Brooks-Tlc Hospital System, Inc.

“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: 48506 Based on policy review, document review, medical record review, and interview, the facility failed to comply with the Emergency Medical Treatment and Active Labor Act (EMTALA). This failure potentially placed all patients at increased risk for adverse outcomes. Findings include: The facility failed to ensure there was on-call obstetric coverage and/or that the on-call obstetrician presented to the hospital when notified for three of seven patients (A-2404), the facility did not ensure that an appropriate medical screening examination was performed for two of seven patients (A-2406), and the facility did not provide an appropriate transfer for two of seven patients (A-2409). Cross Reference: 489.20 (r) (2) and 489.24 (j) (1-2)- On Call Physicians 489.24 (a) & 489.24 (c)-Medical Screening Exam 489.24 (e) (1)-(2)- Appropriate Transfer”

“ON CALL PHYSICIANS CFR(s): 489.20(r)(2) and 489.24(j)(1-2) §489.20(r)(2) [The hospital (including both the transferring and receiving hospitals), must maintain] a list of physicians who are on call for duty after the initial examination to provide further evaluation and/or treatment necessary to stabilize an individual with an emergency medical condition. §489.24(j)(1) Each hospital must maintain an on-call list of physicians on its medical staff in a manner that best meets the needs of the hospital’s patients who are receiving services required under this section in accordance with the resources available to the hospital, including the availability of on-call physicians. §489.24(j)(2)(i) The hospital must have written policies and procedures in place to respond to situations in which a particular specialty is not available or the on-call physician cannot respond because of circumstances beyond the physician’s control. §489.24(j)(2)(ii) The hospital must have written policies and procedures in place to provide that emergency services are available to meet the needs of patients with emergency medical conditions if it elects to permit on-call physicians to schedule elective surgery during the time that they are on call or to permit on-call physicians to have simultaneous on-call duties. This Standard is not met as evidenced by: 48506 Based on policy review, medical record review, document review, and interview, the facility failed to ensure there was on-call obstetric coverage for Patient #1 and failed to ensure that the on-call obstetrician presented to the hospital when notified for two of seven pregnant patients (Patients #24 and #27). Failure to ensure obstetric coverage has the potential for a delay in care, inadequate care, and/or an adverse patient outcome. Findings include: Review of the policy “Medical Screening Exam, Stabilization, and Transfers From the Emergency Department” last revised November 2022 indicated that if the emergency department physician or attending physician feels a consultation by a specialist is necessary to further assess or stabilize an individual with an emergency medical condition, the appropriate on-call physician will be notified and expected to respond in a timely manner. Urgent calls are to be answered within 15 minutes and all others within one hour. The medical screening examination includes a history and physical examination/evaluation, appropriate testing within the capabilities of the hospital including the use of on-call physicians as appropriate to determine if an individual has an emergency medical condition. Review of the policy “Medical, Dental and Podiatric Staff Rules and Regulations,” last revised 12/19/22 indicated that the on-call provider should respond to calls from the emergency department within 15 minutes and must arrive to the hospital to evaluate the patient within 30 minutes of the call for emergent conditions. Review of the emergency department medical record dated 11/19/23 for Patient #1 revealed the following: - At 07:42 PM, Patient #1 arrived ambulatory with complaints of being in labor. - At 07:49 PM, the triage assessment revealed that Patient #1 reported a full-term pregnancy and had been in labor since yesterday. Patient #1 had complaints of “a lot of bleeding.” Patient #1 denied having any prenatal care. Patient #1 was triaged as a level two. - At 07:55 PM, a medical screening examination by Staff (M), Physician revealed Patient #1 had no prenatal care and stated that her last use of heroin was approximately one hour ago. Orders were placed for laboratory studies. Fetal heart tones were obtained by the nurse. According to the on-call schedule, there was no obstetrician on-call. Staff (P), Pediatrician was called to the bedside. Staff (J), Obstetric Registered Nurse, performed a vaginal speculum exam that revealed an intact amniotic sac (fluid filled sac that contains and protects a fetus) within the vaginal canal. Patient #1 was fully dilated (opening in the cervix) and effaced (stretching and thinning of the cervix). “Given this state Patient #1 cannot be transferred.” Further attempts were made to contact the obstetricians, but neither of them could be contacted. A call was placed to the labor and delivery hotline at the recipient hospital. Patient #1’s presentation, history, and current state was discussed with the provider at the recipient hospital. Patient #1 was not a candidate for transfer until after delivery. Recommendations (by the recipient hospital hotline provider) were given to provide supportive care through delivery. The recipient hospital provider stated to call back with any other concerns. Staff (L), General Surgeon (on-call), was called in for surgical backup if Patient #1’s condition declined. Staff (L), General Surgeon