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703 N MCEWAN ST

CLARE, MI 48617

COMPLIANCE WITH 489.24

Tag No.: A2400

Based on a review of medical records, hospital policies, observation, and interviews, it was
determined that the facility failed to comply with the requirements of 42 CFR 489.24 [special responsibilities of Medicare hospitals in emergency cases] for two of twenty-one sampled patients who presented at the hospital's dedicated emergency department. The hospital failed to ensure that Patient #6 received an appropriate medical screening examination (MSE) that made use of the hospital's capabilities (including the ancillary services routinely available to the emergency department) to determine whether an emergency medical condition (EMC) existed. The hospital also failed to provide, within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize an identified emergency medical condition for Patient #1 and failed to provide her an appropriate transfer.

Failure to provide an appropriate MSE, stabilizing treatment, and an appropriate transfer to
patients with an emergency medical condition has the potential to result in deterioration of the patient's health or bodily functions (including, but not limited to, risk of fetal distress, preterm labor, organ failure, infection, coagulopathy, sepsis, severe bleeding, risk of future infertility, poor fetal outcomes, and death).

POSTING OF SIGNS

Tag No.: A2402

Based on observation and interview, the facility failed to post Emergency Medical Treatment and Labor Act (EMTALA) signs in areas likely to be noticed by all individuals that visit the emergency department (ED) resulting in the potential for all emergency patients to be uninformed of their rights. Findings include:

On 08/13/2024 at 0945 entrance to the facility occurred through the designated Emergency Room Department entrance. During the observational tour of the ED, on 08/13/2024 at 0950, it was noted that there was only one Emergency Medical Treatment and Labor Act (EMTALA) sign posted in the patient waiting area, which was only written in Spanish. There was no English language EMTALA signage observed in the patient triage area or patient hallway in the emergency department.

In an interview with Staff A (Emergency Department Manager), on 08/13/2024 at 0950, she stated there was no EMTALA sign in English posted in the patient waiting area. The only EMTALA sign in English was posted in the Ambulance entrance area. Staff A stated they would need to get more signs ordered.

MEDICAL SCREENING EXAM

Tag No.: A2406

Based on interview and document review, the facility failed to provide an appropriate medical screening examination (MSE) that made use of the hospital's capabilities (including the ancillary services routinely available to the emergency department) to determine whether an emergency medical condition (EMC) existed for one of twenty-one (Patient #6) patients reviewed. Failure to provide an appropriate MSE placed patients at risk for an undiagnosed emergency medical condition, which has the potential to result in deterioration of the patient's health or bodily functions (including, but not limited to, risk of fetal distress, preterm labor, organ failure, infection, coagulopathy, sepsis, severe bleeding, risk of future infertility, poor fetal outcomes, and death). Findings include:

Review of the facility's policy entitled "Maternal Child-Admission and OB Medical Screening Exam Procedure When Presenting with an Emergency Medical Condition," dated 05/2024 and "applicability: MyMichigan Health and all its wholly owned subsidiaries" revealed the policy purpose was to "To provide appropriate assessment, care and disposition of all patients (greater than 20 weeks gestation) presenting to the Maternity Center/Emergency Department (ED) for evaluation/admission." The policy stated, "All patients greater than 20 weeks gestation who present to the Maternity Center/ED for unscheduled exams/procedures/admission with obstetric complaints will be seen in the OB department. 1. Patients 20 weeks or greater with pregnancy related signs/symptoms or issues will be seen in the OB department... 4. If a patient presents to the ED and delivery is imminent and the patient is not stable for transfer to the OB unit, the ED staff will call the OB unit and an OB nurse, OB provider, and shift supervisor will be called to the ED to assist with delivery... B. RN's [sic] will perform the triage assessment and consult with a physician after the assessment and cervical exam, if necessary, and prior to the patient's discharge. The physicians will refer to the OB triage index. The OB provider is responsible for ruling out false labor, obtaining pertinent information from the nurse, ordering appropriate diagnostic tests, analyzing the results of those tests and determining the appropriate disposition of the patient. The nurse will wait until all lab tests are interpreted by the OB provider to discharge the patient...C. Patients 23 weeks or greater gestation being evaluated on an outpatient basis should receive a 20-minute fetal monitor strip to determine fetal well-being. Patients less than 23 weeks gestation will have fetal heart tones dopplered. The attending OB provider will be notified of the patient's status by either resident or nurse. After observation, the patient will be re-evaluated at which time the attending OB provider will make a decision to admit the patient or send her home undelivered."

