Document Citation: 10 NYCRR 708.5

Header:
NEW YORK CODES, RULES AND REGULATIONS
TITLE 10. DEPARTMENT OF HEALTH
CHAPTER V. MEDICAL FACILITIES
SUBCHAPTER C. STATE HOSPITAL CODE
ARTICLE 1. GENERAL PROVISIONS
PART 708. APPROPRIATENESS REVIEW


Date:
08/31/2009

Document:

ยง 708.5 Specific review criteria

In the review of the following specific hospital and home care services, in order to arrive at a determination regarding the appropriateness thereof, the following criteria shall be applied:

(a) Reserved.

(b) Burn care services.

(1) All services.

(i) The standards of this Chapter shall be applicable to the extent that such standards relate to the service under review or to the physical location in which the service is being provided.

(ii) Every hospital has and follows a prescribed protocol for burn triage, emergency burn care, and referral. The protocol includes as a minimum:

(a) the Lund-Browder chart or a similar chart for estimating total body surface area;

(b) a provision that major burn injury is to be treated, to the extent possible, in a burn unit/center except for emergency care prior to referral to such unit/center; and

(c) a provision that moderate uncomplicated burn injury is to be treated, to the extent possible, in a burn program or burn unit/center.

(iii) The burn unit/center is responsible for training facility and other personnel within the service area on emergency treatment procedures, assessment of total body surface area affected, and the classification of burns and triage protocols.

(iv) A burn service is provided by a financially viable facility.

(v) Reviews of each patient with major burn injury or moderate uncomplicated burn injury are undertaken on a weekly basis by the burn care team.

(2) Burn unit/center.

(i) Each burn unit/center has a minimum of six beds.

(ii) Each burn unit/center treats a minimum of 50 patients with major burn injury to moderate uncomplicated burn injury per year.

(iii) The burn unit/center refers patients for whom there are no available beds to another burn unit/center which can provide the care needed.

(iv) The three-year average occupancy of a burn unit/center is at least 75 percent.

(v) There is no more than one burn unit/center bed for every 225,000 in population. As appropriate, the standard may be adjusted to reflect actual incidence in a health service area.

(vi) Each burn unit/center has available either through direct control or through a network of clearly identified relationships, a system of land and/or air transport which will bring severely burned victims, to the unit/center.

(vii) A burn unit/center has a designated director who is: a board-certified or board-eligible general or plastic surgeon with one additional year of specialized training in burn therapy or equivalent experience in burn patient care.

(viii) Staff for the burn unit/center includes:

(a) a head nurse of the facility who is a registered nurse, with two years intensive care unit or equivalent training and a minimum of six months burn experience;

(b) one nurse for every two intensive care patients at all times;

(c) one nurse for every three non-intensive care patients at all times;

(d) a designated field-trained and licensed and/or registered physical therapist and occupational therapist with a minimum of three months training or six months experience in burn treatment available as needed;

(e) a designated registered dietician available as needed;

(f) a designated medical social worker responsible for referral and follow-up care and individual and group counseling available as needed; and

(g) a psychologist and/or psychiatrist available as needed.

(ix) A burn unit/center has a designated area for providing specialized intensive care and an operating room easily accessible within the hospital.

(3) Burn program.

(i) A burn program treats a minimum of 75 patients with moderate uncomplicated burn injuries per year.

(ii) There is no more than one burn program for every 326,000 in population. As appropriate, the standard may be adjusted to reflect actual incidence and number of patients per program in a health service area.

(iii) The average length of stay per patient in a burn program is no more than 14 days.

(iv) Staff for a facility with a burn program includes:

(a) a board-certified or board-eligible general or plastic surgeon with experience in burn care (preferably a three-month period of burn training) who is responsible for a written plan of burn therapy, maintains and periodically reviews the burn program's admissions and transfer protocols for burn patients having major burn injury, moderate uncomplicated burn injury, or minor burn injury;

(b) a registered nurse with six months intensive care unit experience (preferably three months burn nursing experience) who is responsible for nursing care protocol for burn patients, coordination of care for in-patients requiring burn care, and training of nursing personnel involved in burn care;

(c) a licensed and/or registered occupational therapist or physical therapist with splinting experience available as needed;

(d) on staff or through formal arrangement, a medical social worker responsible for referral and follow-up and individual and group counseling available as needed;

(e) on staff or through formal arrangement, a registered dietician, available as needed; and

(f) on staff or through formal arrangement, a psychologist or psychiatrist, available as needed.

(v) A burn program has these support services:

(a) general surgery;

(b) internal medicine;

(c) pediatrics;

(d) respiratory services;

(e) infectious disease control; and

(f) anesthesiology.

(d) End stage renal disease services.

(1) All services.

(i) The standards of Chapter V of this Title shall be applicable to the extent that such standards relate to the service under review or to the physical location in which the service is being provided.

(ii) Any facility providing services to ESRD patients must comply with Federal regulations for ESRD services.

(iii) The ESRD service is provided by a financially viable facility.

(2) Dialysis services.

(i) Dialysis services are provided to patients at their convenience whenever feasible and arrangements are made to accommodate employed patients who wish to be dialyzed during nonworking hours, either through extended shifts or cooperative arrangements among facilities.

(ii) Medical care for emergencies on a 24-hour day, seven-day week basis is provided. There is posted at the nursing/monitoring station a roster with the names of the physicians on duty to be called for emergencies and instructions as to how they can be reached.

(iii) Ninety-five percent of the total population of each health region is within a one hour mean travel time, adjusted for permitting weather conditions, of a renal dialysis center/facility providing dialysis services.

(iv) Each renal dialysis center/facility (except those located in New York City) is working toward a goal of at least 15 percent of its patients on home dialysis. As appropriate, a center/facility having less than 15 percent of its total patient load on home dialysis submits its plan and protocols for increasing home dialysis and a statement as to why the minimum goal cannot be attained. In New York City each renal dialysis center/facility is working toward a goal of at least 11 percent of its patients on home dialysis. As appropriate, a center/facility having less than 11 percent of its total patient load on home dialysis submits its plan and protocols for increasing home dialysis and a statement as to why the minimum goal cannot be attained.