felt that Patient #1’s membranes should be ruptured. At 08:50 PM, the membranes were ruptured (by Staff L) with clear fluids noted. Immediately after, a prolapse of the umbilical cord (the umbilical cord connects the developing fetus with the mother to provide nutritents/oxygen and to remove waste. Umbilical cord prolaspse is when the cord slips out of the vagina before the fetus, and is an obstetrical emergency) was noted. An emergent caesarean section (surgical removal of the infant) was needed. The on-call anesthesia staff were notified to come in. A call was placed to the labor and delivery hotline at the recipient hospital again. The recipient hospital provider requested that a dose of ceftriaxone (antibiotic) be given and recommended an emergent caesarean section (surgical removal of the infant). - At 08:00 PM, the nursing supervisor attempted to call the obstetrician’s, but they were not available to come in. The general surgeon and pediatrician were called in. Staff (L), General Surgeon, ruptured the amniotic membranes. The umbilical cord and a leg (infant) immediately protruded from the vagina (the infant’s position was feet first or breech instead of head first. Potential complications for an infant with a breech presentation are injury, the head getting stuck or trapped, and the umbilical chord flattening or twisting causing nerve or brain damage due to lack of oxygen). Manual reduction (staff manually moving and reducing cord compression to maintain oxygenation) of the umbilical cord and leg were performed. Patient #1 was taken to the operating room at 08:55 PM. - At 09:29 PM, Patient #1 delivered a limp, cyanotic (bluish discoloration, apneic (lack of breathing) infant (Patient #2) via caesarean section (surgical removal of the infant). Review of the Obstetrical/Gynecological on-call schedule for November 2023 (no date), revealed Staff (N), Obstetrician, was scheduled to be on-call for 11/19/23. Review of the Obstetrical/Gynecological on-call schedule for November 2023 with a revision date of 11/13/23, revealed that no physician was on-call for the date of 11/19/23. Interview on 11/30/23 at 08:43 AM with Staff (K), Registered Nurse, stated there was a lot of trouble with the on-call schedule. One obstetrical on-call schedule identified there was no provider on call and another schedule identified there was a provider on for 11/19/23. Interview on 11/30/23 at 12:41 PM with Staff (R), Registered Nurse Supervisor, stated there were two on-call schedules. One schedule identified there was obstetrical coverage while the other schedule identified no coverage. Staff (R) made multiple attempts to get a hold of both obstetrical providers with no success. Review of the emergency department medical record dated 03/11/22 revealed that at 07:05 PM, Patient #24 presented to the facility emergency department with the complaint of abdominal pain with uterine contractions (is part of the birthing process where there is a tightening feeling across the stomach, back, and/or thighs) every five to seven minutes that started at 09:00 AM. Patient #24 had an estimated due date of 03/21/22 and was scheduled for a cesarean section on 03/14/22 at another hospital. At 07:05 PM, the initial nursing assessment noted Patient #24 having uterine contractions every one to three minutes that last for 40-60 seconds. At 08:01 PM, a nursing note indicated that Patient #24 was discharged from the facility per telephone conversation with Staff (O), Obstetrician, who instructed Patient #24 to drive their personal vehicle directly to another hospital. At 08:01 PM, Patient #24 left the facility via personal vehicle. (There in no evidence that Staff (O), Obstetrician, who was on-call, came to the hospital to perform an emergency medical screening examination and evaluate Patient #24 to see if an emergency condition existed). Review of the emergency department medical record dated 04/22/23 revealed that at 12:00 AM, Patient #27 arrived ambulatory to the facility with a complaint of premature rupture of membranes and abdominal pain. Patient #27 was leaking amniotic fluid since 11:00 PM. At 12:00 AM, an amnisure test was positive for amniotic fluid. At 12:27 AM, a vaginal examination was performed by Staff (V), Obstetric Registered Nurse, who indicated there was no cervical dilation (the cervix was closed), there was thick effacement (the cervix had no thinning), and the baby was at a high station (how far the baby has descended in the pelvis). Patient #27 was 29 weeks, six days gestation (age). Patient #27 had two prior cesarian sections (surgical removal of the infant). At 12:30 AM, the registered nurse called Staff (O), Obstetrician with an assessment of Patient #27 indicating that per Patient #27, the fetus was in a known breech (infants buttocks or lower extremity entering the pelvis first instead of head first) presentation and was being monitored for pre-eclampsia (pregnancy induced high blood pressure). Staff (O) gave instructions over the phone for Patient #27 to get in their car and drive to another hospital approximately 55 minutes away immediately. At 12:45 AM, Patient #27 was discharged with their husband. (There in no evidence that Staff (O), Obstetrician, who was on-call, came to the hospital to perform an emergency medical screening examination and evaluate Patient #27 to see if an emergency condition existed). Review of the Obstetrical/Gynecological on-call schedule revealed that Staff (O), Obstetrician, was scheduled to be on-call for 03/11/22 and 04/23/23. Interview on 12/13/23 at 02:30 PM with Staff (B), Chief Nursing Officer, stated during this time, obstetrical triage was conducted by a nurse when a laboring patient presented to the facility.”

