HCA Houston Healthcare Clear Lake

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 46010 Based on record review and interview, the hospital failed to ensure an appropriate transfer for Patient ID #1 by: 1. Failing to ensure that they notified receiving hospital and securing an accepting physician, at the terminal facility. 2. Failing to ensure that medical records were transferred with the patient to terminal treating facility and 3. Failing to ensure that qualified transportation for transfer was offered to the patient. Findings Included: Medical record review of Patient ID #1 with ED RN Staff ID #67 showed Patient ID #1 arrived to the Texas City Free Standing location on 2/15/26 at 8:22 with eye pain and possible retained foreign body. He was triaged immediately as an ESI level 4 and medical screen with initiated at 08:30 am by ED Physician Staff ID #73. His physical exam notes a “foreign body at the 1 o clock position with conjunctival injection of the R eye.” The patient received a tetanus shot and had tetracaine administration to facilitate eye exam. ED Physician Staff ID #73 note stated “ 29 year old male with foreign body right eye, from grinding. Symptoms somewhat improved after tetracaine. However, we are out of fluorescein dye. Attempt made to contact ophthalmologist on call with no response. Advised patient to proceed directly to UTMB Galveston emergency department, as they have ophthalmology on call for further evaluation.” The discharge care plan stated prescription for tobramycin eye drops Q 4 hrs. Patient instructions “ED Particle in Eye”. “Additional instructions. Please proceed immediately to UTMB John Sealy Hospital Emergency Department, 301 8th Street, Galveston, Tx (409) 772-1011 for immediate evaluation of your eye.” The patient was discharged from the facility at 08:49 am. ED RN Staff ID #67 confirmed she could find no evidence that the patient was transferred through the standard transfer process for the facility. She was unable to locate transfer orders, transfer memorandum of transfer documentation or evidence that their was a receiving facility with an accepting physician. Record review of EMTALA policy labeled “EMTALA - Transfer Policy”, last revised 6/3/2025, stated “A transfer will be an appropriate transfer if: The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; The receiving facility has available space and qualified personnel for the treatment of the individual and has agreed to accept the transfer and to provide appropriate medical treatment; The transferring hospital sends the receiving hospital copies of all medical records related to the EMC for which the individual presented that are available at the time of transfer as well as the name and address of any on-call physician who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment; and The transfer is effected through qualified personnel and transportation equipment as required including the use of necessary and medically appropriate life support measures during the transport ....” Record review of Ophthalmology call schedule for the facility, showed Ophthalmologist physician staff ID #75 was on call for 24 hour period covering 2/15/2026. Record review of facility policy called “EMTALA - Provision of On Call Coverage”, last approved 6/14/2025, stated “The on-call list maintained for the main hospital Emergency Department shall be the on-call list for the hospital, including any Off-Campus Provider-based Emergency Departments. Physician’s Responsibility. The hospital has a process to ensure that when a physician is identified as being “on-call” to the DED for a given specialty, it shall be that physician’s duty and responsibility to assure the following: include: the level of trauma and emergency care afforded by the hospital; number of physicians on the medical staff who are holding the privileges of the specialty; other demands on the physicians; frequency with which the physician’s services are required; and the provisions the hospital has made for situations where the on-call physician is not available or not able to respond due to circumstances beyond his or her control. The hospital is expected to provide adequate specialty on-call coverage consistent with the services provided at the hospital and the resources the hospital has available. In addition, the on-call list requirement applies to any hospital with specialized capabilities that is participating in the Medicare program regardless of whether the hospital has a DED. Specialty Hospitals must have appropriate on-call specialists available for receiving those individuals transferred pursuant to EMTALA. Hospitals should verify that the privileges of each on-call physician are current as to the procedures that each on-call physician is able to perform and the services that each on-call physician may provide. The on-call list maintained for the main hospital Emergency Department shall be the on-call list for the hospital, including any Off-Campus Provider-based Emergency Departments. Physician’s Responsibility. The hospital has a process to ensure that when a physician is identified as being “on-call” to the DED for a given specialty, it shall be that physician’s duty and responsibility to assure the following: 1. Immediate availability, at least by telephone, to the ED physician for his or her scheduled “oncall” period, or to secure a qualified alternate who has privileges at the hospital if appropriate. 2. If a PLC is being utilized to contact the on-call physician, the on-call physician must respond to the PLC within a reasonable timeframe (generally, within 30 minutes). 