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Based on review of records and interviews, the hospital failed to comply with 489.24 in that
the hospital's Board of Trustees failed to ensure all patients presenting to the Emergency Department (ED) from 08/01/10 to 02/15/11 received an appropriate medical screening examination to determine whether or not an emergency condition existed. All the Registered Nurse's (RN's) who performed medical screening examinations (MSE's) in the Emergency Department (ED) were not appointed through the hospital's credentialing process as Qualified Medical Personnel (QMP). The RN's performing MSE's were not evaluated by the Credentialing Committee, recommended by the Medical Staff, nor appointed by the Governing Board to provide MSE as QMP.

Findings included:

The Medical Staff and Board of Trustee Minutes, from 09/08/09 through 02/15/11 did not reflect formal designations or approval for any RN or AHP as Qualified Medical Personnel to perform medical screening examinations in the ED.

The Board of Trustee Bylaws, not dated, required, "Article VII...The Professional Staff (PS) shall make recommendations to the Board of Trustees concerning...granting of clinical privileges to physicians, dentists and Allied Health Professionals (AHP)...any matters relating to professional competency and conduct of staff members and AHP...All applications for appointment to the PS and/or for the granting of clinical privileges shall be in writing and shall contain adequate information concerning the applicant's education and training, licensure, practice, experience, health status, judgment, current clinical competency, professional conduct and individual character, and any other matters pertinent to the applicant's ability to perform the functions of a member of the PS and/or exercise clinical privileges in accordance with accepted professional standards...shall consider recommendations of the PS...in processing all appointments, reappointments, grants of clinical privileges...which shall comply with all legal and accreditation requirements...shall, in the exercise of its discretion delegate to the members of the PS and those with clinical privileges the responsibility for providing appropriate health care services to patient in the Medical Center...Other health care services shall be provided by Medical Center employees or other designated health care providers under the appropriate degree of supervision by a PS member with the required clinical privileges..."

The Medical Staff Bylaws and Rules and Regulations, "Rules and Regulations of the Professional Staff ", revision date 09/08/09, required, "The Attending Practitioner is responsible for coordinating the patient's care...History and Physical (H&P) Examination...for all aspects of the H&P examination...the elements of the H&P examination must be documented...The following elements are to be part of the Nursing Assessment...the family/guardian expectations for, and involvement in, the assessment, treatment and continuous care of the patient...pertinent history of the injury or illness...pertinent physical assessment...clinical observations...QMP for Screening Examinations...For purposes of ...performing an appropriate MSE of an individual presenting to the Medical Center to determine whether the individual suffers from an emergency medical condition (EMC).The following professionals are deemed to be QMP: a. Physicians on the PS of Medical Center b. RN's with documented assessment skills and orientation to medical screening criteria established by the medical and nursing directors of the ED... "

"The Bylaws of the Professional Staff ", dated 09/14/10, requires, "Section 4. AHP...Qualified individuals in AHP categories approved by the Governing Body (GB) may be granted clinical privileges and/or scope of practice authorization to provide patient care services in the Center...The Medical Board (MB) shall advise the GB with respect to the delineation of clinical privileges and/or scope of practice, the level of delegation, direction and/or supervision required, and the qualifications for AHP...shall be subject to the authority of the appropriate Division Chief, and the use of AHP by Practitioners must comply with their authorization to practice and the requirements in the Credentialing Procedures Manual...Section 6. Processes for Clinical Privileges; Credentialing Procedures Manual...The process for evaluating and granting clinical privileges to Practitioners and AHP shall include the following basic steps: 1. Submission of a written application in the form required by the GB...3.use of a focused professional practice evaluation (FPPE) with all grants of initial clinical privileges. 4. Review and written recommendation by the Credentials Committee (CC), to include review of training, experience, and clinical competence...5.review and written recommendation by the MB; and 6. Review and a final decision by the GB...Section 3. Medical Board...Duties...receive and act upon committee reports...enforce the bylaws...make recommendations on hospital management matters and contracted patient care services to the GB...Fulfill the Staff's accountability to the GB for the professional health care rendered to patients in the Center...Review and investigate the recommendations, as forwarded by the CC of applicants for Staff members and AHP with clinical privileges, and to make recommendations to the GB..."

