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Based on interview and review of documents and policies and procedures, the facility failed to ensure compliance to EMTALA regulations, CFR §489.24, Special responsibilities of Medicare hospitals in emergency cases.

Failure to do so created risk for a adverse patient outcome(s) and harm in the delivery of emergency services at complainant's and/or respondent's emergency departments.

Findings:

As detailed in Tag 2404, 2405, 2407 and 2409 it was determined that the hospital failed to provide adequate policies and procedures related to on-call responsibilities; implementation of the obstetrical patient emergency log; stabilizing treatment by an on-call provider and [parental] transfer consent for 1 of 25 patients whose emergency department (ED) medical records were reviewed, and therefore failed to comply with CFR §489.24.

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Based on record review and interview, the facility failed to develop and implement written on-call policies and procedures that clearly defined the responsibility of on-call physicians to respond, examine and treat patients with an emergency medical condition, including steps to be taken if a particular specialty was not available.

Failure to do so created risk that the facility response to a patient emergency would be not be adequate to the level of need and could result in patient harm and/or loss of function.

Findings included:

1.a. Record review of CHI Franciscan Health Medical Staff "Rules and Regulations" Section 2, Version 05/24/2018 showed that each clinical section and/or specialty group shall design a call system for provision of care to patients needing consultation or those patients needing those specialties at each campus. It also stated that each designated practitioner shall have the responsibility to either take the rotation or be responsible to arrange for a substitute.

In the section on Emergency Medical Treatment And Active Labor Act/Patient Transfers (EMTALA) on page 19 of 20 it did not address the duties of on-call providers or conditions for ensuring on-call provider availability (i.e. allowance for simultaneous surgery, etc).

b. Record review of a hospital policy titled, "Medical Surgical and ACC Standards," policy # 3138411, Approved 01/2017, stated that the purpose of Medical Surgical Services was to provide patient centered care to adult and adolescent patients, "15 years of age and older". It described surgical services as available 24 hours a day, 7 days a week throughout the year providing quality and patient focused care to include, but not limited to, "Surgical: Urology".

c. Record review of a policy titled, "Pediatric Service Matrix," #952.5, Last Revised 08/2016, under Perioperative Services showed that overnight/extended stays were provided to patients under 15 years of age and older.

d. Record review of Medical Executive Committee Meeting minutes from July 12, 2018 identified discussion about enforcing EMTALA, including on-call provisions. In September there was discussion about developing guidelines and tools to ensure appropriate physician on-call coverage was available. The content of that discussion was referred to other committees and a deadline was identified as January 2019. In March 2019, a decision was made not to modify verbiage about on-call issues related to EMTALA.

e. Review of hospital policy titled, "EMTALA - How to Comply with the Law," #2011111, Reviewed 12/2015, in the on-call obligations section showed that on-call physicians must respond to the hospital within a reasonable time when requested to attend to patients and complete a medical screening exam or provide stabilizing care unless circumstances beyond the physician's control prevent a response. It also stated that the hospital is responsible for establishing provisions for situations in which a physician in a specialty is not available due to resources available to the hospital.

f. Review of the Urology Emergency Department (ED) on-call schedules for February 2019 through April of 2019 did not indicate that there were age restrictions for medical services to patients.

2. a. Record review of the medical record showed that Patient #1 was 15 years old and arrived at the ED with his parents on 04/28/19 at 7:11 PM with a complaint of testicular pain. The patient was placed in a room and the triage process was completed at 7:14 PM. The patient was healthy and weighed 145 pounds. His parents were Spanish-speaking (per records at the receiving hospital). At 7:24 PM an order was placed for imaging in the radiology department. Imaging was started at 9:57 PM and completed at 10:20 PM (almost 3 hours after the order was placed) and it showed torsion of the testicle and significantly impaired blood flow.

