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800 ROSE STREET

LEXINGTON, KY 40536

COMPLIANCE WITH 489.24

Tag No.: A2400

Based on interview, record review, and review of policies and procedures, it was determined the facility failed to comply with 42 CFR 489.24 Special Responsibilities of Medicare hospitals in emergency cases for two (2) of twenty-one (21) patients that presented to the facility extension Emergency Department (ED), Patients #1 and #20. The facility extension failed to ensure a medical screening examination (MSE) was provided for Patient #1 on 01/12/13 after he/she was brought to their ambulance bay for treatment of a possible emergency medical condition. The facility extension failed to ensure an appropriate transfer was accomplished on 07/30/12 for Patient #20 when he/she was transferred to an external psychiatric facility.

The findings include:

Review of the facility policy, "Emergent Care and Emergency Response to Medical Emergencies," policy number A02-055, review/revision date 03/2012, revealed the facility recognized its responsibility to provide an appropriate MSE to any individual who came to the ED. In addition, the facility defined "came to the ED" to include any individual who was in a ground ambulance on the facility hospital property for presentation for examination and treatment for a medical condition at either the main facility ED or the facility extension ED. The policy also revealed the facility would maintain a central log of individuals who came to the ED seeking treatment, indicating whether these individuals refused treatment; were denied treatment; were treated, admitted, stabilized, and/or transferred or were discharged; or the individual (or person acting on his or her behalf) after being informed of the risks and the facility's obligations, requested a transfer.

Review of the facility policy, "Transfer of Patients," policy number A02-015, effective date 10/2008, revealed patients shall be transferred, both internally and to external facilities, in accordance with EMTALA regulations. It further revealed transfers within all facility units were based on medical necessity, such as the need for specialized care only available at another unit. The policy also stated the facility was required to report to the Centers for Medicare and Medicaid Services (CMS) the receipt of an individual who had been transferred in an unstable emergency medical condition from another hospital in violation of the Special Responsibilities of Medicare Hospitals in Emergency Cases set forth in the regulations promulgated under EMTALA. In addition, any facility staff member who believed a patient had been so transferred must report the circumstances to the Compliance Officer immediately, who will investigate the matter and file the report with CMS, if appropriate. Additionally, the policy revealed patients transferred to an external psychiatric facility must have a transfer form completed by the Physician, Social Worker (if applicable), and Nurse. The policy further revealed the patient must be medically and psychiatrically stable before being transferred to an external psychiatric facility. It stated the attending Physician, in consultation with the Psychiatrist would prepare a referral with the signature of the consulting Psychiatrist, and if the patient was seen on an emergent basis, the ED records would be copied and transferred with the patient. It further revealed the Physician would determine the appropriate mode of transport, the supervision required, and the patient's medical condition, and in the ED, the nursing staff would arrange for the transport.

Review of facility policy, "Nursing Triage Process in the Emergency Department," policy number ED08-80, review/revision date 03/2012, revealed presenting ED patients were prioritized for evaluation according to acuteness of conditions using the Emergency Severity Index (ESI) criteria as follows: acuity 1, Critical; acuity 2, Emergent; acuity 3, Urgent; acuity 4, Stable; and acuity 5, Office or Clinic type care needed.

Review of facility policy, "Control of Varicella-Zoster (Chickenpox) Virus in Patient Care Setting," policy number A03-020, review/revision date 08/2011, revealed in all cases of herpes zoster (shingles) standard infection control precautions shall be followed. It further revealed if the patient is immunocompetent with localized herpes zoster, standard precautions would be followed and any lesions completely covered; if this patient had disseminated herpes zoster, standard precautions plus airborne and contact precautions would be followed until lesions were dry and crusted. The policy also stated for immunocompromised patients with localized herpes zoster, standard precautions plus airborne and contact precautions would be followed until disseminated infection was ruled out, then standard precautions until lesions were dry and crusted; if this patient had disseminated herpes zoster, standard precautions plus airborne and contact precautions would be followed until lesions were dry and crusted.

Review of the facility, "Medical Staff Bylaws," amended and restated 12/10/12, revealed in Section 5.6, Medical Screening, Physician Assistants (PA) and Advanced Practice Registered Nurses (APRN) who are members of the Health Professional Staff, to the extent permitted by state and federal law and consistent with clinical privileges granted and facility policy, perform and document MSE's required under 42 CFR 489.24 (a)(1)(i), under the direction of the Chair of Emergency Medicine and subject to supervision of an Active Medical Staff member.

Review of the ED Contract Agency's Emergency Medical Services Agreement, signed by the facility on 07/25/12, revealed Section 1, 2.1 (c) stated the contractor shall provide any services contemplated in this Agreement in compliance with EMTALA and the regulations and standards promulgating thereunder. It further revealed the Contractor and Covering Providers shall participate in any facility training or information programs regarding compliance with EMTALA and shall adhere to all facility rules, regulations, standards, policies or procedures relating to compliance with EMTALA.

1. Review (listening) of the audio tape, on 01/31/13 at 1:25 PM, from the EMS dispatch of 01/12/13 en route to the facility extension ED with Patient #1 on board revealed the Facility Dispatcher called the facility extension ED and spoke with the ED Charge Nurse informing her of a patient en route with lethargy and possible shingles. The audio tape further revealed Patient #1's blood pressure (BP) was 72/50; heart rate was 120; and he/she had received three hundred (300) milliliters (ml) of an intravenous (IV) fluid bolus. EMS stated they would arrive in about ten (10) minutes. Then, the audio tape revealed the ED Charge Nurse told the Facility Dispatcher there were two (2) pregnant practitioners working in the facility extension ED, and neither could see the patient. The ED Charge Nurse stated the Physician working in the ED on 01/12/13 (ED MD) wanted Patient #1 to be diverted to the main facility ED. Then, the Facility Dispatcher told the ED Charge Nurse she would see what she could do. Nothing else was on the audio tape.

