Ascension Seton Williamson

“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: 41964 Based on review of medical records, hospital policies, obstetrical physician on-call schedules, observations, and interviews, it was determined that the hospital failed to ensure one (Patient#15, “P15”) of twenty patient records sampled who presented to the hospital’s Dedicated Emergency Department (DED) received an appropriate Medical Screening Examination (MSE) that made use of the hospital’s capabilities (including but not limited to the ancillary services of the on-call obstetrical physician routinely available to the dedicated emergency department) and consistent with the hospital’s screening process or individuals who present to the ED with the same or similar signs and symptoms to determine if an Emergency Medical Condition (EMC) existed. The hospital’s failure to provide an appropriate medical screening examination, within the capability of the hospital’s emergency department (including but not limited to the ancillary services of the on-call obstetrical physician) and consistent with the hospital’s screening process, placed the patient at risk for deterioration of her health and wellbeing as a result of an untreated emergency medical condition with the likelihood of serious injury, serious harm, serious impairment, or death. Refer to 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: 41964 Based on review of medical records, hospital policies, obstetrical physician on-call schedules, observations, and interviews, it was determined that the hospital failed to ensure one (Patient#15, “P15”) of twenty patient records sampled who presented to the hospital’s Dedicated Emergency Department (DED) received an appropriate Medical Screening Examination (MSE) that made use of the hospital’s capabilities (including but not limited to the ancillary services of the on-call obstetrical physician routinely available to the dedicated emergency department) and consistent with the hospital’s screening process for individuals who present to the ED with the same or similar signs and symptoms to determine if an Emergency Medical Condition (EMC) exists. The hospital’s failure to provide an appropriate medical screening examination, within the capability of the hospital’s emergency department (including but not limited to the ancillary services of the on-call obstetrical physician) and consistent with the hospital’s screening process, placed the patient at risk for deterioration of her health and wellbeing as a result of an untreated emergency medical condition with the likelihood of serious injury, serious harm, serious impairment, or death. Findings include: 1. Review of facility policy “Emergency Medical Treatment and Active [sic] Labor Act (EMTALA) and Transfer” revealed “Medical Screening Examination (MSE) is the process required to reach with reasonable clinical confidence the point at which it can be determined whether an Emergency Medical Condition exists. Screening is to be conducted to the extent necessary, by physicians and/or other Qualified Medical Person (QMP), to determine whether an Emergency Medical Condition exists, and is an on-going evaluation including ancillary services available to the emergency department. The Medical Screening Examination must be consistent for every individual coming to the Hospital’s emergency department with those signs and symptoms, regardless of the individual’s ability to pay for medical care.” 2. Review of the hospital’s “Bylaws of the Medical Staff”, “Duties and Responsibilities of Members of the Medical Staff” revealed each member of the Medical Staff shall have the duties and responsibilities set forth in the Bylaws including but not limited to the following: To provide patients with appropriate quality care and continuous care and to abide by the current Medical Staff Bylaws, Rules and Polices and by all other lawful standards. Responsibilities of Members of the Medical Staff” revealed each member of the Medical Staff shall have the duties and responsibilities set forth in the Bylaws including but not limited to the following: To provide patients with appropriate quality care and continuous care and to abide by the current Medical Staff Bylaws, Rules and Polices and by all other lawful standards. 3. Review of facility policy “Rules of the Medical Staff, Consultations” revealed: - Any qualified member of the Medical Staff with clinical privileges may be called for consultation within their area of expertise. A consulting member of the Medical Staff shall, with regard to the consulting services provided, be responsible for completing and signing of any instructions to patient and family members, and communication of patient reports to the admitting physicians, next provider of care, the patient, and patient relatives, as appropriate. Shall document with a written order in the patient’s chart any transfer of consulting responsibilities to another member of the hospitals consulting medical staff and shall provide medical care and treatment of a patient within the scope of the consultation. The extent of the consulting member of the Medical Staff’s involvement in the care and treatment of a patient shall be at the consulting member of the Medical Staff’s discretion and consistent with the prevailing standards of practice in the community. Consultations shall be documented in the Medical Record and shall include a review of the patient’s record by the consultant, pertinent findings identified on physical exam, and the consultant’s opinions and recommendations. -Physicians are encouraged to request consultation in cases where the patient’s medical needs are complex, unusual, or whatever the requesting physician believe consultation with another physician would benefit the patient. Direct physician-to-physician communication is optimal for enhancing the efficiency, quality and safety of patient care. Consultation is a collegial and collaborative activity. Direct communication is encouraged and preferred for all routine consultations. In all cases, the specific reason for the consultation shall be documented in the medical record, whether in progress notes or part of the requesting physician’s orders. 