“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: 48506 Based on policy review, medical record review, and interview, the facility did not ensure that an appropriate medical screening examination was performed for two of seven patients (Patients #24 and #27). Failure to provide an appropriate medical screening examination has the potential for an adverse patient outcome. Findings include: Review of the policy “Medical Screening Exam, Stabilization, and Transfers From the Emergency Department” last revised November 2022, indicated that all persons who present to the emergency department requesting examination or treatment will be provided a medical screening exam by qualified medical personnel. All presenting individuals will be afforded a medical screening exam based upon their priority as determined by the triage nurse. No individual presenting to the emergency department shall be denied a medical screening exam. The medical screening examination includes a history and physical examination/evaluation of the individual and appropriate testing within the capabilities of the hospital, to determine if the individual has an emergency medical condition. Completion of appropriate documentation is required. An emergency medical condition is manifested by acute symptoms of sufficient severity that can result in placing the health of the individual, pregnant woman and/or unborn child in serious jeopardy, serious impairment of bodily function, serious dysfunction of any bodily organ/part: or in respect to a pregnant woman who is having contractions, inadequate time for a safe transfer to another hospital before delivery. Review of the emergency department medical record dated 03/11/22 revealed that at 07:05 PM, Patient #24 presented to the facility emergency department with the complaint of abdominal pain with uterine contractions (is part of the birthing process where there is a tightening feeling across the stomach, back, and/or thighs) every five to seven minutes that started at 09:00 AM. Patient #24 had an estimated due date of 03/21/22 and was scheduled for a cesarean section on 03/14/22 at another hospital. At 07:05 PM, the initial nursing assessment noted Patient #24 having uterine contractions. At 08:01 PM, a nursing note indicated that Patient #24 was discharged from the facility per telephone conversation with Staff (O), Obstetrician, who instructed Patient #24 to drive their personal vehicle directly to another hospital (approximately 55 minutes away). At 08:01 PM, Patient #24 left the facility via personal vehicle. (There was no evidence to indicate Patient #24 received an emergency medical screening examination by a physician while in active labor (the first stage of giving birth or labor to an infant. The cervix, the female reproductive organ that connects the vagina to the uterine cavity, dilates or opens from six to 10 centimeters, and contractions become stronger, closer together, and regular). Review of the emergency department medical record dated 04/23/23 revealed that at 12:00 AM, Patient #27 arrived ambulatory to the facility with a complaint of premature rupture of membranes and abdominal pain. Patient #27 was leaking amniotic fluid since 04/22/23 at 11:00 PM. At 12:00 AM, an amnisure test was positive for amniotic fluid. At 12:27 AM, a vaginal examination was performed by Staff (V), Obstetric Registered Nurse, indicated there was no cervical dilation (the cervix was closed), there was thick effacement (the cervix had no thinning), and the baby was at a high station (how far the baby has descended in the pelvis). Patient #27 was 29 weeks, six days gestation (age). Patient #27 had two prior cesarian sections (surgical removal of the infant). At 12:30 AM, the registered nurse called Staff (O), Obstetrician with an assessment of Patient #27 indicating that per Patient #27, the fetus was in a known breech (the infants buttocks or lower extremity entering the pelvis first instead of the head) presentation and was being monitored for pre-eclampsia (pregnancy induced high blood pressure). Staff (O) gave instructions over the phone for Patient #27 to get in their car and drive to another hospital (approximately 55 minutes away) immediately. At 12:45 AM, Patient #27 was discharged with their husband. (There was no evidence to indicate Patient #27 received an emergency medical screening examination by a physician). Interview on 12/13/23 at 02:30 PM with Staff (S), Vice President of Quality, verified these findings.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 48506 Based on policy review, medical record review, and interview, the facility did not provide an appropriate transfer for two of seven patients (Patients #24 and #27). Failure to provide an appropriate transfer has the potential for an adverse patient outcome. Findings include: Review of the policy “Medical Screening Exam, Stabilization, and Transfers From the Emergency Department” last revised November 2022, indicated that if a medical transfer is necessary, the transferring hospital must provide treatment within its capacity which minimizes the risks to the woman in active labor and the risks to the unborn child. The transferring hospital should obtain agreement from a receiving facility that it will accept the transfer and provide appropriate treatment. All medical records related to the emergency condition must be sent with the individual at the time of transfer. The transferring hospital must provide or ensure that the transfer is safely affected with qualified personnel and transportation equipment. Review of the emergency department medical record dated 03/11/22 revealed that at 07:05 PM, Patient #24 presented to the facility emergency department with the complaint of abdominal pain with uterine contractions (is part of the birthing process where there is a tightening feeling across the stomach, back, and/or thighs) every five to seven minutes that started at 09:00 AM. At 07:05 PM, the initial nursing assessment noted Patient #24 having uterine