress notes shall be written and signed at least weekly by the occupational therapist and summarized upon completion of the treatment program.

(g) Occupational therapy staff shall be involved in orientation and in-service training of hospital employees.

(h) There shall be staff representation at the multidisciplinary conferences in order to plan and review patient treatment.

(i) Procedures shall be established for outpatient treatment, home visits and referrals to appropriate community agencies. (j) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70519 Occupational Therapy Service Staff.

(a) An occupational therapist shall have overall responsibility for the service.

(b) The occupational therapy director shall be responsible for the coordination of activity therapies which may include but not be limited to recreation, dance, art, music, poetry and drama.

(c) There shall be sufficient staff to meet the needs of the patients and scope of the services offered. The staff shall consist of occupational therapist(s) and may additionally consist of occupational therapy assistants, occupational therapy aides and other supportive personnel.

(d) The occupational therapist shall supervise treatment rendered by aides and occupational therapy assistants. When occupational therapy aides are providing treatment, an occupational therapist shall provide direct supervision of the treatment rendered.

§ 70521 Occupational Therapy Service Equipment and Supplies.

(a) There shall be sufficient equipment and supplies appropriate to the needs of the services offered. In addition there shall be:

(1) A telephone.

(2) A handwashing sink in the treatment area.

(3) Equipment made accessible to patients in wheelchairs, on crutches, or when using other adaptive equipment.

This shall include but not be limited to: (A) Adequate width of door openings.

(B) Toilets with grab bars on both sides of the commode.

(C) Over-sink mirrors.

(D) Drinking fountains.

(E) Adjustable tables.

§ 70523 Occupational Therapy Service Space.

(a) Adequate space shall be maintained for the equipment and supplies necessary to provide occupational therapy service. The minimum floor area for occupational therapy service shall be 28 square meters (300 square feet), no dimension of which shall be less than 4 meters (12 feet).

(b)Office space, separate from the treatment area, shall be provided.

(c) There shall be adequate ventilation and lighting, and sufficient power outlets, both 110 V and 220 V, for equipment.

(d) Floor finishes shall be of a nonslip variety to minimize hazard.

(e) Architectural barriers, as defined by the American National Standards, A117.1, 1961 (reaffirmed 1971), including thresholds and stairways shall be provided with alternate means of access such as ramps.

(f) Suitable waiting space shall be provided.

§ 70527 Outpatient Service General Requirements.

§ 70525 Outpatient Service Definition. Outpatient service means the rendering of nonemergency health care services to patients who remain in the hospital less than 24 hours with the appropriate staff, space, equipment and supplies.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the outpatient service to the medical staff and administration shall be defined.

(c) If outpatient surgery is performed, the written policies and procedures shall make provision for at least the following:
(1) The types of operative procedures that may be performed.
(2) Types of anesthesia that may be used.
(3) Preoperative evaluation of the patient, meeting the same standards as apply to inpatient surgery.
(4) Informed operative consent.
(5) The delivery of all anatomical parts, tissues and foreign objects removed to a pathologist designated by the hospital and a report of findings to be filed in the patient's medical record.
(6) Written preoperative instructions to patients covering:
(A) Applicable restrictions upon food and drugs before surgery.
(B) Any special preparations to be made by the patient.
(C) Any postoperative requirements.
(D) An understanding that admission to the hospital may be required in the event of an unforeseen circumstance.
(7) Examination of each patient by a licensed practitioner whose scope of licensure permits prior to discharge.

(d) A medical record shall be maintained for each patient receiving care in the outpatient service. The completed medical record shall include the following, if applicable:
(1) Identification sheet to include but not be limited to the following patient information:
(A) Name.
(B) Address.
(C) Identification number (if applicable).
1. Hospital number. 2. Social Security. 3. Medicare. 4. Medi-Cal.
(D) Age.
(E) Sex.
(F) Marital status.
(G) Religious preference.
(H) Date and time of arrival.
(I) Date and time of departure.
(J) Name, address and telephone number of person or agency responsible for the patient.
(K) Initial diagnostic impression.
(L) Discharge or final diagnosis.
(2) Medical history including:
(A) Immunization record.
(B) Screening tests.
(C) Allergy record.
(D) Nutritional evaluation.
(E) Neonatal history for pediatric patients.
(3) Physical examination report.
(4) Consultation reports.
(5) Clinical notes including dates and time of visits.
(6) Treatment and instructions, including:
(A) Notations of prescriptions written.
(B) Diet instructions, if applicable.
(C) Self-care instructions.
(7) Reports of all laboratory tests performed.
(8) Reports of all X-ray examinations performed.
(9) Written record of preoperative and postoperative instructions.
(10) Operative report on outpatient surgery including preoperative and postoperative diagnosis, description of findings, techniques used and tissue removed or altered, if appropriate.
(11) Anesthesia record including preoperative diagnosis, if anesthesia is administered.
(12) Pathology report, if tissue or body fluid was removed.
(13) Clinical data from other providers.
(14) Referral information from other agencies.
(15) All consent forms.

(e) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Section 1275, Health and Safety Code; and Section 2725, Business and Professions Code.

§ 70529 Outpatient Service Staff.

(a) The outpatient service shall have a person designated to direct and coordinate the service.

(b) All physicians, dentists and podiatrists providing services in the outpatient unit shall be members of the organized medical staff. All other health care professionals providing services in outpatient settings shall meet the same qualifications as those professionals providing services in inpatient services.

(c) A registered nurse shall be responsible for the nursing service in the outpatient service.

(d) There shall be sufficient nursing and other personnel to provide the scope of services offered.

Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Section 1276, Health and Safety Code.

§ 70531 Outpatient Service Equipment and Supplies.

There shall be sufficient and appropriate equipment and supplies related to the scope and nature of the anticipated needs and services.

§ 70533 Outpatient Service Space.

(a) The number of examination and treatment rooms shall be adequate in relation to the volume and nature of work performed.

(b) Waiting areas shall be readily accessible to patients and personnel. Rest rooms, drinking fountain and a public telephone shall be provided.