Review of the facility's "Emergency Medical Treatment and Active [sic] Labor Act (EMTALA) Policy and Procedure, dated 11/2023 and applicability : Medical Center Clare revealed the policy purpose was "To assure that all MyMichigan Medical Centers, their associates and medical staff members, comply with the rules and regulations of the federal Emergency Medical Treatment and Active Labor Act (EMTALA). Under "Procedure, 1. Presenting for Care and Medical Screening Examination...G. The purpose of the medical screening examination is to determine if an individual is experiencing an emergency medical condition. The medical screening examination is more than providing triage; triage is a process used to determine the presence or absence of an emergency medical condition. The medical screening examination represents a spectrum ranging from a simple process that involves performing ancillary studies and procedures. It is an on-going process, not an isolated event... 1. An "emergency medical condition" is a condition manifesting symptoms (including severe pain, psychiatric disturbances and/or symptoms of substance abuse) which, in the absence of immediate medical attention, is likely to cause serious dysfunction of impairment to a bodily organ or function or serious jeopardy to the health of the individual or unborn child. 2. A pregnant woman who is having contractions is considered to be an "emergency medical condition" if there is not enough time to safely transfer the woman prior to delivery or a transfer would pose a threat to the woman or her unborn child.

Review of Patient #6's medical record revealed that Patient #6 presented to the hospital's emergency department (ED) 6/30/2024 at 2315 complaining of "possible decreased fetal movement" and "possible UTI" (urinary tract infection). Documentation by ED physician Q, dated 6/30/2024 at 2315, said, "Patient presents with possible UTI [and] possible decreased fetal movement...33-year-old female with symptoms of urinary tract infection. Patient [states] symptoms have been going on for the last 2 days[;] no dysuria [painful urination] but positive odor noted[,] consistent with prior urinary tract infections. Patient denies any fevers or chills[;] patient denies any abdominal pain[,] vaginal bleeding[,] or vaginal discharge[;] patient denies any current back pain. Patient is currently 30-ish weeks pregnant at this time. Seeing OB/GYN doctor for prenatal care." Physician Q documented Patient 6's past medical history as including gestational diabetes, placenta previa (when the placenta attaches low in the uterus and covers all or part of the cervix, which can result in heavy bleeding), and spontaneous abortion (miscarriage) complicated by need for dilation and curettage (a surgical procedure to remove abnormal tissue from the uterus after a miscarriage complication). The "Medical Decision Making" documented by Physician Q included only "Labs: ordered" and incorporation of urinalysis results showing bacteria and 5-10 white blood cells per high power field in the urine (an indication of possible inflammation in the urinary tract." Documentation by Staff R described that Patient #6 "thinks she might have less fetal movement today" and documented assessment of "fetal heart rate 141" (normal) on 6/30/2024 at 2338. Patient #6 was discharged on 7/1/2024 at 0013 with a prescription for antibiotics and discharge instructions to "please notify your OB/GYN doctor."

The medical record did not contain documentation that Patient #6 was evaluated in the "OB department," as required by hospital policy, nor that her screening included further evaluation of fetal status described by hospital policy, including ongoing fetal monitoring or attending OB provider notification. The hospital's on-call obstetrical physician, Staff N was available and on-call when Patient #6 presented to the hospital's emergency department but did not participate in the evaluation or management of Patient #6.