(v) Each facility providing dialysis services has a written protocol to screen candidates for transplantation, institutional dialysis, home dialysis, early identification of home dialysis patients, and the training of patients and family in home dialysis training. This protocol would require at a minimum that:

(a) the facility has a goal of increasing its current home dialysis patient load, including criteria for identifying appropriate candidates for home dialysis; and

(b) each patient has been informed of all treatment options and has signed an informed consent document to be placed in his/her medical records file acknowledging his/her choice of modalities.

(vi) Each facility providing dialysis services shall provide directly or by formal arrangements, home training and supervision.

(vii) All personnel of the facility participate in educational programs for initial orientation, continuing in-service training and procedures for infection control on a regular basis.

(viii) Each facility maintains and reviews for each patient a written long-term program and a written patient care plan. The care plan includes at a minimum an annual evaluation of the dialysis patient by a transplant surgeon, where available, nephrologist, nurse, social worker, nutritionist, and medical director of the home dialysis training program.

(ix) Each renal dialysis center/facility maintains complete medical records for all patients, including self dialysis patients within the self dialysis unit and home dialysis patients whose care is under the supervision of the facility.

(x) Each renal dialysis center/facility reports to the Kidney Disease Institute, as required, patient information, including up-to-date information on medical and socioeconomic status.

(xi) A home dialysis care plan provides for periodic monitoring of the patient's home adaption, including provisions for visits to the home by qualified personnel to the extent possible and a back-up for the patient's emergency needs.

(xii) The medical director of a renal dialysis center/facility:

(a) is board-eligible or board-certified in internal medicine or pediatrics by a professional board and has at least 12 months combined experience and/or training in the care of patients at ESRD facilities; or

(b) has during the five-year period prior to September 1, 1976, served for at least 12 months as director of a dialysis or transplantation program.

(xiii) The responsibilities of the physician-director shall include:

(a) selection of a suitable treatment modality;

(b) development of adequate training of facility personnel in dialysis procedures and techniques;

(c) monitoring of the patients and the dialysis process including periodic assessment of patient performance of dialysis tasks;

(d) development and implementation of a patient care policy and procedure manual; and

(e) provision of self dialysis or home dialysis patients with teaching materials for self dialysis or home dialysis training.

(xiv) A renal dialysis center/facility has on staff:

(a) a licensed registered nurse who:

(1) has at least 12 months of experience in clinical nursing and an additional six months of experience in nursing care of patients with permanent kidney failure or who are undergoing or have undergone kidney transplantation, including training in and experience with the dialysis process; or

(2) has at least 18 months of experience in nursing care of patients on maintenance dialysis or in nursing care of patients with kidney transplant, including training and experience with the dialysis process; and

(b) a nurse responsible for self care dialysis who has as part of her total ESRD experience at least three months of experience in training self-care patients.

(xv) A renal dialysis center/facility has available on staff or through formal arrangement:

(a) a certified social worker, whose services include social services to patients and their families directed at supporting and maximizing the social functioning and adjustment of patients. The social worker's responsibilities include:

(1) conducting psychosocial evaluations;

(2) participating in team review of patient progress;

(3) recommending changes in treatment based on the patient's current psychosocial needs;

(4) providing casework and group services; and

(5) identifying community social agencies and resources; and

(b) a dietitian who is eligible for registration by the American Dietetic Association and has one year of experience in clinical nutrition, or a bachelor of arts or advanced degree with major studies in food and nutrition or dietetics and one year experience in clinical nutrition. The dietitian's services include:

(1) evaluating nutritional needs of patients in consultation with attending physicians;

(2) recommending the nutritional and dietetic programs;

(3) developing therapeutic diets;

(4) counseling patients on the importance of diet; and

(5) monitoring the diets.

(xvi) A renal dialysis center performs a minimum of nine dialyses per station per week.

(xvii) A renal dialysis facility performs a minimum of 10.8 dialyses per station per week.

(3) Renal transplantation center. (i) A renal transplantation center performs at least 15 renal transplants annually.

(ii) Each renal transplant center participates in research of renal disease of related areas.

(iii) Each renal transplant center provides access to the full range of diagnostic and therapeutic services necessary to support its function including medical, surgical, radiological, and radio-isotopic services.

(iv) Each renal transplant center has access, either within the facility or through formal contract arrangement, to laboratory services, including tissue typing.

(v) The renal transplantation center participates in a patient registry program for patients who are awaiting cadaveric donor transplantation.

(vi) If a renal transplantation center utilizes the services of an organ procurement agency to obtain donor organs, it has a written agreement covering these services.

(vii) Transplantation shall be performed by physicians trained in the disciplines of general or vascular surgery and urology and who have at least 12 months training or experience in the performance of renal transplant and the care of patients with renal transplants.

(viii) Transplantation teams consist of:

(a) a surgeon or urologist trained in general and vascular surgery with documented experience in renal transplantation;

(b) an internist with subspecialty training in nephrology and hemodialysis and with documented experience in the management of renal transplant patients;

(c) a physician who is assigned the primary responsibility for post-operative management of patients and whose experience in management of such patients must be documented;

(d) consultants for immunology and infectious disease who must be associated with the transplantation center; and

(e) a pediatrician, when the renal transplant of a child is performed, who is trained in the subspecialty of pediatric nephrology and who has documented experience in the management of renal-transplant pediatric patients.

(e) Computed tomography services.

(1) The standards of Chapter V of this Title shall be applicable to the extent that such standards relate to the service under review or to the physical location in which the service is being provided.

(2) Each facility providing computed tomography services does not refuse treatment of a patient on the basis of the referring physician or his/her facility affiliation. All referrals from outside the provider facility will be reviewed by a board-eligible or board-certified radiologist at the provider facility prior to the scan being performed.

(3) Institutions will accommodate patients who require computed tomography diagnostic or treatment planning services outside normal working hours.

(4) Ninety-five percent of the total population of each health region is within 45 minutes mean travel time, adjusted for permitting weather conditions, of a facility providing computed tomography services.