In an interview with the CNO (Personnel #1), at 4:10 PM on 02/15/11, she was asked who provided the Medical Screening in the ED. She stated, "Our RN's do the Medical Screening. Our Board of Trustees has determined that RN's in the ED can do medical screening and are Qualified Medical Personnel." She was asked if the Physician Assistant's (PA's) that practice in the ED are QMP. She stated, "No, our PA's do not do Medical Screenings and we do not consider them as QMP's." She was asked if the individual RN's that are providing MSE's have been individually named and credentialed by the Board of Trustees as QMP's. She stated, "No. I sit on the Medical Staff and Credentialing Committee's and we have not named any individual nurses as QMP's. "

In an interview with the Director of ED (Personnel #2) at 4:30 PM on 02/15/11, she was asked if the ED RN's were responsible for the triage process. She stated, "No, the RN's do the Medical Screening." She was asked if the RN's have been designated as a QMP by the Governing Body. She stated, "The RN's are QMP's by their education, training and experience. They have PALS (Pediatric Advanced Life Support) and/or ENPC (Emergency Nurse Pediatric Course) along with a Medical Screening course we provide at the facility. We provide orientation and competencies for the Medical Screening." She was then asked who provided the Medical Screening course and source of the approved curriculum. She stated, "Our ED nurse educator teaches the course and the course was developed in-house. We used PALS, ENPC, and ENA to help develop our course." She was asked if the PA's were designated QMP. She stated, "No, we only have two PA's and they only work in the ED LITE (non-urgent care area of the ED). We do not use them as QMP's." She was asked if the RN's providing Medical Screening were Advance Practice Nurses (APN's) or Nurse Practitioner's (NP). She stated, "No, we do not have any APN's or NP's employed in the ED." She was asked if the Governing Body designated the individual QMP to perform MSE. She stated, "The Board of Trustees has designated RN's that have had training as QMP in the ED to perform MSE." She was asked if the RN's with MSE training have gone through the credentialing process as required by the Medical Staff and if appropriate documentation was in the personnel files. She stated, "The RN's have had competencies done for MSE and placed in their personnel files but do not have an appointment letter." She was asked if the ED CQI (Continuous Quality Improvement) program monitored the appropriateness of the MSE and treatment provided by the RN's. She stated, "No."

Based on review of records and interviews, 1 of 1 patient (Patient #1) medically screened by the RN (Personnel #13) in the ED on 09/13/10 was not provided further medical examination and stabilizing treatment when the parents continually requested help. The failure of the RN to perform a complete initial nursing assessment, reassessment, examination and provide stabilization resulted in a delay of appropriate treatment for Patient #1. The patient was triaged by the RN as ED LITE (non-urgent). Patient #1's medical condition deteriorated as he waited in the ED LITE area and died that evening while in the ED.

Findings included:

Patient #1, age 15 months, presented on 09/13/10 at 6:09 PM to the hospital ED accompanied by his parents for complaints of fever and vomiting for 2 days.
The patient's ED medical record, timed at 6:10 PM, revealed the medical screening examination performed by the RN (Personnel #13), "maximum temperature 102.0? Fahrenheit (F)...vomiting since yesterday...vomited 3 times today...Pulse 182 beats per minute..."
There was no comprehensive physical nursing assessment, plan of care, treatment or interventions documented at this time. The RN documented the medical screening examination to be non-urgent.

At 7:48 PM, the medical record showed Patient #1 was taken to Room 2 in ED LITE (non-urgent).