3. Arrival or response to the DED within a reasonable timeframe (generally, response by the physician is expected within 30 minutes). The ED physician, in consultation with the on-call physician, shall determine whether the individual’s condition requires the on-call physician to see the individual immediately. The determination of the ED physician or other practitioner who has personally examined the individual and is currently treating the individual shall be controlling in this regard. 4. The on-call physician has a responsibility to provide specialty care services as needed to any individual who comes to the Emergency Department either as an initial presentation or upon transfer from another facility. 5. The on-call physician has a responsibility to notify the Medical Staff Office of changes to the on-call schedule. Interview with ED Medical Director Physician Staff ID #74 on 3/24/26 at 3:05 pm. He confirmed that the Free Standing Emergency Department in Texas City has a Woods lamp, Slit lamp and Tonopen available for ophthalmology assessment equipment for ED physicians. He stated he was not made aware of any reports of difficulty reaching ophthalmology consulting physician Staff ID # 75, by his ED attending staff ID #73. He stated that he has found ophthalmologist Staff ID #75 to be extremely available, when contacted. He stated that referring patients to Ophthalmologist Staff ID #75 for follow-up, is also very seamless, as there is a process when an order is placed, and the patient can obtain follow-up on next business day, if indicated. He stated that fluorescein is often utilized to look for corneal ulcers or abrasions, but it is possible to sometimes see those without stain. He confirmed that he believed the facility had ophthalmology consult specialist available, per the call schedule, and that the consultant ophthalmologist staff ID #75 should have been reached or if more specialized ophthalmology care was needed, the patient could have been offered transfer to their main campus location. He stated that the process for referring patients to specialty care: including offering the patient the option to transfer, if emergent, or discharging the patient home to follow-up, with specialist, at a specific interval.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 46010 Based on record review and interview, the facility failed to ensure that there was an adequate number of registered nurses to perform patient care on 6 East IMU unit for 9 of 26 shifts reviewed. Findings Included: Record review of facility “6 East IMCU - Patient Care Assignment Sheets” dated 8/20/25 through 09/01/2025. The following days/shifts demonstrate there were only 3 Registered Nurses assigned to the unit (1 Clinical Nurse Coordinator (CNC) and 2 Registered Nurses. This resulted in 2 Registered nurses having 5 patients in their assignment. The sheets reflected: 8/22/25 PM Shift “1 CNC and 2 RNs”. There were 12 patients. 8/23/25 PM shift “1 CNC and 2 RNs.” There were 12 patients. 8/24/25 AM shift “1 CNC and 2 RNs.” There were 12 patients. 8/25/25 PM shift “1 CNC and 2 RNs.” There were 12 patients. 8/29/25 PM shift “1 CNC and 2 RNs.” There were 12 patients. 8/30/25 AM and PM shifts. “1 CNC and 2 RNs.” There were 12 patients. 8/31/25 AM and PM shifts. “1 CNC and 2 RNs.” There were 12 patients. Record review of facility policy titled “Nursing Staffing Plan”, last revised 6/3/2025, stated “Each department director/manager does the following:contract agreements 1.Each unit will develop a staffing plan (matrix) using standards established by the Texas Board of Nurse Examiners and Nursing Code of Ethics as well as recommendations by professional organizations such as AACN, AANN, APNA, SPN, and AWHONN. The staffing matrix will set the minimum staffing levels for the typical patient population.” It further stated “If available staff are not sufficient to safely care for the patients on the unit, the unit Director, Nursing Supervisor or AOS will take the following actions to secure additional staff: a. Utilize staff on-call b.Reassign staff from another unit, c.Secure staff from an approved staffing agency d.Request staff work additional hours.” Interview with Nursing Director Staff ID # 70 on 9/3/2025 at 11:45 am. She confirmed the unit utilized a “staffing matrix” for staffing. She stated that the unit frequently stays full with 12 patients. The staffing grid for 12 patients on the unit is 1 clinical nurse coordinator, who is usually a free charge nurse, and 3 Registered nurses and 1 patient care technician. Interview with Nursing Operations Director Staff ID # 73 on 9/3/25 at 1:45 pm. She confirmed the facility is aware of staffing needs on the 6 East IMU unit and has been actively working to address it. She stated the facility had opened an IMU in an adjacent unit to help with capacity issues and some of the core staff had been routed to this unit. She reported the facility utilizes internal float pool and internal contracts to assist with staffing shortages. In addition, staff can be re-distributed from other medical/surgical and ICU areas, if needed.