contractions every one to three minutes that last for 40-60 seconds. At 08:01 PM, a nursing note indicated that Patient #24 was discharged from the facility per telephone conversation with Staff (O), Obstetrician, who instructed Patient #24 to drive their personal vehicle directly to another hospital (approximately 55 minutes way). Patient #24’s father asked if it was safe for Patient #24 to travel to another hospital by car instead of an ambulance. The nurse stated that Staff (O), Obstetrician, did not think a transfer via ambulance was necessary, but that “they are more than welcome to call for an ambulance to take them if they prefer.” Patient #24 and their father declined at that time. At 08:01 PM, Patient #24 left the facility via personal vehicle. Discharge documentation was provided to Patient #24, but no transfer documentation was found in the medical record (No medical screening examination was performed. Patient #24 was discharged from the hospital with instructions to go to another hospital approximately 55 minutes away by private vehicle instead of being transferred via ambulance, in active labor (the first stage of giving birth or labor to an infant. The cervix, the female reproductive organ that connects the vagina to the uterine cavity, dilates or opens from six to 10 centimeters, and contractions become stronger, closer together, and regular). The hospital did not contact the receiving hospital/physician for notification and/or acceptance of the transfer, and there was no evidence that medical records and/or documentation were sent with Patient #24). Review of the emergency department medical record dated 04/23/23 revealed that at 12:00 AM, Patient #27 arrived ambulatory to the facility with a complaint of premature rupture of membranes and abdominal pain. Patient #27 was leaking amniotic fluid since 04/22/23 at 11:00 PM. At 12:00 AM, an amnisure test was positive for amniotic fluid. At 12:27 AM, a vaginal examination was performed by Staff (V), Obstetric Registered Nurse, who indicated there was no cervical dilation (the cervix was closed), there was thick effacement (the cervix, a female reproductive organ that connects the vagina to the uterine cavitiy, had no thinning), and the baby was at a high station (how far the baby has descended in the pelvis). Patient #27 was 29 weeks, six days gestation. Patient #27 had two prior cesarian sections (surgical removal of an infant). At 12:30 AM, the registered nurse called Staff (O), Obstetrician with an assessment of Patient #27 indicating that per Patient #27, the fetus was in a known breech (the infants buttocks or lower extremity entering the pelvis first instead of the head) presentation and was being monitored for pre-eclampsia (pregnancy induced high blood pressure). Staff (O), Obstetrician, gave instructions for Patient #27 to get in their car and drive to another hospital (approximately 55 minutes away) immediately. At 12:45 AM, Patient #27 was discharged with their husband. Discharge documentation was provided to Patient #27, but no transfer documentation was found in the medical record (No medical screening examination was performed. Patient #27 was discharged from the hospital with instructions to go to another hospital approximately 55 minutes away by private vehicle instead of being transferred via ambulance, with pregnancy complications. The hospital did not contact the receiving hospital/physician for notification and/or acceptance of the transfer, and there was no evidence that medical records and/or documentation were sent with Patient #27). Interview on 12/13/23 at 02:30 PM with Staff (B), Chief Nursing Officer, verified these findings.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 48608 Based on medical record review, document review, policy review, and interview, for one of one governing body (who is responsible for the conduct of the hospital) reviewed, the facility failed to ensure compliance with all Conditions of Participation and medical staff bylaws. Specifically, the Governing Body failed to ensure the emergency department medical director was board certified prior to appointment (A0045). Cross Reference: 482.12(a)(1)- Medical Staff- Appointments”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 48608 Based on medical record review, document review, policy review, and interview, in 2 of 27 medical records reviewed the medical staff, that operates under bylaws approved by the governing body, failed to be responsible for the quality of medical care provided to patients. Specifically, the medical staff failed to ensure the emergency department medical director had the required qualifications, according to the medical staff bylaws, prior to medical staff re-appointment (A0341). Cross Reference: 482.22 (a)(2)- Medical Staff Credentialing”

“EMERGENCY SERVICES CFR(s): 482.55 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 48608 Based on medical record review, document review, policy review, and interview, in 2 of 27 medical records reviewed, the facility failed to meet the emergency needs of patients. Specifically, the hospital failed to ensure the emergency department services were under the direction of a qualified member of the medical staff. The emergency department medical director was not board certified (A1102). The hospital failed to ensure all personnel in the emergency department are qualified in emergency care to meet the needs of the community, specifically: the hospital failed to ensure that there was obstetrical/gynecological physician on-call coverage for the emergency department. An emergency cesarean section was performed on Patient #1 by the general surgeon due to the infant’s (Patient #2) breech presentation (the fetus is positioned with buttocks and/or feet to come out first during a delivery. This position makes delivery difficult and has an increased risk of complications) and prolapsed umbilical cord (the umbilical cord comes out of the uterus into the vagina before or with the fetus, compresses the