STABILIZING TREATMENT

Tag No.: A2407

Based on document review, interview, and policy review, the facility failed to provide, within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize an identified emergency medical condition for one (Patient #1) of twenty-one patients reviewed. Failure to provide stabilizing treatment has the potential to result in deterioration of the patient's health or bodily functions (including, but not limited to organ failure, infection, coagulopathy, sepsis, severe bleeding, risk of future infertility, and death). Findings include:

Cross-refer to A-2406 for hospital policies

Review of Patient #1's medical records revealed that Patient #1 presented to the hospital's ED on 6/26/2024 at 0839 with "Chief Complaints" of "Abdominal Pain" and "Vaginal Bleeding - Pregnant."
Documentation by Physician I, dated 6/26/2024 0839, said, "This is a 31 y.o. [year old] female with a history of POTS [postural orthostatic tachycardia syndrome, a condition that can cause symptoms when transitioning from lying down to standing up, such as a fast heart rate, dizziness and fatigue] and a DVT [deep vein thrombosis, a blood clot generally treated with blood-thinning medications] who presents today to the Emergency Department for evaluation of abdominal pain onset 2 hours ago. Patient is currently 16 weeks pregnant and states that last night, she began to have some vaginal bleeding[,] and this morning she was having abdominal pain and spotting. She notes that she feels as though she is having contractions that are minutes apart. Patient mentions that this is her fifth pregnancy and that she only had complications after her first pregnancy in which she had developed a DVT[,] and her child was born at 32 weeks. She states that she is currently on Lovenox [brand name for a blood thinning medication used to prevent or treat blood clots] but did not take any of it due to it possibly causing her nausea and abdominal pain." Physician I documented the "onset" of both the abdominal pain and vaginal bleeding as "sudden" and Patient #1's "Physician Exam" as including "Gravid [pregnant] uterus" but no other genitourinary examination or characterization of bleeding, cervical dilation, or presentation of fetal parts.

ED nurse Staff K documented on 6/26/2024 at 1015 "Bleeding Amount: Gush" and then at 1216 "Pt [patient] expelled fetus [at] approximately 0950 am. Pt proceeded to expel several blood clots. At [approximately] 11 am[,] pt became dizzy and reported blurry vision and vomiting. Pt noted to have soft [low] blood pressures at this time."

At 1032, Staff S documented, "Transfer Initiation" and "passed infant in ED- no placenta, on lovenox [sic] for clots...recommended admit to OB under oncall."

Between arrival and 1145, the record indicated that Patient #1's blood pressure dropped from 125/77 (normal) at 0845 to 102/58 at 1045, 94/44 at 1100, 90/51 at 1115, 90/54 at 1130, and 81/68 at 1145.

At 1129, Physician I documented, "Patient with episode of hypotension [low blood pressure] but also had vomiting and then syncope [loss of consciousness]. Concern for vagal episode as well as potential severe bleeding."

At 1203, Physician I documented, "Hemoglobin [blood count] decreased slightly from 12.3 [to] 9.7. This likely represents dilution after 2 L normal saline. Last BP 100/60."

At 1207, Physician I documented, "Shortly after arrival[,] patient had passed the fetus. It appears deceased, pale and with no movement."

The medical record did not contain evidence that Patient #1 delivered both the fetus and placenta prior to being transferred on 6/26/2024 at 1212 (cross-refer to A-2409). There was no evidence the hospital considered or attempted spontaneous delivery of the placenta prior to transfer, nor that the hospital considered the potential benefits of delivery of the placenta, including minimizing the risk of post-partum hemorrhage.

In an interview on 08/13/2024 at 1505, Physician I stated he was a board-certified emergency physician and had been doing approximately two shifts per month at this facility for 5 years. He said that after Patient #1 delivered the fetus, he "walked in her room" but "did not physically assess [her] for bleeding" and "did not deliver the placenta."

During interview with ED nurse, Staff K, on 8/14/2024 at approximately 1010, she stated that she recalled that sometime after arrival, Patient 1 activated her call light and notified Staff K that her "water just broke." Staff K went in the room and helped patient change in the gown. Staff K left the room to notify Physician I. While speaking to the physician at the nurses' station, the call light was activated by Patient #1, who notified staff that she "delivered the baby." Staff K, Physician I, and triage nurse Staff E all went to patient's room. Staff K recalled observing Patient #1 sitting in bed with the fetus between her legs. When asked to describe the fetus, Staff K stated it was about the size of her hand, with short, thin umbilical cord, like a "dry thin noodle." When asked if a physician assessed for placenta delivery and bleeding, Staff K stated "no." Staff K said that the triage nurse, Staff E, left the room to call OB services for fetus care instructions. Staff K stayed in the room to take care of the patient and fetus. Staff K said she remembered assisting patient to a bedside commode and inspecting discharge for placenta tissue.