At 8:37 PM, (approximately 2 hours and 25 minutes after the initial exam by the RN) the medical record showed Patient #1 was examined by the Physician Assistant (Personnel #5). The examination showed, "vomiting 5-6 times today with increasing fussy for 2 hours...hoarseness in throat, a rash on the back for 24 hours, phlegm...decrease in sleeping...decrease in oral intake...diarrhea...last emesis just before entering room...alert but whimpering...erythematous macular rash with questionable petechia on his back...left tympanic membrane bulging..."

The Physician Orders, timed at 8:44 PM showed a STAT chest x-ray, Intravenous (IV) normal saline, IV antibiotics, blood work including a CBC (complete blood count), ABG (arterial blood gas), electrolytes and a blood glucose was ordered.

At 8:47 PM, the "Laboratory Serology" results for "Group A Rapid Strep" test showed positive for streptococcus.

At 8:48 PM, the primary care RN (Personnel #15) documented Patient #1 was "Lethargic...rash to upper back...slow capillary refill...Dr. called ER to move..."

At 11:50 PM, the "Physician Progress Notes" showed the Physician (Personnel #6) wrote a late entry, revealing the PA (Personnel #5) asked her to examine Patient #1 after her initial exam. The Physician's (Personnel #6) examination revealed, "eyes open...faint cry...ill appearing...tachycardiac (fast heart rate)...bounding central pulses...upper extremities capillary refill 3-4 seconds (normal less than 2 seconds)...lower extremities cool and mottled with a capillary refill approximately 6 seconds...central capillary refill approximately 3-4 seconds...skin mottled appearing...did not resist sternal rub or withdraw from pain...no recent vital signs to compare...discussed with parents immediate need to immediately transfer patient to main ED for resuscitation...had acute deterioration on transfer...once in room, central refill decreased from the initial 3-4 seconds, baby less responsive...immediately taken to resuscitation room..."

At 9:25 PM, the ED record showed Patient #1 went into ventricular fibrillation then into asystole (no heart beat). CPR (cardiopulmonary resuscitation) was initiated without being successful. Patient #1 was pronounced dead. The diagnosis documented on the ED Record, showed, "Sepsis (blood stream infection)."

In an interview at 9:15 AM on 02/17/11, the medical screening RN (Personnel #13) was asked if she performed MSE on patients presenting to the ED. She stated, "Yes." She was asked if she had received any specialized training to perform MSE's. She stated, "Yes, I have had training at another hospital (Hospital B) and here at Cook Children's Medical Center." She was asked if she was an Advanced Practice Nurse or Nurse Practitioner. She stated, "No." She was asked if she had been designated by the Governing Body as a Qualified Medical Personnel. She stated, "The hospital has designated me as qualified by my education, training and experience." She was asked to review the medical record of Patient #1. She was then asked if she performed the MSE on Patient #1. She stated, "Yes, but I don't remember anything about him." She was then asked if she had performed a comprehensive nursing assessment on Patient #1. She stated, "We don't do a comprehensive assessments in screening. We only do a quick focus screening on the presenting complaint to make a determination of the screening level." She was asked if a nursing plan of care was initiated at this time. She stated, "No, we do not do nursing care plans in the ED." She was asked if the RN that was medically screening was responsible for reassessing patients in the waiting room. She stated, "We reassess if the paramedics tell us something is wrong." She was then asked if the RN QMP consulted with a physician regarding the medical screening process or any treatments ordered. She stated, "A physician is available in the main ED if we need something."

In an interview at 9:40 AM on 02/17/11, the hospital EMT, Orderly (Personnel #21), she was asked if she remembered Patient #1. She stated, "Yes, I remember him being in the ED LITE (non-urgent) waiting room. Everything seemed normal." She was asked if she remembered the father asking for help or for someone to look at Patient #1. She stated, "Yes, He came to the window in ED LITE and asked in Spanish for someone to come look at the baby. The Paramedic (Personnel #20) went out and assessed him." She was then asked if she remembered if anyone else had looked at Patient #1. She said, "No." She was asked if she remembered how long it was before Patient #1 was taken back to a room to be examined. She stated, "No."

