East Houston Medical Center

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 37490 Based on observation, interview, and record review, the Governing Body failed to effectively discharge its oversight responsibilities by failing to review and approve a medical student “observer program” to include program description & curriculum; signed agreements with medical schools; and an established vetting process for all students in one patient care procedure. (ID# 9) Findings include: Observation on 8/22/25 at 7:30 am showed a four (4) persons wearing scrubs at the nurses station. Staff RN (55) identified as medical students that observe procedures. Record review of the facility Governing Body Bylaws, approved 6/12/2021 showed the following: 2.2. The board shall establish policies relating to the affairs of the Hospital; shall be responsible for the control and operations of the Hospital; shall make and enforce rules and regulations necessary for the administration, protection, and maintenance of the Hospital and facilities... Medical record for patient (ID# 9) for sate of service 8/22/25 showed the following: Consent Form for Student and Resident Observation Observer names listed included (ID#s 69, 70, 71, and 72), signed by surgeon (ID# 59). Interview with staff (ID #52) on 8/22/25 at 1:00 pm stated that there was not contract with a medical school for the observers, they just come and observe cases with physician (ID # 59). The facility failed to show documentation of: criminal background checks; drug screening, and professional and/or personal references. There was no transcript of current medical school education. There was no documented training for: infection prevention /control; fire safety / evacuation; and emergency preparedness.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 46010 Based on observation, interview and record review, the facility failed to ensure anesthesia consent was obtained by the provider qualified to administer anesthesia for 1 of 13 patients reviewed (Patient ID #12). Findings Included: Observation 8/22/2025 at 10:15 am, Patient ID #12 was seated in pre-admit holding room 2. Her chart was reviewed and noted to have a “Disclosure and Consent Anesthesia” form completed identifying Anesthesiologist Staff ID #66 as the physician anesthesiologist. The blank next to “General Anesthesia” and “Moderate Sedation” was initialed by the patient. The boxes in the “Granting of Consent for Anesthesia/Analgesia” section were all checked. Patient ID #12 signature is noted and signed 08/22/2025 at 09:07 am. The Anesthesiologist staff ID # 66 has dated “08/22/2025 at 09:07 am”. The witness is RN Staff ID # 54 on “8/22/2025 at 09:07 am.” Record review of facility policy titled “Moderate Sedation and the care of the patient”, last reviewed 6/16/2025, stated “10. Informed consent will be obtained prior to any procedure ensuring that the risks, benefits, potential complications, and any alternative options associated with the planned procedure have been discussed and explained to the patient by his/her physician.” Record review of Title 25, Part 7 TEXAS MEDICAL DISCLOSURE PANEL, Chapter 604, TAC Rule §604.5 titled Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia). The Texas Medical Disclosure Panel stated the “following form which shall be used to provide informed consent to a patient or person authorized to consent for the patient of the possible risks and hazards involved in anesthesia and/or perioperative pain management (analgesia).” Record review of facility “Medical Staff Rules and Regulations”, last amended 5/12/2021, stated “5. Members shall be responsible for obtaining the patient’s informed consent for procedures and surgery. When consent is not obtainable, the reason shall be entered in the patient’s medical record. The medical record shall contain evidence of informed consent for procedures and treatments for which it is required by Hospital policy. The patient/designee shall sign the consent form affirming that the Member had informed the patient of the risks and benefits of the procedure and alternative treatments available. Space shall be provided on the form for the Member to document what was explained to the patient and that the patient understood and agreed to the proposed treatment.” Interview with RN Staff ID #54 on 8/22/2025 at 10:21 am. She confirmed “I did the anesthesia consent.” She further confirmed that Anesthesiologist Staff ID # 66 had not spoken with patient yet. Interview with Patient ID #12 on 8/22/2025 at 10:23 am. She stated she had “not spoken with an anesthesiologist yet” or anesthesia representative yet. She stated Staff RN # 54 had “gone over the information to the best of her ability” and asked her to sign the form. Interview with Nurse Manager Staff ID #52 on 8/22/2025 at 10:30 am. She stated that it was part of the preadmit process at the facility for nurses to have the anesthesia consent completed. She confirmed that Patient ID #12 had been asked to sign consent for anesthesia services, by facility nursing staff, without engagement by the anesthesia provider.”