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 46010 Based on observation, record review and interview, the facility failed to ensure that nursing staff provided and/or documented turning and/or repositioning every 2 hours per institutional and national standards, in 3 out of 3 current patient records reviewed who had pressure related wounds (Patient ID #s 1, 15 and 16). Findings Included: Observation 9/3/2025 at 11:15 am on 6E Nursing Unit of EMR with Charge Nurse Staff ID # 75 for Patient ID #1, 15 and 16. She confirmed it is a unit practice to turn and reposition patients every 2 hours, unless there is a contraindication to do so. She displayed the Meditech EMR record for Patient ID #1, 15 and 16. She stated it is a unit protocol to turn patients every 2 hours. She stated there is not a place for these turning and repositioning activities to be charted by bedside staff and therefore she could not locate evidence of this occurring. She confirmed that Patient ID #1, 15 and 16 all were current patients on the unit with 1 or more pressure injuries. Record review 9/3/2025 at 11:20 am of the Charge Nurse Report sheet for 6E IMU. Patient ID #1, 15 and 16 were listed as having current wounds and staff were perfroming wound care. Record review of facility document titled “Clinical practice guidelines for pressure injuries and at-risk wounds”, last revised 5/12/25, stated “B. Nursing Interventions: Based on assessment findings, appropriate interventions will be initiated that align with NPIAP guidelines and will be documented in the patient’s plan of care.” It further stated “STANDARD OF CARE: 1. Comprehensive skin assessments will be recorded in the electronic medical record. 2. High-risk areas (e.g., sacrum, heels) will be assessed. 3. Preventative measures will be initiated based on risk level. PRESSURE INJURY INTERVENTIONS: 1. Maintaining skin integrity through cleaning, moisturizing, and protection. 2. Promoting mobility and minimizing shear/friction through appropriate repositioning. 3. Utilizing interdisciplinary collaboration for nutrition support and complex wound management.” Record review of NPIAP (National Pressure Injury Advisory Panel) guidelines, version February 25, 2025, stated “R7. We reocmmend that either repositioning at the two hourly or three hourly intervals could be implemented for most individuals at risk of pressure injuries, if they are also on an appropriate pressure redistribution full body support surface.” Record review of Patient ID # 1, 15 and 16 with Informaticist Staff ID # 81. She confirmed she was unable to locate the frequency or side of turning and repositiong in their medical records. She confirmed that registered nurses would document under the “Routine Daily Care” section near the beginning of their shift, corresponding to their shift assessment. The line item stated “Activity - turn.” She confirmed there was no documentation of the planned or actual frequency of this turning for Patient ID #1, 15 and 16. Interview 9/3/2025 at 09:00 am with Manager of Wound Care Team Staff ID # 78. He confirmed the facility practices would include turning and repositioning every 2 hours, low air loss mattress utilization, use of wedges and positioners, possible use of Prevalon boots as well as other technologies for wound pressure prevention strategies. He confirmed he was unable to ascertain frequency of turning for inpatients Patient ID #1, 15 and 16.”

“DISCHARGE PLANNING - PT RE-EVALUATION CFR(s): The hospital’s discharge planning process must require regular re-evaluation of the patient’s condition to identify changes that require modification of the discharge plan. The discharge plan must be updated, as needed, to reflect these changes This Standard is not met as evidenced by: 46010 Based on interviews and record review, the facility failed to ensure patient’s discharge plans were re-evaluated and updated by the multi-disciplinary team to reflect occurrences/updated information and recommended care provided at the facility in preparation for discharge. (Patient ID # 1 and 2). Therefore, patients and/or families failed to receive: 1) safe discharge plan after staff filed an adult protective service complaint for concern for “safety at home” prior to patient’s discharge home from the facility. The facility failed to engage adult protective services to ensure safe discharge plan prior to discharge home, despite their concerns and failed to demonstrate safe discharge plan which considered multi-disciplinary team recommendations (Patient ID #1) 2) thorough comprehensive discharge orders which included the recommended modified full liquid diet with nectar thickened liquids and necessary follow-up and care for this limitation/restriction (Patient ID #2) 3) failure to communicate and provide written notification/communication of patient’s difficulty airway status prior to discharge (Patient ID #2). Findings included: Record review of facility policy titled “Discharge Planning”, last reviewed 01/2025 stated “C. During the hospital stay. The discharge planning needs of the patient are identified, assessed and planned for in many ways during the hospital stay. An interdisciplinary team meets routinely on each unti to discuss high risk patients. Case managers/social workers will reassess patient needs based on changes in care and discharge plan. All discharge planning activities will be documented in the medical record. D. On discharge... Discharge documentation will accurately reflect the final discharge plan and include the actual final disposition.” Record review of facility policy titled “Abuse and Neglect”, last reviewed 06/2024, stated “Neglect: the failure to provide for one’s self the goods or services, inclduing medical services that are necessary to avoid physical harm, mental anguish, mental illness, or the failure of the caretaker to do so.” It further defines “E. Neglect of exploitation 1. Family members are indifferent, angry or violent.” The procedure listed in the policy