b. A note indicated that at undisclosed times, the ED physician attempted to re-position the testicle but the testicle became more swollen. He attempted re-positioning 2 more times but was not successful. At 10:40 PM the ED physician recorded that a urology consultation with a facility physician was completed via phone. At 10:47 PM a consult was called to the local children's hospital. At 11:13 PM the ED physician recorded the patient's disposition as "Transfer to Another Facility". At 11:13 PM the ED physician printed out patient discharge instructions (usually provided to patients discharged from the hospital). At 11:18 PM, a nurse recorded that the patient was off the floor [gone] although at 10:20 PM a note by another nurse indicated that an intravenous line was placed (in anticipation of emergency surgery at the other facility). The patient and family departed by foot to travel to the 2nd hospital by private vehicle.

c. Records from the receiving hospital showed the patient arrived at the 2nd hospital's adult ED at 11:25 PM and was rated as a high acuity patient. Another set of ED intakes and assessments were completed at the second hospital by ED staff, an attending ED physician and accepting urologist. The accepting surgeon's note indicated that he accepted the patient as an emergency transfer because the urologist at the 1st hospital refused to come to the hospital to evaluate/treat the patient. The patient's status was changed to admission to the hospital at 11:48 PM and he was admitted to the operating room at 12:10 AM. The patient required surgical treatment for removal of his right testicle and surgical treatment for re-positioning of the other testicle.

3. a. On 05/15/19 at 10:55 AM the investigator interviewed the attending ED physician (Staff #2) at the sending hospital. He stated that when he made phone contact with the on-call urologist about the emergency medical condition, the physician told him that he did not provide care to patients less than 18 years old, nor did any of his specialty colleagues.

The attending ED physician stated that he "deferred" to the surgical specialist's statement. He did not take additional steps to secure onsite specialty care for the patient. He relayed that he was aware the patient had an emergency medical condition and that posed related time constraints for handling the patient's condition. When asked if he knew what the hospital's age range was for adolescent and pediatric inpatient surgical care, he stated that he did not know. Additionally, he stated he could not recall facility training about their patient care policies.

b. On 05/15/19 at 10:30 AM another ED physician (Staff #3) stated that if she had questions to determine whether a patient met age criteria for care treatment at the facility, she involved nursing staff and/or the admitting physician to make determinations.
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Based on record review and interview, the facility failed to demonstrate that it developed and maintained a central log of ED obstetrical (OB) patients that included information about whether they refused treatment, were refused treatment, or whether the patient was transferred, admitted and treated, stabilized and transferred or discharged.

Failure to do so created risk that problems with care delivery of ED services to OB patients would not be identified and may result in harm to pregnant mothers.

Findings included:

1.Record review of facility policy titled, "EMTALA - How to Comply with the Law," #345, Reviewed 12/2015, stated on page 11 that required record keeping of encounters included a central log on each individual seeking emergency services and coming to the hospital emergency department or anywhere on the hospital campus and other locations. The log must include information about whether the individual refused treatment or transfer or was transferred, admitted ad treated, stabilized and transferred or discharged. It also stated the logs maintained in other departments that perform medical screening exams, such as Labor and Delivery, shall be deemed a part of the central log and are subject to the same requirements as the central log.

2. a. Record review of the obstetrical log identified and located in the OB triage area showed that there were omissions in data gathering about OB patient care including, but not limited to, whether they refused treatment, were refused treatment, or whether the patient was transferred, admitted and treated, stabilized and transferred or discharged.

b. In review of entries in the OB Log of 10 patients seen in the OB triage area for 05/15/19 and 05/16/19, the disposition status section was blank for 4 patients. Other entries of information indicated that 3 went home, 1 went to the delivery room, and 2 went to inpatient beds. The column titled "medical screening exam" was blank for 10 patients.

3. On 05/16/19 at 3:30 PM, the investigator interviewed a Clinical Manager of OB Services (Staff #1). She was asked about data gathering in the OB log. She acknowledged that content was missing from within the log. She also acknowledged that there was not a system of electronic data gathering and regular dissemination of information (coordinated with the main Emergency Department) to track of the OB-ED care per required content of a central log.
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Based on record review and interview, the facility staff failed to ensure that an emergency medical condition had been stabilized prior to, during transfer and upon arrival to another facility.

Failure to do so created risk for harm related to delays in required stabilizing treatment.

