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Tag No.: A2400
Based on document review, record review, policy review and interview the Hospital failed to ensure the Emergency Medical Treatment and Labor Act (EMTALA) requirements were met by failing to: 1. ensure a central log was maintained for each individual who presented to the emergency department seeking medical care; and 2. provide an appropriate medical screening exam (MSE) for patients who presented to the emergency department seeking medical care. This deficient practice has the potential to place patients at risk for unidentified emergency medical conditions and delays in treatment resulting harm and injury up to an including death.
Finding Include:
The hospital failed to ensure a central log was maintained for each individual who presented to the emergency department (ED) seeking medical care. (Refer to A2405)
The hospital failed to provide an appropriate medical screening exam for 2 of 20 patients (Patient 1 and Patient 18) within the capability of the hospital's emergency department, including ancillary services routinely available. (Refer to A2406)
Tag No.: A2405
Based on policy review, hospital document review, and interviews the Hospital failed to ensure a central log was maintained for each individual who presented to the emergency department (ED) seeking emergency medical care. This failure has the potential to affect all patients presenting to the ED.
Findings Include:
Review of hospital policy titled "EMTALA - Central Log" last revised 02/2016, showed, "Policy; The hospital will maintain a Central Log containing information on each individual who comes on the hospital campus requesting assistance or whose appearance or behavior would cause a prudent layperson observer to believe the individual needed examination or treatment, whether he or she left before a medical screening examination ("MSE") could be performed, whether he or she refused treatment, whether he or she was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred or discharged ...All Central Logs maintained by [Above Named Hospital] are incorporated by reference and hereby become part of the facility's EMTALA Central Log. The EMTALA Central Log can be accessed by contacting the ED Managers or by printing the Central Log ...The Central Log of individuals who have come to the hospital seeking medical attention or who appear to need medical attention will be available within a reasonable amount of time for surveyor review and must be retained for a minimum of five years from the date of disposition of the individual ..."
Review of a hospital document titled, "Electronic CENTRAL Log" provided to surveyors on 10/21/24 failed to include the "Electronic Central Log" for Hospital 1 for the following dates, 06/07/24, 06/09/24, 06/24/24 through 06/27/24, 07/01/24 through 07/17/24, 08/02/24, 08/03/24, 08/07/24, 08/09/24, 08/13/24, 09/04/24, 09/05/24, 09/09/24, 09/10/24, 09/13/24, 09/19/24 through 09/21/24, 09/23/24 through 09/26/24, and 09/28/24 through 09/30/24.
There was no "Electronic CENTRAL Log" for 44 days out of 114 days.
During an interview on 10/21/24 at 11:22 AM, Staff C, Director of Quality, stated, "The person who did the central log quit and so they are little behind and trying to get caught up on the ED central log."
During an interview on 10/23/24 at 11:28 AM, Staff L, Process Improvement Coordinator, stated that when they started the central logs were a little behind because no one was in the position. No time frames were given to when logs are to be completed, the goal is to get them done as soon as possible. Staff L, stated, "I guess they fall out after a certain time frame where the central log can't be printed."
During an interview on 10/23/24 at 12:38 PM, Staff E, Vice President of Emergency Services, stated "There are gaps in June and July central log and currently working on getting caught up with timeline."
Tag No.: A2406
Based on interview, record review, and policy review, the Hospital failed to provide an appropriate medical screening exam (MSE) to determine if an emergency medical condition existed for 2 (Patient 1 and Patient 18) of 20 patient who presented to the emergency department (ED) seeking medical care. Failure to provide an appropriate MSE has the potential for unidentified emergency medical conditions placing patients at risk for harm.
Findings Include:
Review of hospital document titled "MEDICAL STAFF RULES & REGULATIONS MANUAL" dated February 2022, showed, " ...Obligation Each physician assigned to the Active (Provisional) category of the medical staff has an obligation to participate in the emergency (unassigned) call schedule commensurate with his/her clinical privileges. All physicians appointed to the medical staff shall cooperate to the fullest extent in order to provide screening and stabilizing treatment to emergency patients within the services and facilities available at the medical center and in compliance with federal guidelines ...
