Vaughan Regional Medical Center Parkway Campus

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 41624 Based on review of Medical Staff Bylaws and Rules and Regulations, hospital EMTALA (Emergency Medical Treatment and Labor Act) policy and procedure, medical records and interview, it was determined Vaughn Regional Medical Center Parkway Campus failed to: 1. Identify and approve individual(s) qualified to perform the medical screening examination (MSE) in the facility medical staff bylaws or rules and regulations. This had the potential to affect all patients presenting to the emergency department (ED). 2. Document that risks of leaving and the benefits of staying to complete the medical screening exam and receive stabilizing treatment were explained to one of four patients that left the hospital emergency department ED against medical advice (AMA). This deficient practice affected Patient Identifier # 5 and had the potential to affect all patients leaving AMA. Refer to A2406 and A2407 for findings.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 41624 Based on medical record (MR) review, Medical Staff Bylaws and Rules and Regulations, hospital procedure and interview, it was determined the hospital failed to provide a medical screening exam (MSE) by qualified medical personnel (QMP) for patients presenting to the emergency department (ED). This deficient practice affected five (5) of 21 MR’s reviewed, including Patient Identifier (PI) # 19, PI # 14, PI # 3, PI # 1, and PI # 4, and had the potential to affect all patients presenting to the ED seeking a MSE for evaluation of an emergency medical condition (EMC). Findings include: Hospital Policy: Emergency Medical Treatment and Labor Act (EMTALA) - Screening, Stabilizing, and Transferring Procedures for Patients with Emergency Conditions, 02-780-0064 Policy Number: 1154531 Last Revised: 11/2013 Approved: 04/2022 Procedure: Part I: Screening Procedures Whenever an individual comes to the hospital ED requesting an examination or treatment, a physician or other QMP, as determined and stated in writing by the hospital board of trustees, must screen the individual to determine whether an emergency condition exists. Hospital Rules and Regulations: Article VI: Emergency Medical Screening, Treatment, Transfer, and On-Call Roster Policy Screening, Treatment and Transfer 6.1 (a) Screening: ...(3) All patients shall be examined by QMP, which shall be defined as a physician trained in emergency medicine, or in the case of a woman in labor, a registered nurse trained in obstetric nursing pursuant to hospital policy...who may determine true, false or no labor but may not make a medical diagnosis. 1. PI # 19 presented to the ED via private car on 6/19/24 at 3:57 PM with a chief complaint of right hip pain. Review of the MR revealed PI # 19 received a MSE at 4:04 PM by a certified registered nurse practitioner (CRNP) and not a physician as required in the hospital Rules and Regulations. An interview was conducted on 9/12/24 at 1:58 PM with Employee Identifier (EI) # 2, ED Medical Director and Chief Medical Officer, who confirmed the hospital Rules and Regulations/Bylaws failed to include mid-level practitioners (CRNPs and Physician Assistants) as QMP. 2. PI # 14 presented to the ED via private car on 7/15/24 at 9:03 PM with a chief complaint of a cut on the right hand. Review of the MR revealed PI # 14 received a MSE at 9:06 PM by a CRNP. An interview was conducted on 9/12/24 at 1:58 PM with EI # 2 who confirmed the hospital Rules and Regulations/Bylaws failed to include mid-level practitioners as QMP. 3. PI # 3 presented to the ED via private car on 8/23/24 at 2:48 PM with a chief complaint of pain in the right arm, nausea and vomiting. Review of the MR revealed PI # 3 received a MSE at 2:51 PM by a Physician Assistant (PA). An interview was conducted on 9/12/24 at 1:58 PM with EI # 2 who confirmed the hospital Rules and Regulations/Bylaws failed to include mid-level practitioners as QMP. 4. PI # 1 presented to the ED via private car on 8/23/24 at 10:54 PM with a chief complaint of chest pain and spitting up blood. Review of the MR revealed PI # 1 received a MSE at 11:07 PM by a PA. An interview was conducted on 9/12/24 at 1:58 PM with EI # 2 who confirmed the hospital Rules and Regulations/Bylaws failed to include mid-level practitioners as QMP. 5. PI # 4 presented to the ED via private car on 9/10/24 at 8:56 AM with a chief complaint of chest pain and nausea. Review of the MR revealed PI # 4 received a MSE at 8:56 AM by a CRNP. An interview was conducted on 9/12/24 at 1:58 PM with EI # 2 who confirmed the hospital Rules and Regulations/Bylaws failed to include mid-level practitioners as QMP.”