“VENTILATION, LIGHT, TEMPERATURE CONTROLS CFR(s): 482.41(c)(4) There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas. This Standard is not met as evidenced by: 37490 Based on observation, interview and record review, the facility failed to ensure proper ventilation and temperature and humidity were maintained and recorded in multiple areas of the hospital. Findings include: Review of facility document titled” Infection Prevention & Control Program,” dated 5/27/2025 showed the following: GOALS The goals of the infection prevention and control program include, but are not limited to: -Limiting exposure for designated infectious diseases... -Enhancing hand hygiene -Minimizing risk of transmitting infections with the use of procedures during the use of medical equipment... -maintaining a sanitary environment to avoid sources of and transmission of infections... MAINTENANCE OF A SANITARY PHYSICAL ENVIRONMENT The organization has developed specific policies, procedures or other systemic work processes that address the following: -Ventilation, temperature, humidification, and water quality control issues including measures taken to maintain a safe environment ... Observation on 8/22/2025 at 9:38 am showed a room in the pre-operative area that contained respiratory supplies. The room housed sterile items (i.e. endotrachial tubes). There was no record of temperature and humidity for this room. Observation on 8/22/2025 at 9:57 am showed a room in the restricted surgical area named “anesthesia workroom” that contained sterile supplies. The room housed sterile items (i.e. endotrachial tubes, spinal needles). There was no record of temperature and humidity for this room. Interview with RN staff (ID# 52) on 8/22/2025 at 10:00 am confirmed the above findings, stating the facility follows Association of periOperative Registered Nurses (AORN) standards and recommendations as best as we know how.” She went on to say that the facility recently lost two staff members in key leadership positions including infection Prevention. Record review of the facilities 2024 and 2025 ventilation assessment showed the following: 2024: The operating room is required to have a minimum 20 air changes per hour. The operating room has low air changes (14.6) Isolation rooms are required to have a minimum of 12 air changes per hour. Isolation Room #4 has low air changes (10.2) Sterile Processing is required to have positive room pressure and a minimum of 4 air changes per hour. Sterile Processing has negative pressure and low air changes (3.2). Decontamination rooms are required to have negative pressure and a minimum of 6 air changes per hour. The decontamination has positive room pressure and low air changes (3.5) Clean utility rooms are required to have a minimum of 4 air changes per hour. The clean utility has low air changes (0.0). the sterile storage (inside OR#1) has low air changes (2.4). Soiled utility rooms are required to have a minimum of 6 air changes per hour. The pre-op soiled utility has low air changes (4.5), the post- op soiled utility has low air changes (4.4). 2025: The operating room is required to have a minimum 20 air changes per hour. The operating room has low air changes (14.6) Isolation rooms are required to have a minimum of 12 air changes per hour. Isolation Room #4 has low air changes (10.0) Decontamination rooms are required to have negative pressure and a minimum of 6 air changes per hour. The decontamination has positive room pressure and low air changes (3.9) Soiled utility rooms are required to have a minimum of 6 air changes per hour. The pre-op soiled utility has low air changes (5.0), the post- op soiled utility has low air changes (3.6). Interview with staff (ID 74) on 8/22/25 at 12:47, stated one of his duties is Life Safety Coordinator. He confirmed the above findings and stated a third party company was handling the issues improperly and another company has been obtained to fix the issues, but a date has not been set. The surveyor asked for filter change logs for the facility to include what type of filter and HEPA filters were being used. This document was not provided prior to exit.”

“OPERATIVE REPORT CFR(s): 482.51(b)(6) An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. This Standard is not met as evidenced by: 46010 Based on observation, interview and record review, the facility failed to ensure that immediate post-operative notes/reports were being completed AFTER the patient had a surgical procedure, in 2 of 4 case observations in the pre-admit holding area (Patient ID #s 11 and 12). Findings Included: Observation in the Preadmit testing area on 8/22/2025 at 10:00 am included Patient ID #11 waiting in Patient Room number 1. His chart and clipboards were located on the counter of the pre-admit testing area and reviewed with Nurse Manager Staff ID # 52. She confirmed the patient was in the pre-admit area and waiting to go back to the Operating Room. Observation in the Preadmit testing area on 8/22/2025 at 10:00 am included Patient ID #11 waiting in Patient Room number 2. Her chart and clipboards which were located on the counter of the pre-admit testing area and reviewed with Nurse Manager Staff ID # 52. She confirmed the patient was in the pre-admit area and waiting to go back to the Operating Room. Record Review of the medical record included “Surgeon’s Immediate Post-Operative Note” for Patient ID #11. The note had Patient ID #11 sticker on the chart. The following sections were completed in black ink and signed illegibly by Physician Staff ID # 59. The form was dated 8/22/2025 and untimed. “Surgeon (Redacted) Staff ID #59 last name”. The Pre/Post Operative diagnoses were completed but illegible. “Procedure: Colonoscopy”. “Anesthesia Type: MAC” (is circled), “Pathology Specimen sent: Yes” (is circled). “Implants/Grafts” - Null sign is written. “EBL ___ ml” - Null sign is written in blank. “Blood given: None” is circled. “Drains: JP” (is circled). “Complications” - Null sign is written. “Postop Condition: Stable” (is circled), “Disposition: PACU” is circled. Record Review of the medical record for Patient ID #12 located on the pre-admit counter included “Surgeon’s Immediate Post-Operative Note” for Patient ID #12. The note had Patient ID #12 sticker on the chart. The following sections were completed in black ink and signed illegibly by Physician Staff ID # 59. The form was dated 8/22/2025 and untimed. “Surgeon (Redacted) Staff ID #59 last name”. The Pre/Post Operative diagnoses were blank. “Procedure and Findings” were blank. “Anesthesia Type: MAC” (is circled), “Pathology Specimen sent: Yes” (is circled). “Implants/Grafts” - Null sign is written. “EBL ___ ml” - Null is written in blank. “Blood given: None” is circled. “Drains: JP” (is circled). “Complications” - Null sign is written. “Postop Condition: Stable” (is circled), “Disposition: PACU” is circled. Record review of facility Medical Staff Rules and Regulations, last revised 05/12/2021, stated “A Member of the Medical Staff shall be responsible for the overall medical care of each patient in the Hospital. The attending physician shall be responsible for the treatment and the prompt completion and accuracy of the medical record, for necessary special instructions and for transmitting reports of the condition of the patient, if appropriate, to the referring Member.” It further stated “C. Medical Records: 1. The attending physician shall be responsible for the preparation of a complete, accurate, timely, legible and verifiable medical record for each patient.” Interview 8/22/2025 at 10:20 am with Patient ID #12. She confirmed that she was waiting to go to the operating room for a procedure with physician Staff ID #59. Interview with Nurse Manager Staff ID #52 on 8/22/2025 at 10:04 am. She confirmed that both “Surgeon’s Immediate Post-Operative Notes” had been pre-completed on Patient ID #11 and 12 who had not been to the operating room yet that day. She stated “that is not acceptable.””