Findings included:

1.a. Record review of CHI Franciscan Health Medical Staff "Rules and Regulations" Section 2, Version 05/24/2018 showed that each clinical section and/or specialty group shall design a call system for provision of care to patients needing consultation or those patients needing those specialties at each campus. It also stated that each designated practitioner shall have the responsibility to either take the rotation or be responsible to arrange for a substitute.

In the section on Emergency Medical Treatment And Active Labor Act/Patient Transfers (EMTALA) it did not address the duties of on-call providers or conditions for ensuring on-call provider availability (i.e. allowance for simultaneous surgery, etc).

b. Record review of a hospital policy titled, "Medical Surgical and ACC Standards, policy # 3138411, Approved 01/2017, stated that the purpose of Medical Surgical Services was to provide patient centered care to adult and adolescent patients ("15 years of age and older"). It described surgical services as available 24 hours a day, 7 days a week throughout the year providing quality and patient focused care to include, but not limited to, "Surgical: Urology".

c. Record review of a policy titled, "Pediatric Service Matrix", #952.5, Last Revised 08/2016 in the section under Perioperative Services it stated, that there were overnight/extended stays were provided to patients under 15 years of age and older.

2. a. Record review of the medical record showed that Patient #1 was 15 years old and arrived at the Emergency Department (ED) with his parents on 04/28/19 at 7:11 PM with a complaint of testicular pain. The patient was placed in a room and the triage process was completed at 7:14 PM. The patient weighed 145 pounds. At 7:24 PM an order was placed for imaging in the radiology department. Imaging was started at 9:57 PM and completed at 10:20 PM (almost 3 hours after the order was written). At 10:33 PM a student nurse handed off care to the "next shift RN".

A note indicated that at undisclosed times, the ED physician attempted to re-position the testicle but the testicle became more swollen. He attempted to re-position it 2 more times but was not successful. At 10:40 PM the ED physician recorded that a urology consultation was completed via phone. At 10:47 PM a consult was called to the local childrens' hospital. At 11:13 PM the ED physician recorded the patient's disposition to "Transfer to Another Facility". At 11:13 PM the ED physician printed out discharge instructions. At 11:18 PM, a nurse recorded that the patient was off the floor [gone] although at 10:20 PM a note by night nurse indicated that an intravenous line was placed (in anticipation of emergency surgery at the other facility). The patient and family departed by foot to travel to the 2nd hospital by private vehicle.

b. The medical record from the receiving facility showed the patient arrived at the 2nd hospital's adult ED at 11:25 PM and was rated as a high acuity patient. Another set of ED intakes and assessments was completed at the second hospital by ED staff, an attending ED physician and accepting urologist. The accepting surgeon's note indicated that he accepted the patient as an emergency transfer because a urologist at the 1st hospital refused to come to the hospital to evaluate/treat the patient. The patient's status was changed to admission to the hospital at 11:48 PM and he was admitted to the operating room at 12:10 AM. The patient required surgical treatment for removal of his right testicle and surgical treatment for re-positioning of the other testicle.

3. On 05/15/19 at 10:55 AM the investigator interviewed the attending ED physician (Staff #2) at the sending hospital. He stated that when he made phone contact with the on-call urologist about the emergency medical condition, the physician told him that he did not provide care to patients less than 18 years old, nor did any of his specialty colleagues. The attending ED physician stated that he "deferred" to the surgical specialist's statement and then focused on getting another urologist to manage the patient's condition. He was aware that the patient had an emergency medical condition that was not yet stabilized. When asked if he knew what the hospital's age range was for adolescent or pediatric inpatient surgical care, he stated that he did not know. Additionally, he stated he could not recall facility training about the patient care policies.
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Based on record review and interview, the facility staff failed to ensure that a patient with an unstabilized medical condition had a completed transfer consent containing written certification of a summary of risks and benefits.

Failure to do so created conditions for transfer without the patient/guardian consent about the risk of harm and related benefits, including consent/refusal for the mode of transportation from one hospital setting to another hospital setting.