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 41624 Based on medical record (MR) review, hospital policy and staff interview, it was determined the hospital failed to document the specific medical risks and benefits of leaving the hospital emergency department (ED) before completing the medical screening exam (MSE) and receiving stabilizing treatment. This deficient practice affected one of four patients reviewed who left AMA (against medical advice), including Patient Identifier (PI) # 5, and had the potential to affect all patients leaving the hospital ED AMA. Findings include: Hospital Policy: Patient Leaving AMA Policy Number: 03-780-0007 Approved Date: 05/2024 Purpose: Establish criteria for documentation of patients leaving AMA. Policy: All patients indicating the desire to leave AMA shall sign an AMA form. - The Registered Nurse and/or physician shall discuss, with the patient and/or family, the potential complications that may occur if the patient leaves prior to the physician discharging the patient. - The AMA form shall state the possible consequences. ... - Document the patient’s desire to leave AMA, conversations on potential complications and patient’s condition prior to leaving the ED. 1. PI # 5 presented to the ED via emergency medical service on 8/24/24 at 1:04 AM with a chief complaint of Motor Vehicle Crash, Chest Pain and Body Ache. Review of PI # 5’s MR revealed PI # 5 received a MSE by the ED physician at 2:12 AM, and then left AMA after ordered labs were collected. Review of the AMA form revealed PI # 5 signed the form at 2:42 AM. “Other” was checked under both Medical Risks and Medical Benefits. There was no description of the specific medical risks of leaving AMA nor the benefits of staying to complete the MSE and receiving stabilizing treatment documented on the AMA form. An interview was conducted on 9/12/24 at 4:06 PM with Employee Identifier # 1, ED Director, who confirmed the specific risks and benefits before leaving AMA were not documented.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 25370 Based on a review of medical records (MR), hospital policy and procedure, Hospital Rules and Regulations, and interviews with patients and staff, it was determined the hospital failed to ensure that individuals who comes to the emegency must provide an apprpriate medicalsreening examination within the capability of the hospital’s emergency department, including ancillay services routinely avaiable to the emergency department to determine whether or not an emergency medical condition existed for 2 Patients, Patient Identifier (PI) PI #14 and Pt.#23) of 23 sampled ED patients: Refer to findings in Tag A-2406.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 25370 Based on a review of medical records (MR), hospital policy and procedure, Hospital Rules and Regulations, and interviews with patients and staff, it was determined the hospital failed to ensure that individuals who comes to the emergency must provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department to determine whether or not an emergency medical condition existed. for 2 (two) Patients, Patient Identifier (PI) PI #14 and Pt.#15) of 23 sampled ED patients: This affected three of 23 MR reviewed including Patient Identifier (PI)- PI # 14, PI # 23, and had the potential to affect all individuals coming to this Emergency Department seeking care. 1. Conduct a Medical Screening Examination (MSE) to determine if an Emergency Medical Condition (EMC) existed for all persons presenting to the ED for care. 2. Reassess patients every 30 - 60 minutes as directed in the hospital policy. Findings include: Vaughan Regional Medical Center Rules and Regulations Revised: 8/19/19 ...6.1(a) Screening 1. Any individual who presents to the Emergency Department of this hospital for care shall be provided with a medical screening examination to determine whether that individual is experiencing an emergency medical condition... Hospital Policy: LL.026 EMTALA - Medical Screening and Treatment of Emergency Medical Conditions Policy Number: 14495714 Approved: 11/16/2023 ...Purpose: To ensure that individuals coming to an ... Emergency Department seeking assessment or treatment for a medical condition ... receive an appropriate Medical Screening Examination... L. Medical Screening Examination is the process required to reach...whether or not an Emergency Medical Condition exists... Hospital Policy: Assessment and Reassessment, 02-780-0017 Policy Number: 14964955 Revised: 11/2013 Policy: All patients presenting to the Emergency Department will be triaged and categorized according to the 5 tier triage system... Hospital Policy: Triage, 02-780-0016 Policy Number: 14964811 Revised: 7/2011 ...Procedure: The Registered Nurse will evaluate and categorize each patient upon arrival to the Emergency Department into levels of priorities... Priority 1...Immediate Care required... Priority 2...Care required within 15 - 30 minutes... Priority 3...Care is required within 60 minutes. Condition is acute but not severe. Initial assessment and reassessment documented every 30 - 60 minutes... Priority 4...Care is required within 120 minutes. Initial assessment and reassessment documented every one hour... Priority 5... Care is required within 120 minutes. Initial assessment and reassessment documented every two hours... 1.. PI # 14 presented to the ED on 1/17/24 at 12:13 AM with a complaint of difficulty breathing. Review of the Emergency Patient Record, Triage Assessment, dated 1/17/24 at 12:45 AM revealed a blood pressure (BP) of 101/59, pulse 83, respirations 19, and oxygen saturation (O2 sat) of 99. Further review of the Triage Assessment completed by EI # 12, Registered Nurse (RN), dated 1/17/24 at 12:45 AM revealed PI # 14 was assigned a triage classification priority of three (3) which, per hospital policy, required care within 60 minutes and reassessments documented every 30 to 60 minutes. The surveyor was unable to contact EI # 12, for interview. Review of the Emergency Patient Record, Departure Information, dated 1/17/24 revealed the staff documented PI # 14 did not answer when called at 8:39 AM, which was 8 hours and 26 minutes after the patient arrived at the ED. There was no documentation the patient was reassessed every 30 to 60 minutes and no documentation a MSE was performed. In an interview conducted on 3/7/24 at 11:05 AM, Employee Identifier (EI) # 1, Emergency Room Director, confirmed the hospital failed to ensure reassessments were performed and documented per hospital policy and failed to ensure a MSE was performed. In an interview conducted on 3/7/24 at 1:55 PM, EI # 2, ED Medical Director, stated the reassessments of patients after triage had been an ongoing issue and the department had discussed the issue. EI # 2 stated the problem is with nursing staff shortage and it is a work in progress. 3. PI # 23 presented to the ED on 1/17/24 9:20 AM with a chief complaint of pregnancy and feeling like she wanted to pass out. Review of the Emergency Patient Record, Triage Assessment, dated 1/17/24 at 9:25 AM revealed the staff documented a BP of 143/91, pulse 99, respirations 18, and O2 sat of 100. There was no documentation of the gestational age of the fetus. Further review of the Triage Assessment dated 1/17/24 at 9:25 AM revealed PI # 23 was assigned a triage classification of 3, which required care within 60 minutes and reassessments to be documented every 30 to 60 minutes. Review of the Emergency Patient Record, Departure Information, dated 1/17/24 revealed the staff documented PI # 23 did not answer when called at 12:05 PM, which was 2 hours and 45 minutes after the patient arrived at the ED. There was no documentation PI # 23 was reassessed every 30 to 60 minutes per hospital policy and no documentation a MSE was performed. In an interview conducted on 3/7/24 at 4:00 PM, PI # 23 stated he/she was in the waiting area for a “couple of hours” before leaving and the nurse did not check on him/her while waiting for a room and was not evaluated by the ED doctor. PI # 23 stated he/she is currently 27 weeks pregnant. In an interview conducted on 3/7/24 at 1:25 AM, EI # 1 confirmed the hospital failed to ensure patient reassessments were performed and documented every 30 to 60 minutes and failed to ensure a MSE was performed.”