(5) Each facility providing computed tomography services must accept referrals from other institutions. Facilities that are members of a computed tomography service consortium have a written plan which describes the shared service and the participation of each facility within the shared service plan. The written plan provides at a minimum, the following information:

(i) the identification of the host facility and satellite facilities in the shared service;

(ii) stated commitment of the provider facility to give priority to bona fide medical emergencies independent of referral source, and equal consideration to inpatients and outpatients independent of referral source;

(iii) the process used by the provider facility to determine instances of bona fide medical emergency;

(iv) the process used by a certified radiologist at the provider facility to determine, prior to the procedure being performed, the necessity and appropriateness of the procedure;

(v) the availability of the computed tomography services unit, on a 24-hour basis, seven day-a-week basis, for the diagnosis of emergency conditions;

(vi) clear delineation of the patient information which is to accompany a patient from a referral facility; and

(vii) assignment of nursing care responsibility for patients referred from other institutions.

(6) A facility offering computed tomography services has available, either directly or through formal arrangements, a full range of diagnostic services including, at a minimum, diagnostic and therapeutic radiology services, nuclear medicine and diagnostic ultrasound.

(7) A facility offering computed tomography services has available, either on staff or through formal arrangements, individuals for the treatment of neurological, thoracic, cardiac, abdominal, medical and radiological oncological, gynecological, neurosurgical and genitourinary conditions, as well as any other conditions diagnosed by computed tomography.

(8) A facility offering computed tomography services is responsible for guiding physicians and other staff at the host and referral facilities in order to encourage that physicians and other staff become familiar with the safe and appropriate use of the service.

(9) A computed tomography service is provided by a financially viable facility.

(10) On an individual basis, each C.T. scanner's utilization is at a minimum of 2,000 patient procedures or 3,400 head equivalent computed tomography (HECT) units per year at the end of the second year of operation.

(11) On a regional basis, C.T. scanner utilization is at a minimum average of 2,500 patient procedures or 4,250 head equivalent computed tomography (HECT) units per year.

(12) Based on the recognition that not all of the additional scanner time required for teaching can be obtained through expanded operation of equipment, a maximum variance of 25 percent from current utilization standards cited in this subdivision is established for teaching hospitals. In order to qualify for the variance, the teaching hospital must be able to:

(i) document its affiliation with a qualified medical school; and

(ii) document the existence of a diagnostic radiology program which averages a total of four residents per year for a period of at least three years.

(13) Variances from scanner utilization standards for research usage are recommended only for those units in teaching hospitals which can provide at a minimum:

(i) documentation of levels of past research;

(ii) copies of written protocols describing current research; and

(iii) proof that research funding from all sources exceeds $ 50,000 annually.

(14) The director of the service in which a C.T. scanner is located is a board-eligible or board-certified radiologist.

(15) The C.T. scanner is staffed by at least one full-time New York State licensed radiological technician per staff shift.

(16) A facility with a C.T. scanner has on staff, or through formal arrangements, a radiological physicist holding a degree in physics who is either certified or eligible for certification by the American Board of Radiology or the American Board of Health Physicists.

(f) (Repealed)

(g) Comprehensive inpatient physical medicine and rehabilitation. (1) The standards of Chapter V of this Title shall be applicable to the extent that such standards relate to the service under review or to the physical location in which the service is being provided.

(2) The following general standards address the distribution of services and issues related to all facilities which provide comprehensive inpatient physical medicine and rehabilitation:

(i) The beds shall be in a designated area which is organized, staffed, and equipped for the specific purpose of providing a comprehensive physical medicine and rehabilitation program.

(ii) A free-standing inpatient facility devoted exclusively to providing a comprehensive physical medicine and rehabilitation program shall contain a minimum of 30 beds. Comprehensive physical medicine and rehabilitation units within a general hospital shall contain a minimum of 15 beds.

(iii) The comprehensive inpatient program shall maintain a minimum occupancy rate of 75 percent.

(iv) The program shall be directed by a chief of physical medicine and rehabilitation who dedicates full-time to the facility's rehabilitation services. The chief of physical medicine and rehabilitation shall be a board-certified physiatrist, or a physician who by training and experience is knowledgeable in physical and rehabilitative medicine.

(v) The physician of record for a patient in the program must be a rehabilitation physician, a physician who is board-certified in physical medicine and rehabilitation or a physician who by training and experience is knowledgeable in physical medicine and rehabilitation.

(vi) Nursing care shall be under the direction of a registered professional nurse with certification in rehabilitation nursing, or its equivalent, and progressive leadership experience.

(vii) The program shall include the following services which are provided by full-time staff whose training and experience are consistent with New York State licensure/certification/registration requirements: rehabilitation nursing, physical therapy, occupational therapy and social work. Psychologists and speech-language therapists shall be available as needed.

(viii) Dependent upon the needs of those served, the program shall provide to make formal arrangements for the following services: vocational rehabilitation, education, orthotics, prosthetics, rehabilitation engineering, driver education, audiology, and therapeutic recreation.

(ix) The following support services shall be available: dietetics, diagnostic radiology, laboratory, dentistry, chaplaincy and pharmacy.

(x) Physician consultive services shall include, but not be limited to: general surgery, internal medicine, neurology, neurosurgery, ophthalmology, orthopedic surgery, otorhinolaryngology, pediatrics, physical medicine and rehabilitation, plastic surgery, psychiatry, pulmonary medicine, urology.

(xi) Services shall be offered through a coordinated inter-disciplinary team approach, which shall include a comprehensive evaluation upon admission followed by regularly scheduled conferences. These conferences shall result in a documented decision on feasible rehabilitation goals, identification of services needed to progress toward those goals, and evaluation of progress toward meeting established goals.

(xii) Each facility shall have written guidelines that identify procedures to follow for the following areas: intake and orientation, assessment and evaluation, program management, referral discharge, and follow-up.

(xiii) The program shall establish formalized relationships with other area hospitals which shall include provision for consultation, inservice education, and the sharing of common treatment protocols.

(xiv) All facilities shall have written transfer agreements in place for the transfer of patients who need medical or specialty care not available at the facility of admission. Transfer agreements shall be mutually agreed upon by both the transferring and receiving facility and shall be reviewed on an annual basis.

(xv) There shall be an organized outpatient physical medicine and rehabilitation program at the facility which shall provide a range of services equal in scope to that of the inpatient program.

(xvi) There shall be an organized program for follow-up care to maintain and/or improve health status following discharge.

(xvii) The service area for determining public need for comprehensive inpatient physical medicine and rehabilitation shall be the designated health systems agency regions.