(c) Laboratory, radiology and pharmacy services shall be readily available to the outpatient service.

(d) If outpatient surgery is performed in the outpatient service area, the basic facilities shall include: (1) Appropriately equipped and staffed operating room and postanesthesia recovery area.

(2) Appropriate means of control against the hazards of infection, electrical or mechanical failure, fire and explosion.

(3) Provision for sterilizing equipment and supplies and for maintaining sterile technique.

(4) Appropriate equipment and instrumentation for anesthesia, emergency cardiopulmonary resuscitation and other life support systems.

(5) The operating room shall be so located that it does not directly connect with a corridor used for general through traffic. Entry and exit shall be controlled with respect to personnel, patients and materials handling.

(6) Construction of the operating room shall be in conformity with provisions of Division T17, Title 24, California Administrative Code.

(e) If beds are provided in the outpatient unit, they shall not be included in the licensed bed capacity.

(1) Inpatients shall not be allowed to occupy an outpatient bed.

(2) Outpatients shall not be allowed to remain over 24 hours in outpatient beds.

§ 70537 Pediatric Service General Requirements.

§ 70535 Pediatric Service Definition. Pediatric service means the observation, diagnosis and treatment (including preventive treatment) of children and their illnesses, injuries, diseases and disorders by appropriate staff, space, equipment and supplies.

(a) There shall be written policies and procedures developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. These policies and procedures shall be based upon the standards and recommendations of the American Academy of Pediatrics (Care of Children in Hospitals, 1971). Policies shall be approved by the governing body. Procedures shall be approved by the medical staff and administration where such is appropriate.

These policies and procedures shall include but not be limited to:
(1) Admission policies.
(2) Visiting privileges and parent participation.
(3) Accidents.
(4) Patient emergencies.
(5) Reporting of child abuse or neglect.
(6) Consultation requirements.
(7) Infection control and isolation procedures.
(8) Drug reactions and interactions.

(b) The responsibility and the accountability of the pediatric service to the medical staff and administration shall be defined.

(c) A pediatric nursing unit shall be provided if the hospital has eight or more licensed pediatric beds.

(d) Patients beyond the age of 13 shall not be admitted to or cared for in spaces approved for pediatric beds unless approved by the pediatrician in unusual circumstances and the reason documented in the patient's medical record.

(e) An activity program appropriate to the needs of the patients and the scope of the service shall be provided. Participation in such program shall be with the approval of the attending physician. The activity program shall be under the direction of a designated member of the hospital staff.

(f) The hospital shall inform the parent or guardian as soon as possible of any accident affecting the child.

(g) Periodically, an appropriate committee of the medial staff shall evaluate the services provide and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70539 Pediatric Service Staff.

(a) A physician shall have overall responsibility for the pediatric service. This physician shall be certified or eligible for certification by the American Board of Pediatrics. If such a pediatrician is not available, a physician with training and experience in pediatrics may administer the service. In this circumstance, a pediatrician, qualified as above, shall provide consultation at a frequency which will assure high quality service.

(b) A registered nurse who has had training and experience in pediatric nursing shall be responsible for the nursing care and nursing management in the pediatric service.

(c) In addition to the above, there shall be a registered nurse present on each shift with responsibility for patient care.

(d) There shall be sufficient other staff to provide adequate care.

(e) There shall be evidence of continuing education and training for the nursing staff in pediatric nursing.

§ 70541 Pediatric Service Equipment and Supplies.

Sufficient equipment and supplies shall be provided to adequately care for pediatric patients. This shall include a full range of sizes and modifications suitable for use with infants and small children.

§ 70543 Pediatric Service Space.

(a) Beds in the pediatric unit, including bassinets, cribs and youth beds, shall be included in the total licensed bed capacity of the hospital.

(b) The rooms for pediatric patients shall be located to provide adequate observation by nursing and other personnel.

(c)The rooms for infants under the age of three years shall be separate from older children.

(d) A private room shall be available for any pediatric patient in need of physical separation as defined by the infection control committee.

(e) An examination and treatment room shall be located in or adjacent to the pediatric unit.

(f) A play area of sufficient size should be provided.

Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Section 1276, Health and Safety Code.

§ 70547 Perinatal Unit General Requirements.

§ 70545 Perinatal Unit Definition. A perinatal unit means a maternity and newborn service of the hospital for the provision of care during pregnancy, labor, delivery, postpartum and neonatal periods with appropriate staff, space, equipment and supplies.

(a) A perinatal unit shall provide: (1) Care for the patient during pregnancy, labor, delivery and the postpartum period. (2) Care for the normal infant and the infant with abnormalities which usually do not impair function or threaten life. (3) Care for mothers and infants needing emergency or immediate life support measures to sustain life up to 12 hours or to prevent major disability. (4) Formal arrangements for consultation and/or transfer of an infant to an intensive care newborn nursery, or a mother to a hospital with the necessary services, for problems beyond the capability of the perinatal unit.

(b) There shall be written policies and procedures developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. These policies and procedures shall reflect the standards and recommendations of the American College of Obstetricians and Gynecologists “Standard for Obstetric-Gynecologic Hospital Services,” 1969, and the American Academy of Pediatrics “Hospital Care of Newborn Infants,” 1971. Policies shall be approved by the governing body. Procedures shall be approved by the medical staff and administration where such is appropriate. Such policies and procedures shall include but not be limited to:
(1) Relationships to other services in the hospital.
(2) Admission policies, including infants delivered prior to admission and infants transferred from an intensive care newborn nursery.
(3) Arrangements for maternity patient overflow.
(4) Consultation from an intensive care newborn nursery.
(5) Infection control and relationship to the hospital infection committee.
(6) Transfer of mothers to appropriate care services and/or infants to and from an intensive care newborn nursery.
(7) Provision, where deemed necessary, for family centered perinatal care, including rooming-in and care of infants by parent or surrogate.
(8) Prevention and treatment of neonatal hemorrhagic disease.
(9) Care of the premature or low birth weight infant.
(10) Visiting privileges.
(11) Resuscitation of newborn.
(12) Administering and monitoring of oxygen and respiratory therapy.
(13) Transfusion.
(14) PKU screening.
(15) Rhesus (Rh) hemolytic disease identification, reporting and prevention.
(16) Management of hyperbilirubinemia.
(17) Induction of labor and administration of oxytocic drugs.
(18) Provision for parent education regarding childbirth, child care and family planning.
(19) Discharge and continuity of care with referral to community supportive services.
(20) Obstetric-pediatric-pathologic-radiologic conferences.
(21) Patient identification system.
(22) Care routines for the mother and infant.
(23) Handwashing technique.
(24) Individual bassinet technique.
(25) Credo treatment of eyes of newborn.
(26) Breast feeding.
(27) Gavage feedings.
(28) Formula preparation and storage.

