ED.1 ORGANIZATION

SR.1 The CAH shall provide Emergency Services and be available twenty-four (24) hours a day, seven (7) days per week. 485.618(a), 485.635(b)(4)

SR.2 The CAH shall provide direct emergency medical services to meet the emergency needs of its patients as a first response to common life-threatening injuries and acute illness in accordance with acceptable standards of practice. 485.635(b)(4)

SR.3 Emergency Services shall be organized and integrated with other departments under the direction and supervision of a qualified member of the medical staff or other appropriately qualified practitioner.

SR.4 The medical staff shall be responsible for developing and maintaining policies and procedures governing the medical care delivered. 485.635(a)(3)(ii)

Interpretive Guidelines:

The CAH “makes available 24-hour emergency services.” This does not mean that the CAH must remain open 24 hours a day when it does not have inpatients (including swing-bed patients). A CAH that does not have inpatients may close with no staff present, provided that it has an effective system in place to meet the requirement. The system must ensure that a practitioner with training and experience in emergency care is on call and immediately available by telephone or radio, and available on site within 30 minutes, (or 1 hour in certain frontier areas), 24 hours a day. In addition to these items, the CAH must maintain the types, quality and numbers of supplies, drugs and biologicals, blood and blood products, and equipment required by state and local law and in accordance with accepted standards of practice

All emergency services must be provided as a direct service in the CAH. The ED cannot be a provider-based off-site location. Emergency needs of patients must be met in accordance with acceptable standards of practice.

Acceptable standards of practice include maintaining compliance with applicable Federal and State laws, regulations, and guidelines governing all services provided in the CAH’S emergency department, as well as any standards and recommendations promoted by or established by nationally recognized professional organizations such as the

American Medical Association, American Association for Respiratory Care, American Society of Emergency Medicine, American College of Surgeons, American Nursing Association, etc.

The CAH’s emergency services must be integrated with the other departments of the CAH (e.g. surgical services, laboratory, ICU, diagnostic services) and be accessible in the delivery of emergency care for patients.

The CAH’S emergency services must be integrated into the CAH-wide quality management system.. The emergency department will be under the direction of a qualified member of the medical staff.

The medical staff will define the criteria that include the qualifications for the director of emergency service as well as delineating the qualifications a medical staff member must possess in order to be granted privileges for the provision of emergency care services. in accordance with Federal and State law.

The medical staff will ensure that policies and procedures are developed and implemented to govern the emergency services provided.

Emergency care necessary to meet the needs of its inpatients and outpatients would include the provision of respiratory services as needed by the CAH’S emergency patients. When respiratory services are provided those services must be provided in accordance with acceptable standards of practice. The scope of diagnostic and/or therapeutic respiratory services offered by the CAH should be defined in writing, and approved by the medical staff The CAH has the responsibility and must abide by the Emergency Treatment and Labor Act (EMTALA). It is intended to reinforce that the EMTALA responsibility of the CAH with a dedicated emergency department begins when an individual arrives on CAH property (ambulance arrival) and not when the CAH “accepts” the individual from the gurney. An individual is considered to have “presented” to the CAH when her or she arrives at the CAH’s dedicated emergency department or on CAH property and a request is made by the individual or on his or her behalf for examination or treatment of an emergency medical condition (42 CFR 489.24(b)). Once an individual comes to the emergency department of the CAH, whether by EMS or otherwise, the CAH has the obligation to provide an appropriate medical screening examination and, if an emergency medical condition is determined to exist, provide any necessary

stabilizing treatment or an appropriate transfer. Failure to meet these requirements constitutes a potential violation of EMTALA.

EMTALA obligations would also apply to the CAH that has accepted transfer of a patient from another facility, as long as it is an “appropriate transfer” under EMTALA. An appropriate transfer is one in which the transferring CAH provides medical treatment that minimizes risks to an individual’s health and the receiving CAH has the capability and capacity to accept the patient at the time the transfer is effectuated. A CAH that delays the medical screening examination or stabilizing treatment of a patient who arrives via transfer from another facility, by not allowing EMS to leave the patient, could also be in violation of EMTALA.

A CAH policy or practice that relies on calling 9-1-1 in order for EMS to substitute its emergency response capabilities for when the CAH is required to maintain as stated above. The CAH may not rely on 9-1-1 to provide appraisal and initial treatment of medical emergencies that occur at the CAH.

Surveyor Guidance:

Verify that emergency services are organized under the direction of a qualified member of the medical staff.

Review and validate policies and procedures (including triage of patients and any respiratory services provided) and that they are evaluated and updated on an ongoing basis no less than once per year.

