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Based on staff interview, clinical record and administrative document review, the hospital failed to comply with the provisions of CFR 489.24 when one of twenty patients (Patient 1) was diagnosed with Stevens-Johnson Syndrome (SJS-a severe and sometimes fatal skin condition often requiring hospitalization) and was discharged home with instructions to call a dermatology clinic to arrange an appointment later that morning. The dermatology clinic was approximately 70 miles away from Hospital 1. Patient 1 was subsequently admitted to Hospital 2's emergency department on 6/17/15 at 3:57 p.m. (11 hours after discharge from Hospital 1). Patient 1 was admitted to the in-patient medical surgical area of Hospital 2 for symptoms of SJS.

The failure to provide stabilizing measures within the capabilities of the hospital resulted in the potential for patient harm during the time Patient 1 was not in a hospital setting.

Based on staff interviews, clinical record review, administrative document review, and authoritative Internet medical sources, the hospital (Hospital 1) failed to provide stabilizing treatment within the capabilities of the facility and staff for a known emergency medical condition (EMC) when:

Patient 1 arrived at Hospital 1's Emergency Department (ED) via ambulance from a local urgent care with symptoms of Stevens Johnson Syndrome (SJS - a rare, potentially serious disorder of the skin and mucous membranes, that usually requires hospitalization and is considered a medical emergency; SJS begins as a painful rash that spreads and blisters) and was discharged home on 6/17/15 at 2:48 a.m. with instructions to follow-up in the dermatology clinic of a university hospital (Hospital 2) located 71 miles from Hospital 1. On 6/17/15 at 2:45 p.m., a physician's note documented Patient 1 was seen at the Hospital 2's dermatology clinic. He was subsequently admitted to Hospital 2's emergency department on 6/17/15 at 3:57 p.m. (11 hours after discharge from Hospital 1). Patient 1 was admitted to the in-patient medical surgical area of Hospital 2 for symptoms of SJS.

The failure to provide stabilizing measures within the capabilities of the hospital resulted in the potential for patient harm during the time Patient 1 was not in a hospital setting.

Findings:

A review of Patient 1's clinical record indicated the following:

On 6/16/15 at 7:14 p.m., Patient 1 arrived by ambulance at Hospital 1, presenting with a red raised rash with blisters on his upper body and lower extremities. He was assigned an Emergency Severity Index of 3 (a five-level triage system used to evaluate both patient acuity and facility resources).

On 6/16/15 at 7:20 p.m., the Emergency Department physician (EDP) documented in the ED note Patient 1 presented to the ED with a "rash described as intensely itchy and worsening in progression with blister formation.... Patient tried to modify symptoms with benadryl [diphenhydramine-an antihistamine medication used to alleviate itching] and prednisone [a type of steroid medication used to treat inflammation] as prescribed to him 4 days previous." The physical exam of Patient 1 indicated, ".... Intensely red raised large plaque [an elevated skin lesion] covering trunk and extremities with vesicle [a small fluid filled blister] formation on the lower legs...."

On 6/16/15 at 7:22 p.m. Patient 1 was roomed in ED room 38.

On 6/16/15 at 7:24 p.m. the EDP ordered a saline lock IV (a portal placed and left in a vein, used episodically for fluid or medication infusions, referred to as intravenous, or IV, access), diphenhydramine 25 milligrams (mg) injected IV, and blood sample to be taken for laboratory tests (a Complete Blood Count, or CBC, a Comprehensive Metabolic Panel with GFR (Glomerular Filtration Rate, used to assess kidney function), and an Erythrocyte Sedimentation Rate).

On 6/16/15 at 9:17 p.m., the hospitalist (HMD-a physician whose professional activities are performed chiefly within a hospital) consult was ordered by the EDP.

On 6/16/15 at 9:48 p.m., as documented in the facility document, "Patient Care Timeline", the EDP indicated he discussed Patient 1 with the HMD who "will admit" Patient 1.

On 6/16/15 at 9:50 p.m., as documented in the facility document, "Patient Care Timeline", EDP documented, "ED disposition set to Decision to Admit" and a bed request on a medical surgical unit was made.

