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Tag No.: A0115
Based on interview and record review, the facility failed to ensure the patient was aware of options for fetal remain disposition following miscarriage for 1 (P-1) of 7 patients reviewed for miscarriage fetal remain disposition and failed to complete Face-to-Face documentation for 3 (P-5, P-11, P-12) of 3 patients reviewed for Face-to-Face documentation, resulting in the potential for unrecognized care needs and the potential for harm. Findings include:
See tags:
A-0130 Failure to allow patient to participate in Care Planning
A-0179 Failure to perform Face-To-Face evaluation
Tag No.: A0130
Based on interview and record review, the facility failed to allow patient participation in the plan of care for 1 (P-1) of 7 patients reviewed following miscarriage resulting in the loss of patient rights. Findings include:
Review of medical record on 2/24/2025 at 1350 reveals a Surgical Pathology Report, Case Number, MS25-827, with P-1's name at the top. The report lists the following information about the specimen: Taken 1/9/2025; Received 1/16/2025; Reported 1/17/2025. Diagnosis of Fetal Products: Gross examination only. Clinical history: Miscarriage. Gross Description: "...received in formalin is a 0.268 g tan tissue resembling a fetus and small fragments of blood clot. The head circumferential measurement is 1.2 cm. An interpreted eyeball is identified. The rump to grown measurement is 3.4 cm. There are several striations on the surface making up what appears to be part of the rib cage and spinal column. A 0.9 cm possible limb is identified."
During the tour of the Emergency Department (ED) on 2/24/2025 at 1118 the ED provider (Staff H) that cared for P-1 was working and an interview was conducted. Staff H revealed she remembered P-1 and that she has presented to the ED for miscarriage. Staff H stated she did a physical examination, however P-1 declined a pelvic exam due to discomfort. Staff H added that she ordered bloodwork, vaginal ultrasound, IV fluids and IV Tylenol. Staff H explained she remembered being called into P-1's ED exam room by her nurse because she had reported that felt like she had passed something into her brief. Staff H revealed that when she briefly looked in the brief she was wearing she saw what appeared to be fetal remains and that she asked the ED staff to send them to Pathology. When queried if this was the normal process in the ED following a miscarriage, she replied "yes". When queried if P-1 had requested to see the fetus or to keep the fetus after delivery, Staff H revealed she did not and she was in her room about 4-5 times following the delivery. Staff H added that P-1 was very upset and just wanted to go home. When queried if she has ever released fetal remains to a patient in the ED, Staff H stated it is against the law for us to release something like that.
During the tour of the Emergency Department (ED) on 2/24/2025 at 1100 with the ED Assistant Manager (Staff F) it was revealed the facility has created a new process for ED staff to follow for Management of Perinatal Death following review of P-1's experience. Staff F explained the staff have access to a quick reference with step-by-step instructions guiding them about the management of fetal remains after a miscarriage in the ED. During the tour of the ED a pink folder was observed hanging on the wall near the nursing station with the new procedure. When queried how the staff had been notified this information was available, Staff F revealed an email was sent out on 2/6/2025. Staff F was queried how she can ensure that all of the ED staff read the email and confirm they received the information, Staff F revealed she cannot be sure, but they have been talking about it frequently in the department.
Requested to interview the Emergency Department (ED) nurse that provided care for P-1 and she was "on-leave" and unavailable.