In an interview at 10:15 AM on 02/17/11, the hospital Paramedic (Personnel #20) was asked if he remembered Patient #1. He stated, "Yes, I remember him being in the ED LITE waiting room with his parents. He was sitting in his mothers lap and had been crying loudly the whole time he was in the waiting room. His father knocked on the window and said, 'My baby sick. My baby sick ' I went out and assessed him. He was sitting in the mom's lap crying and moving around. I took his temp and it was 38.7 ? C (101.4? F)." Personnel #20 stated Patient #1's abdomen was mottled and "could tell dad was concerned." He was asked if he remembered how long Patient #1 had been in the ED LITE waiting room before the father asked him to check on his son. He stated, "It was approximately 15-20 minutes that he had been in the waiting room when the father asked me to check on him. It was about another 15-20 minutes before he went back to the room." He was asked if he had notified anyone or a nurse about the increase in temperature or the parents concerns. He stated, "No, I did not think anything was abnormal..."

In an interview at 9:50 AM on 02/17/11, the primary RN (Personnel #15) was asked if she was assigned as Patient #1's Primary Nurse. She stated, "Yes." She was then asked if she remembered taking care of him. She stated, "Yes." She was asked if she had performed a nursing assessment on Patient #1. She stated, "The PA (Personnel #5) came into the room and was examining the patient before I had a chance to assess him. The first time I saw him; the PA was in the room and asked for labs and an IV start. I started working on getting the labs and IV. The PA did a strep swab and then the Dr. (Personnel #6) came in to examine him. At this point his skin was mottled. It was shortly after this we moved him to the main ED." She was asked if the paramedic (Personnel #20) or the orderly (Personnel #21) had notified her that Patient #1's father was requesting help. She stated, "No, I don't remember the dad asking for help." She was asked what the hospital's policy was on how long after the patient was taken back to a room that a nursing assessment was performed. She stated, "I am not sure." She was asked how long Patient #1 had been in the examination room before he was seen by someone. She stated, "I do not know."

In a telephone interview at 11:50 AM on 02/17/11, the PA (Personnel #5) was asked if she remembered examining Patient #1. She stated, "Yes." She was asked if any RN, paramedic or orderly had notified her prior to her exam regarding any changes in Patient #1's presentation, appearance or family concerns that he was getting worse while waiting in the ED. She stated, "No." She was asked what she remembered when examining the patient. She stated, "I remember him being in the mom's lap, his eyes were open and he was whimpering. He was not toxic appearing at this time and was not resisting the exam. I had the interpreter in to translate. The father said he was acting normal until right before the exam and began getting more fussy. I was concerned and went and asked the doctor (Personnel #6) to come examine him. When I returned with the doctor, which was about a minute, he had changed drastically. The doctor examined him and transferred him to the main ED immediately "

In an interview at 11:20 AM on 02/17/11, the Attending Physician (Personnel #6) was asked if she remembered examining Patient #1. She stated, "Yes, the PA (Personnel #5), came and told me (Patient #1) did not look right and asked me if I would come to ED LITE and evaluate him. I went immediately to his room and examined him. He was very ill and lethargic appearing. I did not have any recent vital signs so I asked the tech to get some and started making arrangements to move him over to the main ED. I discussed with the father through the translator that we needed to transfer him over to the main ED for treatment. The dad told me he had been acting his normal self until about 2 hours prior to me examining him." She was asked if the father told her that he had asked for help and did not receive any help from the staff. She stated, "He kept saying he was really worried about him and told the staff multiple times." She said the father told her, "I kept saying he was getting worse." She was asked what happened next after moving Patient #1 to the main ED. She stated that as he was being moved, he deteriorated during transfer and once in the room he became less responsive. He was then moved to the resuscitation room and doctor (Personnel #30) took over the resuscitative efforts. She stated that once (Personnel #30) took over, she went back to ED LITE and heard later that (Patient #1) had died."

