Piedmont Fayette Hospital

“CONTENT OF RECORD: INFORMED CONSENT CFR(s): 482.24(c)(4)(v) [All records must document the following, as appropriate:] Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent. This Standard is not met as evidenced by: 47717 Based on staff interviews, record review, and review of facility policies and procedures, it was determined that the facility failed to ensure the consent form accurately identified the staff member who witnessed the patient’s signature. Specifically, Registered Nurse (RN) CC signed P1’s consent form as a witness dated 03/17/2024, when she was not on the staffing schedule. Findings include: A review of P1’s medical record revealed she was admitted to the facility on 03/17/2024, at 9:54 AM. A review of the admission history and physical revealed P1 presented to the facility in labor reporting irregular contractions for one week with acute worsening overnight. P1 reported waking every two hours due to back labor and was now feeling contractions every five to six minutes and noted bloody show with wiping prior to presenting for evaluation. P1 denied leaking. The fetal movement was normal. Pregnancy complicated by a history of cesarean section (a surgical procedure in which a baby is delivered through an incision made in the mother’s abdomen and uterus), retained placenta (a flattened circular organ in the uterus, nourishing and maintaining the fetus through the umbilical cord), advanced maternal age, and anemia (a condition characterized by a deficiency of healthy red blood cells or hemoglobin, leading to insufficient oxygen delivery to the body’s tissues). The plan was to admit to labor and delivery and proceed to the operating room for a repeat cesarean section. A review of the consent for surgery revealed the procedure to be performed was a cesarean section delivery. P1 signed the consent on 03/17/2024, at 10:56 AM, and RN CC witnessed the consent on 03/17/2024, at 10:56 AM. The provider signed the consent on 03/17/2024, at 10:56 AM. A review of the medication administration record (MAR) revealed P1 was given Tylenol 1000 milligrams (mg) by mouth on 03/17/2024, at 11:04 AM by RN AA. P1 was given Pepcid 20 mg intravenous and Bicitra 20 milliliters (ml) by mouth at 12:17 PM by RN BB. P1 was taken to the operating room at 12:21 PM . A review of the repeat cesarean section procedure note revealed P1’s preoperative diagnoses were labor, history of cesarean section times one, desires repeat and advanced maternal age. The post-operative diagnoses were the same with the addition of meconium (the earliest stool of a newborn). A medical doctor assist was required due to the potential complexity of the case. The indication for the procedure was a 40-year-old gravida 2 Para 1 (a woman that has been pregnant twice and has had one pregnancy reach a gestational age of at least 20-24 weeks) presented to the Obstetrics Emergency Department (OBED) with complaint of regular, painful contractions and bloody show. The decision was made to proceed to the operation room for delivery. While awaiting type and screen and complete blood count, patient progressed rapidly from 2 centimeters (cm) to 9 cm dilation. Cesarean delivery counseling was explained to P1 and she expressed an understanding of all of these risks and elected to proceed with the Cesarean Delivery. A further review of the procedure note revealed that P1 was taken to the operating room where her cervix (the narrow passage forming the lower end of the uterus) was checked and confirmed 9 cm with a bulging bag (the amniotic sac protruding into or through the cervix during labor). Her spinal anesthesia was then placed and P1 confirmed she declined Trial of Labor after Cesarean Section (TOLAC-an attempt to have a vaginal birth after a previous cesarean delivery). A low transverse (situated or extending across something) incision was made with the scalpel. Hysterotomy (a surgical incision made in the uterus, typically performed to deliver a fetus or access the uterus for medical procedures) was entered bluntly. Meconium-stained fluid noted. The infant’s head was located and brought up to the level of the hysterotomy but was unable to deliver with fundal pressure (uterine fundal massage after placental expulsion provides uterine contractions by stimulating endogenous prostaglandin secretion). The vacuum was applied with 1 pop off. Maylard (a transverse abdominal incision made through the rectus abdominis muscle to provide wider exposure to the pelvic organs) utilized to improve space. The vacuum was applied 2 additional times with 1 pop off (occurs when the vacuum