(c) The responsibility and the accountability of the perinatal service to the medical staff and administration shall be defined.

(d) The hospital laboratory should have the capability of performing blood gas analyses, pH and microtechniques.

(e) The hospital shall have the capability for operative delivery including caesarean section at all times.

(f) The Infection Control Committee shall develop and implement policies for the management, including physical separation from other infants, of infants with diarrhea of the newborn or draining lesions.

(g) All infections shall be reported to the hospital infection control committee promptly.

(h) All persons in the delivery room shall wear clean gowns, caps and masks during a delivery.

(i) Oxygen shall be administered to newborn infants only on the written order of a physician. The order shall include the concentration (volume percent) or desired arterial partial pressure of oxygen and be reviewed, modified, or discontinued after 24-hours.

(j) All patients shall be attended by a physician or licensed nurse when under the effect of anesthesia or regional analgesia, when in active labor, during delivery or in the immediate postpartum period.

(k) Rooming-in should be permitted if requested by the family.

(l) Smoking shall be prohibited in delivery rooms and nurseries.

(m) The delivery room is considered an electrically sensitive area and shall meet the requirements of section 70853 of these regulations.

(n) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of medical staff and administration.

Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Section 1276, Health and Safety Code.

§ 70549 Perinatal Unit Staff.

(a) A physician shall have overall responsibility of the unit. This physician shall be certified or eligible for certification by the American Board of Obstetrics and Gynecologists or the American Board of Pediatrics. If a physician with one of the above qualifications is not available, a physician with training and experience in obstetrics and gynecology or pediatrics may administer the service. In this circumstance, a physician with the above qualifications shall provide consultation at a frequency which will assure high quality service. He shall be responsible for:
(1) Providing continuous obstetric, pediatric, anesthesia, laboratory and radiologic coverage.
(2) Maintaining working relationships with intensive care newborn nursery.
(3) Providing for joint staff conferences and continuing education of respective medical specialties.

(b) A physician who is certified or eligible for certification by the American Board of Pediatrics shall be responsible for the nursery.

(c) There shall be one registered nurse on duty on each shift assigned to the labor and delivery suite. In addition, there shall be sufficient trained personnel to assist the family, monitor and evaluate labor and assist with the delivery.

(d) There shall be one registered nurse on duty for each shift assigned to the antepartum and postpartum areas. In addition, there shall be sufficient trained personnel to assess and provide care, assist the family and provide family education.

(e) A registered nurse who has had training and experience in neonatal nursing shall be responsible for the nursing care in the nursery.
(1) A registered nurse trained in infant resuscitation shall be on duty on each shift.
(2) A ratio of one licensed nurse to eight or fewer infants shall be maintained for normal infants.

(f) There shall be evidence of continuing education and training programs for the nursing staff in perinatal nursing and infection control.

§ 70551 Perinatal Unit Equipment and Supplies.

(a) General equipment shall include at least the following:
(1) Amniocentesis tray.
(2) DC defibrillator immediately available.
(3) Blanket warmer.
(4) Solutions and supplies for intravenous fluids, blood, plasma and blood substitutes or fractions.

(b) A fetal heart rate monitor should be available.

(c) Labor rooms shall contain at least the following equipment:
(1) Oxygen and suction outlets.
(2) A labor bed with adjustable side rails.
(3) Foot stool.
(4) One or more comfortable chairs.
(5) Handwashing facilities.
(6) Toilet and handwashing facilities shall be in or immediately adjacent to labor room and shall be shared by no more than two patients.
(7) Adjustable examination light.
(8) Sphygmomanometer.
(9) Regular and fetal stethoscope.

(d) Delivery rooms shall have at least the following equipment:
(1) Adjustable delivery table.
(2) Surgical light.
(3) Equipment for inhalation anesthesia and regional analgesia.
(4) Clock with sweep second hand.
(5) An elapsed time clock.
(6) Emergency supplies such as packings, syringes, needles and drugs.
(7) Emergency call button.
(8) Provision for oxygen and suction for mother and infant.
(9) Thermostatically controlled incubator or radiant heating device.
(10) Sterile one percent silver nitrate and irrigating solutions for prophylactic Crede treatment of the eyes.
(11) Sterile clamps or ties for umbilical cord.
(12) Resuscitation equipment and supplies to include at least:
(A) Glass trap suction device with catheter.
(B) Pharyngeal airways, assorted sizes.
(C) Laryngoscope, including a blade for premature infants.
(D) Endotracheal catheters, assorted sizes with malleable stylets.
(E) Arterial catheters, assorted sizes.
(F) Ventilatory assistance bag and infant mask.
(G) Bulb syringe.
(H) Stethoscope.
(I) Syringes, needles and appropriate drugs.

(e) Nursery equipment shall include at least the following:
(1) A separate bassinet for each infant made of easily cleanable material such as metal or clear plastic.
(2) Enclosed storage unit for clean supplies for each infant.
(3) Diaper receptacles with a cover, foot control and disposable liner.
(4) A hamper with a disposable liner for soiled linen.
(5) A wall thermometer and hygrometer.
(6) Accurate beam scales or the equivalent.
(7) Thermostatically controlled incubators or radiant heating devices to maintain proper ambient temperature.
(8) Oxygen and compressed air supply, regulating devices and administration equipment.
(9) Resuscitation equipment as required in delivery rooms.
(10) Suction equipment.
(11) At least one duplex electrical outlet for every two bassinets.
(12) One handwashing sink with controls not requiring direct contact of the hands for operation (wrist or elbow blade handles are not acceptable) for each six bassinets.