(xviii) The maximum number of comprehensive inpatient physical medicine and rehabilitation beds in each health systems agency required to meet public need shall be determined by dividing the projected annual patient days for the service by 365, and dividing the result by .90 to allow for 90 percent occupancy. The projected comprehensive inpatient physical medicine rehabilitation patients days used in this calculation shall be determined as follows:

(a) The diagnostic categories used in computing the need for comprehensive inpatient physical medicine and rehabilitation shall be: brain dysfunction, traumatic brain dysfunction, orthopedic disorders, spinal cord dysfunction, traumatic spinal cord dysfunction, stroke, amputation of limb, congenital deformities, neurological conditions, and arthritis.

(b) The annual number of potential comprehensive inpatient physical medicine and rehabilitation candidates shall be determined by calculating the total number of annual general hospital discharges from categories considered, excluding the number of discharges in these categories with a length of stay less than two days, and multiplying the resulting figure by .25.

(c) The number of potential comprehensive inpatient physical medicine and rehabilitation candidates shall be multiplied by a 34-day rehabilitation length of stay to project the annual number of comprehensive inpatient physical medicine and rehabilitation patient days.

(3) The following general standards address the distribution of services and issues related to all facilities which provide a spinal cord injury program.

(i) The spinal cord injury program shall be an organized program within a comprehensive physical medicine and rehabilitation program or a distinct comprehensive physical medicine and rehabilitation program for the spinal cord injured.

(ii) The spinal cord injury program shall maintain a minimum of 10 beds and/or 30 new admissions per year.

(iii) The spinal cord injury program shall maintain a minimum occupancy rate of 75 percent.

(iv) The spinal cord injury program shall be a designated unit for spinal cord injured people with a designated staff to serve the spinal cord injured patients.

(v) The spinal cord injury program shall be directed by a physician with special interest and competence in the area of those with spinal cord injury.

(vi) The nurse supervisor shall be a registered professional nurse with certification in rehabilitation nursing, or its equivalent, and clinical experience in the care of spinal cord injury.

(vii) The following services shall be available seven days a week, 24 hours per day: rehabilitation nursing, trained personnel capable of providing intermittent catheterization, and respiratory therapy.

(viii) In addition to the services previously identified, there shall be a formally organized program for patient/family spinal cord injury education regarding: bladder management, bowel management, pulmonary care, skin care, instruction in medications, nutrition, access to follow-up medical care, care of equipment, and sexual counseling.

(ix) There shall be an organized outpatient physical medicine and rehabilitation program which shall offer a range of services equal in scope to those of the inpatient spinal cord injury program.

(x) There shall be an organized program of follow-up care to maintain and/or improve health status following discharge.

(4) The following standards shall apply to emergency services:

(i) A person presenting to the emergency service for emergency care shall be promptly seen by a physician (or a nurse practitioner or a physician's assistant operating under the direction of the emergency services physician director), or evaluated by a registered nurse and seen by a physician, nurse practitioner, or physician's assistant prior to discharge.

(ii) Every emergency service shall have written policies and procedures for initial assessment of patients presenting to the emergency service.

(iii) At least one physician, nurse practitioner, or registered physician assistant shall be on duty in the emergency service 24 hours a day, seven days a week. In addition, a licensed physician shall be available within 30 minutes when a registered physician assistant or nurse practitioner is on duty in the absence of a licensed physician.

(iv) The brain injury program shall be a designated unit with a designated staff to serve the brain injured.

(v) The brain injury program shall be directed by a physician with advanced training and experience in the care of the brain injured.

(vi) The nurse supervisor shall be a registered professional nurse with certification in rehabilitation nursing, or its equivalent, and clinical experience in the care of the brain injured.

(vii) The following diagnostic services shall be available: electrodiagnostic services, including EEG, EMG and evoked potentials, and CT scanner.

(viii) In addition to services previously identified, there shall be an integrated treatment program that addresses the following areas: medical and neurological issues, nutrition, sensorimotor capacity, cognitive, perceptual, and communicative capacity, affect and mood, activities of daily living, educational and/or vocational capacities, sexuality, family counseling and community reintegration.

(ix) There shall be an organized outpatient physical medicine and rehabilitation program which offers a range of services equal in scope to those in the inpatient brain injury program.

(x) There shall be an organized program of follow-up care to maintain and/or improve health status following discharge.

(h) Emergency department and emergency services.

(1) The standards of this Chapter shall be applicable to the extent that such standards relate to the service under review or to the physical location in which the service is being provided.

(2) A hospital with a minimum volume of 15,000 emergency visits a year must meet the requirements for an emergency department. Those hospitals providing emergency care with less than 15,000 emergency visits per year may meet the requirements of an emergency department if they elect to provide these services, but at a minimum must meet the requirements of an emergency service.

(3) The following standards apply to emergency departments:

(i) A person presenting oneself to the emergency department for emergency care shall be promptly seen and evaluated by a physician.

(ii) Every emergency department shall have written policies and procedures for initial assessment of patients in the emergency department.

(iii) At least one emergency physician shall be on duty in the emergency department 24 hours a day, seven days a week.

(iv) The emergency department staff physicians must be licensed to practice medicine in New York State; and:

(a) be board certified in emergency medicine; or

(b) have three years post graduate experience in emergency medicine, surgery, internal medicine, family practice or pediatrics in addition to current certification in advance cardiac life support (ACLS), and advanced trauma life support (ATLS) or equivalent training and experience.

(v) The emergency department shall have a designated physician director qualified as an emergency department staff physician.

(vi) Emergency physicians shall be assigned exclusively to the emergency department. The number of patients seen by the emergency department physician shall not, on an annual average, exceed 20 patients per eight-hour period.

(vii) All nurses in the emergency department shall be registered professional nurses with New York State licensure and current registration. The nurse must have at least one year of clinical experience, have successfully completed the emergency nursing orientation program and be able to demonstrate skills and knowledge necessary to perform basic life support measures. Within one year of assignment to the emergency department, all emergency department staff nurses must obtain current advanced cardiac life support (ACLS) certification or the equivalent.

(viii) There shall be a nurse manager in the emergency department who is a registered professional nurse with New York State licensure and current registration who possesses all of the qualifications required of a staff nurse and who becomes a certified emergency nurse, or its equivalent, within one year of appointment. The nurse manager shall have at least three years clinical experience, two of which are in emergency nursing, and shall be assigned exclusively to that department.