Review and validate the coordination and communication between the Emergency Department and other CAH services/departments (e.g. laboratory, diagnostic services, surgical services).

Ascertain by record review of patients admitted through the emergency department, interviews with staff, patients, and families, and/or observations that ED services were made available to patients presenting on a 24-hour a day basis. How does the CAH ensure that emergency services are made available on a 24-hour a day basis?

Review any policies and procedures for emergency services in the CAH. What evidence indicates that the CAH is capable of providing necessary emergency care for its inpatients and outpatients?

Determine if the CAH provides any degree of respiratory care services and that the type and amount of respiratory care provided meets the needs of the patients and is delivered in accordance with acceptable standards of practice. Review the CAH policies and procedures to verify that the scope of the diagnostic and/or therapeutic respiratory care services provided is defined in writing and approved by the medical staff.

If blood gases or other laboratory tests are performed as part of the delivery of respiratory services, verify that there is a current CLIA certificate

Interview staff to determine that they are knowledgeable, within their own level of participation in emergency care including:

Parenteral administration of electrolytes, fluids, blood and blood components; Care and management of injuries to extremities and central nervous system; Prevention of contamination and cross infection; and

Provision of emergency respiratory services. ED.2 STAFFING

SR.1 Adequate medical and nursing staff qualified in emergency care must be present to meet the written emergency procedures and needs determined by the CAH. 485.618(d), 485.635(b)(4)

SR.1a Except as specified under §485.618 (d)(2), A doctor of medicine or osteopathy, physician assistant, nurse practitioner, or clinical nurse specialist, with training or experience in emergency care shall be on call at all times and immediately available by telephone or two-way radio and available onsite within thirty (30) minutes 485.618(d)(1), 485.618(d)(1)(i), 485.635(b)(4)

SR.1b A doctor of medicine or osteopathy, physician assistant, nurse practitioner, or clinical nurse specialist with training or experience in emergency care shall be on call at all times and immediately available by telephone or two-way radio and available onsite within thirty (30) minutes if the CAH is located in an area designated:

as a frontier area;

or in an area that meets the criteria for a remote location adopted by the State in its rural health care plan, and approved by CMS under section 1820(b) of the Act;

the State has determined, under criteria in its rural health plan, that allowing emergency response time longer than 30 minutes is the only feasible method of providing emergency care to residents of the area served by the CAH; or

The State maintains documentation showing the response time of up to 60 minutes at a particular CAH it designates is justified because other available alternatives would increase the time

needed to stabilize a patient in an emergency 485.618(d)(1)(ii), 485.618(d)(1)(ii)(A) SR.2 A qualified clinician shall perform patient triage upon presentation to the emergency department.

485.635(b)(4)

SR.3 A registered nurse with training and experience in emergency care can be utilized to conduct specific medical screening examinations only if: 485.618(2) , 485.618(3)

SR.3a The registered nurse is on site and immediately available at the CAH when a patient requests medical care; and 485.618(2)(i)

SR.3b The nature of the patient's request for medical care is within the scope of practice of a registered nurse and consistent with applicable State laws and the CAH's bylaws or rules and regulations. 485.618(2)(ii)

SR.3c The CAH has no greater than 10 beds; 485.618(3)(i)

SR.3d The CAH is located in an area designated as a frontier area or remote location as described in ED.2; SR.1b; 485.618(3)(ii)

SR.3e The State in which the CAH is located in accordance with State law or regulation or submits a letter to CMS signed by the Governor, following consultation on the issue of using RNs on a temporary basis as a part of their State rural health plan with the State Boards of Medicine and Nursing, and in

accordance with State law, requesting that a registered nurse with training and experience in emergency care be included in the list of personnel specified in ED.2. The letter from the Governor must attest that he or she has consulted with the State Boards of Medicine and Nursing about issues related to access to and the quality of emergency services in the State. The letter from the Governor must also describe the circumstances and duration of the temporary request to include registered nurses on the list of personnel specified in ED.2.

SR.3f Once the Governor submits a letter specified in as stated in SR.3e above, a CAH must submit

documentation to the State survey agency demonstrating that is has been unable, due to the shortage of such personnel in the area, to provide adequate coverage as specified under this requirement. SR.3g The request, as specified in SR.3e above, and the withdrawal of the request may be

submitted at any time, and are effective upon submission. Interpretive Guidelines:

The CAH must ensure that a qualified member of the medical staff is on premises and available to supervise the provision of emergency services at all times.

The CAH shall also provide nursing staff qualified in emergency care, as outlined in the written scope of service, to be present when emergency services are provided.