On 6/16/15 at 9:54 p.m., the Registered Nurse (RN) 1 documented in ED Notes the HMD was at Patient 1's bedside for evaluation.

On 6/16/15 at 10:04 p.m., the EDP documented in an ED Note, "Discussed further with [HMD], who states the hospital is not equipped to treat Stevens-Johnson. She recommends referral to burn center at [Hospital 2]."

On 6/16/15 at 10:21 p.m., the HMD documented Patient 1's skin was "erythematous [red] maculopapular [round flat areas as well as firm bumps on the skin] rash with borders and coalescing [areas of the rash that have grown to the point of joining other areas]". The HMD assessment indicated "Erythematous and coalescing rash with blisters and borders suspecting Steven Johnson Syndrome vs other." She indicated in the plan "Recommend transfer to [Hospital 2] burn center for higher level of care and derm [dermatology is the medical specialty of care and treatment of skin conditions] consult; IVF [IV fluids] for hydration en route; [Patient 1] was [treated] with benadryl and has not had relief, feels rash is becoming worse."

On 6/17/15 at 12:30 a.m., the EDP documented, ".... Case discussed with [HMD], who recommends transfer out to burn center or other outlying facility with dermatology for consult. [Hospital 2], [Hospital 3], and [Hospital 4] declined transfer to their facilities. Patient will likely be referred to [Hospital 2] Dermatology Clinic. Multiple institutions have been called but either do not have hyperbaric chambers [pressure chambers used to deliver oxygen at higher pressures than the atmosphere, used to treat various medical conditions], have no dermatology, or no beds...."

On 6/17/15 at 1:52 a.m., the EDP ordered diphenhydramine 25 mg injected IV.

Hospital 1 document titled, "Transfer Center Pre-Admit Face Sheet" created by CentralLogic, Hospital 1's transfer center made calls to 12 hospitals, requesting transfer of Patient 1 from Hospital 1's ED to an inpatient bed. No transfer occurred due to lack of services requested at the other facilities or the other hospitals were at maximum capacity at the time the calls were placed.

On 6/17/15 at 2:23 a.m., in the facility document, "Patient Care Timeline", the EDP documented, "ED disposition set to Discharge." An explanation or rationale for the change in disposition was not documented.

On 6/17/15 at 2:40 a.m. the discharge medication list indicated, "START taking these medications: diphenhydramine (BENADRYL) 25 mg Tab. Take 1-2 Tabs by mouth every 4 hours as needed for itching...."

On 6/17/15 at 2:48 a.m., RN 2 documented in Patient 1's clinical record Patient 1's IV was removed. Discharge instructions were printed with a diagnosis of Stevens-Johnson syndrome. Stevens-Johnson Syndrome education was included with the discharge instructions. Patient 1's after care instructions indicate Patient 1 was to "Call [Hospital 2] Dermatology Clinic at 8:30 a.m. I will also call them and give information about you to help you get an appointment. When you call, tell them we spoke with the transfer nurse tonight and they gave you a medical record number..." Patient 1 ambulated (walked) to the lobby.

Clinical records from Hospital 2's Dermatology Clinic, signed dated 6/17/15 at 2:45 p.m., indicated Patient 1 was seen with ".... Erythematous-violaceous [red-violet] targetoid confluent plaques [target shaped, joined together flat or raised patches on skin] of the right and left upper extremities, chest, abdomen, back, and legs; Flaccid [weak or soft] and tense blisters with yellow-clear fluid seen on the right upper extremity, right back, left abdomen, and legs; Erythematous sloughing [shedding] of the right ear, back, lateral abdomen, and legs... The patient has flaccid and tense bullae [fluid filled blisters] on the trunk and extremities with evidence of skin sloughing on the left ear, right back/flank, and lower extremities. He is hemodynamically stable now but he is at increased risk for infection and insatiable [possible misspelling of insensible, meaning gradual by very small amounts] loss [of fluid]. Because he is starting to slough and there is development of blisters, I believe the patient should be managed in the hospital... The ER was also notified of his arrival..."