stated “D. Case management will assist staff with coordinating all information/activities involving protective agencies and coordinate appropriate discharge of the patient as deemed appropriate by protective agencies.” Record review of Patient ID #2 medical record with Nurse Informaticist on 3/27/2025 at 11:45 am. Patient ID #2 Anestheisa record on 8/23/24 stated “(Difficult Intubation notes): Grade IV view with DL. Attempt with Glidescope (4 Blade). Grade II view. Pt extremely anterior. Difficulty advancing tube and/or bougie. Successful attempt with glidescope + bougie.” Anesthesia record stated “Attempts 4”. This was recorded by CRNA Staff ID # 69. Speech therapy Staff ID # 72 note dated 8/29/24 at 11:15 am stated “Full liquid with Dysphagia 2 - Nectar thickened liquids” as a recommendation. Hospitalist Staff ID # 66 entry on 8/30/24 at 1:01 pm stated “Discharge home. Diet: Resume home diet and feeds.” There was no mention of the Difficult Airway or Difficult airway instructions/safety precautions. There was no case management or discharge planning note which addressed Patient ID #2 modified diet with need for thickener agentand how to obtain this once discharged. Interview with Director of Case Management Staff ID # 63 on 3/27/2025. She confirmed that discharge planning is documented by clinical staff and case managers in the medical record. She confirmed that clinical changes or modifications to the patients care should be documented by clinical staff and followed up with case management. She confirmed that Patient ID # 1 had an entry placed by Case Manager staff ID # 73 on 11/26/24 at 2:51 pm which stated “SW submitted APS (Adult Protective Services) report due to safety concerns at home. E-Report Confirmation # (redacted).” She confirmed that the patient was discharged home on 11/26/24 at 09:18 pm. She confirmed there was no documentation of which transportation service discharged patient home in the clinical record. She confirmed there was no documentation why the APS report was filed by the social worker, no social work consult and no documentation by social worker/case manager as to what the safety concerns in the home were. She confirmed that APS needed to engage with patient and staff, prior to discharge home, if an APS report had been filed related to safety with discharge plan. She stated Case Manager Staff ID #73 no longer was employed at the facility so was not available to interview related to this case. Interview with Anesthesia Medical Director Staff ID # 61 on 3/28/25 at 10:25 am. He confirmed that Patient ID #2 qualified to recieve a “Difficult Airway” letter after his surgery on 8/23/24 per the practice guidelines for the anesthesia group. He provided a blank form letter for review. This letter is printed on anesthesia group letterhead and is titled “Subject: Difficult Airway.” The letter stated “In the course of your recent anesthetic, your Anesthesiologist identified that you have a Difficult Airway. This is a serious condition that could be life-threatening.” He confirmed that he was unable to locate the duplicate copy in Patient ID #2 medical record and could find no documentation that this had been provided prior to discharge from the facility.”

“DELIVERY OF ANESTHESIA SERVICES CFR(s): 482.52(b) Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of pre-anesthesia and post-anesthesia responsibilities. The policies must ensure that the following are provided for each patient: This Standard is not met as evidenced by: 46010 Based on document review and interview, the facility failed to properly consent 2 of 13 patients for anesthesia services (Patient ID #2 and 6). The facility was not following the established policy that required the anesthesiologist to obtain a separate completed consent for anesthesia services. Findings Included: Review of the medical records for patient ID #2 date of service 08/23/24 revealed “Disclosure and Consent - Anesthesia and/or Perioperative Pain Management” forms with Nurse Informaticist Staff ID # 68 on 3/27/25 at 11:40 am. She confirmed that the lines were left blank next to boxes checked “Physician Anesthesiologist Dr. ____________ (Name) and “Certified Registered Nurse Anesthetist: _______________ (Name). She confirmed both lines had been checked but there was no name of responsible anesthesiologist/nurse anesthetist listed. Review of the medical records for patient ID #6 date of service 03/27/25 with PACU Director Staff ID #75. She confirmed that “Disclosure and Consent - Anesthesia and/or Perioperative Pain Management” form was present. However, the lines were left blank next to boxes checked “Physician Anesthesiologist Dr. ____________ (Name) and “Certified Registered Nurse Anesthetist: _______________ (Name). She confirmed both lines had been checked but there was no name of responsible anesthesiologist/nurse anesthetist listed. She confirmed the patient had already undergone a procedure 3/27/25 and been discharged home from the facility. Record review of facility policy titled “Disclosure and Consent (Informed Consent), last reviewed 04/2024, stated “b. Anesthesia Consent 1. Prior to elective surgery, invasive procedure or treatment, the anesthesiologist has a duty to obtain informed consent regarding type of anesthetic, risks and benefits, side effects, significant alternatives and results of non-treatment.” Interview with Anesthesia Medical Director Staff ID # 61 on 3/28/25 at 10:10 am. He confirmed that the anesthesia consent form should be completed in entirety per facility policy and anesthesia practice guidelines.”