Review of the hospital's on-call schedule revealed that an OB/GYN physician, Staff N, was available and on-call when Patient #1 presented to the hospital's emergency department and was credentialed to perform spontaneous deliveries, including delivery of the placenta.

Review of hospital credentialing information for Physician I revealed that he was also credentialed to perform spontaneous deliveries, including delivery of the placenta.

Review of the hospital's public website revealed the facility holds itself out to the public as offering "a full range of services in specialty areas, including...gynecology," "surgical services," and "women's health."


Cross refer to tag A-2409.

APPROPRIATE TRANSFER

Tag No.: A2409

Based on document review, interview, and policy review, the facility failed to appropriately transfer one (Patient #1) of twenty-one patients reviewed when it identified Patient #1 as having an emergency medical condition as a "pregnant woman who is having contractions...that there is inadequate time to effect a safe transfer to another hospital before delivery" because they had knowledge that her delivery was already in progress, so it would have been impossible for her to be transferred "before" delivery. The hospital expressly listed "deterioration" and "worsening condition" as risks of the transfer, which also indicate the hospital's knowledge of an unstabilized emergency medical condition. The hospital erroneously represented her emergency medical condition in the medical record and in transfer documentation as "stabilized" at the time of transfer. Failure to provide appropriate transfer has the potential to result in deterioration of the patient's health or bodily functions (including, but not limited to, organ failure, infection, coagulopathy, sepsis, severe bleeding, risk of future infertility, and death). Findings include:

Cross-refer to A-2406 for hospital policies .

Cross-refer to A-2407. Briefly, review of Patient #1's medical records revealed that Patient #1 presented to the hospital's ED on 6/26/2024 at 0839 with "Chief Complaints" of "Abdominal Pain" and "Vaginal Bleeding - Pregnant." Documentation by Physician I, dated 6/26/2024 0839, included, "Patient is currently 16 weeks pregnant and states that last night, she began to have some vaginal bleeding[,] and this morning she was having abdominal pain and spotting. She notes that she feels as though she is having contractions that are minutes apart."
ED nurse Staff K documented on 6/26/2024 at 1015 "Bleeding Amount: Gush" and then at 1216 "Pt [patient] expelled fetus [at] approximately 0950 am. Pt proceeded to expel several blood clots. At [approximately] 11 am[,] pt became dizzy and reported blurry vision and vomiting. Pt noted to have soft [low] blood pressures at this time."

At 1032, Staff S documented, "Transfer Initiation" and "passed infant in ED- no placenta, on lovenox [sic] for clots...recommended admit to OB under oncall."

Between arrival and 1145, the record indicated that Patient #1's blood pressure dropped from 125/77 (normal) at 0845 to 102/58 at 1045, 94/44 at 1100, 90/51 at 1115, 90/54 at 1130, and 81/68 at 1145.

At 1129, Physician I documented, "Patient with episode of hypotension [low blood pressure] but also had vomiting and then syncope [loss of consciousness]. Concern for vagal episode as well as potential severe bleeding."

At 1137, Physician I documented on the electronic "EMTALA Transfer Form" "Patient stabilized." Physician I documented the "Risks of Transfer" to include "deterioration" and "worsening condition." There was no evidence the hospital considered or attempted spontaneous delivery of the placenta prior to transfer, nor that the hospital considered the potential benefits of delivery of the placenta, including minimizing the risk of post-partum hemorrhage. The medical record also contained evidence that the hospital knew that Patient #1 had yet to deliver the placenta prior to being transferred on 6/26/2024 at 1212 and, therefore, could not have had her EMC "stabilized," as defined in 42 CFR 489.24(b) (cross-refer to A-2407).