On 6/17/15 at 3:57 p.m., Hospital 2's ED record indicated Patient 1 received a Medical Screening Exam (MSE). The Emergency Department Physician at Hospital 2 documented, ".... Patient began taking Prednisone pills and Benadryl 4 days ago with no improvement in rash. Seen in derm clinic today and sent in for admission for SJS. Quality: itching, burning; Severity: 8/10; Time Course: constant; Progression: gradually worsening.... Erythematous ring like lesions, coalescing across bilateral back, arms, legs, chest and abdomen. Some areas of blistering and open blisters on lateral aspect of R[ight] arm, back, and lateral aspect of L[eft] arm... After history and exam, I feel the differential diagnosis includes, but is not limited to erythema multiforme, Stevens Johnson syndrome, dehydration, electrolyte problems, or super infection.... Patient will be admitted to the hospital for hydration, wound care, possible steroids, supportive care...."

Patient 1 was admitted to Hospital 2 on 6/17/15 as an inpatient on a medical surgical unit.

On 6/17/15 at 7:40 p.m., Patient 1's History and Physical (H&P) was dictated by a physician at Hospital 2. The H&P indicated, "....DERMATOLOGIC: ... there is a large confluent patches and plaques, right upper and left upper extremities, chest, abdomen, back and legs. There are some tense blisters in the right upper extremity and the right leg. There is some sloughing of the back, lateral abdomen, and legs.... Stevens-Johnson syndrome: I discussed the case with Dermatology... I used SCORTEN risk stratification tool to predict his mortality given his age, body surface area, and BUN [a laboratory blood test stand for blood, urea, nitrogen; test to evaluate kidney function], and gives him three risk factors, bringing his mortality rate to 35%. Though the patient looks stable clinically [16 hours 52 minutes after discharge from Hospital 1's ED], given the extensive involvement and body surface area, and his mortality risk, I discussed the case with both Burn Surgery and MICU [Medical Intensive Care Unit]... I will therefore go ahead and admit to a med/surg [medical surgical unit in a hospital] bed with close monitoring, IV fluid, nutritional support, pain control...."

Patient 1's discharge summary from Hospital 2, dated 6/21/15, signed 6/22/15 at 2:30 p.m. indicated "The biopsy did come back revealing vacuolar inter[f]ace dermatitis [a connective tissue, which includes skin, condition] which can be seen with both EM [erythema multiforme, a mild to serious skin condition] and SJS.... Skin: multiple erythematous maculopapular plaques with involvement of bilateral upper extremities, trunk, and lower extremities. Some blisters with serous fluid. Some erosions... overall improved.... The histologic [microscopic study of cells] differential diagnosis [used to diagnose a specific disease] includes erythema multiform[e], but identical changes may be seen in Stevens Johnson syndrome."

Patient 1 was discharged from Hospital 2 on 6/21/15.

On 12/28/15 at 3:15 p.m., during a concurrent observation and staff interview, a tour of Hospital 1's ED took place. The Assistant Emergency Department Director (AEDD) stated, ".... A hospitalist evaluates [patients] when an ED physician wants to admit. Occasionally an ED physician will admit, but usually it is a hospitalist..."

On 12/30/15 at 7:23 a.m., during an interview, the EDP stated he was the physician assigned to Patient 1 on the dates in question and was familiar with the course of treatment. He stated he remembered Patient 1 and had an opportunity to review his clinical record prior to the interview. He stated Patient 1 had a number of vesicles. He stated the HMD agreed Patient 1's rash was possibly Stevens Johnson and "if he got worse we wouldn't be able to handle it here." The EDP stated he called multiple facilities but none of them thought Patient 1 "...sounded that bad." When asked to clarify the decision to discharge Patient 1 home as opposed to admission, the EDP stated, "The person I spoke to from [Hospital 2] suggested the dermatology clinic in the morning when they open. They gave [Patient 1] a medical record number... I can't admit him here [at Hospital 1], vitals are normal; no one else will take him, it's just a few hours from now [when the Dermatology Clinic opens at 8:30 a.m.]... That's better than nothing." No other rationale was offered for the decision to discharge Patient 1 home.

On 12/30/15 starting at 11:06 a.m., the following individuals agreed to be interviewed in a group setting held in the Boardroom of Hospital 1. All were asked if they were familiar with the clinical care of Patient 1, and all confirmed familiarity and stated they were able to review Patient 1's clinical record.