Review of Patient #1's emergency medical services (EMS) ambulance transport record, incident number 00001068, revealed EMS received a call concerning this patient on 01/12/13 at 7:17 PM with the chief complaint being that Patient #1 had fainted and was unconscious. The EMS record stated Patient #1 was lethargic with family reporting he/she had not had any fluids to drink over the last twenty-four (24) hour period. The family also stated Patient #1 had been a patient at the facility extension earlier in the week and had been diagnosed and treated for shingles. The record further revealed the family requested Patient #1 be transported to the facility extension ED. In addition, the record showed EMS personnel gave Patient #1 a five hundred (500) ml IV bolus of normal saline solution. After this initial treatment, EMS reported Patient #1 showed improvement in mental status, and the electrocardiogram (ECG) showed a change from sinus tachycardia (heart rate over one hundred (100) beats per minute) to sinus rhythm. Next, the EMS report stated a call was made to the facility extension ED, and the transport was completed at 7:58 PM. The EMS report further revealed at this time, the Facility Dispatcher told EMS not to take Patient #1 into the ED. It further stated after three (3) to four (4) minutes EMS was told by dispatch to take Patient #1 into the facility extension ED but was met by a nurse that told the Paramedic EMS could not enter until it was sorted out by the facility extension where Patient #1 would go. The report stated this scenario happened multiple times. The report further revealed EMS was told to take Patient #1 to the main facility ED at 8:21 PM.

Review of Patient #1's EMS ambulance transport record, incident number 00001076, revealed EMS received a dispatch from the facility to transport Patient #1 from the facility extension ED overhang to the main facility ED on 01/12/13 at 8:21 PM and reached the main facility ED at 8:30 PM. The chief complaint of Patient #1 was listed as lethargy and dehydration. The report listed vital signs at 8:29 PM as blood pressure (BP) 91/41; heart rate 102, respiratory rate 16, oxygen saturation 100% with oxygen, blood sugar 162, and Glasgow coma scale 15. The report also stated IV fluid administration had continued, Patient #1 reported feeling much better, and his/her ability to communicate had improved.

Review of Patient #1's ED record from the main facility ED revealed he/she arrived on 01/12/13 at 8:38 PM. Triage time was 8:39 PM. Patient #1 was assigned an acuity level of two (2), Emergent. Vital signs were BP 67/34, heart rate 99, oxygen saturation 97% on two (2) liters of oxygen per minute via nasal cannula. The ED Interim Summary Note described an erythematous squama papular rash over the patient's left forehead and stated the patient was recently diagnosed with shingles on his/her left forehead. Patient #1 stayed in the ED until 01/13/13 at 5:29 AM at which time he/she was admitted to the facility with Diagnoses which included Dehydration, Hypotension, Hyponatremia, Shingles, Emphysema, Chronic Kidney Disease, and possible Sepsis. ED treatment included IV fluid boluses (two (2) liters of Lactated Ringers); IV antibiotics (Levofloxacin 750 milligrams and Piperacillin 3.375 grams); stat ECG and chest x-ray; and stat lab work (hemogram with differential, complete metabolic profile, blood cultures, and catheterized urinalysis with culture). The record further revealed lab results as follows: white blood count 14.2 (normal 4.0 to 10.5); white blood count neutrophils 89% (normal 42 to 74%); hemoglobin 10.9 (normal 11.9 to 15.5); hematocrit 31.0% (normal 35.0 to 45.0%); blood urea nitrogen 44 (normal 8-23); creatinine 2.86 (normal 0.60 to 1.10); sodium 122 (normal 136 to 145); and chloride 87 (normal 101 to 108). The record further revealed, in the Discharge Summary Note, Patient #1's condition improved with continued treatment including a fourteen (14) day course of Acyclovir for shingles (rash was resolving well at time of discharge), and he/she was discharged from acute care to a rehabilitation facility on 01/21/13.

Observation of the ED Log at the facility extension, on 01/30/13, revealed there was no entry for Patient #1 on 01/12/13, and no medical record of that event could be produced by the facility extension.

Interview with the Medical Director of the ED (facility extension), on 01/30/12 at 11:30 AM, revealed for backup of Physician coverage in the ED, hospitalists in the facility extension were called. He also stated he lived near the facility extension and could be there quickly if needed. Interview with the Medical Director of the ED (facility extension) per telephone, on 01/31/13 at 3:15 PM, revealed he did not learn of the 01/12/13 incident involving Patient #1 until 01/13/13. The ED MD did not call him and request assistance during this incident. He further revealed universal precautions are used for every patient because the ED practitioner may not know what communicable diseases a patient had; therefore, personal protective equipment (PPE) must always be worn and isolation procedures instituted on a case by case basis. The Medical Director of the ED (facility extension) also stated he had been trained in EMTALA guidelines and used to do the ED schedule for providers, but now the contract agency does the scheduling.

Interview with the ED Contract Agency Compliance and Legal Officer, on 01/31/13 at 3:15 PM per telephone, revealed the agency had provided EMTALA training for its practitioners in 07/2012 and 09/2012. She further revealed both the ED MD and the Physician Assistant (PA) working in the facility extension ED on 01/12/13 during the incident with Patient #1 (ED PA) had received EMTALA training. Also, she stated, since the incident on 01/12/13, the agency had sent out an e-mail to all practitioners regarding the need to take a refresher course on EMTALA; but, as of yet, no training had been conducted. She further revealed the agency had policies and procedures on EMTALA and the ED MD would be placed on code of conduct probation.

Interview, on 01/30/13 at 1:45 PM, with the Paramedic who transported Patient #1 to the facility extension ED and the main facility ED on 01/12/13, revealed he agreed with everything in the EMS ambulance transport reports, number 00001068 and number 00001076. He revealed Patient #1's son had told him the patient could have shingles; his/her Physician was not sure but was treating Patient #1 for shingles. The Paramedic stated when he arrived at the facility extension ambulance bay, he received a call from the Facility Dispatcher telling him not to take Patient #1 into the facility extension ED. He then received a call telling him to take the patient into the ED at the facility extension. He further revealed this was about to happen for the third time, when he received a call to transport Patient #1 to the main facility ED. He stated the reason given to him for not allowing Patient #1 into the facility extension ED was because both practitioners, the ED MD and the ED PA, were pregnant and did not want to expose their fetuses to shingles. The Paramedic further stated the ambulance with Patient #1 sat in the ambulance bay for more than twenty-one (21) minutes with the facility extension's staff members refusing to allow Patient #1 to enter the facility extension ED. In addition, he stated he asked the facility extension's ED staff members to sign the ambulance trip form, but each refused.