cup detaches from the baby’s head during the procedure) 2/2 (secondary to) poor suction. The infant was delivered atraumatically (with extreme care to prevent tissue damage). The cord was clamped and cut without delay, and infant was handed off to the awaiting pediatricians. P1 tolerated the procedure well and was updated on the procedure and was transported to the recovery room in stable condition. A review of the discharge summary from 03/19/2024, revealed P1desired to be discharged home. Discharge medication alone with instructions were given and P1 was discharged home at 1:14 PM in stable condition. A review of the facility’s policy titled, “Consent/Refusal of Treatment,” PolicyStat ID 19369567, last revised 11/25/2025, revealed the purpose is to establish consistent guidelines for obtaining a patient’s consent or refusal for medical surgical, diagnostic and/or therapeutic procedures in accordance with applicable laws and regulatory requirements and outline the requirements for documenting consent for procedures. The responsible practitioner is responsible for disclosing the required information and for obtaining a proper consent. He/she must sign the consent form in the Responsible Practitioner Statement section. Employees of “hospital name” may not be designated by the responsible practitioner to disclose such information or obtain the patient’s consent in the absence of the physician, but they may serve as witnesses to signatures. An interview was conducted in the conference room on 07/28/2026, at 9:00 AM with RN BB. RN BB revealed she remembered preparing P1 for a cesarean-section and administering her medications. RN BB stated she did not remember which medications she gave P1 without reviewing the medical record. RN BB stated a consent form for surgery or a procedure was usually witnessed by the RN who was assigned to the patient. RN BB stated the consent form should not be signed by someone who was not present at the time of the explantation of the surgery or procedure. An interview was conducted via telephone on 07/28/2026, at 9:27 AM with RN AA. RN AA stated she did not remember P1. RN AA stated a consent for surgery or a procedure should be witnessed by the patient’s primary RN at the bedside. RN AA stated if she found a consent that had not been witnessed, she would refer this incident to her charge nurse or manager. An interview was conducted with Director of Women’s Services (DWS) DD in the conference room on 07/28/2026, at 10:05 AM. DWS DD revealed it was her expectation that the RN who was assigned to a patient witness a consent form for a procedure or surgery. The RN would sign her name and date the consent the day the procedure or surgery was explained to the patient by the provider. A review of the staffing assignment for 03/17/2024, for Labor and Delivery failed to reveal RN CC’s name on the schedule.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 45841 Based on record review, review of policy and procedures, and staff interviews, the facility failed to ensure restraints were implemented appropriately in accordance with hospital policy for one Patient (P) P#5 of two sampled patients reviewed for restraints. Findings included: Review of a facility policy titled “Restraint/Seclusion,” last revised 01/03/2024, indicated, “A. Each restraint episode will be ended at the earliest possible time.” The policy specified, “D. Discontinuation of restraints should be documented by the Nurse in the patient’s electronic health record.” Per the policy, “E. Non-Violent - Assessment and monitoring documentation should take place every 2 hours in the patient’s electronic health record and must include clinical justification, patient behavior, circulation/signs of injury, range of motion, skin assessment, fluid and foods offered, and hygiene/elimination needs addressed.” P#5’s medical record included an order dated 10/11/2024 at 10:29 p.m., for bilateral secured mitts. Per the order, the order expired on 10/12/2024 at 11:59 PM. P#5’s “Non-Violent Restraint Type Documentation” flowsheet revealed that the right and left secured mitts were last continued on 10/12/2024 at 4:00 p.m. There was no documentation to indicate the bilateral mitts for the patient were discontinued or further assessed per the facility’s policy. P#5’s “Nursing Notes,” dated 10/12/2024 at 9:40 p.m., indicated the patient discharged from the facility. During an interview on 01/09/2025 at 10:38 AM, Nurse Manager (NM) #8 stated it was unknown when P#5 was removed from restraints. She stated that the nurse last documented the mitts as continued 10/12/2024 at 4:00 PM.”