(ix) On annual average there shall be a nurse to patient ratio of 1:10 unscheduled visits per eight-hour period, with a minimum of two nurses assigned to the emergency department on each shift. If, on average, the volume of patients per eight-hour shift is over 25, there shall be a charge nurse in addition to the minimum of two nurses per shift. If, on average, the volume exceeds 50 patients per shift, there shall be an assessment nurse in addition to the charge nurse and regular shift nurses. Staffing for scheduled visits shall be in addition to the staffing required for unscheduled visits.

(x) There shall be at least one person on duty at all times to perform patient registration, reception and other clerical duties as required. The clerical staff shall be responsible to, and function under the direction of, the emergency department staff.

(xi) There shall be sufficient support personnel, exclusive of the professional staff, available at all times to perform messenger service, acquisition of supplies and equipment, delivery of lab specimens, obtaining records, patient transport, and other duties as required.

(xii) All personnel working in the emergency department must complete a hospital and department orientation program.

(xiii) An emergency department must have immediate access to laboratory services that are staffed and equipped 24 hours a day.

(xiv) X-ray capability, using both fixed and mobile equipment, must be immediately available in close proximity to the emergency department 24 hours a day.

(xv) The hospital's medical staff must have a schedule for every specialty represented on the hospital's medical staff, to provide back-up support to the emergency department in a timely manner, 24 hours a day, seven days a week. At a minimum, these specialties shall include general surgery, internal medicine, orthopedics, anesthesiology, radiology and pediatrics.

(xvi) Each emergency department must make provision for referral for needed follow-up care.

(xvii) The specific equipment and pharmacologic/therapeutic drugs and agents needed in the emergency department shall be determined jointly by the medical director and nurse manager by consulting recommendations such as the guidelines of the American College of Emergency Physicians. These requirements shall be reviewed every two years.

(xviii) Each emergency department shall have written protocols and agreements for the treatment, triage and transfer of patients who cannot receive definitive care at the receiving hospital. These shall include, but not be limited to, burn patients, spinal-cord injury patients, brain injury patients, cardiac patients, patients with behavioral problems, multiple injury patients, replantation patients, neonatal and pediatric patients, and patients in need of hemodialysis.

(xix) Each emergency department shall adopt and implement written policies and procedures for the following:

(a) provision for triage of patients and transfer to the most appropriate hospital;

(b) medical control and direction of prehospital emergency medical services;

(c) review of quality of patient care on a regular basis (at least quarterly) with prehospital providers, emergency department personnel, and physicians, in order to improve field operations and make recommendations for continuing education;

(d) clinical and continuing education in emergency medical services, for prehospital providers;

(e) provision of liaison and direction for the supply of medications, fluids, and other items utilized by ambulance organizations; and

(f) provision of patient utilization data for the State EMS Data System. Where there is an established regional emergency medical services system, the emergency department shall coordinate its performance of these functions with the other participants in the regional system.

(xx) The emergency department shall establish and implement written policies and procedures for:

(a) the provision of appropriate social services 24 hours a day;

(b) consultation with a poison control center; and

(c) the maintenance of sexual offense evidence as part of the hospital-wide provisions required by this Title.

(xxi) All cases of suspected child abuse or neglect shall be reported immediately to the New York State Central Register of Child Abuse and Maltreatment and with respect to such cases the hospital shall comply with article 6, title 6 of the Social Services Law.

(xxii) The emergency department personnel shall give information regarding community resources and the Domestic Violence Hotline telephone number to those persons who are suspected or confirmed victims of domestic violence.

(4) The following standards shall apply to emergency services:

(i) A person presenting to the emergency service for emergency care shall be promptly seen by a physician (or physician's assistant operating under the direction of the emergency services physician director), or evaluated by a registered nurse and seen by a physician or physician's assistant prior to discharge.

(ii) Every emergency service shall have written policies and procedures for initial assessment of patients presenting to the emergency service.

(iii) At least one physician, or a registered physician assistant shall be on duty in the emergency service 24 hours a day, seven days a week. In addition, a licensed physician shall be available within 20 minutes when a registered physician assistant is on duty.

(iv) Emergency service staff physicians must be licensed to practice medicine in New York State and have:

(a) board certification in emergency medicine or family practice; or

(b) two years post graduate experience in emergency medicine, surgery, internal medicine, family practice or pediatrics in addition to current certification in advanced cardiac life support (ACLS), and advanced trauma life support (ATLS) or equivalent training and experience.

The registered physician assistants must have current certification in advanced cardiac life support (ACLS) or the equivalent training and experience, as well as training in trauma management equivalent to ATLS.

(v) The emergency service shall have a designated physician director qualified as an emergency service staff physician.

(vi) All nursing staff in the emergency service shall be registered professional nurses with New York State licensure and current registration who possess current, comprehensive knowledge and skills in emergency health care. They must have at least one year of clinical experience, have successfully completed an emergency nursing orientation program and be able to demonstrate skills and knowledge necessary to perform basic life support measures. Within one year of assignment to the emergency service, all emergency service staff nurses must obtain current advanced cardiac life support (ACLS) certification or the equivalent.

(vii) There shall be a nurse manager in the emergency service who is a registered professional nurse with New York State licensure and current registration who possesses all the qualifications required of a staff nurse, who becomes a certified emergency nurse, or its equivalent, within one year of appointment, and who has at least three years clinical experience, two of which in emergency nursing.

(viii) On annual average, there shall be a nurse-to-patient ratio of 1:10 per eight-hour period, with a minimum of one nurse assigned to the emergency service and an additional nurse available on each shift. If, on average, the volume of patients per eight-hour shift is over 25, there shall be a charge nurse in addition to a minimum of two nurses per shift. If, on average, the volume exceeds 50 patients per shift, there shall be an assessment nurse counted separately in addition to the charge nurse and regular shift nurses.

(ix) There shall be sufficient support personnel to perform patient registration, reception, messenger service, acquisition of supplies, equipment, delivery of lab specimens, obtaining records, patient transport and other functions as required.

(x) All personnel working in the emergency service must complete a hospital orientation program.

(xi) Laboratory and X-ray capability must be available within 20 minutes, 24 hours a day.