Interview with ED Registered Nurse (RN) #1, on 01/30/13 at 4:15 PM, revealed the process for receiving ED patients via EMS was for EMS to call the Facility Dispatcher who then called the facility extension ED. When EMS was en route, a brief report was called to the facility extension ED. RN #1 further revealed personal protective equipment (PPE) was always available and was stocked by Central Supply every morning. She also stated patients were given a mask if contagious, and ED Room #2 was a negative pressure room. She revealed with using proper PPE, the ED should be able to care for any patient. She further stated she knew of no patients with communicable diseases that had presented to the ED that were not seen.

Interview with the facility extension ED Nurse Manager, on 01/31/13 at 9:20 AM, revealed the facility extension ED was not on diversion the night of 01/12/13, PPE was available, and treating patients with shingles or chicken pox was in the facility extension ED's scope of practice. She verified that at the time of the incident with Patient #1, the ED MD and the ED PA were working and were both pregnant. The ED Nurse Manager revealed she received a call from the ED Charge Nurse the next day, 01/13/13, who reported the incident with Patient #1 arriving for treatment but being diverted to the main facility ED. The ED Nurse Manager reported the facility extension ED Charge Nurse stated she took a call from the the facility dispatch office that a patient was en route via EMS with shingles; the ED MD overheard the call and told the ED Charge Nurse to divert Patient #1 to the main facility ED because neither of the practitioners wanted the exposure; the ED Charge Nurse tried to call the facility dispatch office, but the ambulance had already arrived in the ambulance bay; the ED Charge Nurse stated she went outside to tell EMS to hold on entering because the patient was going to be diverted to the main facility ED; while the patient was waiting in the ambulance, the facility ED nurse told EMS to take the patient inside the facility extension ED; then, the ED MD had called a facility ED Physician that agreed to accept Patient #1. So, Patient #1 was transported to the main facility ED. The ED Nurse Manager further revealed the hospitalist was called to come to the ED and examine Patient #1, but he was not able to leave patient care in the Intensive Care Unit (ICU). She further revealed, the ED practitioners at the facility extension were contract employees, and the facility did not control the staffing, the contract agency did. The ED Nurse Manager also stated after the incident, the leadership group viewed a webinar on EMTALA guidelines and were in the process of putting together educational materials for all staff. She further revealed that all nurses had already received training and information on EMTALA.

Interview with the Facility Dispatcher, on 01/31/13 at 1:40 PM, revealed she had taken a call from the facility extension ED Charge Nurse on 01/12/13, requesting Patient #1 be diverted to the main facility ED because of shingles. She reported she contacted EMS, which stated the ambulance was pulling into the ED bay, so she told them not to enter because of the two (2) pregnant providers. The Facility Dispatcher further revealed she spoke to the the facility ED Charge Nurse that told her to tell the facility extension ED to take the patient to their ED for treatment. The Facility Dispatcher further stated the facility extension ED did not answer the call, so she called EMS and told the Paramedic it was okay to take Patient #1 into the ED. EMS replied with a 10-4 copy. The Facility Dispatcher stated, about six (6) to eight (8) minutes later, EMS personnel called her back and stated the ambulance was still in the ED bay because the facility extension ED Charge Nurse came outside and stated Patient #1 could not go inside. She also stated, about twenty (20) minutes later, EMS called her and stated they were en route to the main facility ED. The Facility Dispatcher revealed the EMS Paramedic was very upset.

Interview with the facility ED Physician, on 01/31/13 at 1:50 PM via telephone, revealed she received a call from the facility extension ED MD to see if she would accept Patient #1 because both providers were pregnant and an OB Chief Resident had given them an instruction that neither should see or care for Patient #1. The facility ED Physician stated the ED MD had tried to consult with infectious disease without success. The facility ED Physician agreed to accept Patient #1 at the main facility ED. She further revealed she did not know Patient #1 was already at the facility extension ED.

Interview with the facility Chief Compliance Officer, on 01/31/13 at 2:00 PM, revealed he had been contacted by the Enterprise ED Director on 01/14/13 because his office was responsible for investigating possible EMTALA violations. The primary concern was whether Patient #1 received the required MSE. He further revealed there were some conflicting statements and could not validate that either the ED MD or the ED PA performed a MSE on Patient #1. The Chief Compliance Officer further revealed when employees start working, they are trained face-to-face and with computer modules on issues such as protected health information (PHI) and EMTALA. He also stated the facility was not responsible for training ED contract agency personnel; however, he revealed ED contract employees were required to follow the facility's policies and procedures.

Interview with the facility ED Charge Nurse, on 01/31/13 at 2:20 PM, revealed she received a call from the facility dispatch office stating there was a patient with shingles at the facility extension ED, both providers were pregnant, and the ED MD wanted to divert Patient #1 to the main facility ED. She revealed she told the extension facility that the patient needed to be seen in their ED because the patient had requested to be seen at the facility extension. She stated the next communication she heard was that Patient #1 was not allowed to enter the facility extension ED and was en route to the main facility ED. She further revealed upon assessment of Patient #1, he/she had no open or crusted skin lesions but did have a reddened area on the left side of the face and forehead. She reported Patient #1 was lethargic and hypotensive and was given IV fluid boluses within the first five (5) minutes of arrival. The facility ED Charge Nurse stated it took approximate four (4) liters of IV fluids to get Patient #1's systolic BP in the 90's over a four (4) hour period. She stated Patient #1 was given the option of being admitted to the facility extension; however, he/she was admitted to the main facility because the family stated they were tired of Patient #1 being shuffled around. The facility ED Charge Nurse also revealed the Paramedic stated Patient #1's family had requested to go to the facility extension ED, but the facility extension ED Charge Nurse had met them outside and would not let EMS enter the ED. The Paramedic also revealed he had attempted to unload Patient #1 two (2) to three (3) times and was stopped by the facility extension ED personnel.

Interview with Patient #1's son by telephone, on 01/31/13 at 2:35 PM, revealed the incident with Patient #1 seemed to last thirty (30) to forty-five (45) minutes. He stated Patient #1 was somewhat confused because of the dehydration and did not seem to know what was happening. He further revealed he thought the situation was kind of weird but was only concerned about Patient #1 receiving treatment. He stated he was told the reason the patient could not enter the facility extension ED was because a nurse was pregnant and could not be around anyone with shingles. He further revealed he was not aware of the ED MD coming out to see Patient #1.