“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: 42060 Based on a review of medical records, policies and procedures, medical staff bylaws, and staff interviews, it was determined that the facility failed to provide an ongoing, appropriate medical screening examination (MSE) within its capacity and stabilizing treatment for one (P#1) of 21 sampled patients. P#1, who was 21 weeks pregnant, presented to the facility’s (F#1) emergency department (ED) on 10/14/22 with complaints of abdominal pain for several days. P#1 reported that she had been seen in another facility’s ED twice for the same complaints. On 10/15/22, P#1 presented to another facility’s (F#2) ED with persistent pain. It was determined that P#1 required immediate surgical intervention, and she suffered a fetal demise prior to the start of the procedure. Findings included: Cross refer to A2406 as it relates to F#1’s failure to ensure that an appropriate ongoing medical screening examination was conducted on P#1.”

“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: 42060 Based on review of medical records, policy and procedures, medical staff bylaws, and staff interviews it was determined that the facility (F#1) failed to provide an ongoing appropriate medical screening examination (MSE) within its capability for one patient (P) (P#1) of 21 sampled patients. Specifically: P#1 presented to the facility’s emergency department on 10/14/22 at 11:43 a.m. with complaints of “ Generalized weakness and Abdominal pain for three days” and was 21 weeks pregnant. Facility#1 failed to provide radiologic services and fetal monitoring to the patient and was treated with medications and discharged home. P #1 presented to F#2 on 10/15/22 with persistent abdominal pain. It was determined that P#1 required surgical intervention for ovarian torsion (twisted) and bilateral ovarian cysts. P #1 was admitted to F#2 and suffered a fetal demise prior to undergoing an exploratory laparotomy. Findings included: Review of the medical record revealed that Patient #1 (P #1) presented to the facility’s (F#1) Emergency Department (ED) on 10/14/2022 at 11:43 a.m. for chief complaint of generalized weakness and abdominal pain. P #1 was 21 weeks pregnant. P#1 reported abdominal pain at 10 on a scale of 0 to 10 and described the pain as worse pain ever. P#1’s vital signs at 11:46 a.m. included a heart rate of 116 beats per minute (normal was 60-100 beats per minute and respiratory rate (RR) of 19 breaths per minute (normal was 12-20 breaths per minute. Other vital signs were within normal limits. P #1 was placed in a room at 11:48 a.m., triage started at 12:07 p.m. P #1 reported to triage nurse that she was 21 weeks pregnant and had had abdominal pain a few days prior to her coming to the ED. P #1 said she was seen at an affiliated hospital the day prior and was told that her abdominal pain was not related to her pregnancy. P #1 also reported that she had seen her Primary Care Doctor today and the doctor sent her to the ED to get lab work done. P #1 said she had her last bowel movement (BM) four days ago. P #1 had an acuity (emergency severity index ESI) 3 when triage was completed. Continued review of the record revealed that orders were entered at 12:08 p.m. for blood work, urinalysis, and pregnancy test (HCG). Blood was collected for the lab tests at 12:16 p.m. Lab results at 12:26 p.m. included a White Blood Cell (WBC) (one indication of infection) count of 15.70 (Normal Range: 3.40 - 10.80). A medical screening examination was started by Doctor DD at 2:03 p.m. and documented at 2:30 p.m. revealed that P #1 was a 25-year-old female who was currently 21 weeks pregnant; presented to the ED for evaluation of abdominal cramping with an onset of 3 days ago. P #1 stated she believed symptoms were related to food poisoning. Patient #1 reported the pain was associated with nausea and vomiting that has resolved within the last 24 hours. P #1 was currently able to tolerate oral intake. Patient also noted onset of constipation for the last 4 days. P #1 reported pain worsened with movement. She denied any other alleviating factors for her symptoms. Patient noted symptoms persisted this morning prompting ED visit. Patient denies history of appendectomy (removal of the appendix) or cholecystectomy (removal of the gallbladder). P #1 denied onset of fever, vaginal discharge, vaginal bleeding. MD notes stated Per Medical Record, P #1 was evaluated at a sister facility 3 days prior on 10/13/22 where she was told her symptoms were not pregnancy related. P #1 was sent here to get labs drawn and for treatment of persistent symptoms. Vital signs taken at 2:20 p.m. included