§ 70553 Perinatal Unit Space.

(a) General: (1) A storage room for supplies and equipment used in labor and delivery areas shall be maintained. (2) Dressing room for staff personnel should be provided.

(b) Labor rooms: (1) At least one labor room, having a minimum of 9.3 square meters (100 square feet) of floor space shall be provided. (2) Labor room beds shall not be included in the licensed bed capacity of the hospital. (3) A labor room shall contain no more than two beds.

(c) Delivery rooms: (1) Delivery rooms shall be provided which are used for no other purpose. The operating room may serve as the delivery room in rural area hospitals having a licensed bed capacity of 25 or less. (2) Delivery rooms shall have a minimum floor area of 30 square meters (324 square feet) with no dimension less

(d) Nurseries: (1) Sufficient floor area shall be provided so that there is at least 2.3 square meters (25 square feet) per bassinet with at least 1 meter (3 feet) between bassinets. (2) A workroom or control station shall be maintained which shall provide for handwashing, gowning and charting. (3) There shall be 100 foot candles of light at each bassinet. (4) Bassinets in the normal newborn nursery are not included in the total licensed bed capacity of the hospital.

§ 70557 Physical Therapy Service General Requirements.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the physical therapy service to the medical staff and administration shall be defined.

(c) Physical therapy shall be given only on the signed order of a person lawfully authorized to give such an order.

(d) When physical therapy is ordered, the patient shall be evaluated by the physical therapist and a treatment program shall be established to include the modalities, frequency and duration of treatments. This program and any modifications shall be approved by the person who signed the order for service.

(e) Signed notes shall be entered into the record each time physical therapy service has been performed

(f) Progress notes shall be written and signed at least weekly by the physical therapist and summarized upon completion of the treatment program.

(g) Physical therapy service staff shall be involved in orientation and in-service training of hospital employees.

(h) There shall be written techniques for cleaning and culturing of hydrotherapy equipment.

(i) Procedures shall be established for outpatient treatment, home visits and referrals to appropriate community agencies.

(j) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70555
Physical Therapy Service Definition. (a) Physical therapy service means those services to a patient by or under the supervision of a physical therapist to achieve and maintain the highest functional level with appropriate staff, space, equipment and supplies. Physical therapy services include but are not limited to:
(1) Providing the physician with an initial written evaluation of the patient's rehabilitation potential.
(2) Applying muscle, nerve, joint and functional ability tests.
(3) Treating patients to relieve pain, develop or restore function.
(4) Assisting patients to achieve and maintain maximum performance using physical means such as exercise, massage, heat, sound, water, light, ice, and electricity.

§ 70559 Physical Therapy Service Staff.

(a) A physical therapist shall have overall responsibility for the physical therapy service.

(b) There shall be sufficient staff to meet the needs of the patients and scope of the services offered. The staff shall consist of physical therapists and may additionally consist of physical therapist assistants, physical therapy aides and other supportive personnel.

(c) The physical therapist shall supervise treatment rendered by aides and assistants. When physical therapy aides are providing treatment, a physical therapist shall provide direct supervision of the treatment rendered.

§ 70561 Physical Therapy Service Equipment and Supplies.

(a) There shall be sufficient equipment and supplies appropriate to the needs and the services offered. In addition there shall be:
(1) A telephone.
(2) A handwashing sink in the treatment area.
(3) Equipment accessible to patients in wheelchairs, on crutches, or when using other adaptive equipment. This shall include but not be limited to:
(A) Adequate width of door openings.
(B) Toilets with grab bars on both sides of the commode.
(C) Over sink mirrors.
(D) Drinking fountains.
(E) Adjustable tables.

§ 70563 Physical Therapy Service Space.

(a) Adequate space shall be maintained for the equipment and supplies necessary to provide physical therapy service. The minimum floor area for physical therapy service shall be 28 square meters (300 square feet), no dimension of which shall be less than 4 meters (12 feet).

(b) Office space, separate from the treatment area, shall be provided.

(c) Floor finishes shall be of a nonslip variety to minimize hazard.

(d) Architectural barriers as defined in Specifications for Making Buildings and Facilities Accessible and Usable by the Physically Handicapped, A-117.1 1961 (reaffirmed 1971) by the American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018, shall have alternate means of access such as ramps. (e) A suitable waiting area shall be provided.

§ 70567 Podiatric Service General Requirements.

§ 70565 Podiatric Service Definition. Podiatric service means the diagnosis and treatment of disorders of the foot by podiatrists with the appropriate staff, space, equipment and supplies.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the podiatric service to the medical staff and administration shall be defined.

(c) A physician member of the medical staff shall be responsible for the care of any medical problem arising during the hospitalization of podiatric patients.

(d) There shall be a record of all podiatric services provided for the patient and this shall be made a part of the patient's medical record.

(e) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70569 Podiatric Service Staff.

A podiatrist shall have overall responsibility for the service.

§ 70571 Podiatric Service Equipment and Supplies.

There shall be sufficient equipment, instruments, and supplies for the scope of services provided.

§ 70573 Podiatric Service Space.

There shall be adequate space maintained to meet the needs of the service.

§ 70577 Psychiatric Unit General Requirements.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the psychiatric service to the medical staff and administration shall be defined.

(c) The psychiatric unit shall be used for patients with he diagnosis of a mental disorder requiring hospital care. For purposes of these regulations “mental disorder” is defined as any psychiatric illness or disease, whether functional or of organic origin.