cord, and decreases oxygenation to the fetus. This condition is treated as an obstetrical emergency). Despite resuscitation efforts, the infant (Patient #2) expired shortly after birth. The obstetrics registered nurse was not qualified to perform a speculum exam for Patient #1 (A1112). On 12/01/23 at 03:30 PM, an Immediate Jeopardy was identified for the Condition of Participation for Emergency Services related to the failure to ensure obstetrical/gynecological on-call provider coverage in the emergency department. On 12/01/23 at 11:10 PM, the hospital provided a corrective action plan to onsite survey staff and implemented the following corrective actions: - At 04:31 PM, the emergency department was placed on New York State Department of Health service limitation and diversion (ambulances will be diverted from the hospital and take all obstetrical emergency patients to the most appropriate hospital) for all obstetrical related emergencies. Service limitation/diversion will be implemented when the hospital has no available obstetrical on-call medical provider as determined by executive leadership. The emergency department will continue to treat, stabilize, and transfer all walk-in obstetric patients per emergency medical treatment and labor act (EMTALA) guidelines when service limitation/diversion is implemented. - Education on obstetrical service limitation and diversion procedures was provided to all nursing supervisors, emergency department registered nurses, patient care aides, unit clerks, obstetrical registered nurses, emergency department physicians and advanced practice providers. On 12/04/23 at 10:15 AM, the Immediate Jeopardy was removed based on onsite verification which included observations, policy review, document review, and interviews with staff, which verified the corrective action plan was fully implemented. Cross Reference: 482.55(a)(1) Qualified Member of Emergency Service Staff 482.55(b)(2) Qualified Emergency Personnel”

“MEDICAL STAFF CFR(s): 482.12(a)(1) [The governing body must] determine, in accordance with State law, which categories of practitioners are eligible candidates for appointment to the medical staff. This Standard is not met as evidenced by: 48608 Based on policy review, document review, and interview, in one (1) of one (1) record review, the governing body, in accordance with State regulation, failed to ensure the emergency department medical director had the required qualifications, according to the medical bylaws, prior to their medical staff re-appointment. Specifically, the emergency department medical director was not board certified. Findings include: Review of the policy “Medical and Podiatric Staff Bylaws,” last revised 12/19/22 indicated that every practitioner who seeks medical staff membership must at the time of appointment, and continuously thereafter, demonstrate qualifications that include board certification. Current specialty board certification is required for physicians, or they must have completed a United States residency or fellowship program and obtain board certification within the timeframe established by the respective American Board of Medical Specialists or ABMS (following medical training, a physician is board eligible. Depending on the specialty examination, the physician will have three to seven years to take the board certification examination according to the ABMS Member Board Requirements for Initial Certification in a Specialty guidance document). Certification by the appropriate specialty board is required for other specified individuals holding a license to practice in the state of New York. Review of the regulations for the New York State Department of Health “Title 10, Part 405- Hospital -Minimum Standards, Section 405.19- Emergency Services,” effective 07/19/23, revealed that the emergency service shall be directed by a licensed and currently registered physician, who is board-certified or board-admissible, for a period not to exceed five years after the physician first attained board admissibility in emergency medicine, surgery, internal medicine, pediatrics, or family practice. Review on 11/30/23 of emails received from the facility related to the credentialing of Staff (Q), Medical Director of the Emergency Department revealed between 03/23/15 to 07/07/23, Staff (Q), Medical Director of the Emergency Department, has been asked to provide evidence of board certification. An email on 07/07/23 from Staff (Q) to the credentialling staff indicated “I am currently taking a course through the Center for Personalized Education for Professional” which will make me board eligible again as my eligibility ran out. I will be board eligible again in October.” Review on 11/30/23 of the New York State Office of the Professions website to verify Staff (Q), Medical Director of the Emergency Department’s credentials revealed on 05/19/02, Staff (Q) received a degree from the University of Buffalo School of Medicine for Emergency Medicine. On 05/06/05, Staff (Q) registered and received a New York State license to practice medicine. The physician profile is blank for board certification. Review on 11/30/23 of the Board of Trustees Board meeting minutes, dated 07/24/23, revealed a privilege (authorization for a medical practitioner to provide a specific practice of patient care) request for the reappointment of Staff (Q), Medical Director of the Emergency Department. The reappointment was unanimously approved. Review on 11/30/23 of the credential file for Staff (Q), Medical Director of the Emergency Department, revealed a hire date of 07/10/12. On 08/30/23, the “Reappointment to the Active Staff,” letter to Staff (Q) indicated the Board of Directors approved the two-year reappointment at the 07/24/23 meeting. The letter was signed by Staff (A), President/Chief Executive Officer. No evidence was found to indicate that Staff (Q) has obtained board certification. Interview on 12/04/23 at 10:00 AM with Staff (T), Medical Staff and Quality Coordinator verified these findings.”

