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Based on policy review, medical record reviews, and staff interviews, the facility staff failed to obtain informed consent for Tracheoesophageal Puncture (TEP), voice prosthesis for 10 of 13 patients (Patients #2, #3, #7, #9, #10, #11, #12, #13, #14, and #15).

Findings included:

Review on 4/10/2023 of facility policy, "Consent for Surgery, Anesthesia and Other Medical Treatments, 1R1.ADM.0029" revised 12/12/2022 revealed, "SCOPE ....AUTHORIZED TO PERFORM: ...Privileged Provider ...Other members of the health care team based on scope of practice [space] PURPOSE [space] The purpose of this policy is to establish a procedure to assure that adequate permission is obtained to provide services to the patient. The goal of the consent is to assure that a mutual understanding exists between the patient and the physician, independent practitioner, advanced practitioner ...POLICY ...INFORMED CONSENT ...TYPES OF CONSENT [space] General Consent for Treatment ...Consent for Surgery/Procedure [space] A. Patient consent must be obtained for every surgery/procedure and documented on the facility's 'Consent for Surgery/Procedure' form. B. ...C. Patient consent is valid for one (1) procedure. When a patient requires a subsequent but identical procedure, a new consent must be obtained. ..." Review revealed informed consent was required for procedures.

1.Open medical record review on 4/6/2023 revealed on 6/5/2020, patient #7, an 81-year-old was referred to [FAC A] for TEP fitting and placement. The first visit occurred 7/1/2020. A subsequent visit occurred 9/15/2022, as ordered, for TEP evaluation. SLP #6 evaluated the TEP and dilated the site with a dilator to a 22 French (Fr) diameter. Review revealed no procedural consent was available for review for the 9/15/2022 procedure performed by the facility staff.

Interview 4/11/2023 at 1100 with a staff member from Outpatient Services revealed management of TEP was considered a procedure but the facility staff failed to obtain procedural consent for the 9/15/2022 visit for patient #7.

2. Open medical record review on 4/6/2023 revealed on 1/25/2021 and 5/19/2021, patient #9, a 73-year-old was referred to [FAC A] for TEP change and management. On 10/25/2022, the patient presented to the facility. SLP #7 evaluated the TEP and dilated the site with a dilator to a 22.5Fr diameter. Review revealed no procedural consent was available for review for the 10/25/2022 procedure performed by the facility staff.

Interview 4/11/2023 at 1100 with a staff member from Outpatient Services revealed management of TEP was considered a procedure but the facility staff failed to obtain procedural consent for the patient 10/25/2022 visit for patient #9.

3. Open medical record review on 4/6/2023 revealed on 3/7/2022, patient #10, a 70-year-old was referred to [FAC A] for TEP change and management. On 8/10/2022, the patient presented to the facility. SLP #6 evaluated the TEP and dilated the site with a dilator to a 20Fr diameter. Review revealed no procedural consent was available for review for the 8/10/2022 procedure performed by the facility staff.

Interview 4/11/2023 at 1100 with a staff member from Outpatient Services revealed management of TEP was considered a procedure but the facility staff failed to obtain procedural consent for the 8/10/2022 visit for patient #10.

4. Closed medical record review on 4/6/2023 revealed on 2/10/2021, patient #11, a 78-year-old was referred to [FAC A] for TEP fitting and placement. On 2/15/2021, the patient presented to the facility. SLP #6 evaluated the TEP and dilated the site with a dilator to a 22Fr diameter. Review revealed no procedural consent was available for review for the 2/15/2021 procedure performed by the facility staff.

Interview 4/11/2023 at 1100 with a staff member from Outpatient Services revealed management of TEP was considered a procedure but the facility staff failed to obtain procedural consent for the 2/15/2021 visit for patient #11.

5. Open medical record review on 4/6/2023 revealed on 10/13/2021, patient #12, a 69-year-old was referred to [FAC B] for TEP fitting and placement. On 12/21/2021, the patient presented the facility. SLP #6 evaluated the TEP and dilated the site with a dilator to a 20Fr diameter. Review revealed no procedural consent was available for review for the 12/21/2021 visit for patient #12.

Interview on 4/11/2023 at 1100 with a staff member from Outpatient Services revealed management of TEP was considered a procedure but the facility staff failed to obtain procedural consent for the 12/21/2021 visit for patient #12.

6. Open medical record review on 4/6/2023 revealed on 11/11/2020, patient #13, a 58-year-old was referred to [FAC B] for TEP fitting and placement. On 6/10/2021, the patient presented to the facility. SLP #6 evaluated the TEP and dilated the site with a dilator to a 20Fr diameter. Review revealed no procedural consent was available for review for the 6/10/2021 visit for patient #13.

Interview on 4/11/2023 at 1100 with a staff member from Outpatient Services revealed management of TEP was considered a procedure but the facility staff failed to obtain procedural consent for the 6/10/2021 visit for patient #13.