(xii) The specific equipment and pharmacologic/therapeutic drugs and agents needed in the emergency service shall be determined jointly by the medical director and the nurse manager by consulting recommendations such as the guidelines of the American College of Emergency Physicians. These requirements shall be reviewed every two years.

(xiii) Each emergency service shall have written protocols and agreements for the treatment, triage and transfer of patients who cannot receive definitive care at the receiving hospital. These shall include but not be limited to burn patients, spinal cord injury patients, brain injury patients, cardiac patients, patients with behavioral problems, multiple injury patients, replantation patients, neonatal and pediatric patients.

(xiv) All emergency services shall adopt and implement written policies and procedures for:

(a) provision for triage and transfer of patients to the most appropriate hospital;

(b) medical control and direction of prehospital emergency medical services;

(c) review of quality of patient care on a regular basis (at least quarterly) with prehospital providers, emergency services personnel, and physicians, in order to improve field operations and make recommendations for continuing education;

(d) continuing education in emergency medical services;

(e) provision of liaison and direction for the supply of medications, fluids, and other items utilized by ambulance organizations; and

(f) provision of patient outcome data to the State EMS Data System. Where there is an established regional emergency medical services system, the emergency service shall coordinate its performance of these functions with the other participants in the regional system.

(xv) The emergency service shall establish and implement written policies and procedures for:

(a) the provision of appropriate social services 24 hours a day;

(b) consultation with a poison control center; and

(c) the maintenance of sexual offense evidence as part of the hospital-wide provisions required by this Title.

(xvi) All cases of suspected child abuse or neglect shall be reported immediately to the New York State Central Register of Child Abuse and Maltreatment and the hospital shall comply with article 6, title 6 of the Social Services Law.

(xvii) The emergency service personnel shall give information regarding community resources and the Domestic Violence Hotline telephone number to those persons who are suspected or confirmed victims of domestic violence.

(i) Trauma centers.

(1) The standards of Chapter V of this Title shall be applicable to the extent that such standards relate to the service under review or to the physical location in which the service is being provided.

(2) The following general standards address the distribution of services and issues related to all hospitals that provide care to trauma patients:

(i) The designation of trauma centers will be planned on a regional basis, and will be based on an annual incidence of one severe/life-threatening case per thousand population.

(ii) All hospitals will have a written transfer agreement with a regional trauma center and an area trauma center (as appropriate) for the transfer of severely injured trauma patients. This transfer agreement shall include written guidelines for determining the basis for seeking consultation and arranging the transport of trauma patients.

(iii) A regional trauma system is based on the prompt delivery of the trauma patient to a designated trauma center. In large urban cities (more than one million population), the total prehospital time of transport to a trauma center (time from receipt of call to arrival at the hospital) should be within 30 minutes. Outside of large urban cities, the total prehospital time to a trauma center should be within 60 minutes. If the total prehospital time will exceed 60 minutes, then the patient should be treated initially at the nearest available hospital before being transported to a trauma center. The decision to transfer a patient to a trauma center is the responsibility of the physician in the initial receiving hospital. Trauma specialists are available at the designated trauma center to give consultative advice about patient management and the need for transfer. Physician to physician contact should occur before transfer as circumstances permit.

(iv) Once the decision to transfer has been made, it should be effected as soon as possible. Resuscitation and stabilization should begin at the referring hospital, realizing that the patient's problems may be such that true stabilization may only be possible at the regional trauma center.

(v) The mode of transportation used for transfer shall be determined based on time, medical interventions necessary for ongoing life support during transfer, and availability of resources. The receiving and accepting physicians must agree on who will assume responsibility for on-line medical control during transfer.

(vi) Each hospital within a region will have a written agreement to cooperate with a regional trauma center in a quality assurance program for the regional trauma system.

(vii) Each hospital within a region will participate in planning activities to incorporate its resources and capabilities into local and regional mass casualty and disaster plans.

(3) The following standards apply to regional trauma centers:

(i) The hospital has a designated trauma service with a general surgeon (board certified or board admissable in surgery with advanced training and experience in trauma care or with training and experience equivalent to board preparation and advanced training and experience in trauma care) who is responsible for the multidisciplinary and interdepartmental coordination of trauma care.

(ii) The hospital has a pediatric trauma service pursuant to paragraph (5) of this subdivision or a written transfer agreement with a regional trauma center that has a pediatric trauma service.

(iii) There is an emergency department with a qualified emergency physician, who is a designated member of the trauma team, physically present in the emergency department 24 hours a day.

(iv) There is a general surgeon (board-certified or board-admissable or with separate equivalent training and experience) available in the hospital 24 hours a day. This requirement may be fulfilled by postgraduate trainees in their fifth or later years capable of assessing emergency situations. They must be capable of providing surgical treatment immediately and of providing control and surgical leadership for the care of the trauma patient. When post graduate trainees are used to fulfill this requirement, staff specialists must be on call and available within 20 minutes.

(v) There is a neurosurgeon (board-certified or board-admissable or with equivalent training and experience) available in the hospital 24 hours a day. This requirement may be fulfilled by an in-house neurosurgeon, surgeon, or a post graduate trainee in the fifth or later years who has special competence, as judged by the chief of neurosurgery and the hospital, in the care of patients with neural trauma, and who is capable of initiating measures directed toward stabilizing the patient and initiating diagnostic procedures. When non-neurosurgeons are used to fulfill this requirement, staff specialists must be on call and available within 30 minutes.

(vi) The following surgical specialties staffed by qualified specialists (board-certified or board-admissable or with equivalent training and experience) are available to the hospital within 30 minutes: cardiac or thoracic surgery; microsurgery; gynecologic surgery; hand surgery; maxillofacial or oral surgery (dental); orthopedic surgery; ophthalmic surgery; otorhinolaryngologic surgery; pediatric surgery; plastic surgery; and urologic surgery.

(vii) A specialist (board-certified or board-admissable or with equivalent training and experience) in anesthesiology is available in the hospital 24 hours a day. This requirement may be met by post graduate trainees in the fourth or later years. When post graduate trainees are used to fulfill this requirement, staff specialists are on call and available within 20 minutes.

(viii) The following nonsurgical specialists (board-certified or board-admissable or with equivalent training and experience) are available to the hospital within 30 minutes: cardiology; pulmonology; gastroenterology; hematology; infectious diseases; internal medicine; nephrology; neuroradiology; pathology; pediatrics; psychiatry; and radiology.