A facility policy titled, "EMTALA [Emergency Medical Treatment and Active Labor Act]-Medical Screening Examination and Stabilization," with an effective date of 04/2024, indicated, "III. Procedure 1. When an MSE [medical screening examination] is Required: A hospital must provide an appropriate MSE within the capability of the hospital's emergency department, including ancillary services routinely available to the DED [designated emergency department], to determine whether or not an EMC [emergency medical condition] exists: (i) to any individual, including a pregnant woman having contractions, who requests such an examination; (ii) an individual who has such a request made on his or her behalf; or (iii) an individual whom a prudent layperson observer would conclude from the individual's appearance or behavior needs an MSE. An MSE shall be provided to determine whether or not the individual is experiencing an EMC or a pregnant woman is in labor ..."
Review of hospital policy titled "Assessment of the Pregnant Patient - Emergency Department" revised 01/2018, showed, " ...Purpose: To provide guidelines for the assessment of maternal and fetal well-being when a pregnant patient presents to the Emergency Department for unscheduled care and for a safe and timely transport of pregnant patients to the Birthrooms. II. Policy: Main ED: Pregnant patients with a gestational age less than 20 weeks will be cared for by Emergency Department staff until dismissed or transferred to an inpatient location as determined by the medical provider assessment ..."
Review of hospital policy titled "Care of the Emergency Department Patient" last revised 03/2021, showed, " ...Ambulatory patients: 1. Patients who present ambulatory or by wheelchair to the triage front desk are greeted by an emergency department staff member who will obtain patient information. If unable to be immediately bedded the patient will be triaged by a triage trained registered nurse to determine the severity of illness or injury. If a bed in the treatment area is available, or if the patient's condition is not stable or is considered emergent (level 1 or Level 2), the patient is taken immediately to the appropriate patient care bed. The provider will be notified immediately of the patient's arrival ...Treatment: 1. All patients are evaluated and treated by an Emergency Department physician or an Advanced Practice Professional (APP) with the exception of those patients whose personal attending physician (provided he/she has medical staff privileges at [Above Named Hospital] has agreed to meet and treat the patient in the Emergency Department, thereby assuming responsibility for that patient. The Emergency Department physician, however, does assume responsibility of those patients if they are in a compromised medical condition and/or the attending physician does not present in a timely manner ... In any case where the patient requires care beyond the scope of the Emergency Department, the Emergency Department physician maintains responsibility for that patient until the appropriate attending and/or referral physician has been contacted and has verbally accepted the patient ..."
Review of a hospital policy, titled, "Patient Assessment and Reassessment-Emergency Department," dated 12/2022, indicated, "The Emergency Severity Index (ESI) will be used to assign acuity levels." The policy also indicated, "Level 1 [requies immediate life saving interventions] and Level 2 [high risk, should go to treatment as soon as possible] Patients: Patient will be reassessed a minimum of every 15 minutes or more frequently if condition requires. Vital signs at these intervals will include blood pressure, pulse, respiration, and pulse oximetry. Frequency of vital signs can be decreased based on stability of patient condition and normalization of vital signs. This decision must be documented in the patient record before vital sign frequency is decreased. 2. Level 3 [any patient who does not meet level 1 or 2 but requies two or more resources to reach disposition] Patients: Patient will be reassessed a minimum of every hour or more frequently if condition requires. Vital signs at these intervals will include blood pressure, pulse, respiration, and pulse oximetry. Frequency of vital signs can be decreased based on stability of patient condition and normalization of vital signs. This decision must be documented in the patient record before vital sign frequency is decreased."
Review of a hospital policy titles, "Triage Emergency Severity Index (ESI) - Emergency Department" effective date 03/2021, indicated, " ...To provide guidelines for the immediate brief assessment and evaluation of all patients presenting to the Emergency Department. ... Level 1: a. Immediate threat to life (or imminent risk of deterioration) requiring immediate life-saving interventions. Must go to treatment area immediately ... ...Level 2: High risk situations, acute confusion, lethargy, disorientation, severe pain, or distress that cannot be managed in the Triage Area. Should go to treatment area as soon as possible. ...Level 3: Any patient who does not meet Level 1 or 2 criteria but requires two or more resources to reach disposition ..."
Patient 1
Review of Patient 1's ED medical record showed, a 38-year-old female, presented to the emergency department (ED) of Hospital 1 on 09/26/23 at 12:48 PM by private vehicle with her husband. Patient 1 was triaged at an ESI level 3 at 2:29 PM with complaint of " ...Found out pregnant one week ago and started bleeding 3 days ago. LMP [last menstrual period] was at the beginning of August but has irregular periods. Reports that the blood is bright red in color. States that pain in the middle lower ABD [abdomen] and in lower back bilat [bilateral] ...Numeric pain scale: Severe pain - 7 ..."
