Nell J Redfield Memorial Hospital

“SURGICAL SERVICES CFR(s): If a CAH provides surgical services, surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body, or responsible individual, of the CAH in accordance with the designation requirements under paragraph (a) of this section. This Condition is not met as evidenced by: 39430 Based on review of medical records, operative documentation, professional standards, and staff interviews, the Critical Access Hospital failed to ensure that surgical services were provided in accordance with accepted standards of practice, including AORN requirements for communication and verification of laterality. This directly affected 1 of 8 patients (Patient #8) whose records were reviewed. This failure resulted in inconsistent documentation and lack of required intraoperative communication regarding which ovary was removed during surgery for Patient #8. The 2022 AORN Guideline for Team Communication, Section 6, states that perioperative teams must establish and implement a standardized debriefing process, and that this process may include discussion of counts performed and confirmed, the procedure performed, and the labeling and disposition of specimen containers. This guideline was not followed. Patient #8 was a 38-year-old female admitted for surgery to remove her Right ovary on 2/19/26. Patient #8’s signed consent authorized removal of the right ovary only, and there was no documentation of discussion or consent for removal of the left ovary. The operative report dated 2/19/26 documented removal of the right ovary, while postoperative recovery orders documented removal of the left ovary. These discrepancies were not reconciled at the time of care. Patient #8’s medical record included a pathology report. The pathology report confirmed receipt of a specimen labeled as the right ovary, contradicting a later operative addendum entered by the DO one month after surgery in response to concerns about a potential wrongsite procedure. The addendum stated that the left ovary had been removed and that the right ovary had been left in place, which conflicted with both the original operative report and the pathology findings. There was no documentation that any change in laterality was communicated to the circulating nurse, anesthesia provider, or scrub staff. There was also no evidence that a debriefing occurred that would have clarified which ovary had been removed or verified specimen labeling in accordance with accepted practice Patient #8 presented to the ED 4 times after her surgery on 2/19/26 for right sided abdominal pain An interview was conducted with the ED physician who attended to Patient #8 on 3/25/26 beginning at 1:45 PM . The physician confirmed that Patient #8 returned several times after the surgery. The physician reported Patient #8 presented to the ED with extensive right quadrant pain - “she couldn’t keep things down.” The physician reported he did an ultrasound which revealed that the right ovary was still in place and the left ovary had been removed. The physician reported he and Patient #8 were surprised by this result - stating “in the operative note it says the right was removed.” During interview on 3/25/26 at 10:15 AM, the Chief Nursing Officer stated there was no documentation indicating that the surgeon communicated a change in laterality to the surgical team or to the patient, stating, “There is nothing showing that the team was informed of a change in which ovary was being removed.” The Operating DO was interviewed on 3/24/26 beginning at 1:00 PM During interview the DO stated he had not directly informed Patient #8 at the time of the surgery or at the follow up appointment, that the left ovary had been removed and the right ovary left in place, but that he had “provided her pictures.” The Critical Access Hospital failed to ensure that surgical services were provided in accordance with accepted standards of practice, failed to implement required communication and verification processes, and failed to ensure that care was delivered consistent with the patient’s informed consent. 2. Refer to 1104 as it relates to Patient #8’s medical record not being complete and accurate. 3. Refer to 1110 as it relates to the hospitals informed consent not specifying risks, benefits, and all options addressed and informed consent acquired prior to surgery for all patients. The cumulative effect of these deficient practices resulted in the CAH’s inability to ensure that surgical services were provided in accordance with the Condition of Participation for Surgical Services. These failures demonstrated a lack of an effective organizational system to ensure safe surgical care and to protect the health and safety of all patients receiving surgical services.”