In an interview at 11:00 AM on 02/17/11, the Patient Advocate (Personnel #10) was asked if he remembered Patient #1. He stated, "Yes, I was called in by the PA (Personnel #5) to translate in ED LITE and then they called in the doctor (Personnel #6)." He was asked if he remembered if the father discussed with him about asking for help and not receiving any help from the staff. He stated, "Yes, the father told me they had been waiting over two hours and the baby kept getting worse while they were waiting. He said he kept asking for help and wanting to know how much longer it was going to be because the child kept getting sicker. He said when they got back to the room he asked again. He said he kept pressing on his chest and the child was not responding." He stated right after the PA saw the patient, she went and got the doctor (Personnel #6) and they took the child back to the main ED."

The Administrative Policy, "MC 011, Emergency Medical Screening and Transfer of Patients" , dated "April 2009" reflected, "The Board of Trustees... after consultation with the Medical Staff, has adopted the following policy...provides for emergency Medical Screening Examination (MSE) and stabilizing care to individuals with emergency medical conditions (EMC) in and on all hospital grounds and property...Individuals seeking medical treatment of their rights to receive an appropriate MSE, necessary stabilizing treatment...EMC means...a medical condition manifesting itself by acute symptoms of sufficient severity...such that the absence of immediate medical attention could reasonably expect to result in...serious jeopardy to the health of the individual...serious impairment to bodily functions...QMP are personnel who have been identified for purposes of (1) performing an appropriate MSE of an individual presenting to the Medical Center to determine whether the individual suffers from an EMC...at the direction of the responsible Physician, the following are deemed by the Board of Trustees to be QMP: 1. Physicians; 2. RN's with demonstrated assessment skills and documented orientation to medical screening criteria established by the medical and nursing directors of the ED...Stabilize means, with respect to an EMC as defined above, to provide such medical treatment of the condition as may be necessary to assure, within reasonable probability, no material deterioration of the condition is likely...Procedures: 1. Initial medical screening procedures: Initial medical screening will be done by an ED RN who is trained and experienced in patient assessment, or other QMP as defined herein. The screening shall include a history, vital signs, a physical examination and a medical assessment to determine whether an EMC exists...If the RN performing the initial medical screening determines a medical emergency exists or possibly exists, the MSE is immediately continued in the ED by a physician and the condition will be stabilized...initial MSE is performed uniformly on all individuals who come to the ED requesting medical examination or treatment in accordance with the medical screening criteria established by the medical and nursing directors of the ED...If after the MSE it is determined and EMC exists...such further medical examination and treatment required to stabilize the medical condition within the capabilities of the medical staff and facilities available at the hospital..."

The ED Policy, "ED 101, Direction of Patients in the ED", dated "May 2010" reflected, "The MSE is a physical assessment performed by the ED Screening Nurse to determine whether a patient has an EMC. The ED Screening Nurse will document the findings of the MSE...will include an assessment of: General appearance, Airway (A) (patency of airway, color), Breathing (B) (ventilation, breath sounds, resp. rate, work of breathing), Circulation (C) (HR, pulses, cap refill, temp., BP), Disability (D) (mental status), Focused exam related to the patient's specific complaint. Based upon the MSE, the ED Screening Nurse will categorize the patients into Medical Screening Levels (MSL), to determine priority and the most appropriate initial plan of care (POC ...Utilizing the information obtained from the MSE and knowledge of the workload in the ED, the ED Charge Nurse will assist with determining the priority of patients. The ED Charge Nurse may assign additional severity to increase of patients who have the same MSL...Non-Urgent (N): ...diarrhea with history of vomiting but no vomiting in last 24 hours...Urgent (U):...mild tachycardia ...Risk Factor/Red Flags: Fever ? 3 months to ? 24 months, ? 3 months with fever ? 102.2 ? F or 39 ?C...Intervention (I)...Moderate distress...Decreased activity, delayed capillary refill of 3-4 seconds, weak peripheral pulses, S/S of shock...Irritability, lethargy, poor feeding...diaphoretic, pale, petechiae, purpura (bruising)...Direction of Patients: Following the MSE, the patient will be assigned a MSL, and directed as outlined...All patients screened as Level I (Intervention)...emergent, will require diagnostic or therapeutic intervention, and will be moved into the ED ASAP (as soon as possible) for further evaluation and treatment...Level U...urgent and will be treated in the ED...Level N...non-urgent...and more appropriately treated in a PCP clinic or office..."