On 2/24/2025 at 1535 an interview with the Manager of Laboratory Services (Staff P) was conducted and revealed she was notified of the incident involving P-1 when the phlebotomy coordinator contacted her that P-1 had come to the facility requesting to pick up the fetal remains. Staff P revealed once this request was made, arrangements were made to transport the fetal remains back to the facility as they had been sent out to another facility for Pathology. Staff P revealed she was told that the family did not want the fetal remains to be analyzed and wanted them back so they could have a funeral. Staff P explained once the fetal remains were returned, arrangements were made to have the OB manager meet with parents so they could view them and sign a consent for release, but the mother was upset upon seeing them because they did not look like what she had observed in her brief on the day of delivery. Staff P revealed she contacted the bench technician that processed the specimen and discovered that the ED had only sent the tissue in the specimen cup, which did not contain fetal remains. Upon this discovery, they asked the bench technician to look for the brief in the medical waste bin and check for the fetal remains, which were found and sent to pathology for confirmation. Staff P explained the Pathology Department confirmed the specimen was a fetus, returned the fetal remains back to the facility and the CEO (Staff A) returned them to the parents. Staff P revealed she participated in a debrief following the incident and changes in the process have been updated. She also revealed that the employee that inadvertently discarded the brief with the fetal remains was re-educated about specimen processing. When queried if all staff had been re-educated about specimen processing, Staff P explained the education was in person and she does not have a list of employee names with specific dates or times this occurred.
On 2/24/2025 at 1435 an interview with the Quality, Patient Safety and Patient Relations Director (Staff M) was conducted and revealed the facility received a voicemail from P-1 on 1/11/2025 which was a Saturday, and a follow-up call was made the following business day on 1/13/2025. Staff M explained that when she spoke with P-1 she indicated she was upset that staff did not allow her to hold her baby following the delivery or explain her options before sending the fetal remains to pathology. Staff M revealed she spoke with the Laboratory manager (Staff P) following the call to notify her that the parents did not want the fetal remains to go to Pathology and requested they be returned to the facility and they received them on 1/13/2025. Staff M explained after the facility received the fetal remains arrangements were made to have the parents come to the facility on 1/14/2025 to sign a release and pick them up, as the mother had indicated she wanted to have a funeral. Staff M explained she received notification that the tissue that was presented to the parents was not what P-1 saw in the ED and the Laboratory Manager was notified to speak with the bench technician to ensure they had sent the correct material. Staff M revealed she participated in a Team Debrief on 1/15/2025 with the Patient Relations Manager, the Manager of Laboratory Services, the ED Manager, ED Assistant Manager, Chief Medical Officer and a representative from Legal Department. Staff M revealed the fetal remains were found in the laboratory in the medical waste bin and were sent to Pathology for confirmation, which were then returned to the facility on 1/16/2025. Staff M revealed that on 1/21/2025 the Chief Executive Officer (CEO) met with the parents and returned the fetal remains to the parents. Staff M added since the incident the Obstetrics providers have been working on a policy with legal to outline a new process. At the time of the survey, the new policy had not been approved and implemented. The new process had been initiated but verification of education for staff could not be validated.
During an interview on 3/4/2025 at 1224 with the Obstetrics physician (Staff V) that cared for P-1, it was revealed she saw her in the office on 1/13/2025 following the miscarriage in the ED. Staff V shared she was concerned that the ED provider did not contact her while P-1 was in the ED. Staff V revealed she has shared with the ED providers that she wants to be contacted when one of her patients present to the ED with OB concerns. Staff V also expressed this was an unusual situation as a mother does not typically request fetal remains at such an early gestation. Staff V revealed P-1 told her that she felt like the ED staff did not explain what was was going to happen with the fetal remains or give her other options before they sent them to Pathology and added it is not typical to release fetal remains below 20 weeks to a mother following a miscarriage .
Review of facility policy titled "Death: Neonatal, Embryo and Fetal", policy ID #12908510, last revised 8/28/2023 reveals in Section titled "Transfer of Fetus Less than 20 Weeks of Gestation to Lab, Section B, #2. Note parents' wishes for disposition of fetus; a. Funeral requested and choice of funeral home. b. Hospital disposition for less than 20 weeks gestation. c. No decision regarding final disposition." The current policy did not have an option for disposition for less than 20 weeks gestation.