“PRE-ANESTHESIA EVALUATION CFR(s): 482.52(b)(1) [The policies must ensure that the following are provided for each patient:] A pre-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, performed within 48 hours prior to surgery or a procedure requiring anesthesia services. This Standard is not met as evidenced by: 46010 Based on interview, and record review, the facility failed to perform/accurately document pre-anesthesia evaluations in 1 of 13 patients reviewed. (Patient ID# 6). Findings Included: Record review with Informatics Nurse Staff ID # 68 on 3/27/25 at 11:45 am. She confirmed the following findings: Patient ID #2 on date of service 08/23/2024 had “Anesthesia Assessment” form had “Anesthesia Planned” box checked “Gen.” The box which stated “Risks and benefits of sedation/anesthesia have been explained” was not checked/marked. NPO stated “>8 hrs”. The signature line housed an illegible signature. The anesthesiologist last name was [printed]. The date and time were left blank. The section which stated “Update” was completely blank. “Date, Time, Anesthesia Planned. ASA Classification. Signature. Printed Name. Date and Time” were all blank. Informatics Nurse Staff ID # 68 confirmed the anesthesia plan and pre-anesthesia evaluation was incomplete for Patient ID #2. Record Review of facility policy titled “Guidelines for Anesthesia Care”, last reviewed 04/2024 stated “Pre-anesthesia evaluation shall be done by a licensed independent practitioner for each patient for whom anesthesia is contemplated.” It further stated “the pre-anesthetic evaluation should be recorded prior to the transfer of the patient to the operating room. Entry in the medical record shall be dated and timed.” Interview with Anesthesia Medical Director Staff ID # 61 on 3/28/25 at 10:15 am. He confirmed that the pre-anesthesia evaluation/assessment should be completed per facility policy and anesthesia practice guidelines prior to the patient leaving the pre-op area to go to the operating room. He confirmed that the evaluation should include a physician signature, date and time when the assessment was completed.”

“POST-ANESTHESIA EVALUATION CFR(s): 482.52(b)(3) [The policies must ensure that the following are provided for each patient:] A post-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, no later than 48 hours after surgery or a procedure requiring anesthesia services. The post-anesthesia evaluation for anesthesia recovery must be completed in accordance with State law and with hospital policies and procedures, which have been approved by the medical staff and which reflect current standards of anesthesia care. This Standard is not met as evidenced by: 46010 Based on observation, interview, and record review, the facility failed to perform/ accurately document post-anesthesia evaluations in 8 of 13 patients reviewed. (Patient ID#s 7, 8, 9, 11, 12, 15, 16, 17). Findings Included: Observation on 3/27/25 at 2:25 pm in Phase 2 Post-Anesthesia Care Unit (PACU). Medical Record storage drawer held paper chart records for patients who had undergone surgeries today as identified by Staff Nurse RN # 76. Patient ID # 6, 7 and 8 medical records were located. Staff RN #76 confirmed the patients had surgical procedures today (3/27/2025) and were already discharged from the PACU. Record review of Patient ID # 7 and 8 anesthesia records revealed there was no date and time for post-anesthesia evaluation on 3/27/2025. Interview with PACU Director Staff ID # 75 om 3/27/25 at 2:45 pm. She confirmed that all patients should receive a post-anesthesia evaluation prior to discharge from Phase I PACU per facility policy. She confirmed this should be documented on Page 2 of the “Anesthesia Intraoperative Form” in the space labeled “Post Anesthesia Evaluation.” Record review with Informatics Nurse Staff ID # 68 on 3/27/25 at 11:45 am. She confirmed the following findings: Patient ID # 9 - there was no date and time for post-anesthesia assessment on 10/25/2024. Patient ID #11 - there was no date and time for post-anesthesia assessment on 12/9/2024. Patient ID # 12 - there was no anesthesia provider signature and no date and time that post-anesthesia assessment was performed on 12/9/2024. Patient ID # 15 - there was no post-anesthesia evaluation for the patient who went to ICU post-operatively on 12/9/2024 within 48 hours. Patient ID # 16 - there was no time for post-anesthesia evaluation on 2/14/2024. Patient ID # 17 - there was no time for post-anesthesia evaluation on 2/14/2024. Record review of facility policy titled “Guidelines for Anesthesia Care”, last reviewed 04/2024 stated “8. Post-operative care. The post-operative status of the patient is evaluated on admission to and discharge from post-anesthesia recovery ...12. The anesthesiologist must release the patient from PACU ...15. The post-anesthesia visit will be documented on the medical record and will include date and time.” Record review of facility policy titled “Pre-Anesthesia and Post-Operative Anesthetic Evaluation and Assessment”, last reviewed 12/2024 stated “Post Operative Anesthesia Evaluation”1. The anesthesia department will date and time their post-op visits in the medical record. 2. Outpatients will be discharged from the Same Day Surgery unit by a member of the anesthesia department and the Surgeon.” Interview with Anesthesia Medical Director Staff ID # 61 on 3/28/25 at 10:25 am. He confirmed that the anesthesia post-evaluation assessment should be completed per facility policy and anesthesia practice guidelines prior to the patient leaving post-anesthesia care unit. He confirmed that the evaluation should include a physician signature, date and time that the assessment was completed.”