Interview with the facility extension ED Charge Nurse, on 01/31/13 at 3:43 PM per telephone, revealed she was the ED Charge Nurse on the evening of 01/12/13. She stated a radio patch was received about a patient en route with shingles. Neither the ED MD or the ED PA stated they could care for this patient. The ED Charge Nurse further stated she called the facility dispatch office and the District Charge Nurse (DCN) about the situation, and by then the ambulance had arrived. She stated she asked EMS to wait to see if Patient #1 could be sent to the main facility ED. The DCN then called and said the providers could see this patient, and she told both providers. She further revealed both the ED MD and the ED PA stated they did not feel comfortable caring for Patient #1 because the OB Chief Resident at the facility stated they should not be exposed to this patient with shingles. The ED Charge RN stated she notified the DCN of this, and thought the ED MD called a Physician at the main facility ED because Patient #1 was accepted there. She revealed the ED MD talked with EMS personnel and wanted to know the condition of Patient #1. She further revealed at one point the ED MD said to let Patient #1 come inside, put a mask on the patient, and the ED MD would also wear a mask. The ED Charge Nurse further revealed by that time, Patient #1 had been accepted at the main facility ED, and she also stated the the ED MD never came out to see Patient #1 while he/she was in the ambulance at the ED entrance. She also revealed, on 01/12/13, ED personnel had PPE and Infection Control protocols available, and since this incident, ED personnel had a meeting to review EMTALA, but so far, there had been no formal or specific education or training.

Interview with the ED PA, on 01/31/13 at 4:04 PM, revealed she was working as a provider on 01/12/13 when the ED received a patch from the facility dispatch office that Patient #1 was en route and had been diagnosed with shingles. Attempts were made to call the facility dispatch office and EMS to get Patient #1 routed to the main facility ED, but then the ambulance arrived in the ED bay. She further revealed the ED MD called the OB Chief Resident at the facility and explained the gestational age for each of the practitioners. The ED PA further revealed the OB Resident said it was not safe for either of the practitioners to see Patient #1, even if wearing PPE. She also stated she never went out to see the patient. The ED PA further revealed the Medical Director of the ED, facility extension, had instructed her there was no danger in taking care of a patient with shingles if PPE was used; and she stated she had received EMTALA training in the summer of 2012.

Interview with the ED MD, on 01/31/13 at 8:35 PM per telephone, revealed she was the Physician working in the facility extension ED the evening of 01/12/13 when the incident with Patient #1 occurred. She stated the ED Charge Nurse took a communication from EMS that the ambulance was en route with a patient with shingles that had experienced a syncopal episode at home and that had been treated earlier in the week at the facility extension. She further revealed she called the OB Chief Resident because of her pregnancy and was told under no circumstances, even if wearing PPE, should she, or the ED PA, because of her pregnancy, care for this incoming patient. She also stated she called the hospitalist, but he could not come to the ED because he was caring for a patient in the ICU that was critical and deteriorating, and she did not call the Medical Director of the ED. The ED MD stated, at this point, an effort was made to divert Patient #1 to the main facility ED and was told there was no reason either practitioner could not care for this patient; however, she believed the OB Resident and did not want to expose either fetus to unnecessary risks. She further revealed, by this time, the ambulance had arrived at the ED bay, and she went out to talk with the family/EMS personnel and observe Patient #1 through the ambulance windows, having no direct contact with the patient or going inside the ambulance. The ED MD further stated from the information given to her by the family and the EMS personnel the patient was stabilizing with an increased BP and improved ability to communicate and interact. She also revealed she called a Physician at the main facility ED who agreed to accept Patient #1. The ED MD stated her main goal was for Patient #1 to be seen as quickly as possible, and under the circumstances, she stated she felt like the best option was for Patient #1 to be sent to the main facility ED. She also revealed she believed she did the best she could do in performing a MSE in that she was told it was not safe for either practitioner to directly evaluate and treat Patient #1, even if wearing PPE. The ED MD also stated she had received training in EMTALA prior to this incident and had been researching its requirements since then.

Interview with the Director of Enterprise Accreditation and Regulatory Compliance, on 01/31/13 at 4:30 PM, revealed the facility, in the ED Charge Nurse Meeting on 01/23/13, addressed EMTALA and produced a copy of the minutes which stated a MSE must be done even on active labor patients. She also stated an outline was being developed for an EMTALA education offering for all hospital and medical personnel. This educational offering was to be in 02/2013.

2. Review of Patient #20's ED record revealed he/she arrived at the facility extension ED on 07/30/12 at 2:51 AM with a chief complaint of suicidal ideation with no attempt made and was escorted by law enforcement. The Physician ED note listed unremarkable vital signs and negative/noncontributory review of systems. It also listed a Psychiatric consult was done, a urine drug screen was presumptively positive, and the patient had an appropriate mood and behavior. Patient #20 was transferred to an external psychiatric facility. There was no documentation the receiving psychiatric facility had agreed to accept the transfer, had been sent the required hospital records, or that the patient had been transported appropriately and safely to the receiving psychiatric facility. The record revealed there was no facility transfer form.

Interview with the Enterprise ED Director and the facility RN ED Manager, on 01/31/13 at 4:25 PM, revealed both stated the facility extension ED had not been completing transfer forms that had required information for ED patients transferred to an external facility since 2010 when personnel were told they did not have to complete the transfer forms for an intra-facility transfer, (transfer from the facility to the facility extension.) They both stated, at this point, the staff stopped completing any transfer forms for any patients, no matter where they were being transferred. They further revealed the problem was discovered during an Office of the Inspector General (OIG) Validation Survey conducted 01/14/13 through 01/18/13 and since the problem was identified, the facility had started completing transfer forms (one to go with patient and one to stay in ED record) for patients transferred outside the facility system.

Confirmation of the facility extension completing a transfer form was accomplished by review of a closed ED record, Patient #9, which revealed he/she was seen in the facility extension ED on 01/27/13 with a chief complaint of suicidal ideation with no attempt made. The record revealed this patient was transferred on 01/27/13 to an external psychiatric facility. The record also revealed it contained a "Transfer Agreement" that listed the medical condition of the patient, the reason for transfer, the approval of the receiving facility for transfer, the Physician accepting transfer, who received the patient report at the receiving facility, the transfer method, and treatment information. This form must be signed by the Discharging Nurse. This form also has a section for transfer of unstable patients with the required Physician completion and signature.