(ix) All physicians who are members of the trauma team shall have current certification in advanced cardiac life support (ACLS) and advanced trauma life support (ATLS) or have training and experience equivalent to ACLS and ATLS.

(x) All registered professional nurses who are members of the trauma team shall have current certification in advanced cardiac life support (ACLS) or have training and experience equivalent to ACLS.

(xi) There is an intensive care unit (ICU) for trauma patients with a physician on duty in the ICU 24 hours a day or immediately available in the hospital. (The physician on duty in the ICU is not the emergency department physician.)

(xii) The physician on duty in the ICU has special competence, as judged by the director of the trauma service and the hospital, in the care of trauma patients.

(xiii) The minimum ratio of registered professional nurses to trauma patients in the ICU is 1:2 on each shift.

(xiv) The following equipment is available to the ICU: airway control and ventilation devices; oxygen source with concentration controls; cardiac emergency cart; temporary transvenous pacemaker; electrocardiograph-oscilloscope-defibrillator; cardiac output monitoring; electronic pressure monitoring; mechanical ventilator-respirators; patient weighing devices; pulmonary function measuring devices; temperature control devices; drugs; intravenous fluids and supplies; and intracranial pressure monitoring devices.

(xv) There is a postanesthetic recovery room (a surgical intensive care unit is acceptable) with registered professional nurses available 24 hours a day and appropriate monitoring and resuscitation equipment available.

(xvi) In-house hemodialysis capability is available within two hours, 24 hours a day.

(xvii) There is either a designated burn center/unit available at the facility or a written transfer agreement with a designated burn center/unit.

(xviii) Comprehensive inpatient physical medicine and rehabilitation, spinal cord injury rehabilitation, and head injury rehabilitation programs are either available at the facility or there is a written transfer agreement with a designated provider for these services.

(xix) The following radiological capabilities are available at the facility: angiography of all types available 24 hours per day with 30 minutes maximum response time; sonography; nuclear scanning; and CT scanning available 24 hours per day with 30 minute maximum response time.

(xx) There is an operating room that is staffed in-house and is immediately available 24 hours a day.

(xxi) The operating room has the following equipment: operating microscope; thermal control equipment for patients and for blood; x-ray capability; all varieties of endoscopes; equipment for craniotomies; monitoring equipment; and autotransfusion capability.

(xxii) The following clinical laboratory services are available 24 hours a day: standard analyses of blood, urine and other body fluids; blood typing and cross matching; coagulation studies; comprehensive blood bank or access to a community central blood bank and adequate hospital storage facilities; blood gases and pH determinations; microbiology; and drug and alcohol screening.

(xxiii) There is an organized quality assurance program that includes: special audit for all trauma deaths; morbidity and mortality review; regular multidisciplinary trauma conferences including all members of the trauma team; medical/nursing audit; utilization review; tissue review; and review of prehospital and regional systems of trauma care.

(xxiv) The regional trauma center maintains a trauma registry with documentation of severity of injury (by trauma score, age, sex, injury severity score) the cause of the injury, and outcome (survival, length-of-stay), with a monthly review of statistics.

(xxv) Each regional trauma center has a 24-hour telephone physician consultation service with the authority to accept the transfer of trauma patients.

(xxvi) There is a program of public education for injury prevention in the home and industry, on the highways and athletic fields, standard first-aid, problems confronting public, medical profession, and hospitals regarding optimal care for the injured.

(xxvii) There is an active program of trauma research.

(xxviii) There are outreach programs and programs in continuing education provided by the regional trauma center for trauma center staff, community nurses, physicians, and allied health personnel.

(xxix) The regional trauma center shall have a written transfer agreement with all hospitals in the region. This transfer agreement will specify the scope of services provided by the receiving hospital and the transferring hospital.

(xxx) The regional trauma center shall establish field triage protocols and procedures with the prehospital providers in its service area which include the mechanism of injury and abnormal physiologic signs. Where there is an established regional emergency services system, the regional trauma center shall coordinate the establishment of field triage protocols with other participants in the regional system.

(4) The following standards apply to an area trauma center:

(i) The hospital has a designated trauma service with a general surgeon (board-certified or board-admissable in surgery with advanced training and experience in trauma care or with training and experience equivalent to board preparation and advanced training and experience in trauma care) who is responsible for the multidisciplinary and interdepartmental coordination of trauma care.

(ii) The hospital has a pediatric trauma service pursuant to paragraph (5) of this subdivision or a written transfer agreement with a regional or area trauma center that has a pediatric trauma service.

(iii) There is an emergency department with a qualified emergency physician, who is a designated member of the trauma team, physically present in the emergency department 24 hours a day.

(iv) The area trauma center shall ensure that a trauma surgeon is present in the emergency department at the time of the patient's arrival. When sufficient prior notification has not been possible, a designated member of the trauma team will immediately initiate the evaluation and resuscitation. Definitive surgical care must be instituted by the trauma surgeon in a timely manner that is consistent with established standards.

(v) The area trauma center shall ensure that a neurosurgeon (board-certified or board-admissible or with equivalent training and experience) is present in the emergency department at the time of the patient's arrival. When sufficient prior notification has not been possible, a surgeon or postgraduate trainee in the fifth or later years who has special competence, as judged by the chief of neurosurgery and the hospital, in the care of patients with neural trauma, shall initiate measures to stabilize the patient and initiate diagnostic procedures. Definitive neurosurgical care shall be instituted by the neurosurgeon in a timely manner that is consistent with established standards of neurosurgical care.

(vi) The following surgical specialties staffed by qualified specialists (board-certified or board-admissable or with equivalent training and experience) are available to the hospital within 30 minutes: cardiac or thoracic surgery; gynecologic surgery; ophthalmic surgery; maxillofacial or oral surgery (dental); orthopedic surgery; otorhinolaryngologic surgery; plastic surgery; and urologic surgery.

(vii) A specialist (board-certified or board-admissable or with equivalent training and experience) in anesthesiology is available in the hospital 24 hours a day. This requirement may be met by a certified nurse anesthetist (CRNA) capable of assessing emergency situations in trauma patients and of initiating and providing indicated treatment under the supervision of the operating surgeon. Under these conditions the staff anesthesiologist is on-call and available within 20 minutes.