Tag No.: A0179
Based on record review and interview the facility failed to document physician face to face assessments within one hour for patients in violent restraints for 3 (P-5, P-11, P-12) of 3 patients reviewed for restraints from a total sample of 12 patients, resulting in the potential for loss of patient rights, risk of injury and risk for negative outcomes. Findings include:
Review of P-5's medical record on 03/4/2025 at 1000 revealed he was a 23-year-old who presented on 02/22/2025 at 0424 with schizoaffective disorder who was brought to the Emergency Department (ED) after his mother found "unhinged" posts on social media that focused on religious imagery and very rambling in nature, P-5 has been asking his grandmother to take him to the hospital because he needs hospitalization for 3 days and he has not been making any sense. He was petitioned. Review or ED Report dated 2/22/2025 at 1832 reveals in the medical decision making, "Please see previous documentation for details up to this point. I arrived to find patient in an altercation with police, getting out of his restraints." and "Haldol, Benadryl, Ativan are ordered. Will escalate as necessary. He is grabbing staff and attempting to assault nurses. He has mentioned several times how he wants to kill himself." Another provider note dated 2/22/2025 at 1933 reveals, "When I left at 7 AM this morning he had to be restrained but those restraints are off and he is sleeping right now."
Review of physician orders for P-5 revealed violent restraint order dated 02/22/2025 at 0709 for Order: Restraints Violent, Wrist, Twice-as-Tough, BILATERAL. Order: Obtain Violent Restraint Order Task Comment: Every 4 hours, a provider must decide whether to discontinue or reorder "Restraints Violent".
Review of entire medical record did not reveal a face-to-face evaluation after the violent restraint physician orders.
Review of P-11's medical record on 03/4/2025 at 1135 revealed he was a 16-year-old who presented to the facility on 01/15/25 with dizziness. P-11 reported onset after alcohol intoxication and vomiting after drinking 1/5th of vodka. Review of Emergency Department (ED) Provider Documentation dated 01/15/2025 for P-5 reveals he was combative and attempting to punch staff, yelling and screaming.
Review of physician orders for P-11 revealed violent restraint order dated 01/15/2025 at 2024 for Restraints: Violent/Self-Destructive, Nursing to monitor/reassess patient a minimum of every two hours and PRN, Restraint Type/Limb Velcro: 4 point, Reason for Restraints physical safety of patient.
Review of entire medical record did not reveal a face-to-face evaluation after the violent restraint physician orders.
Review of P-12's medical record on 03/4/2025 at 1221 revealed she was a 19-year-old who presented on 11/7/2024 to the ED after she was found by law enforcement attempting to jump off a bridge following an escape from a crisis residential unit. Review of Emergency Department (ED) Provider Documentation dated 11/8/2024 at 1821 reveals, "Patient had an episode where she came out into the hallway and had to be talked to by security and kept from absconding from the emergency department." and "the patient did require a brief period of 4 point soft restraints for her safety as well as staff safety as she was kicking at times when the nurses were trying to administer her IM (intramuscular) medications".
Review of physician orders for P-12 revealed violent restraint order dated 11/8/2024 at 1309 for Restraints: Violent/Self-Destructive, Nursing to monitor/reassess patient a minimum of every two hours and PRN, Restraint Type/Limb Velcro: Side rails up x 4, Velcro: 4 point, Reason for Restraints: physical safety of patient.
Review of entire medical record did not reveal a face-to-face evaluation after the violent restraint physician orders.
In an interview on 03/4/2025 at 1305 with Staff O, the Emergency Department Medical Director, was conducted. Staff O was queried whether it is an expectation for the ED Providers to document a Face-to-Face evaluation for patients that have violent 4-point restraints ordered, Staff O answered "yes".
On 03/4/2025 Review of facility Policy, "Use of Physical Restraints: Ordering, Monitoring and Documentation Requirements", dated 04/11/2024 revealed for Violent or Self-Destructive Patient - Face to Face Assessment Required - Within 1 hour of initial restraint application. After 24 hours, before entering a new order, a provider must see, assess, and document a face-to-face assessment: The patient's immediate situation. The patient's reaction to the intervention. The patient's medical and behavioral condition. The need to continue or terminate the restraint or seclusion.