The CAH must staff the emergency department with the appropriate numbers and types of professionals and other staff who possess the skills, education, certifications, specialized training and experience in emergency care when emergency services are provided.

The CAH must work with Federal, State and local agencies and officials in order to identify risks to the community (e.g., natural disasters, mass casualties, terrorist acts), to anticipate demands and resources needed by the CAH emergency services, and accordingly, develop plans and methods to address and coordinate anticipated needs. When State laws are more stringent and require more stringent staffing or expanded operational hours, the CAH must staff its emergency department in accordance with state laws. For example, if State law requires the CAH emergency department be open and be staffed with a MD/DO 24/7 then the CAH must comply.

Surveyor Guidance:

Verify that a qualified member of the medical staff is on premises and available to supervise the provision of emergency services at all times.

Verify that the appropriate numbers and types of professionals and other staff who possess the skills, education, certifications, specialized training and experience in emergency care when emergency services are provided. Review staffing schedules to determine that the number and type of staff available is appropriate to the volume and types of treatments furnished.

Review on-call schedules to determine how the CAH ensures that a qualified staff member is on call 24 hours a day and available on site at the CAH within 30 minutes, or 60 minutes in certain frontier areas.

What documentation demonstrates that a MD/DO, nurse practitioner, physician assistant, or registered nurse (as allowed under (d)(2)) with emergency training or experience has been on call and available on site at the CAH within 30 or 60 minutes, as appropriate?

Review and validate the processes in place to demonstrate that the CAH works with Federal, State and local agencies and officials in order to identify risks to the community to anticipate demands and resources needed by the CAH emergency services.

ED.3 EQUIPMENT, SUPPLIES and MEDICATION

Equipment, supplies, and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. 485.618(a)

SR.1 Drugs and biologicals commonly used in life-saving procedures shall be provided at a minimum to include: 485.618(a)(1)

SR.1a Analgesics SR.1b Local Anesthetics SR.1c Antibiotics SR.1d Anticonvulsants SR.1e antidotes and emetics SR.1f serums and toxoids SR.1g antiarrythmics, SR.1h cardiac glycosides SR.1i antihypertensives SR.1j diuretics

SR.1k electrolytes and replacement solutions

SR.2 Equipment and supplies (adult and pediatric sizes) shall be provided at a minimum to include: 485.618(a)(2), 485.635(b)(4)

SR.2a airways, endotracheal and nasogastric tubes; SR.2b ambubag, valve and masks;

SR.2c oxygen;

SR.2d immobilization devices and splints; SR.2e tourniquets;

SR.2f suction machine and related supplies; SR.2g IV therapy supplies;

SR.2h defibrillator and cardiac monitor; and, SR.2i chest tubes and indwelling catheters Interpretive Guidelines:

The CAH must provide the appropriate equipment and qualified personnel necessary to furnish all services offered in a safe manner in accordance with acceptable standards of practice.

There should be written policies for the delivery of any services provided. The policies and procedures must be developed and approved by the medical staff and include the participation of any mid-level practitioners working in the ED. The written policies should address the following services, as appropriate.

The qualifications, including job title, licensure requirements, education, training and experience of personnel authorized to perform each type of respiratory care service and whether they may perform it without supervision;

Equipment assembly and operation;

Safety practices, including infection control measures; Handling, storage, and dispensing of therapeutic gases; Cardiopulmonary resuscitation;

Procedures to follow in the advent of adverse reactions to treatments or interventions; Pulmonary function testing;

Therapeutic percussion and vibration; Bronchopulmonary drainage;

Mechanical ventilatory and oxygenation support;

Aerosol, humidification, and therapeutic gas administration; Administration of medications; and

Procedures for obtaining and analyzing blood samples (arterial blood gases).

In addition to these items, the CAH must maintain the types, quality and numbers of supplies, drugs and biologicals, blood and blood products, and equipment required by State and local law and in accordance with accepted standards of practice

Surveyor Guidance:

How does the CAH ensure that the required equipment, supplies and medications are always readily available in the CAH?

Interview staff and tour the ER to ascertain compliance and ability to provide emergency services. How does the CAH ensure that staff knows where drugs and biologicals are stored?

How does the CAH ensure that staff knows where emergency equipment and supplies are stored?

Determine when the last time emergency supplies were used and who is responsible for monitoring supplies? Examine sterilized equipment (e.g., tracheostomy sets) for expiration dates when applicable

Examine equipment to determine if it is working order. For example, check the force of the vacuum (suction)

equipment to see that it is in operating condition. Determine if there is there an equipment maintenance schedule for equipment. Ask staff if equipment has ever failed to work when needed.