(viii) The following nonsurgical specialists (board-certified or board-admissable or with equivalent training and experience) are available to the hospital within 30 minutes: cardiology; hematology; internal medicine; nephrology; pathology; pediatrics; and radiology.

(ix) All physicians who are members of the trauma team shall have current certification in advanced cardiac life support (ACLS) and advanced trauma life support (ATLS) or have training and experience equivalent to ACLS and ATLS.

(x) All registered professional nurses who are members of the trauma team shall have current certification in advanced cardiac life support (ACLS) or have training and experience equivalent to ACLS.

(xi) There is an intensive care unit (ICU) for trauma patients with a physician on duty in the ICU 24 hours a day or immediately available in the hospital. (The physician on duty in the ICU is not the emergency department physician.)

(xii) The physician on duty in the ICU is a postgraduate trainee in the second or later years who has special competence, as judged by the director of the trauma service and the hospital, in the care of trauma patients. When post graduate trainees are used to fulfill this requirement, staff specialists in critical care medicine must be on call and available within 30 minutes.

(xiii) The minimum ratio of registered professional nurses to trauma patients in the ICU is 1:2 on each shift.

(xiv) The following equipment is available to the ICU: airway control and ventilation devices; oxygen source with concentration controls; cardiac emergency cart; temporary transvenous pacemaker; electrocardiograph-oscilloscope-defibrillator; cardiac output monitoring; electronic pressure monitoring; mechanical ventilator-respirators; patient weighing devices; pulmonary function measuring devices; temperature control devices; drugs; intravenous fluids and supplies; and intracranial pressure monitoring devices.

(xv) There is a postanesthetic recovery room (a surgical intensive care unit is acceptable) with registered professional nurses available 24 hours a day and appropriate monitoring and resuscitation equipment available.

(xvi) In-house hemodialysis capability is available within two hours, 24 hours a day.

(xvii) There is either a designated burn center/unit available at the facility or a written transfer agreement with a designated burn center/unit.

(xviii) Comprehensive inpatient physical medicine and rehabilitation, spinal cord injury rehabilitation, and head injury rehabilitation are either available at the facility or there is a written transfer agreement with a designated provider of these services.

(xix) The following radiological capabilities are available at the facility: angiography of all types available 24 hours per day with 30 minute maximum response time; sonography; nuclear scanning; and CT scanning available 24 hours per day with 30 minute maximum response time.

(xx) There is an operating room that is staffed in-house and is immediately available 24 hours a day.

(xxi) The operating room has the following equipment: operating microscope; thermal control equipment for patients and for blood; x-ray capability; all varieties of endoscopes; equipment for craniotomies; monitoring equipment; and autotransfusion capability.

(xxii) The following clinical laboratory services are available 24 hours a day: standard analyses of blood, urine, and other body fluids; blood typing and cross matching; coagulation studies; comprehensive blood bank or access to a community central blood bank and adequate hospital storage facilities; blood gases and pH determinations; microbiology; and drug and alcohol screening.

(xxiii) There is an organized quality assurance program that includes special audit for all trauma deaths; morbidity and mortality review; regular multidisciplinary trauma conferences including all members of the trauma team; medical/nursing audit; utilization review; tissue review; and review of prehospital and regional systems of trauma care.

(xxiv) The area trauma center maintains a trauma registry with documentation of severity of injury (by trauma score, age, sex, injury severity score), the cause of the injury, and outcome (survival, length of stay), with a monthly review of statistics.

(xxv) Each area trauma center has a 24-hour telephone physician consultation service with the authority to accept the transfer of trauma patients.

(xxvi) There is a program of public education for injury prevention in the home and industry, on the highways and athletic fields; standard first-aid; problems confronting public, medical profession, and hospitals regarding optimal care for the injured.

(xxvii) The area trauma center shall have a written transfer agreement with the regional trauma center. This agreement will specify the scope of services provided by the receiving hospital and the transferring hospital.

(xxviii) The area trauma center shall establish field triage protocols and procedures with the prehospital providers in its service area which include the mechanism of injury and abnormal physiologic signs. Where there is an established regional emergency medical services system, the area trauma center shall coordinate the establishment of field triage protocols with other participants in the regional system.

(5) The following standards apply to pediatric trauma services:

(i) To be designated to receive pediatric trauma patients, regional trauma centers shall have a pediatric trauma service directed by a pediatric surgeon (board certified or board admissable in pediatric surgery or with training and experience equivalent to board preparation and with advanced training and experience in trauma care) who is responsible for the multidisciplinary and interdepartmental coordination of pediatric trauma care.

(ii) To be designated to receive pediatric trauma patients, an area trauma center shall have a pediatric trauma service directed by a pediatric surgeon (board certified or board admissible in pediatric surgery or with training and experience equivalent to board preparation and with advanced training and experience in trauma care) or a general surgeon (board certified or board admissable or with equivalent training and experience) with special interest and expertise in pediatric trauma.

(iii) The attending physicians in pediatric trauma shall be pediatric surgeons (board certified or board admissable or with equivalent training and experience) or general surgeons (board certified or board admissable or with equivalent training and experience) with special interest and expertise in pediatric trauma.

(iv) All senior physicians (attending or postgraduate trainees in their fifth or later years) and registered professional nurses who are members of the pediatric trauma team shall have current certification in pediatric advanced life support (PALS) or have training and experience equivalent to PALS.

(v) The anesthesiologist (and physicians from other services) on-call for pediatric trauma shall be experienced in the management of children. Whenever possible, these responsibilities shall be met by physicians with advanced training, certification, and/or experience in the pediatric branch of the (sub) specialty training, certification, and/or experience in the pediatric branch of the (sub) specialty.

(vi) All registered professional nurses who are members of the pediatric trauma team shall have had training (intramural or extramural) in the management of pediatric trauma patients.

(vii) Critically ill pediatric trauma patients shall be cared for by the pediatric trauma service in a properly equipped pediatric intensive care area staffed 24 hours a day by physicians and nurses credentialed by the hospital to manage pediatric intensive care.

(viii) The emergency department must be properly equipped for care of children and staffed 24 hours-a-day by physicians and registered professional nurses with expertise in pediatric resuscitation.