Review of "Vital Signs" dated 09/26/23 at 1:10 PM showed, "Pulse 99, Resp [Respiration] 16; B/P [Blood Pressure] 123/83; ..."
There were no other vital signs found in the ED medical record prior to her discharge from the emergency department on 09/27/24 at 1:13 AM.
Review of order "HCG QUANT INTACT (Human Chorionic Gonadotropin - hormone produced in body during pregnancy)" dated 09/26/23 at 1:03 PM, showed, collected on 09/26/23 at 2:39 PM; Received: 09/26/23 at 2:48 PM, the results 26,725 and verified 09/26/23 at 3:28 PM.
Review of "Ultrasound - US [Ultrasound] PREG [Pregnancy] 1st Trimester [Starts on the first day of the last menstrual period and goes until the 13th week of pregnancy]" dated 09/23/23 ordered at 1:03 PM, showed, "09/26 1530 [3:30 PM] ...Impression: Pregnancy of indeterminate location and viability. No sonographic findings on the current exam of an intrauterine [pregnancy inside uterus] or extrauterine [pregnancy outside the uterus] gestation which is concerning given the bHCG level of 26,725. Findings are of concern for ectopic pregnancy [Ectopic pregnancy occurs when a pregnancy implants outside the uterus and can be associated with life-threatening hemorrhage, loss of future fertility, infection, coagulopathy [dysfunction of the body ' s blood clotting organs and system], and damage or dysfunction to the uterus, fallopian tubes, ovaries, and/or other abdominal and pelvic organs.], incomplete miscarriage [some pregnancy tissue has passed but some pregnancy tissue remains in the uterus] or early IUP [intrauterine pregnancy] [pregnancy in the womb but fetus is too small to see or hear heartbeat]. Close clinical follow-up is advised with serial beta hCG levels and pelvic sonogram to confirm or exclude a viable intrauterine gestation ..."
Review of "Emergency Provider Report" dated 09/26/23, untimed, showed, " ...Medical Decision Making Discussion: Patient is a 38-year-old female who presents for lower pelvic pain and vaginal spotting. Patient had an ultrasound which showed no evidence of intrauterine pregnancy. Her hCG level was 26,000. OB/GYN [Obstetrician/Gynecologist - a physician that cares for women and babies during pregnancy and childbirth] was consulted and came to evaluate the patient ... Risk of Complications and/or Morbidity or Mortality of Patient Management: moderate. Medications/prescriptions management: prescriptions considered but not given ... Disposition of the patient/consideration of hospitalization: there is no indication for acute hospitalization at this time, patient will be discharged ... Disposition Decision ...Discharged to Home Yes; Time 1830 [6:30 PM]; Date 09/26/23..."
Review of the "Supervising Physician Note" signed by Staff Q, Physician on 10/12/23 at 1:20 AM, (approximately 15 days after Patient 1's encounter) appeared to describe additional context for events that occurred after the documentation that Patient 1 had been discharged, including, "The PA/NP has seen the patient, and I have performed this visit along with the involvement of the PA/NP. I agree with the PA/NP[']s findings and plan...Patient with elevated quantitative hCG level. OB recommends repeating the level to confirm. Repeat level remains elevated. Ultrasound shows no intrauterine pregnancy. This patient likely has an ectopic pregnancy given the high levels of her quantitative hCG level. I contacted the OB attending physician. Residents to see in the ED, OB recommended obtaining a CT of the abdomen and pelvis. CT identified likely left lower quadrant/left adnexal ectopic. Vital signs still stable. OB agrees to admit, plan for operative intervention. Patient went directly from the emergency department to the OR."
Review of "COMPUTERIZED TOMOGRAPHY - CT ABD/PELVIS W/O CONTRAST" dated 09/26/23 ordered at 8:40 PM showed, " ...Report impression- ...09/27/2023 0015 [12:15 AM]; ...1. Heterogeneous thick walled collection in the left adnexa with surrounding edema extending to the uterus and adjacent bowel segments, compatible with an ectopic pregnancy given provided clinical history ..."
Review of "Emergency Provider Report" dated 09/26/23, untimed, showed, "[Staff Q, MD] documented: "HPI Greet [history of present illness] ... Primary Impression: Ectopic pregnancy ...Admit Physician OB/GYN ...Accepted time 0005 [12:05 AM]; Accepted Date 09/27/23..."