“PATIENT RIGHTS: GRIEVANCES CFR(s): 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. This Standard is not met as evidenced by: 46010 Based on interview and record review, the facility failed to follow its established grievance policy and process for 4/5 grievances reviewed (Patient ID #s: 1, 2, 4 and 5). The facility failed: 1) to follow their policy for acknowledging the grievance within 7 days 2) investigating the grievance thoroughly in a timely fashion and 3) failed to follow-up with a written response with-in 21 days to the complainant. Findings Included: Record Review of facility policy titled “Patient Grievance and Complaint Management”, effective 10/2021, stated stated “Purpose: to establish a process for timely referral, prompt review, investigation and resolution of patient grievances and complaints.” It further defined “Patient Grievance is a written or verbal complaint by a patient, or the patient’s representative, regarding the patient’s care, abuse or neglect, issues related to compliance with the CMS Conditions of Participation or a Medicare beneficiary billing complaint related to rights and limitations ...” “2. Upon receipt of a grievance, the appropriate department director/manager will be contacted to review, investigate and resolve with the patient or patient representative, with the goal of resolution within 7 days of receipt of grievance ... 3. If the grievance will not be resolved, or if the investigation is not or will not be completed within 7 days, the complainant should be informed that the facility is still working to resolve the grievance and that the facility will follow-up with a written response within twenty-one (21) days. 4. In resolution of the grievance, a written notice of the decision must be provided to the complainant which should contain the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance investigation, and the date of completion.” Record Review of Grievances from the facility’s grievance log dated May 2023 - November 30, 2023 and the supporting documentation to Patient ID #1, 2, 4 and 5 stated: Patient ID #1, there was no grievance recorded in the electronic tracking system Patient ID # 4, grievance entered 10/6/23 for “quality of care concern.” 7 day letter sent 10/20/23 and investigation resolution letter sent 11/29/23. Patient ID # 2, grievance entered 11/10/23. There was no acknowledgement letter sent. There was limited investigation and no acknowledgment letter sent. Patient ID # 5, grievance entered 8/18/23 for “discharge complaints.” The 7 day letter was sent on 11/28/23. There was no evidence of investigation in a timely manner. Interview with Patient Safety Director Staff ID # 55 on 11/30/23 at 2:45 pm, she stated that the department had attrition which resulted in the facility’s inability to document, investigate and follow-up on grievances. She confirmed Patient ID #1 family had arrived to facility, in person, to discuss issues with Patient ID #1 care, communication, discharge coordination and planning. She confirmed these issues and meeting request met threshold for grievance. She confirmed there was no acknowledgment, investigation was not completed on the issues relayed and therefore no follow-up had occurred. She confirmed that Patient ID # 1, 2, 4 and 5, had not had grievance investigation, notification and resolution process/ follow-up.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 37490 Based on interview and record review, the facility failed to effectively implement their Infection Prevention and Control Program/Plan. a.) Four (4) of 4 incidents of contaminants in the operating room were not documented as occurrences/variances. This deficient practice resulted in a failure in a full investigation and oversight by infection control practitioner. b.) Two (2) two sterile processing staff failed to have documented skills for use of facility specific disinfection/sterilization equipment. Findings included: Record review of facility document titled “Infection Prevention & Control Program/Plan,” showed the following: PROGRAM OVERVIEW: To evaluate, assess, and prevent harm to our patients, team members, and visitors. The Infection Prevention Program at HCA Houston Clear Lake, HCA Houston Mainland, and its affiliated campuses utilizes multi-faceted surveillance activities to target the implementation of evidence-based practices in the prevention and control of infections. PURPOSE: To evaluate, assess, and prevent infectious harm to our patients, team members, and visitors ... Prioritized 2023 Clear Lake and Mainland goals are: VII. To ensure infection prevention procedures related to decontamination, disinfection and sterilization process meet all requirements. i. Ensure all team members completion of annual competencies for high-level disinfection (HLD), quality assurance processes, and any additional competencies requires for use of particular disinfection/ sterilization equipment. ii. Ensure all team completion of annual competencies for low-level disinfection, quality assurance processes, and any additional competencies required for disinfection of equipment utilized. iii. Conduct defined periodic rounds and audits of environmental and equipment disinfection, reporting back to facility and unit/departmental leadership. a.) Record review of Infection Prevention Committee Meeting Minutes dated August 24, 2023, showed the following: -Surgical Services- no issues Q1 and Q2 Record review of incident/variance reports for surgical services for August 2023-November 29, 2023, showed no record of instrument decontamination/sterilization issues or equipment failures. Interview with surgeon (ID#96) on 11/29/23 at 7pm, he stated that last week he canceled cases because