“RECORDS SYSTEM CFR(s): The records are legible, complete, accurately documented, readily accessible, and systematically organized. This Standard is not met as evidenced by: 39430 Based on review of medical records, operative documentation, pathology reports, and staff interviews, the Critical Access Hospital failed to ensure that the medical record for 1 of 8 patients who received surgery (Pt #8) was accurate, complete, and entered in a timely manner. This failure had the potential to place the patient at risk for incorrect clinical information and compromised continuity of care. Patient #8 was a 38 year old female admitted for surgery to remove her Right ovary on 2/19/26. Patient #8’s medical record included transvaginal ultrasound dated 1/15/26. It documented that the patient’s right ovary contained a simple 3 cm cyst and an adjacent dominant follicle measuring 1.9 cm. The left ovary contained a small hemorrhagic follicle measuring 1.7 cm. Patient #8’s medical record included a signed a consent for a right laparoscopic salpingooophorectomy, authorizing removal of the right ovary only. There was no documentation indicating discussion or consent for removal of the left ovary on the signed consent form. The operative report dated February 19, 2026 and signed by the operating DO documented that the right ovary was grasped with a tenaculum, circumcised with the harmonic scalpel, placed in an endobag, and removed through the 12 mm trocar site. The narrative described removal of the right ovary. Postoperative recovery orders documented “S/p lap LSO,” indicating a left salpingooophorectomy, which conflicted with both the operative report and the signed consent. Patient #8’s medical record included a pathology report which identified the received specimen as the right ovary, consistent with the consented procedure and inconsistent with the postoperative order documenting removal of the left ovary. Patient #8’s medical record included the CRNA anesthesia record. It documented the procedure as a “right salpingectomy laparoscopic.” An addendum to the operative report was entered on 3/19/26, one month after surgery and after the potential wrongsite surgery had been identified by an ED physician and the Hospital. The addendum stated that the DO had removed the left ovary and that the right ovary was normal in appearance, contradicting both the original operative report and the pathology findings. The Operating DO was interviewed on 3/24/26 beginning at 1:00 PM During interview the DO stated he had not directly informed Patient #8 at the time of the surgery or at the follow up appointment, that the left ovary had been removed and the right ovary left in place, but that he had “provided her pictures.” The delayed addendum, conflicting documentation, and lack of contemporaneous and accurate entries failed to ensure that Patient #8’s medical record was complete and correctly reflected the care provided.”

“RECORDS SYSTEM CFR(s): For each patient receiving health care services, the CAH maintains a record that includes, as applicable-- (i) Identification and social data, evidence of properly executed informed consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient; This Standard is not met as evidenced by: 39430 Based on review of the Critical Access Hospital’s surgical consent forms, and staff interviews, the CAH failed to ensure that patients were afforded their right to informed consent. The CAH used a blanket consent clause that did not specify the exact procedure, laterality, or scope of surgery, and permitted surgeons to perform additional or different procedures without obtaining procedure specific informed consent. This systemic failure had the potential to compromise patient autonomy and violate patient rights. Review of the CAH’s standard surgical consent form showed that it included the following statement: “I have been advised by the above physician that during the course of the procedure unforeseen conditions and additional findings may necessitate an extension of the original procedure or the performance of different procedures than set forth above. I therefore authorize and request that the above named physician, assistants, or designees perform such procedures as are necessary and desirable in the exercise of professional judgment. This authority granted by me shall extend to the treatment of any conditions not known to the aforementioned doctor at the time the procedure is commenced.” This language functioned as a blanket authorization and permitted the performance of unspecified or different procedures without the patient’s explicit consent. The form did not require the surgeon to explain the nature of any additional or changed procedure, its associated risks, benefits, and alternatives, or to obtain new consent prior to proceeding. Federal regulations define consent as: “Informed consent means the patient or patient representative is given the information, explanations, consequences, and options needed in order to consent to a procedure or treatment.” Review of the CAH’s standardized consent form demonstrated that it did not meet this definition, as it did not require that specific information about additional or changed procedures be provided, nor did it ensure that the patient had the opportunity to consent to such changes. During interview on 3/24/26 beginning at 1:45 PM the Chief Nursing Officer stated that surgeons were not required to obtain new consent when the planned procedure changed and acknowledged the concerns of the blanket consent clause. The CAH failed to ensure that patients received procedure specific informed consent.”

“The facility is a single story, Type II (211) structure, originally constructed in 1970. It is connected to a Skilled Nursing Facility that also comprises a partial basement. The two-hour fire barrier of the building, separates the structure, but does not provide a separation of occupancy. Backup emergency power is supplied through an on-site, Emergency Power Supply System (EPSS) generator set. The facility is fully sprinklered with an interconnected fire alarm, smoke detection system and a Type 1 piped in medical gas system. Currently, the facility is licensed for 11 Critical Access Hospital beds, with a census of 6 on the date of the survey. The facility was found to be in substantial compliance during the Fire/Life Safety survey conducted on June 13, 2024. The facility was surveyed under the Life Safety Code, 2012 Edition, Existing Healthcare Occupancies, in accordance with 42 CFR 482.41”