“MEDICAL STAFF CREDENTIALING CFR(s): 482.22(a)(2) The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations. A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section. This Standard is not met as evidenced by: 48608 Based on policy review, document review, and interview, the medical staff failed to ensure that for one of one emergency department medical director had the required qualifications, according to the medical staff bylaws, prior to medical staff re-appointment. Specifically, the emergency department medical director was not board certified. Findings include: Review of the policy “Medical and Podiatric Staff Bylaws,” last revised 12/19/22, indicated that every practitioner who seeks medical staff membership must at the time of appointment, and continuously thereafter, demonstrate qualifications that include board certification. Current specialty board certification is required for physicians, or they must have completed a United States residency or fellowship program and obtain board certification within the timeframe established by the respective American Board of Medical Specialists or ABMS (following medical training, a physician is board eligible. Depending on the specialty examination, the physician will have three to seven years to take the board certification examination according to the ABMS Member Board Requirements for Initial Certification in a Specialty guidance document). Certification by the appropriate specialty board is required for other specified individuals holding a license to practice in the state of New York. Review of the regulations for the New York State Department of Health “Title 10, Part 405- Hospital -Minimum Standards, Section 405.19- Emergency Services,” effective 07/19/23 revealed that the emergency service shall be directed by a licensed and currently registered physician, who is board-certified or board-admissible, for a period not to exceed five years after the physician first attained board admissibility in emergency medicine, surgery, internal medicine, pediatrics, or family practice. Review on 11/30/23 of emails received from the facility related to the credentialing of Staff (Q), Medical Director of the Emergency Department revealed between 03/23/15 to 07/07/23, Staff (Q), Medical Director of the Emergency Department, has been asked to provide evidence of board certification. An email on 07/07/23 from Staff (Q) to the credentialling staff indicated “I am currently taking a course through the Center for Personalized Education for Professional which will make me board eligible again as my eligibility ran out. I will be board eligible again in October.” There was no evidence provided which indicated the facility ensured board eligibility was obtained by October 2023. Review on 11/30/23 of the New York State Office of the Professions website to verify Staff (Q), Medical Director of the Emergency Department’s medicine credentials revealed on 05/19/02, Staff (Q) received a degree from the University of Buffalo School of Medicine for Emergency Medicine. On 05/06/05, Staff (Q) registered and received a New York State license to practice medicine. The physician profile is blank for board certification. Review on 11/30/23 of the credential file for Staff (Q), Medical Director of the Emergency Department, revealed a hire date of 07/10/12. On 08/30/23, the “Reappointment to the Active Staff,” letter to Staff (Q) indicated the Board of Directors approved the two-year reappointment at the 07/24/23 meeting. The letter was signed by Staff (A), President & CEO. No evidence was found to indicate that Staff (Q) has obtained board certification. Interview on 12/04/23 at 10:00 AM with Staff (T), Medical Staff and Quality Coordinator verified these findings.”

“ORGANIZATION OF EMERGENCY SERVICES CFR(s): 482.55(a)(1) [If emergency services are provided at the hospital --] (1) The services must be organized under the direction of a qualified member of the medical staff. This Standard is not met as evidenced by: 48608 Based on policy review, document review, and interview, emergency services is not organized under the direction of a qualified member of the medical staff. Specifically, for 1 of 10 credential files, the emergency department medical director was not board certified. Findings include: Review of the policy “Medical and Podiatric Staff Bylaws,” last revised 12/19/22, indicated that every practitioner who seeks medical staff membership must at the time of appointment, and continuously thereafter, demonstrate qualifications that include board certification. Current specialty board certification is required for physicians, or they must have completed a United States residency or fellowship program and obtain board certification within the timeframe established by the respective American Board of Medical Specialists or ABMS (following medical training, a physician is board eligible. Depending on the specialty examination, the physician will have three to seven years to take the board certification examination according to the ABMS Member Board Requirements for Initial Certification in a Specialty guidance document). Certification by the appropriate specialty board is required for other specified individuals holding a license to practice in the state of New York. Review of the regulations for the New York State Department of Health “Title 10, Part 405- Hospital -Minimum Standards, Section 405.19- Emergency Services,” effective 07/19/23, revealed that the emergency service shall be directed by a licensed and currently registered physician, who is board-certified or board-admissible, for a period not to exceed five years after the physician first attained board admissibility in emergency medicine, surgery, internal medicine, pediatrics, or family practice. Review on 11/30/23 of the New York State Office of the Professions website to verify Staff (Q), Medical Director of the Emergency Department’s medicine credentials revealed on 05/19/02, Staff (Q) received a degree from the University of Buffalo School of Medicine for Emergency Medicine. On 05/06/05, Staff (Q) registered and received a New York State license to practice medicine. The physician profile is blank for board certification. Review on 11/30/23 of the credential file for Staff (Q), Medical Director of the Emergency Department, revealed a hire date of 07/10/12. On 08/30/23, the “Reappointment to the Active Staff,” letter to Staff (Q) indicated the Board of Directors approved the two-year reappointment at the 07/24/23 meeting. The letter was signed by Staff (A), President & CEO. No evidence was found to indicate that Staff (Q) has obtained board certification. Interview on 12/04/23 at 10:00 AM with Staff (T), Medical Staff and Quality Coordinator verified these findings.”