there was a bug in one instrument set and the next two sets had residual bone and cement still visible, one set was still wet. He stated that there was another surgeon who had similar issues. Interview with Surgical Technologist (ID#85) on 11/30/23 at 1105am stated that last week on Wednesday there were multiple sets that had to be cleaned and re-sterilized due to cement or old blood that was still visible on the instrument tray or on an instrument. There has been a gnat found in the instrument set before. Interview with operating room (OR) nurse (ID#86) on 11/30/23 at 11:15am, she stated that instruments that come to the operating room that have been sterilized but that are still dirty has been happening more frequently lately, it comes in waves. She also confirmed previous statements from staff (ID#85) regarding instruments sets being contaminated last Wednesday. She stated that she is not sure if there is an incident report, she never has done one. She stated that it gets reported to the OR management team or service lead. Interview with sterile processing (SPD) manager (ID#88) on 11/30/23 at 1135am he stated that the only piece of equipment out of service is the ultrasonic machine used for decontamination. He went on to say that recently there had been issues with loaner sets coming into the facility late and that they were going to have to enforce the vendor policy stating that the sets need to be received by a certain time. We determined that staff were feeling rushed to get them completed for the next day. He stated that last week there were quite a few instances for the same doctor due to bioburden issues. He also stated that in the past, there was an issue with bugs in the SPD department; facility maintenance installed a bug light to control the issue. Interview with OR Manager (ID#99) on 11/30/23 at 1145am when asked about instrument set contamination due to bugs or residual bioburden, he stated that they do not always get incident reports. He went on to say that “we do not have a policy in place that instruct staff to do that.” Interview with infection preventionist (ID#84) on 12/1/23 at 9:44am he stated that the infection prevention team typically tacks immediate use sterilization, machine failures and out of service equipment. He also stated that he was not aware of any instances of bug found in the instrument sets/packaged items, recent issues with bioburden being left on surgical instruments or that the ultrasonic machine was out of service. Interview with surgeon (ID# 97) on 12/1/23 at 1030am stated that he has occasionally had residual bone or cement left on an instrument/tray. He stated recently there was a bug in a packaged item. The item was a purchased sterile item, not something that was sterilized at the facility. He stated that the operating room administrative staff had contacted the vendor. b.) Record review of SPD employees (ID#s 89 and 90) showed computer based sterile procession competencies via HealthStream. No evidence of equipment specific or skills checkoffs were found. Interview with infection preventionist (ID#84) on 12/1/23 at 9:50am he stated that when he rounds on the department the staff seem to be knowledgeable of their duties, as he is not familiar with the tasks or equipment specifically. Interview with Director of Patient safety (ID# 55) at 12:00pm she confirmed that the SPD staff had no documented skills/equipment check offs.”

“DISCHARGE PLANNING - PT RE-EVALUATION CFR(s): The hospital’s discharge planning process must require regular re-evaluation of the patient’s condition to identify changes that require modification of the discharge plan. The discharge plan must be updated, as needed, to reflect these changes This Standard is not met as evidenced by: 46010 Based on interviews and record review, the facility failed to ensure the discharge planning process included the regular re-evaluation of the patient’s condition to identify changes that required modification to the discharge plan. The discharge plan was not updated to reflect referrals, changes to post-acute planning and failed to fully document case management activities. The facility failed to document planning, acquisition, education and training for durable medical equipment needed for safe discharge. The facility failed to confirm completion of patient/family education prior to patient’s discharge home. The facility failed to provide contact information and specialty contact information for medical follow-up care (Patient ID #1). Findings Included: HHSC Intake for Patient ID #1 was received via email on 11/2/2023 for Patient ID #1. Complainant stated “(Patient ID #1) was moved to the stroke unit, I let manager of the nurses, Staff ID #76 know that discharge home was unacceptable as he could not climb the 30 steps needed to access the home. She said she began to work with case managers to locate a charity bed (rehab). I was told repeatedly ‘options were being explored’ as we continued to wait for a bed. There was not a follow-up after that.” Complainant went on to state “After (patient ID #1) was discharged home, I went back to the facility to have a meeting ... I told them in great detail my ordeal. I was not put in touch with a social worker, given a prescription for a wheelchair ... I told them how I literally almost pulled my arms out of place trying to move my husband without anything. (Patient ID #1) weighs 313 pounds ... I was not given even brief use of any equipment to help move Patient ID #1 safely around our home ... There was no care plan meeting. There was no training about how to get Patient ID #1 out of the condo if an emergency arises. There was no wheelchair given. There was no loaner equipment given to temporarily