MEDICAL SCREENING EXAM

Tag No.: A2406

Based on interview, record review, document review, and review of facility policies and procedures, it was determined the facility failed to ensure one (1) of twenty-one (21) patients selected for review and who had presented to the facility extension's Emergency Department (ED) seeking medical care received a medical screening examination (MSE), Patient #1. A review of documentation in the Emergency Medical Services (EMS) ambulance transport records revealed Patient #1 arrived at the facility extension ED ambulance bay on 01/12/13 at 7:58 PM and left per ambulance for the main facility ED on 01/12/13 at 8:21 PM without disembarking from the ambulance or receiving a MSE because facility extension ED personnel would not let Patient #1 enter the ED.

The findings include:

Review of the facility policy, "Emergent Care and Emergency Response to Medical Emergencies," policy number A02-055, review/revision date 03/2012, revealed the facility recognized its responsibility to provide an appropriate MSE to any individual who came to the ED. In addition, the facility defined "came to the ED" to include any individual who was in a ground ambulance on the facility hospital property for presentation for examination and treatment for a medical condition at either the main facility ED or the facility extension ED. The policy also revealed the facility would maintain a central log of individuals who came to the ED seeking treatment, indicating whether these individuals refused treatment; were denied treatment; were treated, admitted, stabilized, and/or transferred or were discharged; or the individual (or person acting on his or her behalf) after being informed of the risks and the facility's obligations, requested a transfer.

Review of the facility policy, "Transfer of Patients," policy number A02-015, effective date 10/2008, revealed patients shall be transferred, both internally and to external facilities, in accordance with EMTALA regulations. It further revealed transfers within all facility units were based on medical necessity, such as the need for specialized care only available at another unit. The policy also stated the facility was required to report to the Centers for Medicare and Medicaid Services (CMS) the receipt of an individual who had been transferred in an unstable emergency medical condition from another hospital in violation of the Special Responsibilities of Medicare Hospitals in Emergency Cases set forth in the regulations promulgated under EMTALA. In addition, any facility staff member who believed a patient had been so transferred must report the circumstances to the Compliance Officer immediately, who would investigate the matter and file the report with CMS, if appropriate.

Review of facility policy, "Nursing Triage Process in the Emergency Department," policy number ED08-80, review/revision date 03/2012, revealed presenting ED patients were prioritized for evaluation according to acuteness of conditions using the Emergency Severity Index (ESI) criteria as follows: acuity 1, Critical; acuity 2, Emergent; acuity 3, Urgent; acuity 4, Stable; and acuity 5, Office or Clinic type care needed.

Review of facility policy, "Control of Varicella-Zoster (Chickenpox) Virus in Patient Care Setting", policy number A03-020, review/revision date 08/2011, revealed in all cases of herpes zoster (shingles) standard infection control precautions shall be followed. It further revealed if the patient is immunocompetent with localized herpes zoster, standard precautions would be followed and any lesions completely covered; if this patient had disseminated herpes zoster, standard precautions plus airborne and contact precautions would be followed until lesions were dry and crusted. The policy also stated for immunocompromised patients with localized herpes zoster, standard precautions plus airborne and contact precautions would be followed until disseminated infection was ruled out, then standard precautions until lesions were dry and crusted; if this patient had disseminated herpes zoster, standard precautions plus airborne and contact precautions would be followed until lesions were dry and crusted.

Review of the facility, "Medical Staff Bylaws," amended and restated 12/10/12, revealed in Section 5.6, Medical Screening, Physician Assistants (PA) and Advanced Practice Registered Nurses (APRN) who are members of the Health Professional Staff, to the extent permitted by state and federal law and consistent with clinical privileges granted and facility policy, perform and document MSE's required under 42 CFR 489.24 (a)(1)(i), under the direction of the Chair of Emergency Medicine and subject to supervision of an Active Medical Staff member.

Review of the ED Contract Agency's Emergency Medical Services Agreement, signed by the facility on 07/25/12, revealed Section 1, 2.1 (c) stated the contractor shall provide any services contemplated in this Agreement in compliance with EMTALA and the regulations and standards promulgating thereunder. It further revealed the Contractor and Covering Providers shall participate in any facility training or information programs regarding compliance with EMTALA and shall adhere to all facility rules, regulations, standards, policies or procedures relating to compliance with EMTALA.

Review (listening) of the audio tape, on 01/31/13 at 1:25 PM, from the EMS dispatch of 01/12/13 en route to the facility extension ED with Patient #1 on board revealed the Facility Dispatcher called the facility extension ED and spoke with the ED Charge Nurse informing her of a patient en route with lethargy and possible shingles. The audio tape further revealed Patient #1's blood pressure (BP) was 72/50; heart rate was 120; and he/she had received three hundred (300) milliliters (ml) of an intravenous (IV) fluid bolus. EMS stated they would arrive in about ten (10) minutes. Then, the audio tape revealed the ED Charge Nurse told the Facility Dispatcher there were two (2) pregnant practitioners working in the facility extension ED, and neither could see the patient. The ED Charge Nurse stated the Physician working in the ED on 01/12/13 (ED MD) wanted Patient #1 to be diverted to the main facility ED. Then, the Facility Dispatcher told the ED Charge Nurse she would see what she could do. Nothing else was on the audio tape.

Review of Patient #1's EMS ambulance transport record, incident number 00001068, revealed EMS received a call concerning this patient on 01/12/13 at 7:17 PM with the chief complaint being that Patient #1 had fainted and was unconscious. The EMS record stated Patient #1 was lethargic with family reporting he/she had not had any fluids to drink over the last twenty-four (24) hour period. The family also stated Patient #1 had been a patient at the facility extension earlier in the week and had been diagnosed and treated for shingles. The record further revealed the family requested Patient #1 be transported to the facility extension ED. In addition, the record showed EMS personnel gave Patient #1 a five hundred (500) ml IV bolus of normal saline solution. After this initial treatment, EMS reported Patient #1 showed improvement in mental status, and the electrocardiogram (ECG) showed a change from sinus tachycardia (heart rate over one hundred (100) beats per minute) to sinus rhythm. Next, the EMS report stated a call was made to the facility extension ED, and the transport was completed at 7:58 PM. The EMS report further revealed at this time, the Facility Dispatcher told EMS not to take Patient #1 into the ED. It further stated after three (3) to four (4) minutes EMS was told by dispatch to take Patient #1 into the facility extension ED but was met by a nurse that told the Paramedic EMS could not enter until it was sorted out by the facility extension where Patient #1 would go. The report stated this scenario happened multiple times. The report further revealed EMS was told to take Patient #1 to the main facility ED at 8:21 PM.