7. Open medical record review on 4/6/2023 revealed on 3/16/2022, patient #14, a 78-year-old was referred to [FAC A] for TEP fitting and placement. On 4/14/2022, the patient presented to the facility. SLP #6 evaluated the TEP and dilated the site with a dilator to a 22Fr diameter. Review revealed no procedural consent was available for review for the 4/14/2022 visit for patient #14.

Interview on 4/11/2023 at 1100 with a staff member from Outpatient Services revealed management of TEP was considered a procedure but the facility staff failed to obtain procedural consent for the 4/14/2022 visit for patient #14.

8. Open medical record review on 4/6/2023 revealed on 4/21/2021, patient #15, a 62-year-old was referred to [FAC B] for TEP fitting and placement. On 12/22/2021, the patient presented to the facility. SLP #6 evaluated the TEP and dilated the site with a dilator to a 20Fr diameter. Review revealed no procedural consent was available for review for the 12/22/2021 visit for patient #15.

Interview on 4/11/2023 at 1100 with a staff member from Outpatient Services revealed management of TEP was considered a procedure but the facility staff failed to obtain procedural consent for the 12/22/2021 visit for patient #15.



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9.Closed medical record review revealed Patient #2 was a 59-year-old male with a chief complaint of squamous cell carcinoma of larynx which resulted in surgery. Review revealed on 06/16/2021 Patient #2 was referred for Speech Therapy evaluation by the treating Medical Doctor. Review revealed on 06/22/2022 Patient #2 had a procedure of TEP (transesophageal prosthetic, a procedure intended to be used by physicians or speech pathologists/therapist trained in the care of rehabilitation of laryngectomized [voice box removed] patients) with the use of (Named) Dilator. Further review revealed on 12/14/2022 Patient #2 again, had a procedure of TEP with the use of (Named) Dilator. Review revealed the hospital failed to obtain an informed consent from Patient #2 for the procedure performed by the staff at the hospital.

10.Closed medical record review revealed Patient #3 was a 61-year-old male with a chief complaint of squamous cell carcinoma of larynx which resulted in surgery. Review revealed on 05/24/2021 Patient #3 was referred for Speech Therapy evaluation by the treating Medical Doctor. Review revealed on 06/01/2021 Patient #3 had a procedure of TEP (transesophageal prosthetic, a procedure intended to be used by physicians or speech pathologists/therapist trained in the care of rehabilitation of laryngectomized patients) with the use of (Named) Dilator. Review revealed the hospital failed to obtain an informed consent from Patient #3 for the procedure performed by the staff at the hospital.

Based on American Speech-Language-Hearing Association (ASHA) Website review, electronic communication from the North Board of Examiners for Speech-Language Pathologists and Audiologists, personnel file reviews, and staff interview, the facility staff failed to ensure competency evaluations were performed for 2 of 2 speech language pathologists (SLP #6 and #7) that performed tracheoesophageal prosthesis.

Findings included:

Review April 11, 2023 of the ASHA website, Special Interest Division 3 revealed, "Knowledge and Skills for Speech-Language Pathologists With Respect to Evaluation and Treatment for Tracheoesophageal Puncture and Prosthesis" approved March 2003 revealed, "The ASHA Scope of Practice (2001) states that the practice of speech-language pathology includes providing services for individuals who undergo tracheoesophageal voice restoration surgery for placement of a tracheoesophageal prosthesis (TEP). The Preferred Practice Patterns (1997) are statements that define universally applicable characteristics of practice. It is required that individuals who practice independently in this area hold the Certificate of Clinical Competence in Speech-Language Pathology and abide by the ASHA Code of Ethics, including Principle of Ethics II Rule B, which states: "Individuals shall engage in only those aspects of the professions that are within the scope of their competence, considering their level of education, training, and experience" (ASHA, 2003). ASHA certification in speech-language pathology is necessary, but meeting certification requirements is not sufficient to qualify a person to perform the preferred practice patterns in speech-language pathology ..."

Electronic communication on April 13, 2023 with the North Carolina Board of SLP and Audiology revealed, SLP training and/or competency was done through the facility they work in and North Carolina licensed Speech-Language Pathologists who practiced in North Carolina may also follow the American Speech-Language-Hearing Association's (ASHA) guidance for TEP.

1. Review on April 6, 2023 of the personnel file for SLP #6 revealed the pathologist was hired at the facility in 1993. Review failed to reveal competency evaluations were performed.

Interview on April 5, 2023 at 1:30 PM with SLP #6 revealed the pathologist had experience that dated back to 1989 and upon hire at the facility, the pathologist did not recall disinfection or sterilization of TEPs as part of the original advanced training or the competency/skills checklist. Interview revealed at the time of the survey, competencies were being reviewed and updated to include the manufacturer's instructions for use.

2. Review on April 6, 2023 of the personnel file for SLP #7 revealed the pathologist was hired at the facility in 2010. Review failed to reveal competency evaluations were performed.

Interview on April 5, 2023 at 1:30 PM with SLP #6 revealed, the pathologist did not recall disinfection or sterilization of TEPs as part of the original advanced training or the competency/skills checklist. Interview revealed at the time of the survey, competencies were being reviewed and updated to include the manufacturer's instructions for use.

NC00200241