4. Review of the Clinical Management Tool titled “Positive Pregnancy Test with No Visible Intrauterine Pregnancy” (a tool provided by the hospital used by its physicians to address clinical variation and ensure every patient receives high-quality care), outlined an algorithm for physicians to follow to provide guidance in determining the probability of an ectopic pregnancy and recommending which hospital resources and capabilities to engage in screening. Box #1 directs the physician to assess the patient and review laboratory and radiology findings and determine if the patient has “ANY” of the following: - “More than trace fluid” on ultrasound. [or] -Tachycardia (faster than normal heart rate) or hypotensive (low blood pressure). [or] -New or suspected new decrease in hemoglobin level (a measure of red blood cell counts). [or] -hCG level (hormone produced during pregnancy) greater than 2,500. [or] -Adnexal mass seen on ultrasound. If the physician validates any of the above signs/symptoms/finding, the algorithm identifies that there is a “high chance of ectopic” pregnancy with “possible rupture” of the fallopian tube. The algorithm directs the physician to obtain an OB evaluation in the ED or admit the patient or transfer the patient for an OB evaluation. If the physician is unable to validate any of the above signs/symptoms or laboratory/radiology results, then the assessment continues to be Box 2. Box #2 directs the physician to assess the patient and determine if the patient has: -diffuse pain or pain with movement. -adnexal tenderness (area of the ovaries, fallopian tubes and uterus) during physical examination. -palpable adnexal mass (abnormal growth in the tissues surrounding the uterus and ovaries) during physical examination. -cervical motion tenderness (pain with movement of the cervix by the physician during gynecological exam). -abdominal tenderness. If the physician validates greater than or equal to >3 of the Box #2 criteria, the algorithm points to the same box described above identifying “high change of ectopic” pregnancy with “possible rupture” of the fallopian tube and directing “OB evaluation.” If the physician validates one or two of the Box #2 criteria, the algorithm identifies there is an “increased chance of ectopic” and directs the physician to obtain a phone consultation with OB, and if discharge is recommended to “arrange” 2-day follow up with a repeat Quant-hCG. If the physician is unable to validate any of the signs/symptoms or laboratory/radiology findings in Box 1 or Box 2, the algorithm identifies that there is “low (<1%) chance of ectopic” pregnancy and directs the physician to set up a 2 day follow up with repeat hCG level and that it is “OK to plan ED follow-up in DC [discharge] instructions.” 5. Review of the ED log report (identification of each person who comes to the emergency department seeking assistance) provided to surveyors on 9/23/2024 showed P15 presented to the ED on 2/21/23 at 6:50pm related to pregnancy and vaginal bleeding and was discharged home 5 hours and 29 minutes later. 6. Review of P15’s medical record under “Physician ED Documentation” “PIT [provider in triage] NOTE” on 2/21/23 at 6:50pm by Physician Assistant B (PA-B) revealed “33 Years Female G1P0 [first pregnancy] [with] no [past medical history] who [presents with] concern for ectopic-seen 2/17/23 and 2/19/23 with beta hCG not decreasing appropriately for a viable pregnancy. No IUP [intrauterine pregnancy] visualized on U/S [ultrasound]. Irregular menses and vaginal bleeding over the last 5 weeks...Has appt w/ new OB/Gyn 3/7/23 but told to come to the ER to evaluate for “ectopic.” A review of systems conducted by PA-B revealed P15 was positive for abdominal cramping and vaginal bleeding. 7. Review of a pain assessment document conducted by RN-F on 2/21/23 at 5:59pm showed lower abdominal pain and rated it at a 2-intensity level on a scale of 1-10. 8. Review of a genitourinary assessment document conducted by RN-D on 2/21/2023 at 11:46pm showed “moderate amount of vaginal bleeding”. 9. Review of the medical record under “Emergency Documentation” signed and dated by Physician A on 2/21/2023 at 11:50pm revealed: -“History of Present Illness: ongoing vaginal bleeding for one-month, positive pregnancy test. Reports being seen by OB physician and an ultrasound and lab work was completed. P15 stated they were unable to see anything on the ultrasound and was following up with her OB for repeat hCG levels and ultrasounds... -Review of Systems: lower abdominal cramping with nausea but no vomiting or diarrhea... -Physical Examination: non-distended abdomen, soft, non-tender, no guarding or rebound tenderness.” 