ED Assistant Medical Director (EDAMD) stated the EDP examined Patient 1 and wanted to admit him "here or transfer to another facility. About five hours elapsed between when he was discharged and when his appointment at the burn clinic was."

The Medical Director of the Hospitalist Program (MDHP) stated Stevens-Johnson Syndrome was highly suspected due to the large percentage of skin involvement. Because of the high percentage of involvement, both the EDP and the HMD agreed a burn center would be best for the patient. She stated, "At this point, the hospitalist stepped out of the picture. We think the patient is going to be admitted elsewhere unless told otherwise. If the ED physician does not feel comfortable sending the patient home, we do reassess and will admit. No apparent request [to reassess] was made in this case. It appears [the HMD] was not informed the patient was not being transferred to the burn center... If that patient had been admitted here, he would not have been seen by an expert as soon as he was [at the dermatology clinic]." When asked if she had ever had a patient with SJS, the MDHP she stated she had one in the past and that patient was admitted.

The Emergency Department Medical Director (EDMD) stated the physician at the burn center was the expert as related to Patient 1's condition. That physician [at the burn center] recommended an appointment with Hospital 2's dermatology clinic in the morning, a few hours after discharge.

The HMD, RN 1 and RN 2 were not available for interview.

The hospital policy and procedure titled, "Triage Policy" dated 5/14/15, indicated " Policy: ... B. All patients presenting to the Emergency Department (ED) for treatment will be assessed by a Registered Nurse to determine the urgency of the patient's condition and will be assigned a triage/acuity level based on the Emergency Severity Index (ESI) system.... ESI: Emergency Severity Index is a five-level triage system that categorizes emergency department patients by evaluating both patient acuity and resources... A resource is: labs... specialty consultation.... The RN will initially obtain and document objective information and assessment to include: 1. Presenting complaint/symptoms.... Upon completion of assessment the RN will use the ESI system to assign a triage level.... the triage nurse should consider how many different resources they think this patient is going to consume in order for the physician to reach a disposition decision. 1. ESI Level 3 requires 2 or more resources... Level 3: Conditions that could pose a potential threat to patient's health requiring timely emergency intervention and would benefit from evaluation and/or treatment....

The facility document "Medical Staff Rules and Regulations" dated 5/12, indicated, "Emergency Care Services... D. No person presenting to [Hospital 1] will be refused emergency services. All persons will be screened and stabilized, within the capability of the hospital...."

According to the Mayo Clinic in an article dated 4/22/14, "Stevens-Johnson syndrome is a rare, serious disorder of your skin and mucous membranes. It's usually a reaction to a medication or an infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters. Then the top layer of the affected skin dies and sheds. Stevens-Johnson syndrome is a medical emergency that usually requires hospitalization..." web address http://www.mayoclinic.org/diseases-conditions/stevens-johnson-syndrome/basics/definition/con-20029623?p=1

According to an article in the Orphanet Journal of Rare Diseases, referenced by the Center for Disease Control, titled, "Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome" dated 12/16/10, indicated "Initial symptoms of ... Stevens Johnson Syndrome can be unspecified and include symptoms such as fever, stinging eyes and discomfort upon swallowing. Typically, these symptoms precede cutaneous manifestations by a few days... The morphology of early skin lesions includes erythematous and livid macules, which may or may not be slightly infiltrated, and have a tendency to rapid coalescence.... In a second phase, large areas of epidermal detachment develop.... The extent of skin involvement is a major prognostic factor. It should be emphasized that only necrotic skin, which is already detached (e.g. blisters, erosions) or detachable skin (Nikolsky positive) should be included in the evaluation of the extent of skin involvement...." Web address http://www.ojrd.com/content/5/1/39.

The Skin Association article titled "Stevens-Johnson Syndrome Symptoms" indicated, "... Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis [a rare, life-threatening skin condition that is usually caused by a reaction to a drug] are very serious, potentially deadly conditions and have to be treated accordingly... Patients have to be treated in meticulously hygienic environments to alleviate the risk of further infection, which could result in death. In cases where the patient has lost a lot of fluid through seeping areas where the skin has come away, intravenous fluid replacement may be required. The hospital may also use topical and oral corticosteroids to treat affected areas." Web address