Findings included:

1.a. Record review of facility policy titled, "EMTALA - How to Comply with the Law," #2011111, Last revised 12/2015, showed that the EMTALA transfer requirements applied only to patients that have an emergency medical condition that cannot be stabilized.

b. Record review of facility policy titled, "Transfer/Discharge of Patient to Another Facility," Policy # 1512379, Revised 07/2013, stated that the provider may transfer a patient with an unstabilized medical condition if the provider certifies in writing that the medical benefits outweigh the risks. It stated that the certification must be on the consent and signed by the transferring provider.

The consent document contained a section for the signature of the patient or legally responsible person with date and time. Under the section on transferring physician responsibilities it stated, "Obtain informed consent certification". Under transferring staff responsibilities it stated "Verify interfacility transfer consent form is complete". It then stated that nursing was to verify the provider had obtained informed consent, appropriate signatures and documentation on the Interfacility Transfer Consent form.

2. Record review of the medical record showed the following:

a. Patient #1 was 15 years old and arrived at the Emergency Department (ED) with his parents on 04/28/19 at 7:11 PM with a complaint of testicular pain. The patient was placed in a room and the triage process was completed at 7:14 PM. The patient weighed 145 pounds. At 7:24 PM an order was placed for imaging in the radiology department. Imaging was started at 9:57 PM and completed at 10:20 PM (almost 3 hours after the order was written) and showed that the patient's testicle was not in proper alignment and blood flow was significantly impaired.

b. At 10:47 PM a consult was called to the local childrens' hospital. At 11:13 PM the ED physician recorded the patient's disposition in the record as "Transfer to Another Facility". At 11:13 PM the ED physician printed out discharge instructions. At 11:18 PM, a nurse recorded that the patient was off the floor [gone]. The patient and family departed by foot to travel to the 2nd hospital by private vehicle.

c. The record showed that the physician obtained "verb [verbal] EMTALA." Information about discussions of risk and benefits of the transfer with a guardian could not be located. A transfer consent form was not completed or signed by a parent. There was no documentation about options of mode of transfer, including but not limited to, by stretcher ambulance.

d. The medical record did not show that language interpreter services were utilized by staff members at the sending hospital for family discussion.

e. The patient arrived at the 2nd hospital's adult ED at 11:25 PM and was rated as a high acuity patient. Another set of ED intakes and assessments was completed at the second hospital by ED staff, an attending ED physician and accepting urologist. The accepting surgeon's note indicated that he accepted the patient as an emergency transfer because a urologist at the 1st hospital refused to come to the hospital to evaluate/treat the patient. The patient's status was changed to admission to the hospital at 11:48 PM and he was admitted to the operating room at 12:10 AM. The patient required surgical treatment for removal of his right testicle and surgical treatment for re-positioning of the other testicle. The patient was discharged from the receiving hospital the next day.

3. a. On 05/15/19 at 10:55 AM the investigator interviewed the attending ED physician (Staff #2) at the sending hospital. He stated that when he made phone contact with the on-call urologist about the emergency medical condition, the physician told him that he did not provide care to patients less than 18 years old, nor did any of his specialty colleagues. The attending ED physician stated that he "deferred" to the surgical specialist's statement and arranged for the patient to receive specialty care at another facility. He stated he obtained "verbal EMTALA" consent with the patient's family about the risk and benefits for the transfer for the patient's condition. He acknowledged that a written transfer consent form was not obtained due to time constraints related to the patient's emergency medical condition that required off-site specialist care to stabilize it.

b. On 05/16/19 at 2:00 PM, the investigator interviewed a ED RN (Staff #4) who provided nursing care to Patient #1 during the latter part of his ED stay. She recalled conversations with the patient/family about plans to receive care at another facility; and discussion with the physician about the patient travelling by ambulance to the other facility. The physician stated arrangements had already made with family for the patient to travel by private vehicle. She also recalled telling the patient/parents that she needed to get paperwork (including transfer consent) organized before they departed. Around that same time she was preparing a critically ill ED patient for transfer to the intensive care unit. Before she returned to Patient #1's room, she was told by the charge nurse that the patient/parents had departed. Upon becoming aware of that, she stated that she or the charge nurse did not take additional steps related to the patient's care.
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