a heart rate of 118. Doctor DD placed an order for Tylenol #3 (Tylenol with codeine) that was administered at 2:54 p.m. Morphine (medication for severe pain) 4mg administered at 2:54 p.m. Zofran (anti vomiting medication) 4 mg administered at 2:55 p.m. and intravenous fluids (IVF) started at 2:54 p.m. At 2:54 p.m. P#1 reported a pain score of 10. At 5:20 p.m. a re-evaluation was completed by Doctor DD and lab results were reviewed. P #1 was advised to follow up with OBGYN (doctor who was taking care of her and her baby during pregnancy) after discharge. The clinical impression was generalized abdominal pain. A review of the Discharge Summary dated 10/28/22 at 9:28 p.m. from Facility (F)#2 revealed that P#1 arrived on 10/25/22 at 10:57 a.m. with complaints of nausea, vomiting and abdominal pain. She reported severe pain. P#1 reported that that she had been seen in F#1’s ED as well as two prior ED visits to another facility. P#1 had been informed that the pain was due to pregnancy. At F#2, results of an ultrasound and CT revealed that P#1 had bilateral ovarian structures with concern for ovarian torsion. Review of Policy Stat ID 11101630, last revised on 1/27/22, titled “Transfer Activities in Accordance with EMTALA Requirements Policy” revealed that the purpose of the policy was to establish guidance for providing appropriate medical screening examinations (MSE), stabilizing treatment and appropriate transfer of patients in accordance with the Emergency Medical Treatment and Labor Act (EMTALA), and all regulations promulgated thereunder. Definitions included: Emergency Medical Condition - A medical condition manifesting itself by acute symptoms of sufficient severity (including, but not limited to, severe pain, psychic disturbances and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in either: a. Placing the health of the individual or, with respect to a pregnant woman, the health of the women or her unborn child in serious jeopardy or; b. Serious impairment to bodily functions; or c. Serious dysfunction of any bodily organ or part; or d. With respect to a pregnant woman who is having contractions: o That there is inadequate time to effect a safe transfer to another hospital before delivery; or o That the transfer may pose a threat to the health or safety of the woman or her unborn child Qualified Medical Person - The qualified medical person (QMP) who performs the medical screening (as outlined in the Medical Rules and Regulations): In the Emergency Room: A physician, Certified Nurse Practitioner or Physician’s Assistant (in conjunction with a physician). Stabilized or to Stabilize - A. With respect to an emergency medical condition: That no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer of an individual from the hospital; or to provide such medical treatment of the condition as is necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from the Hospital Within the capability - of the emergency department or of the Hospital means those capabilities which the hospital is required to have as a condition of its Emergency Department license, including on-call physicians and specialists and ancillary services routinely available to the Emergency Department. The document stated that it is the policy of [Facility]shall abide by the requirements set forth in EMTALA regulations for patients presenting to the hospital seeking emergency treatment by: Providing an appropriate medical screening examination (MSE) Providing necessary stabilizing treatment for emergency medical conditions and labor. Review of Policy Stat ID 12824579, last revised 12/29/2022, titled “Obstetrical Patients in the Emergency Department Policy” revealed that the purpose of this policy was to define the guidelines for all obstetrical (OB) patients presenting to the Emergency Departments across [the hospital system] It is the policy of [the facility] that all obstetrical patients presenting to the Emergency Department will be managed appropriate to their specific needs as determined by the presentation and gestation. The policy revealed that obstetrical patients who present to the Emergency Department with: Gestation equal to or greater than 20 weeks with complaints of labor and/or exhibiting signs and symptoms of labor the following will happen: -A registered nurse will evaluate the patient prior to being transported to Labor and Delivery to verify that delivery is not imminent. - An evaluation and medical screening exam will be performed by a qualified medical provider in Labor and Delivery. o-In the event the patient does not have an obstetrician on staff at the hospital, the obstetrician on-call for the Emergency