(d) Medical services. (1) Psychiatrists or clinical psychologists, acting within the scope of their licensure and subject to the rules of the facility, shall be responsible for the diagnostic formulation for their patients and the development and implementation of each patient's treatment plan. (2) Medical examinations shall be performed as often as indicated by the medical needs of the patient. Reports of all medical examinations shall be on file in the patient's medical record. (3) A psychiatrist shall be available at all times for psychiatric emergencies. (4) An appropriate committee of the medical services shall: (A) Identify and recommend to administration the equipment and supplies necessary for emergency medical problems. (B) Develop a plan for handling and/or referral of patients with emergency medical problems. (C) Determine the circumstances under which electroconvulsive therapy may be administered. (D) Develop guidelines for the administration of a drug when given in unusually high dosages or for purposes other than those for which the drug is customarily used.

(e) Psychological services shall be provided by clinical psychologists within the scope of their licensure and subject to the provisions of Section 1316.5 of the Health and Safety Code. Staff physicians shall assume responsibility for those aspects of patient care which may be provided only by physicians.

(f) Provision shall be made for the rendering of social services by social workers at the request of a patient's attending physician or psychologist.

(g) Therapeutic activity program. (1) Every unit shall provide and conduct organized programs of therapeutic activities in accordance with the interests, abilities and needs of the patients. (2) Individual evaluation and treatment plans which are correlated with the total therapeutic program shall be developed and recorded for each patient.

(h) Education. (1) No hospital shall accept children of school age who are educable or trainable and who are expected to be a patient in the unit for one month or longer unless an educational or training program can be made available for such children in accordance with their needs and conditions. (2) Educational programs provided in the facility shall follow those programs established by law, and shall be under the direction of teachers with California teaching credentials. (3) If children attend community schools, supervision to and from school shall be provided in accordance with the needs and conditions of the patients. (4) Transportation to and from school shall be provided where indicated.

(i) The medical records of all patients admitted to the unit shall contain a legal authorization for admission. Release of information or medical records concerning any patient shall be only authorized under the provisions contained in Article 7 (commencing with Section 5325; and Section 5328 in particular) Part 1,Division5 of the Welfare and Institutions Code.

(j) Restraint of patients. (1) Restraint shall be used only when alternative methods are not sufficient to protect the patient or others from injury. (2) Patients shall be placed in restraint only on the written order of the licensed healthcare practitioner acting within the scope of his or her professional licensure. This order shall include the reason for restraint and the type of restraint to be used. In a clear case of emergency, a patient may be placed in restraint at the discretion of a registered nurse and a verbal or written order obtained thereafter. If a verbal order is obtained it shall be recorded in the patient's medical record and be signed by the licensed healthcare practitioner on his or her next visit. (3) Patients in restraint by seclusion or mechanical means shall be observed at intervals not greater than 15 minutes. (4) Restraints shall be easily removable in the event of fire or other emergency. (5) Record of type of restraint including time of application and removal shall be in the patient's medical record.

(k) Patients' rights. (1) All patients shall have rights which include, but are not limited to, the following: (A) To wear his own clothes, to keep and use his own personal possessions including his toilet articles; and to keep and be allowed to spend a reasonable sum of his own money for canteen expenses and small purchases. (B) To have access to individual storage space for his private use. (C) To see visitors each day. (D) To have reasonable access to telephones, both to make and receive confidential calls. (E) To have ready access to letter writing materials, including stamps, and to mail and receive unopened correspondence. (F) To refuse shock treatment. (G) To refuse lobotomy. (H) To be informed of the provisions of law regarding complaints and of procedures for registering complaints confidentially, including but not limited to, the address and telephone number of the complaint receiving unit of the Department. (I) All other rights as provided by law or regulations. (2) The licensed health care practitioner acting within the scope of his or her professional licensure who has overall responsibility for the unit or his or her designee, may for good cause, deny a person any of the rights specified in (1) above, except those rights specified in subsections (F), (G) and (I) above and the rights under subsection (F) may be denied only under the conditions specified in Section 5326.4, Welfare and Institutions Code. The denial, and the reasons therefore, shall be entered in the patient's medical record. (3) These rights, written in English and Spanish, shall be prominently posted.

(l) Psychiatric unit staff shall be involved in orientation and in-service training of hospital employees.

(m) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

Note: Authority cited: Sections 1275, 100275 and 131200, Health and Safety Code. Reference: Sections 1255, 1276, 1316.5, 131050, 131051 and 131052, Health and Safety Code.

§ 70579 Psychiatric Unit Staff.

(a) If a psychiatrist is not the administrative director of the psychiatric unit, a psychiatrist who is certified or eligible for certification in psychiatry by the American Board of Psychiatry and Neurology, shall be responsible for the medical care and services of the unit, including all those acts of diagnosis, treatment, or prescribing or ordering of drugs which may only be performed by a licensed physician.

(b) A clinical psychologist shall be available on a full-time, part-time or consulting basis. The clinical psychologist shall function on such terms and conditions as the facility shall establish.

(c) A registered nurse with two years experience in psychiatric nursing shall be responsible for the nursing care and nursing management of the psychiatric unit.

(d) There shall be registered nurses with training and experience in psychiatric nursing on duty in the unit at all times.

(e) There shall be sufficient nursing staff, including registered nurses, licensed vocational nurses, psychiatric technicians and mental health workers to meet the needs of the patients.

(f) A qualified therapist should be employed to conduct the therapeutic activity program. Therapists that may be involved in the program include occupational, music, art, dance and recreation therapist.

(g) A social worker shall be employed on a full-time, regular part-time or consulting basis.

§ 70581 Psychiatric Unit Equipment and Supplies.

(a) Sufficient equipment and supplies shall be provided to meet the needs of the patients, including that necessary for the rehabilitative therapy program.

(b) Resuscitative and cardiac monitoring equipment shall be in or readily available to the unit.

§ 70583 Psychiatric Unit Space.