“QUALIFIED EMERGENCY SERVICES PERSONNEL CFR(s): 482.55(b)(2) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. This Standard is not met as evidenced by: 48608 Based on policy review, medical record review, document review, and interview, in one of one emergency departments, the hospital failed to ensure there were adequate medical and nursing staff qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility in the emergency department as evidenced by: 1. There was lack of obstetrical/gynecological physician on-call coverage for the emergency department. On 11/19/23, an emergency cesarean section (surgical removal of the infant) was performed for Patient #1 by the general surgeon for the infant’s (Patient #2) breech presentation (the infant is positioned with buttocks and/or feet to come out first during a delivery. This position makes delivery difficult and has an increased risk of complications) and prolapsed umbilical cord (the umbilical cord comes out of the uterus into the vagina before or with the infant/fetus, compressing the cord, and limits oxygenation to the fetus/infant. This condition is treated as an obstetrical emergency), due to the lack of an obstetrical physician. Despite resuscitation efforts, the infant (Patient #2) expired shortly after birth. 2. The obstetrics registered nurse was not qualified to perform a speculum exam for Patient #1. Review of the policy “Medical and Podiatric Staff Bylaws,” last revised 12/19/22, indicated that it is the obligation and responsibility of each staff member to participate in the on-call coverage of the emergency department, or in other hospital coverage programs, as determined and assigned by the hospital to assist in meeting the needs of the community. Findings #1: Review of the policy “Medical and Podiatric Staff Bylaws,” last revised 12/19/22, indicated that it is the obligation and responsibility of each staff member to participate in the on-call coverage of the emergency department, or in other hospital coverage programs, as determined and assigned by the hospital to assist in meeting the needs of the community. Review of the policy “Medical, Dental and Podiatric Staff Rules and Regulations,” amended 12/19/22, indicated that it is the responsibility of the on-call practitioner to respond in an appropriate time frame. The on-call provider should respond to calls from the emergency department within fifteen minutes and must arrive to the hospital to evaluate the patient within thirty minutes of the call for emergent conditions. It is the on-call practitioner’s responsibility to arrange for coverage and notify the emergency department if he/she is unavailable to take call when assigned. Failure to notify the emergency department of alternate call coverage may result in corrective action. Review of the policy “Provider On-Call, Provider Notification, Provider Response Time, Unassigned and Medicine Patients,” approved 01/13/23, revealed that when a provider (on-call) cannot be reached, one should call any provider in the same specialty. If the additional providers cannot be reached, the next call should be to the clinical care service chairperson or an officer of the medical staff such as the president, vice-president, or secretary/treasurer. If no response from all the above individuals, the next person to call is the chief medical officer. Review of the emergency department medical record for Patient #1 revealed the following: On 11/19/23: -At 07:42 PM, Patient #1 arrived ambulatory with the complaint of being in labor. -At 07:49 PM, the triage assessment revealed that Patient #1 reported a full-term pregnancy and had been in labor since yesterday. Patient #1 had complaints of “a lot of bleeding.” Patient #1 denied having any prenatal care. Patient #1 was triaged as a level two. -At 07:55 PM, Staff (M), Physician performed a medical screening exam. Patient #1 had no prenatal care and last used of heroin approximately one hour ago. Orders were placed for laboratory studies. Fetal heart tones were obtained by the nurse. “According to the on-call schedule, there was no obstetrician on-call.” Staff (P), Pediatrician was called to the bedside. Staff (J), Obstetric Registered Nurse, performed a vaginal speculum exam that revealed an intact amniotic sac (fluid filled sac that contains and protects a fetus) within the vaginal canal. Patient #1 was fully dilated (opening in the cervix) and effaced (stretching and thinning of the cervix). Due to Patient #1’s condition, transfer would need to wait until after delivery. Further attempts were made to contact the obstetricians, but neither of them could be contacted. A call was placed to the labor and delivery hotline at the recipient hospital. Patient #1’s presentation, history, and current state was discussed with the provider at the recipient hospital. Recommendations (by the recipient hospital hotline provider) were given to provide supportive care through delivery. The recipient hospital provider stated to call back with any other concerns. Staff (L), General Surgeon (on-call), was called in for surgical backup. Staff (L), General Surgeon felt that Patient #1’s membranes should be ruptured. At 08:50 PM, the membranes were ruptured (by Staff L) with clear fluids noted. Immediately after rupture, a prolapse of the umbilical cord (the umbilical cord comes out of the uterus into the vagina before or with the fetus, compresses the cord, and decreases oxygenation to the fetus. This