The ED Policy, "ED 040, Documentation in the ED", dated "April 2007" reflected, "The ED Medical Record will contain patient-specific information, as appropriate to the patient's individualized Plan of Care, treatment and services provided...must contain the following information...assessment findings...pertinent past medical history...complaint focused physical/observations including condition of patient...interventions/treatments ordered and patient response...patient response to care, treatment and services provided, reassessment times and findings, revisions of care...physician notifications...diagnosis, diagnostic impressions and/or condition...Nursing documentation will include...Complaint focused initial assessment...Medical and nursing interventions...Patient's response to intervention...Reassessment time and findings..."

The Patient Services Policy, "PS 109, Patient Assessment, Nursing Process, Care Planning, Acuidex and Flowsheet Documentation", dated "October 2010" reflected, "To provide nursing and multidisciplinary staff with guidelines for uniform charting practices and documentation of care...To accurately document assessments, the Plan of Care, notes and interventions in a consistent and concise manner...responsible for charting all pertinent information related to each patient...The initial physical assessment and evaluation which is performed by an RN...All reassessments, as required by the patient's condition...the Plan of Care which reflects the identified nursing diagnosis and/or nursing care needs and the individualized interventions (acuity)...The performance and effectiveness/outcomes of nursing interventions, including the patient's responses...All patients will receive individualized, goal-directed nursing care which shall be provided to the patient through the use of the nursing process...the RN will initiate the physical assessment, planning, intervention, and evaluation...An initial physical assessment of the patient should be performed within 30 minutes of arrival to the unit...In addition to admission assessment, the on-going re-assessment will include...a complete assessment...reassessments will be done a regular intervals during the course of care. These will be based on the patient's condition and response to treatment...will occur when there is a significant change in a patient's condition and/or a significant change in a patient...The patient/family's expectations for and involvement in the assessment, treatment, and care of the patient...at a minimum, the patient's current condition, significant change in condition...vital signs, pertinent information regarding physical assessment findings, recent interventions...and response to such will be communicated..."

The ED Policy, "ED 107, Patient Re-Evaluation", dated "August, 2007" reflected, "A complaint focused on-going re-evaluation with repeat of any abnormal vital signs should be done by the RN or Advanced Care Technician and documented on the ED Record...Airway, Breathing, Circulation and Disability should be evaluated with each re-evaluation and any emergent interventions initiated...Repeat evaluations should be performed as indicated by findings and after any intervention expected to make a change in the patient's condition..."

The ED Policy, "ED 032, Vital Signs", dated "October 2006" reflected, "The initial set of VS is determined by patient's condition and is part of the medical screening assessment...additional VS are measured and documented every 4 hours or more frequently if indicated by the patient's condition ..."

The ED Policy, "ED 129, Rapid Strep", dated, "last reviewed 12/14/10", reflected, "Purpose: To provide guidelines for the implementation of pre-emptive tests in the ED...Assessment - MSE with special attention to airway compromise, dysphagia, dehydration, and overall toxicity. Including but not limited to: sore throat, difficulty swallowing, fever, sore throat with fine " sandpaper" rash ...Orders - Rapid strep screen ...throat swab will be obtained and sent to lab.. "

The hospital had beds and staff available for further medical examination and treatment as required to stabilize the medical condition on 09/13/10, when Patient # 1 was in the ED. This hospital routinely provides medical services for patients in need of emergent medical conditions.