Review of Patient #1's EMS ambulance transport record, incident number 00001076, revealed EMS received a dispatch from the facility to transport Patient #1 from the facility extension ED overhang to the main facility ED on 01/12/13 at 8:21 PM and reached the main facility ED at 8:30 PM. The chief complaint of Patient #1 was listed as lethargy and dehydration. The report listed vital signs at 8:29 PM as blood pressure (BP) 91/41; heart rate 102, respiratory rate 16, oxygen saturation 100% with oxygen, blood sugar 162, and Glasgow coma scale 15. The report also stated IV fluid administration had continued, Patient #1 reported feeling much better, and his/her ability to communicate had improved.

Review of Patient #1's ED record from the main facility ED revealed he/she arrived on 01/12/13 at 8:38 PM. Triage time was 8:39 PM. Patient #1 was assigned an acuity level of two (2), Emergent. Vital signs were BP 67/34, heart rate 99, oxygen saturation 97% on two (2) liters of oxygen per minute via nasal cannula. The ED Interim Summary Note described an erythematous squama papular rash over the patient's left forehead and stated the patient was recently diagnosed with shingles on his/her left forehead. Patient #1 stayed in the ED until 01/13/13 at 5:29 AM at which time he/she was admitted to the facility with Diagnoses which included Dehydration, Hypotension, Hyponatremia, Shingles, Emphysema, Chronic Kidney Disease, and possible Sepsis. ED treatment included IV fluid boluses (two (2) liters of Lactated Ringers); IV antibiotics (Levofloxacin 750 milligrams and Piperacillin 3.375 grams); stat ECG and chest x-ray; and stat lab work (hemogram with differential, complete metabolic profile, blood cultures, and catheterized urinalysis with culture). The record further revealed lab results as follows: white blood count 14.2 (normal 4.0 to 10.5); white blood count neutrophils 89% (normal 42 to 74%); hemoglobin 10.9 (normal 11.9 to 15.5); hematocrit 31.0% (normal 35.0 to 45.0%); blood urea nitrogen 44 (normal 8-23); creatinine 2.86 (normal 0.60 to 1.10); sodium 122 (normal 136 to 145); and chloride 87 (normal 101 to 108). The record further revealed, in the Discharge Summary Note, Patient #1's condition improved with continued treatment including a fourteen (14) day course of Acyclovir for shingles (rash was resolving well at time of discharge), and he/she was discharged from acute care to a rehabilitation facility on 01/21/13.

Review of the ED Log at the facility extension, on 01/30/13, revealed there was no entry for Patient #1 on 01/12/13, and no medical record of that event could be produced by the facility extension.

Interview with the Medical Director of the ED (facility extension), on 01/30/12 at 11:30 AM, revealed for backup of Physician coverage in the ED, hospitalists in the facility extension were called. He also stated he lived near the facility extension and could be there quickly if needed. Interview with the Medical Director of the ED (facility extension) per telephone, on 01/31/13 at 3:15 PM, revealed he did not learn of the 01/12/13 incident involving Patient #1 until 01/13/13. The ED MD did not call him and request assistance during this incident. He further revealed universal precautions are used for every patient because the ED practitioner may not know what communicable diseases a patient had; therefore, personal protective equipment (PPE) must always be worn and isolation procedures instituted on a case by case basis. The Medical Director of the ED (facility extension) also stated he had been trained in EMTALA guidelines and used to do the ED schedule for providers, but now the contract agency does the scheduling.

Interview with the ED Contract Agency Compliance and Legal Officer, on 01/31/13 at 3:15 PM per telephone, revealed the agency had provided EMTALA training for its practitioners in 07/2012 and 09/2012. She further revealed both the ED MD and the Physician Assistant (PA) working in the facility extension ED on 01/12/13 during the incident with Patient #1 (ED PA) had received EMTALA training. Also, she stated, since the incident on 01/12/13, the agency had sent out an e-mail to all practitioners regarding the need to take a refresher course on EMTALA; but, as of yet, no training had been conducted. She further revealed the agency had policies and procedures on EMTALA and the ED MD would be placed on code of conduct probation.

Interview, on 01/30/13 at 1:45 PM, with the Paramedic who transported Patient #1 to the facility extension ED and the main facility ED on 01/12/13, revealed he agreed with everything in the EMS ambulance transport reports, number 00001068 and number 00001076. He revealed Patient #1's son had told him the patient could have shingles; his/her Physician was not sure but was treating Patient #1 for shingles. The Paramedic stated when he arrived at the facility extension ambulance bay, he received a call from the Facility Dispatcher telling him not to take Patient #1 into the facility extension ED. He then received a call telling him to take the patient into the ED at the facility extension. He further revealed this was about to happen for the third time, when he received a call to transport Patient #1 to the main facility ED. He stated the reason given to him for not allowing Patient #1 into the facility extension ED was because both practitioners, the ED MD and the ED PA, were pregnant and did not want to expose their fetuses to shingles. The Paramedic further stated the ambulance with Patient #1 sat in the ambulance bay for more than twenty-one (21) minutes with the facility extension's staff members refusing to allow Patient #1 to enter the facility extension ED. In addition, he stated he asked the facility extension's ED staff members to sign the ambulance trip form, but each refused.

Interview with ED Registered Nurse (RN) #1, on 01/30/13 at 4:15 PM, revealed the process for receiving ED patients via EMS was for EMS to call the Facility Dispatcher who then called the facility extension ED. When EMS was en route, a brief report was called to the facility extension ED. RN #1 further revealed personal protective equipment (PPE) was always available and was stocked by Central Supply every morning. She also stated patients were given a mask if contagious, and ED Room #2 was a negative pressure room. She revealed with using proper PPE, the ED should be able to care for any patient. She further stated she knew of no patients with communicable diseases that had presented to the ED that were not seen.