Patient 1's ED medical record showed Patient 1 was discharged to home, however, Patient 1 remained in the Emergency Department waiting room until 09/27/23 at 1:13 AM, 12 hours and 25 minutes after her arrival to the ED.
The ED medical record failed to show documentation of any additional vital signs despite hospital policy that vital signs be reassessed and documented a minimum of every hour and despite the assertion in the medical record that Patient 1's vital signs were "still stable". Failure to monitor vital signs placed Patient 1 at an increased risk for an unrecognized emergency medical condition, such as acute blood loss from ruptured ectopic pregnancy.
Review of "Operation Procedure Report" dated 09/27/23 dictated at 7:04 PM, showed "Post Procedure Diagnosis ...Removal of left ruptured ectopic pregnancy ..."
During an interview on 10/22/24 at 11:35 AM, Patient's 1 stated " ...When I checked in, I told them I had severe pain. I had been sitting in waiting room for hours, my husband had gone up to them and told them that I was doubling over in pain and gushing blood and then was threatened to be kicked out if not quiet. They started my IV out in the waiting room said they do that often because they were too full. They never assessed me until later after we've met the other doctor at maybe about 10:00 PM that night that's when he started stepping up. Then they told me in the waiting room, I had ectopic pregnancy and needed emergency surgery ..."
During an interview on 10/22/24 at 11:00 AM, Staff J, Registered Nurse (RN), states, "[Patient 1] has only had one set of vital signs at 1:10 PM. Unknown what they were doing to stabilize her condition, it is not normal for a patient would be here for 12 hours with only one set of vital signs. Ectopic pregnancy signs and symptoms of abdominal pain, positive pregnancy test, depending on the presentation they would be triage either a 2 or 3. Abnormal vitals would make you a level 2 which would be abnormal presentation, hard to tell if patient was declining with only one set of vital signs. OB would be consulted for ectopic pregnancy with next steps should be OR. Ectopic pregnancy is an emergency since there is risk for rupture and bleeding out, they usually go to surgery relatively quickly but I could not give a time frame."
During an interview on 10/23/24 at 10:11 AM, Staff O, RN, states "Stabilizing ectopic pregnancy is monitoring vital signs, bleeding and if they have increased pain would show ruptured ectopic. We would call the resident to give update on patient condition."
During an interview on 10/23/24 at 10:11 AM, Staff M, Doctor of Medicine (MD), stated, "A patient coming in at childbearing age saying that they are pregnant with a positive pregnancy test, bleeding and pain you are ruling out ectopic pregnancy. [Patient 1] was seen during the surge process (patient volumes challenge or exceed hospital servicing capacity) this is very challenging but that the providers really don't have much say, we do our part we put in the orders, tell the nurses what needs to happen. From there who gets pulled into a room that's kind of out of our hands we've been pretty much told that's not for you guys to decide that's for nursing protocols and hospital systems to decide. It's a very frustrating system in the ER when you've got limited nursing resources they can only do so many things so they end up working people through the waiting room..."
Review of the ED log dated 09/25/23 showed a total of 369 patients presented to the ED and of those patients, 20 patients remained in the ED waiting admission to the hospital when Patient 1 presented on 09/26/23 at 12:48 PM.
Review of the ED log dated 09/26/23 showed Patient 1 arrived at 12:48 PM and left the ED on 09/27/23 at 1:15 AM with a disposition of "Was admitted & treated".
Review of the ED log dated 09/26/23 showed a total of 356 patient presented to the ED. Of the 356 patients, 22 patients were admitted to the hospital on 09/26/23, 17 patients were held in the ED and admitted to the hospital on 09/27/23 and one patient was held in the ED and admitted on 09/28/23.
During an interview on 10/23/24 at 2:45 PM, Staff Q, MD, stated "If the patient chief complaint is first trimester bleeding and pain, we would be ruling out an ectopic or miscarriage. A first trimester pregnancy that had an ultrasound with no identifiable pregnancy with an HCG over 2000 mlU/ml [milli-international units per milliliter] would have an ectopic pregnancy until proven otherwise. I took over a case from [Staff N, Physician Assistant (PA)] never in my career has HCG been redrawn that was over 2000 mlU/ml. I contacted OB and told them that you have an ectopic pregnancy you need to come and see them. OB came to see her and they notified me at that time that they were taking her straight to the OR from the emergency room. She was upset and uncomfortable but not in distress."