(a) A psychiatric unit shall meet the following space requirements: (1) Consultation room for interviewing patients. (2) Facilities for physical examination and a treatment room for medical procedures. (3) At least one observation room for acutely disturbed patients. This room shall have facilities for visual observation and be located near the nursing station and a bathroom. (4) Separate dining room. (5) Facilities for occupational therapy. (6) Indoor and outdoor facilities for therapeutic activities. (7) A separate nursing station for the psychiatric unit. No beds for patients on the unit shall be located more than 90 feet away from the nursing station. (8) Windows, modified to prevent patients from leaving the unit by way of a window. (9) There shall be a principal entrance to the unit which could be locked if necessary.

(b) A unit which treats children of school age over a substantial period of time (one month or more) shall have physical facilities for an educational program, such as a classroom and an office for the teacher.

(c) Beds in a psychiatric unit shall be counted in the total licensed bed capacity of the hospital.

§ 70587 Radiation Therapy Service General Requirements.

§ 70585 Radiation Therapy Service Definition. Radiation therapy service means the use of external ionizing radiation including X-rays and teletherapy and brachytherapy using sealed sources of radioactive material in the treatment of human illnesses with appropriate staff, space, equipment and supplies.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the radiation therapy service to the medical staff and administration shall be defined.

(c) Radiation therapy shall be given only under the direction of a radiation therapist.

(d) All cancer cases accepted for curative radiation shall have adequate histologic substantiation of diagnosis unless convincing alternative evidence for diagnosis is presented.

(e) Documentation of the initial evaluation, treatment plan, dosimetry, and clinical, technical and follow-up notes shall be maintained.

(f) Adequate communication shall be maintained with referring physicians.

(g) There should be periodic review of case management, complications and treatment results.

(h) There shall be a tumor board, a tumor registry, and/or cancer committee in which the radiation therapy staff shall participate.

(i) There shall be provided: (1) Continuing radiological physics support for radiation therapy in cancer management. (2) Calibration and operation of radiation therapy equipment according to California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17, California Administrative Code. (3) Appropriate radiation treatment localization, simulation and verification. (4) Isodose treatment planning with complex analyses generated in appropriate cases. (5) Treatment record quality control through independent review of records of patients undergoing treatment. The record shall be signed by the reviewer. (6) Radiation protection for patients and staff in accordance with requirements of California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17, California Administrative Code.

(j) Periodic follow-up of patients following completion of treatment shall be coordinated with the referring physician.

(k) The hospital shall have on file and open to inspection by the Department evidence of any and all affiliations currently in effect. These may include but are not limited to: (1) Joint directorship and/or physician collaboration and coordination among several institutions. (2) Interhospital collaboration for professional and administrative management.

(l) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70589 Radiation Therapy Service Staff.

(a) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification in therapeutic radiology by the American Board of Radiology or be certified or eligible for certification in radiology by the American Board of Radiology and have two (2) years of additional full-time experience in radiation therapy.

(b) In remote communities where the population and number of cancer cases are insufficient to require a full-time radiation therapist, a general radiologist may provide radiation treatment of limited scope for those patients whose transportation to larger centers would be undesirable. He shall have an established mechanism to provide the consultation, physics and treatment planning support and referral availability of a radiation therapist.

(c) Other personnel who shall be available full-time, part-time or on a consultative basis, depending upon the activity of the department are: (1) A radiological physicist who is either certified in radiological physics or in therapeutic radiological physics by the American Board of Radiology. (2) A dosimetrist (treatment plan technologist) who is a qualified and experienced radiation therapy technologist with a minimum of one year of additional clinical training in dosimetry under the direction of an experienced dosimetrist and a physicist. (3) A certified therapeutic radiological technologist. (4) Appropriate support personnel including licensed nurses, where patient load requires.

§ 70591 Radiation Therapy Service Equipment and Supplies.

(a) Equipment and supplies shall include: (1) Megavoltage (supervoltage) treatment unit capable of delivering x or gamma rays of effective energy 500 KeV or more and conforming to the requirements of California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17, California Administrative Code.

(2) Access to medium voltage or superficial treatment unit delivering 500 KeV or less, but otherwise having the same functional characteristics as the above megavoltage units and conforming to the requirements of California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17, California Administrative Code.

(3) Access to brachytherapy equipment which shall meet the requirements of California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17, California Administrative Code.

(4) Appropriate examination room equipment.

(5) Emergency trays and medications. (6) Access to radiation measurement and calibration equipment including a calibration constancy instrument and access to a secondary standard dose meter.

§ 70593 Radiation Therapy Service Space.

(a) Rooms accommodating radiation therapy machines shall be of adequate size to permit easy use of stretcher patients. Shielding of the rooms shall meet the requirements of California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17, California Administrative Code.

(b) Sufficient examination rooms of adequate size.

(c) Patient reception, waiting and dressing areas with conveniently located toilets shall be provided.

(d) Space sufficient for medical and physics staff functions shall be provided.

§ 70597 Rehabilitation Center General Requirements.

§ 70595 Rehabilitation Center Definition. Rehabilitation center means a functional unit for the provision of those rehabilitation services that restore an ill or injured person to the highest level of self-sufficiency or gainful employment of which he is capable in the shortest possible time, compatible with his physical, intellectual and emotional or psychological capabilities and in accord with planned goals and objectives.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate. These policies and procedures shall include but not be limited to:
(1) Goals and objectives.
(2) General eligibility and admission criteria.
(3) Geographic area to be served.
(4) Scope of services to be provided.
(5) Rehabilitation staff eligibility requirements.
(6) Relationships between the hospital and other health facilities in the community.
(7) Sources and forms used for referral of patients.

(b) The responsibility and the accountability of the rehabilitation service to the medical staff and administration shall be defined.

(c) As a minimum, physical therapy, occupational therapy and speech therapy shall be provide and the requirements for these individual services, as stated elsewhere in these regulations, shall be met.

(d) There shall be preadmission patient screening done by an appropriate individual who may be the director of the service or his designee. Such screening shall include but not be limited to:
(1) Medical review.
(2) Rehabilitative potential evaluation.
(3) Review of future placement resources.