Interview with the facility extension ED Nurse Manager, on 01/31/13 at 9:20 AM, revealed the facility extension ED was not on diversion the night of 01/12/13, PPE was available, and treating patients with shingles or chicken pox was in the facility extension ED's scope of practice. She verified that at the time of the incident with Patient #1, the ED MD and the ED PA were working and were both pregnant. The ED Nurse Manager revealed she received a call from the ED Charge Nurse the next day, 01/13/13, who reported the incident with Patient #1 arriving for treatment but being diverted to the main facility ED. The ED Nurse Manager reported the facility extension ED Charge Nurse stated she took a call from the the facility dispatch office that a patient was en route via EMS with shingles; the ED MD overheard the call and told the ED Charge Nurse to divert Patient #1 to the main facility ED because neither of the practitioners wanted the exposure; the ED Charge Nurse tried to call the facility dispatch office, but the ambulance had already arrived in the ambulance bay; the ED Charge Nurse stated she went outside to tell EMS to hold on entering because the patient was going to be diverted to the main facility ED; while the patient was waiting in the ambulance, the facility ED nurse told EMS to take the patient inside the facility extension ED; then, the ED MD had called a facility ED Physician that agreed to accept Patient #1. So, Patient #1 was transported to the main facility ED. The ED Nurse Manager further revealed the hospitalist was called to come to the ED and examine Patient #1, but he was not able to leave patient care in the Intensive Care Unit (ICU). She further revealed, the ED practitioners at the facility extension were contract employees, and the facility did not control the staffing, the contract agency did. The ED Nurse Manager also stated after the incident, the leadership group viewed a webinar on EMTALA guidelines and were in the process of putting together educational materials for all staff. She further revealed that all nurses had already received training and information on EMTALA.

Interview with the Facility Dispatcher, on 01/31/13 at 1:40 PM, revealed she had taken a call from the facility extension ED Charge Nurse on 01/12/13, requesting Patient #1 be diverted to the main facility ED because of shingles. She reported she contacted EMS, which stated the ambulance was pulling into the ED bay, so she told them not to enter because of the two (2) pregnant providers. The Facility Dispatcher further revealed she spoke to the the facility ED Charge Nurse that told her to tell the facility extension ED to take the patient to their ED for treatment. The Facility Dispatcher further stated the facility extension ED did not answer the call, so she called EMS and told the Paramedic it was okay to take Patient #1 into the ED. EMS replied with a 10-4 copy. The Facility Dispatcher stated, about six (6) to eight (8) minutes later, EMS personnel called her back and stated the ambulance was still in the ED bay because the facility extension ED Charge Nurse came outside and stated Patient #1 could not go inside. She also stated, about twenty (20) minutes later, EMS called her and stated they were en route to the main facility ED. The Facility Dispatcher revealed the EMS Paramedic was very upset.

Interview with the facility ED Physician, on 01/31/13 at 1:50 PM via telephone, revealed she received a call from the facility extension ED MD to see if she would accept Patient #1 because both providers were pregnant and an OB Chief Resident had given them an instruction that neither should see or care for Patient #1. The facility ED Physician stated the ED MD had tried to consult with infectious disease without success. The facility ED Physician agreed to accept Patient #1 at the main facility ED. She further revealed she did not know Patient #1 was already at the facility extension ED.

Interview with the facility Chief Compliance Officer, on 01/31/13 at 2:00 PM, revealed he had been contacted by the Enterprise ED Director on 01/14/13 because his office was responsible for investigating possible EMTALA violations. The primary concern was whether Patient #1 received the required MSE. He further revealed there were some conflicting statements and could not validate that either the ED MD or the ED PA performed a MSE on Patient #1. The Chief Compliance Officer further revealed when employees start working, they are trained face-to-face and with computer modules on issues such as protected health information (PHI) and EMTALA. He also stated the facility was not responsible for training ED contract agency personnel; however, he revealed ED contract employees were required to follow the facility's policies and procedures.

Interview with the facility ED Charge Nurse, on 01/31/13 at 2:20 PM, revealed she received a call from the facility dispatch office stating there was a patient with shingles at the facility extension ED, both providers were pregnant, and the ED MD wanted to divert Patient #1 to the main facility ED. She revealed she told the extension facility that the patient needed to be seen in their ED because the patient had requested to be seen at the facility extension. She stated the next communication she heard was that Patient #1 was not allowed to enter the facility extension ED and was en route to the main facility ED. She further revealed upon assessment of Patient #1, he/she had no open or crusted skin lesions but did have a reddened area on the left side of the face and forehead. She reported Patient #1 was lethargic and hypotensive and was given IV fluid boluses within the first five (5) minutes of arrival. The facility ED Charge Nurse stated it took approximate four (4) liters of IV fluids to get Patient #1's systolic BP in the 90's over a four (4) hour period. She stated Patient #1 was given the option of being admitted to the facility extension; however, he/she was admitted to the main facility because the family stated they were tired of Patient #1 being shuffled around. The facility ED Charge Nurse also revealed the Paramedic stated Patient #1's family had requested to go to the facility extension ED, but the facility extension ED Charge Nurse had met them outside and would not let EMS enter the ED. The Paramedic also revealed he had attempted to unload Patient #1 two (2) to three (3) times and was stopped by the facility extension ED personnel.

Interview with Patient #1's son by telephone, on 01/31/13 at 2:35 PM, revealed the incident with Patient #1 seemed to last thirty (30) to forty-five (45) minutes. He stated Patient #1 was somewhat confused because of the dehydration and did not seem to know what was happening. He further revealed he thought the situation was kind of weird but was only concerned about Patient #1 receiving treatment. He stated he was told the reason the patient could not enter the facility extension ED was because a nurse was pregnant and could not be around anyone with shingles. He further revealed he was not aware of the ED MD coming out to see Patient #1.

Interview with the facility extension ED Charge Nurse, on 01/31/13 at 3:43 PM per telephone, revealed she was the ED Charge Nurse on the evening of 01/12/13. She stated a radio patch was received about a patient en route with shingles. Neither the ED MD or the ED PA stated they could care for this patient. The ED Charge Nurse further stated she called the facility dispatch office and the District Charge Nurse (DCN) about the situation, and by then the ambulance had arrived. She stated she asked EMS to wait to see if Patient #1 could be sent to the main facility ED. The DCN then called and said the providers could see this patient, and she told both providers. She further revealed both the ED MD and the ED PA stated they did not feel comfortable caring for Patient #1 because the OB Chief Resident at the facility stated they should not be exposed to this patient with shingles. The ED Charge RN stated she notified the DCN of this, and thought the ED MD called a Physician at the main facility ED because Patient #1 was accepted there. She revealed the ED MD talked with EMS personnel and wanted to know the condition of Patient #1. She further revealed at one point the ED MD said to let Patient #1 come inside, put a mask on the patient, and the ED MD would also wear a mask. The ED Charge Nurse further revealed by that time, Patient #1 had been accepted at the main facility ED, and she also stated the the ED MD never came out to see Patient #1 while he/she was in the ambulance at the ED entrance. She also revealed, on 01/12/13, ED personnel had PPE and Infection Control protocols available, and since this incident, ED personnel had a meeting to review EMTALA, but so far, there had been no formal or specific education or training.