During an interview on 10/23/24 at 4:40 PM, Staff W, RN, stated that in cases of an ectopic pregnancy it is typically assessed based on the patient's stability and bleeding status. If deemed an emergency with heavy bleeding or rupture it is scheduled within 30 minutes. For non-emergent cases where the patient is stable and not bleeding heavily the surgery can be delayed up to six hours or the next available. A delay beyond six hours especially up to 12 hours is not encountered in ectopic pregnancies.
Patient 18
Review of Patient 18's "HPI [history of present illness]-Illness," revealed Patient 18 presented to the ED on 06/20/24, with a chief complaint of "pregnant and bleeding." Per the HPI-Illness, Patient 18 was eight weeks pregnant and experienced heavy bleeding for two days that had now stopped. Patient 18 came to the facility because she still had no appetite, which she equated with pregnancy and wondered if she were still pregnant. According to the HPI-Illness, Patient 18 did not report any pain and was not tachycardic (fast heart rate) or hypotensive (low blood pressure). The patient's intact human chorionic gonadotropin (hCG) was high at 76,754 milli-international units per milliliters (mIU/ml) (approximate hCG, 23,100-291,000 mIU/ml, indicates 7-13 weeks pregnant).
Review of Patient 18's "Re-evaluation & MDM" [Medical Decision Making] showed, "Hgb [hemoglobin - red blood cells] - pt has previous anemia but doesn't know numbers-today 9.9 [normal 12 - 16] may have concurrent virus? mild neutropenia [low level of neutrophils-a type of white blood cell] with monocytic [relating to monocytes, a type of white blood cell that fights infection and protects the body from foreign substances] preddominant (sic)/plt [platelets]ok urine without any blood no pain go to [named clinic]-ask for OB [obstetrics] appt [appointment]"
Further review of the medical record showed Patient 18 was discharged home with instructions to call a medical clinic "this morning-make an appt to get a blood draw next Monday or Tuesday called a 'quantitative' (a test for the hormones of pregnancy)." The medical record indicated Patient 18's instructions included "Threatened Miscarriage (ED)" and "Nausea and Vomiting in Pregnancy (ED)."
Patient 18's medical record did not reveal documentation that the hospital made use of its available capabilities, including, but not limited to, sufficient physical examination, diagnostic testing (such as, but not limited to, ultrasound), comparison against prior available data (such as to determine whether the low hemoglobin level represented a change from Patient 18's baseline), and monitoring/re-evaluation sufficient to determine whether or not Patient 18's symptoms were a manifestation of an emergency medical condition. The hospital's on-call OB/GYN physician was also available when Patient 18 presented but did not participate in her evaluation or management.
During an interview on 10/22/24 at 9:59 AM, Staff E, Vice President of Emergency Services stated that Patient 18 did not have an ultrasound completed during her visit.
During an interview on 10/23/24 at 10:13 AM, Staff R, Physician Assistant stated that to check for an ectopic pregnancy, a transvaginal ultrasound and a hCG level would be checked. According to Staff R, if there was a suspicion for an ectopic pregnancy, typically, an OB consult would be placed, either through the patient's designated obstetrician (OB) or the on-call OB, if the patient did not have one yet.
During an interview on 10/23/24 at 1:29 PM, Staff U, Medical Doctor (MD) stated that some testing that could be completed to determine if a patient was having a miscarriage versus an ectopic pregnancy included a urine pregnancy test, and if the test was positive, then testing could also include an hCG quantitative. Per Staff U, based on the level of the hCG, it would help determine what may be seen on the ultrasound and the provider would also need to determine if the patient was in discomfort or having pain, and if the patient was having bleeding, and how heavy was the bleeding, or if it was spotting. Staff U stated that based on the story gathered from the patient, the urine pregnancy test result, the hCG result, the physical exam, and the ultrasound, an OB consult may be placed to either the patient's OB, if they had one, or to the on-call OB if needed. Staff U re-clarified that it was possible to see an ectopic pregnancy on ultrasound. Staff U stated that he did not recall Patient 18 at all. According to Staff U, a reason he would not obtain an ultrasound in first trimester bleeding would be if the patient had already had an ultrasound that confirmed an intrauterine pregnancy and another ultrasound would not be indicated in that case. Staff U stated that typically a pelvic exam would not be done, unless there was heaving bleeding and heaving bleeding could be determined without a pelvic exam based on a physical exam, if the patient used a pad, or if blood was visualized on the bed.