10. Review of the physician orders dated 2/21/2023 showed laboratory and radiology orders and results which included: -Beta hCG Quant results showed a level of 908 mlU/mL -Complete Blood Count (CBC), abnormal results for hemoglobin (protein in the red blood cells that carries oxygen) of 10.2 (normal 12.0-16.0 g/dl) and hematocrit (percentage of red blood cells within the blood) 32.9 (normal 37.0-47.0). -Urinalysis, normal results. -Transvaginal Pregnancy Ultrasound: “Reason: Eval[uate] for ectopic.” 11. P15’s documented ultrasound result, interpreted by radiologist physician (Physician G) on 0/21/23 at 8:5, included “Impression: 1. No evidence of an intrauterine pregnancy. 2. Rounded structure in the right adnexa, indeterminate for ectopic...Results discussed with PA-C on 2/21/23 9:23pm.” 12. Review of the medical record under “Emergency Documentation” signed and dated by Physician A on 2/21/2023 at 11:50pm revealed: - “Medical decision differential diagnosis of spontaneous abortion, incomplete abortion, ectopic pregnancy, dysmenorrhea” (painful menstrual cramps or period pain). - “Brief summary...Case discussed with OB who states that patient is stable for discharge to home. Patient will follow up with primary care provider and OB physician as outpatient.” - “11:47pm: Case discussed with OB Physician-C...there is no definite ectopic pregnancy noted on ultrasound. There is also no IUP.” 13. The medical record did not contain documentation that P15 was evaluated for adnexal tenderness, palpable adnexal mass, or cervical motion tenderness on examination, nor was there documentation that described why the hospital’s typical screening process would be inappropriate or inapplicable to P15’s presentation. The medical record also lacked documentation of an OB consultation conducted by Physician-C to include a review of the patient’s record, pertinent findings identified on physical exam, and any opinions and recommendations from Physician-C, as required by hospital Rules of the Medical Staff. 14. The medical record lacked documentation that Physician-A or the consultant OB (Physician-C) reviewed and discussed the findings of the ultrasound results with the radiologist to identify any new findings compared to previous ultrasound results to determine the presence or absence of ectopic pregnancy. 15. During an interview on 9/25/24 at 12:08pm, PA-B stated she was the “medical screening examiner”. She stated she “did not manage the patient” but would “help get things started” by checking vital signs and ordering labs. She stated she also did a “brief” physical exam. 16. During an interview on 9/25/24 at 9:15am, Physician-A stated he saw P15 on 2/21/23. He recalled no pregnancy was seen in her uterus on the ultrasound. Physician-A said OB was consulted (Physician-C) due to “ultrasound showing something over her ovaries” with no pregnancy seen in the uterus. Physician-A stated there was no difference between a “consult” and “a call to a specialist.” Physician-A verified there was a “Clinical Management Tool” for positive pregnancy test with no visible intrauterine pregnancy that was utilized at this hospital. 17. During an interview on 9/24/24 at 5:00pm, Physician-C stated that “sometimes he writes notes and sometimes doesn’t” when a physician consultation is requested. He stated a “curbside consult” is when he is called and asked for his recommendation, but he does not go to the ED to see the patient face to face and characterized his involvement in P15’s care as such. 18. Review of P15’s discharge documentation showed P15 was discharged from the ED on 2/22/23 at 12:36am with instructions to follow up with her primary care physician in 2-4 days. Physician-D documented the diagnosis as “Spontaneous abortion.” 19. Review of subsequent medical records from 03/03/23 revealed that P15 ultimately required surgical removal of her right fallopian tube and surgical evacuation of hemoperitoneum (internal bleeding in the abdominal cavity) for a diagnosis of ruptured right tubal ectopic pregnancy on 2/22/23.”

“MEDICAL RECORD SERVICES CFR(s): 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This Standard is not met as evidenced by: 31974 Based on review of documentation and interviews, the facility failed to ensure that all patient medical record entries were complete, as evidenced by the failure to document the agency to which a report was made and the name of the person taking report, a dog bite for one (patient #3) of two patients reviewed for animal bites. Findings were: The facility policy entitled “Reportable Conditions and/or Crimes-Identifying and Managing”, last revised 11/21/2023, reflected in part, “ ...Animal Bites/Exposure: 1. Animal bites (possible rabies exposures) are reportable to the appropriate Animal Control officer in the county where the incident occurred. Reporting is mandatory ...Documentation: 1. Document all conversations with patients, the agency to which a report is made, including name/badge number of person taking report, the name/badge number of any persons who are present at the hospital to investigate the incident and/or to receive potential evidence ...3. Thorough, complete, narrative documentation is essential ...” Review of the medical record for Patient #3 revealed in part, “...patient presented to the Ascension Seton Williamson ED 7/20/24 at 15:51 with multiple animal bites to her abdomen and right hand by unprovoked dog while delivering doordash order...” During an interview on the afternoon of 9/4/24, Molly Hundley-Levine, ED Manager stated, “When a patient presents to the Emergency Department with an animal bite, the expectation is that we will call the county animal control that the dog bite happened in. And it will be documented in the patient’s record. It was not documented in patient #3’s record.””