Interview with the ED PA, on 01/31/13 at 4:04 PM, revealed she was working as a provider on 01/12/13 when the ED received a patch from the facility dispatch office that Patient #1 was en route and had been diagnosed with shingles. Attempts were made to call the facility dispatch office and EMS to get Patient #1 routed to the main facility ED, but then the ambulance arrived in the ED bay. She further revealed the ED MD called the OB Chief Resident at the facility and explained the gestational age for each of the practitioners. The ED PA further revealed the OB Resident said it was not safe for either of the practitioners to see Patient #1, even if wearing PPE. She also stated she never went out to see the patient. The ED PA further revealed the Medical Director of the ED, facility extension, had instructed her there was no danger in taking care of a patient with shingles if PPE was used; and she stated she had received EMTALA training in the summer of 2012.

Interview with the ED MD, on 01/31/13 at 8:35 PM per telephone, revealed she was the Physician working in the facility extension ED the evening of 01/12/13 when the incident with Patient #1 occurred. She stated the ED Charge Nurse took a communication from EMS that the ambulance was en route with a patient with shingles that had experienced a syncopal episode at home and that had been treated earlier in the week at the facility extension. She further revealed she called the OB Chief Resident because of her pregnancy and was told under no circumstances, even if wearing PPE, should she, or the ED PA, because of her pregnancy, care for this incoming patient. She also stated she called the hospitalist, but he could not come to the ED because he was caring for a patient in the ICU that was critical and deteriorating, and she did not call the Medical Director of the ED. The ED MD stated, at this point, an effort was made to divert Patient #1 to the main facility ED and was told there was no reason either practitioner could not care for this patient; however, she believed the OB Resident and did not want to expose either fetus to unnecessary risks. She further revealed, by this time, the ambulance had arrived at the ED bay, and she went out to talk with the family/EMS personnel and observe Patient #1 through the ambulance windows, having no direct contact with the patient or going inside the ambulance. The ED MD further stated from the information given to her by the family and the EMS personnel the patient was stabilizing with an increased BP and improved ability to communicate and interact. She also revealed she called a Physician at the main facility ED who agreed to accept Patient #1. The ED MD stated her main goal was for Patient #1 to be seen as quickly as possible, and under the circumstances, she stated she felt like the best option was for Patient #1 to be sent to the main facility ED. She also revealed she believed she did the best she could do in performing a MSE in that she was told it was not safe for either practitioner to directly evaluate and treat Patient #1, even if wearing PPE. The ED MD also stated she had received training in EMTALA prior to this incident and had been researching its requirements since then.

Interview with the Director of Enterprise Accreditation and Regulatory Compliance, on 01/31/13 at 4:30 PM, revealed the facility, in the ED Charge Nurse Meeting on 01/23/13, addressed EMTALA and produced a copy of the minutes which stated a MSE must be done even on active labor patients. She also stated an outline was being developed for an EMTALA education offering for all hospital and medical personnel. This educational offering was to be in 02/2013.

APPROPRIATE TRANSFER

Tag No.: A2409

Based on interview, record review, and review of facility policy, "Transfer of Patients," policy number A02-015, effective date 10/2008, it was determined the facility extension failed to ensure one (1) of five (5) patients selected for review as a transfer from the Emergency Department (ED) (out of a total of 21 patients reviewed) had an appropriate transfer as evidenced by lack of documentation that the receiving facility 1) had agreed to accept the transfer; 2) had been sent the required hospital records; and 3) had received the patient through appropriate transport means, for example qualified personnel with needed equipment, Patient #20.

The findings include:

Review of facility policy, "Transfer of Patients," policy number A02-015, effective date 10/2008, revealed patients transferred to an external psychiatric facility must have a transfer form completed by the Physician, Social Worker (if applicable), and Nurse. The policy further revealed the patient must be medically and psychiatrically stable before being transferred to an external psychiatric facility. It stated the attending Physician, in consultation with the Psychiatrist would prepare a referral with the signature of the consulting Psychiatrist, and if the patient was seen on an emergent basis, the ED records would be copied and transferred with the patient. It further revealed the Physician would determine the appropriate mode of transport, the supervision required, and the patient's medical condition, and in the ED, the nursing staff would arrange for the transport.

Review of Patient #20's ED record revealed he/she arrived at the facility extension ED on 07/30/12 at 2:51 AM with a chief complaint of suicidal ideation with no attempt made and was escorted by law enforcement. The Physician ED note listed unremarkable vital signs and negative/noncontributory review of systems. It also listed a Psychiatric consult was done, a urine drug screen was presumptively positive, and the patient had an appropriate mood and behavior. Patient #20 was transferred to an external psychiatric facility. There was no documentation the receiving psychiatric facility had agreed to accept the transfer, had been sent the required hospital records, or that the patient had been transported appropriately and safely to the receiving psychiatric facility. The record revealed there was no facility transfer form.

Interview with the Enterprise ED Director and the facility RN ED Manager, on 01/31/13 at 4:25 PM, revealed both stated the facility extension ED had not been completing transfer forms that had required information for ED patients transferred to an external facility since 2010 when personnel were told they did not have to complete the transfer forms for an intra-facility transfer, transfer from the facility to the facility extension. They both stated, at this point, the staff stopped completing any transfer forms for any patients, no matter where they were being transferred. They further revealed the problem was discovered during an Office of the Inspector General (OIG) Validation Survey conducted 01/14/13 through 01/18/13 and since the problem was identified, the facility had started completing transfer forms (one to go with patient and one to stay in ED record) for patients transferred outside the facility system.

Confirmation of the facility extension completing a transfer form was accomplished by review of a closed ED record, Patient #9, which revealed he/she was seen in the facility extension ED on 01/27/13 with a chief complaint of suicidal ideation with no attempt made. The record revealed this patient was transferred on 01/27/13 to an external psychiatric facility. The record also revealed it contained a "Transfer Agreement" that listed the medical condition of the patient, the reason for transfer, the approval of the receiving facility for transfer, the Physician accepting transfer, who received the patient report at the receiving facility, the transfer method, and treatment information. This form must be signed by the Discharging Nurse. This form also has a section for transfer of unstable patients with the required Physician completion and signature.