(e) An outpatient service shall be part of the rehabilitation center. This service shall provide continuity of care to patients who have completed inpatient rehabilitation care and will provide comprehensive, integrated care for patients not requiring hospitalization. This service shall have available all of the resources of the rehabilitation center.
(1) A coordinated system of patient scheduling and appointments that serves to minimize waiting time shall be established.
(2) An outpatient medical record shall be maintained for each patient receiving care in the outpatient service. The completed medical record shall include the information required for treatment of all hospital outpatients (Section 70367).

(f) There shall be a written utilization review plan that outlines the:
(1) Organization and composition of the utilization review committee, which shall include at least two physicians who shall be responsible for the utilization review functions.
(2) Requirement that the committee shall meet at least once each month.
(3) Selection of cases, both inpatient and outpatient, for review on a scientifically selected basis.
(4) Summary of the number and types of cases reviewed and the findings on each.
(5) Actions to be taken by the rehabilitation center based on the findings and recommendations of the utilization review committee.

(g) Staff conferences shall be held regularly and include representation and participation by all disciplines involved in the program to assist in the organization and coordination of services offered.

(h) Patient case conferences shall be held regularly to determine need for modification of treatment plans.
(1) There shall be a case conference plan and written minutes of each case conference held.
(2) One member of the rehabilitation service team shall be designated as the patient service coordinator.

(i) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70599 Rehabilitation Center Staff.

(a) A physician experienced in rehabilitation medicine shall have overall responsibility for the service.

(b) A registered nurse with training and at least one year of experience in rehabilitation nursing shall be responsible for nursing care and nursing management of rehabilitation services.

(c) Sufficient registered nurses experienced in rehabilitation nursing shall be employed to meet the needs of the service.

(d) Other personnel experienced in rehabilitation shall be provided to meet the needs of the service and shall include but not be limited to the following:
(1) Full-time physical therapists.
(2) Full-time occupational therapists.
(3) Speech pathologists.
(4) The following personnel shall be available on a consultation or referral basis:
(A) Audiologist.
(B) Orthotist.
(C) Prosthetist.
(D) Vocational rehabilitation counselor.
(E) Recreational therapist.
(F) Psychiatrist.
(G) Psychologist.
(H) Registered nurse with public health nursing certificate.
(I) Learning disability specialist.
(J) Social worker.

§ 70601 Rehabilitation Center Equipment and Supplies.

(a) There shall be sufficient equipment and supplies to fulfill the needs of the services provided.

(b) The equipment shall be of a type, quantity and quality that will provide safe and effective patient care.

§ 70603 Rehabilitation Center Space.

(a)Rehabilitation beds shall be in a designated area of the hospital and shall be included in the licensed bed capacity of the hospital.

(b) The following structural features shall be provided in the rehabilitation service area:
(1) Flooring in rehabilitation areas, while selected for appearance, durability and ease of cleaning and maintenance, shall also be selected and maintained to minimize slipping hazards.
(2) Architectural barriers as defined in Specifications for Making Buildings and Facilities Accessible and Usable by the Physically Handicapped, A-117.1 1961 (reaffirmed 1971) by the American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018, shall have alternate means of access such as ramps.
(3) Sturdy handrails shall be provided on both sides of ramps and stairs in areas used by physically handicapped patients.
(4) Grab bars on both sides of toilets and supports shall be provided in patient bathrooms so that physically disabled patients may use toilet, handwashing and bathing facilities with minimal or no assistance.
(5) Doors and doorways.
(A) Doors to be used by ambulatory and wheelchair patients shall be at least 1.1 meters (three feet, eight inches) wide. Doors 0.9 meter (three feet) wide may be permitted at individual toilet rooms adjacent to patient bedrooms.
(B) Thresholds at doorways shall be flush with the floor.
(C) There should be at least two doors of entry and exit from group activity areas, i.e., craft and workshops. All such exit doors shall be equipped with panic bars.
(D) Doors shall not obstruct wheelchair patients' access to toilets and other patient areas.
(6) Bathing facilities.
(A) Bathtubs shall be of standard height. There shall be access on both sides and one end of bathtub to allow personnel to work on either side or end of tub.
(B) Shower stalls shall have minimum dimensions of at least 1.2 meters (four feet), be equipped with handrails and curtains and be designed for easy accessibility. The floor shall be sloped to provide drainage.
(7) There shall be at least one training toilet area in each patient unit with minimum dimensions of 1.5 meters (five feet) and 1.8 meters (six feet).
(8) Drinking fountains shall be located conveniently in nursing units, treatment areas and the lobby. Fountains shall be usable by wheelchair patients.
(9) Telephones shall be accessible to and usable by wheelchair patients.
(10) All rooms shall contain a minimum of 10 square meters (110 square feet) of usable floor space per bed with greater space provided for special needs such as circ-o-lectric beds.
(11) Beds of adjustable height, preferably electrically operated, adequate to the needs of the service shall be provided. Beds shall be adjustable to the heights of wheelchair seats for use in patient transfer.
(12) A mirror with overhead light, so arranged as to be easily usable by handicapped patients in wheelchairs, shall be provided in patient rooms.
(13) Dining and lounge or recreation area.
(A) Space for group dining shall be provided in a minimum amount of at least 2 square meters (20 square feet) per licensed bed for adults and/or children beyond the crib age.
(B) Space for group recreation or patients lounge shall be provided in the same space ratio as the dining area.
(C) Dining and recreation areas shall be equipped with appropriate height tables to accommodate patients in wheelchairs.
(14) Suitable space shall be provided for staff conferences, patient evaluation and progress reports.
(15) Classroom space.
(16) An examining room equipped with furnishings, equipment and supplies adjacent or readily accessible to the office of the physician in charge of the outpatient service.
(17) A waiting room area with coat or locker space, drinking fountain, telephone and men and women toilet facilities in or adjacent to the rehabilitation outpatient service area.
(18) Access to an outside area to be used in therapeutic procedures for patients.

§ 70607 Renal Transplant Center General Requirements.