Department will be contacted to care for the patient. - If after the medical screening and examination performed in Labor and Delivery, it is determined that the patient is not in active labor, the patient will be discharged home from Labor and Delivery with follow-up care instructions or discharged from Labor and Delivery to the Emergency Department for further evaluation and/or treatment. Review of Medical Staff Bylaws, Article 11, under Emergency Services revealed Emergency Services and care will be provided to any person who comes to the emergency department as that term is defined in the EMTALA regulations, whenever there are appropriate facilities and qualified personnel available to provide such services or care. Medical screening examinations, within the capability, of the hospital will be performed on all individuals who come to the hospital requesting examination or treatment to determine the presence of an emergency medical condition. During an interview with ED Doctor (Doctor) CC on 10/21/24 at 1:30 p.m. in the ED. Doctor CC explained that ED staff print out the specialty on call schedule daily and posted in the nurse’s station. Doctor CC said the on-call was also available online. Doctor CC explained that for pregnant patients, they had OB Doctors on call that he could call directly or send a secure message. Doctor CC said these doctors were in-house Physicians and responded within 30 minutes if they toned to come see a pregnant patient. The on-call OB Doctor would respond to the ED more promptly if necessary. Doctor CC explained that if a pregnant patient was greater than 20 weeks gestation and presented with complaints related to her pregnancy, or any pregnancy concerns, they would call OB as soon as possible. Doctor CC explained that pregnant patients with obstetric complaints underwent fetal heart monitoring. Staff from the OB department would perform a fetal ultrasound in the ED when requested. An interview with Doctor DD took place on 10/23/24 at 9:15 a.m. in the conference room. Doctor DD stated that she did not remember P #1 since the case was over two years ago. Doctor DD however explained that she reviewed the patient’s visit and said P #1’s chief complaint was not related to her pregnancy. Doctor DD said P #1 did not present with vaginal bleeding, did not have any contractions and that was the basis for her decision to treat P #1 with IV fluids and pain medications. Doctor DD said it was standard practice/protocol to do fetal heart tones on patients greater than 20 weeks gestation. Doctor DD explained that it was her usual practice to obtain fetal heart tones. Doctor DD explained that P #1 saw her OB doctor 12 hours prior to coming to the ED. Doctor DD said P #1’s complaint was not related to her pregnancy, but her primary care OB sent her to the ED to have blood work done. Doctor DD reiterated that P #1 went to another ED twice before presenting to F#1 and it was determined that her abdominal pain was not OB related. After review of P#1’s medical record, Doctor DD confirmed that fetal heart tone monitoring was not documented for P#1’s visit on 10/14/22. An interview with the ED Medical Director (Doctor) EE took place on 10/23/24 at 9:40 a.m. in the conference room. Doctor EE explained that when a pregnant patient presented in the ED, it was protocol to first determine if the patient was in labor, the patient’s gestation, and determine if the patient showed signs of preterm labor. Doctor EE said the patient would still be treated and stabilized in the ED regardless of presented signs. Doctor EE explained that the ED provider would send the patient to Labor and Delivery only if the patient showed signs of preterm labor and pregnancy complications such as vaginal bleeding, tearing, fluid leakage. Doctor EE explained that fetal heart tones were performed on patients greater than 20 weeks gestation. He stated that this was the standard even if the patient did not show signs of pregnancy complications. Doctor EE said it did not matter if a patient saw her doctor before coming to the ED, it was still standard to assess the pregnancy. A phone interview with RN GG took place on 10/23/24 at 10:10 a.m. RN GG was one of the nurses who cared for P #1 on 10/14/22 when she presented in the ED. RN GG did not remember P #1. RN GG explained that labor and delivery staff were usually notified of pregnant patient in the ED. RN GG said if the patient was more than twenty weeks pregnant, she would be transferred to labor and delivery. RN GG stated that even if the patient’s chief complaint was not pregnancy related, they still called OB to report that they had a pregnant patient in the ED.”