condition is treated as an obstetrical emergency) was noted. An emergent caesarean section was needed. The on-call anesthesia staff were notified. A call was placed to the labor and delivery hotline at the recipient hospital again. The recipient hospital provider requested that a dose of ceftriaxone (antibiotic) be given and recommended an emergent caesarean section. -At 08:00 PM, a nursing note indicated that the nursing supervisor attempted to call the obstetrician, but they were unable to be reached. The general surgeon and pediatrician were called in. Staff (L), General Surgeon, ruptured the amniotic membranes. The umbilical cord and a leg (Patient #2’s leg) immediately protruded from the vagina. Manual reduction (gentle lifting of the presenting part and continuously holding it off the prolapsed cord to restore fetal blood flow) of the umbilical cord and leg were performed. At 08:55 PM, Patient #1 was taken to the operating room. -At 09:00 PM, an intravenous catheter (tube in the vein to administer medications) was inserted. -At 09:24 PM, Patient #1 was prepped, draped, and given general anesthesia. At 09:25 PM, Patient #1 was intubated (tube inserted to maintain and/or establish an airway to allow a patient to breath), and the first incision was made (for the emergency caesarean section-surgical removal of the infant). -At 09:29 PM, Patient #1 delivered a limp, cyanotic (bluish discoloration), apneic (lack of breathing) infant (Patient #2) via caesarean section. (There was no obstetrical coverage on 11/19/23). Review on 11/30/23 of the document “Obstetrical/Gynecological On-Call Schedule for November 2023,” no date, revealed Staff (N), Obstetrician was scheduled for on-call on 11/19/23 (Staff N switched on-call dates). From 11/21/23 to 11/30/23, there was no physician assigned to be on-call for Obstetrical/Gynecological services. Review on 11/30/23 of the document “Obstetrical/Gynecological On-Call Schedule for November 2023,” revised 11/13/23 revealed there was no obstetric physician assigned to be on-call for November 17, 18, 19, 22, 23, 24, 25, 26, and 27, 2023. Interview on 11/30/23 at 08:43 AM with Staff (K), Registered Nurse, stated there were two obstetrical/gynecological on-call schedules for November. One schedule indicated that there was no obstetrical/gynecological provider on-call for 11/19/23. The other schedule indicated that Staff (N), Obstetrician was scheduled to be on-call on 11/19/23. The emergency department team learned the schedule had been changed at the last minute and there was no coverage. Multiple calls to both obstetricians and additional obstetrical nurses to come in were unsuccessful. Interview on 11/30/23 at 11:04 AM with Staff (M), Physician revealed there was no obstetrics physician coverage due to an error in the on-call schedules. Without an obstetrician for support, Staff (M) called Staff (L), General Surgeon for back-up should Patient #1’s condition worsen. Interview on 11/30/23 at 12:41 PM with Staff (R), Registered Nurse Supervisor, stated that multiple attempts were made to call both obstetrical providers. There were two obstetrical/gynecological on-call schedules. One schedule indicated there was obstetrical coverage, while the other schedule indicated there was no coverage. No calls were made to the Clinical Care Service Chairperson, Officers of the Medical Staff, or the Chief Medical Officer as the policy directs. Staff (R) did not know who to contact in administration should a situation of significance occur again. Interview on 11/30/23 at 02:00 PM with Staff (B) Chief Nursing Officer, revealed that on 11/13/23, Staff (N), Obstetrician was assigned to take call for the weekend of 11/17/23 to 11/19/23. Staff (N), Obstetrician switched their on-call dates from 11/17/23 to 11/19/23 (assigned on-call) to 11/28/23 to 11/30/23 (no on-call coverage assigned). No replacement on-call obstetrics provider coverage was arranged for 11/17/23 to 11/19/23. Staff (B) stated that there is no policy or process in place for the lapse in provider on-call coverage. Finding #2: Review of the policy “Speculum Examinations,” last revised July 2020, indicated that a registered nurse may only assist an obstetrics provider as necessary for a sterile speculum examination (a pelvic exam to check the vagina, cervix, and other reproductive organs for problems. It can be used to assess whether the membranes have ruptured during pregnancy and to obtain specimens to rule out vaginal and uterine infections). Review of the medical record for Patient #1, dated 11/19/23 revealed at 07:55 PM, Patient #1 presented to the emergency department with active contractions in labor. At 08:12 PM, Staff (J), Obstetrics Registered Nurse, performed a sterile speculum examination for Patient #1. (There was not obstetric physician coverage on 11/19/23). Review of the document “Obstetrical/Gynecological On-Call Schedule for November 2023,” revised 11/13/23 revealed there was no obstetric physician assigned to be on-call for November 17, 18, 19, 22, 23, 24, 25, 26, and 27, 2023. Review of the personnel file for Staff (J), Obstetrics Registered Nurse, indicated a hire date 10/30/23. (There is no evidence to indicate that Staff (J) is privileged by the facility and/or has training in performing sterile speculum examinations). Interview on 11/30/23 at 10:26 AM with Staff (J), Obstetrics Registered Nurse, confirmed they performed a sterile speculum examination for Patient #1 on 11/19/23.”