§ 70605 Renal Transplant Center Definition. Renal transplant center means a specialized unit of a hospital for the treatment of patients with end-stage renal disease who manifest the accumulation of excessive nitrogenous waste products. The scope of services offered is comprehensive and includes acute dialysis, renal transplantation and may include peritoneal dialysis or other means for removing toxic or excessive waste products from the blood.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and the administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the renal transplant center to the medical staff and administration shall be defined.

(c) The hospital shall:
(1) Perform a sufficient number of transplants per annum to demonstrate a capability to perform with high quality. Fifteen (15) transplants should be performed per annum.
(2) Offer both living related donor and cadaver donor transplant services.
(3) Contribute to a coordinated system of care by arrangements with other facilities providing care for patients with end-stage renal disease.
(4) Make renal transplant services available to patients with end-stage renal disease referred from facilities that do not provide renal transplant services.
(5) Participate in the development and use of a registry of prospective recipient patients.
(6) Participate in kidney procurement, preservation and transport program.
(7) Cooperate with other facilities for the timely transfer of medical data on patients with end-stage renal disease.

(d) There shall be a written hepatitis control program incorporating the recommendations of Report 33, January 1971, of the Hepatitis Surveillance Program of the Center for Disease Control, Public Health Services, Atlanta, GA 30333.

(e) There shall be in-service training and continuing education for all medical, nursing and other personnel.

(f) The particular requirements for renal transplant and acute dialysis patients shall be accommodated in the disaster and fire plans of the hospital.

(g) The hospital shall provide directly:
(1) Inpatient acute dialysis.
(2) Respiratory therapy.
(3) Angiography.
(4) Nuclear medicine.
(5) Twenty-four hour laboratory capability of performing, as a minimum, the following determinations: C.B.C., B.U.N., creatinine, platelet count, blood typing and cross matching, blood gas analysis, blood pH, electrolytes, serum glucose, coagulation tests, spinal fluid examination, and urinalysis.
(6) Immunofluorescence studies.

(h) The hospital shall provide directly or by arrangement:
(1) Microbiological studies for rickettsiae, fungi, bacteria and viruses.
(2) Electron microscopy.
(3) Outpatient follow-up care of patients with renal transplants.
(4) Tissue culture.
(5) Tissue typing and immunologic testing.
(6) Cadaver kidney preservation.
(7) Chronic dialysis.

(i) Periodically, a committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

§ 70609 Renal Transplant Center Staff.

(a) A physician shall have overall responsibility for the center. This physician shall be certified or eligible for certification by the American Board of Surgery, American Board of Urology, American Board of Internal Medicine or American Board of Pediatrics and shall have a minimum of one year's training or experience in the care of patients with renal transplantation.

(b) The surgeons performing the transplantation procedures shall be certified or eligible for certification by the American Board of Surgery or American Board of Urology and shall have at least one year's training or experience in renal transplantation.

(c) Children (13 years of age or under) receiving transplant services shall be under the care of a physician who is certified or eligible for certification by the American Board of Pediatrics.

(d) Where appropriate, the hospital shall provide timely evaluation and consultation for its patients with renal transplants by the following specialists: (1) Physicians certified or eligible for certification in cardiology, endocrinology, hematology, or infectious disease by the American Board of Internal Medicine. (2) A physician certified or eligible for certification in neurology by the American Board of Psychiatry and Neurology. (3) A physician certified or eligible for certification in psychiatry by the American Board of Psychiatry and Neurology. (4) A physician certified or eligible for certification in orthopaedic surgery by the American Board of Orthopaedic Surgery. (5) A physician certified or eligible for certification by the American Board of Pathology. (6) A physician certified or eligible for certification by the American Board of Urology.

(e) There shall be a registered nurse responsible for the nursing service who has had at least 12 months' general nursing experience or six months' experience in the care of patients with renal transplants.

(f) There shall be sufficient other licensed nurses and skilled personnel to provide the required patient care.

(g) A dietician shall provide diet management and counseling to meet the needs of patients with renal transplants.

(h) A social worker shall provide the social services and counseling needs of patients with renal transplants.

§ 70611 Renal Transplant Center Equipment and Supplies.

(a) Equipment and supplies shall include at least the following if chronic dialysis is provided:
(1) A dialysis machine or equivalent (with appropriate monitoring equipment) for each bed or station.
(2) Dialysis equipment appropriate for pediatric patients, if treated.
(3) Cardiac monitoring equipment.
(4) Resuscitative equipment.

§ 70613 Renal Transplant Center Space.

(a) There shall be a minimum of 10 square meters (110 square feet) of floor space per bed. Beds in the renal transplant center shall be included in the total licensed bed capacity of the hospital.

(b) The following areas shall be provided and maintained if chronic dialysis is provided:
(1) Patient waiting area.
(2) Conference room.
(3) Nurses' station.
(4) Isolation room.
(5) Segregated area for home dialysis training.
(6) Machine storage room.
(7) Supplies storage room.
(8) Utility room.

§ 70617 Respiratory Care Service General Requirements.

§ 70615 Respiratory Care Service Definition.
(a) Respiratory care service means those diagnostic and therapeutic procedures for ventilatory support and associated services to patients with appropriate staff, space, equipment and supplies. These diagnostic and therapeutic procedures include but are not limited to:
(1) Measurement of pulmonary function testing and blood gas analyses.
(2) Procedures to reverse or prevent further physiological abnormalities.
(3) Treatment or prevention of airway problems of respiratory therapy origin.
(4) Positive pressure ventilatory therapy.
(5) Respiratory monitoring.
(6) Cardiopulmonary resuscitation.
(7) Physical therapy of the chest including bronchial drainage and percussion.
(8) Patient instruction.
(9) Care of the intubated and tracheostomy patient.
(10) Constant consideration of infection control.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(b) The responsibility and the accountability of the respiratory care service to the medical staff and administration shall be defined.

(c) There shall be clear delineation as to who may perform the various procedures, under what circumstances and under whose supervision, with the important undesirable side effects noted if an emergency arises.

(d) All services shall be provided on the order of a person lawfully authorized to give such an order and shall specify the type, frequency of treatment, the dose and type of medication, appropriate dilution ratios and which diagnostic procedures are requested.