assist.” Record Review of facility’s “Scope of Service - Stroke Program”, last reviewed 03/2022, stated “The mission of the Stroke Program ... is to reduce the incidence and impact of stroke by utilizing evidence based standardized stroke order sets, facility available technology, providing education to health providers, community and patients with a focus on prevention, treatment rehabilitation and support for all impacted by stroke. This is accomplished through multi-disciplinary, facility team with collaboration of ideas, resources and knowledge.” Record Review of facility’s “Discharge Planning and Care Coordination” policy, last approved 02/2023, stated “Discharge Planning Evaluations (DPE) are documented in Midas. Documentation in the medical record includes: the complete evaluation, the patient’s choice for post-acute providers, participation of patient and/or patient’s representative, family or support persons who will be providing care, the patient’s goals and preferences, education and training to patient’s self-care and physician order to execute post-acute discharge planning.” It further stated “Procedure: G. If the patient is ready for discharge, confirmation of post-discharge arrangements is required. H. Document all assessments, interventions and follow up within the medical record. 2. Case Management C. Develop a post hospitalization plan based on patient’s assessed needs/resources and in collaboration with other members of the patient care team. D. Provide counseling, information, resources, referrals, transfer coordination and follow-up care as appropriate. F. Document discharge planning and social work assessments and interventions in the medical record.” Record Review of Patient ID #1 Medical Record on 11/30/23 at 2:45 with IT Specialist Staff ID # 83: Physical Therapy Inpatient Evaluation completed by Staff ID #95 dated 9/17/23 stated “Post Tx comments: Patient motivated towards return if function. Patient at max. assistance at this time due to flaccid tone on R side of body. Patient will benefit from inpatient rehab prior to DC home for optimum level of functional mobility. Comment: Post acute: IRF.” Occupational Therapy Inpatient Evaluation completed by Staff ID #94 dated 09/19/23 stated “Discharge Recommendations: IP Rehab.” Case management staff ID #69 note on 9/18/22 2:02 pm CM spoke to PT (redacted)she stated that patient will need bariatric W/C with elevated leg rests at DC, will discuss with pt and wife” Case management staff ID #73 note on 9/19/23 10:51 am stated “CM received notification that patient’ wife received cost for WC with Duke is $575; patient’s wife declined. CM notified nursing. Family training will need to be done before initiating DC to home; CM notified nursing.” Case management staff ID #73 note on 9/20/23 9:42 am stated “CM received notification that patient has stairs in his home and will need to try and work with PT for DC home. Patient at this time is Max-Dep; wife stated to nursing patient is waiting for charity bed. Patient does not qualify for charity rehab. Will need to initiate family training and transition DC to home.” Case management staff ID#68 note on 9/20/23 3:21 pm stated “Pt verified she would need DME resources for pt wheelchair when the time came ... SW informed colleague and case management available to assist with DME resources needed.” Case management staff ID #72 note 9/20/23 4:24 pm stated “Wife reported her husband has had a stroke and needs rehab and does not want to leave HCA, wants to be transferred there. Case manager staff ID #73 reported there are no charity beds and that Mr. Hunter does not meet medical qualifications for this program.” Case management staff ID #74 note 9/28/23 11:37 am stated “CM dir in to speak to ptn and wife to discuss d/c options. Have sent referral to HCA home health and pending response. d/c plan: d/c to home with HH.” Physician Staff ID # 93 discharge summary signed on 9/29/23 at 11:52 pm stated “Hospital Course: He was waiting for Inpatient Rehab. We discussed DC plan with family. He will go home with HH ... Discharge Instructions: DC to Home/Self Care. Discharge Instructions: PCP Followup, Consultant Followup. Activity: Resume Normal Activity, As Tolerated. PCP Follow-up (No Primary or Family Physician) in 2-3 weeks.” No consultant specialties or practice names and contact information were located. Interview with Acute Rehabilitation Unit Interim Director on 11/30/23 at 3:15pm. She stated that the decision for in-patient rehab, outpatient rehab or home are joint decisions by the patient, family, physician, therapy services and case management and includes consideration of many factors including payor source. She stated that patients must meet medical necessity and that they should be able to participate in 3 hours a day of therapy. She stated this at times would be difficult to determine as the acute care hospital lacks resources to provide near that intensity of rehab care. Therefore, age and willingness/motivation to work were also factors. She stated that therapy services consider safety and home arrangement prior to recommending home discharges. She stated she had reviewed Patient ID #1’s medical record. She could not locate a physical medicine and rehab consultation. She stated she could not locate the referral to the facility’s inpatient rehabilitation unit. She could not locate evidence of that referral in the patient’s medical record. She validated that the medical record and therapy notes revealed patient was “lower level” (meaning maximal assistance) but she saw repeated documentation of therapy recommendations for inpatient rehabilitation. She confirmed there was no evidence of patient/family training regarding the bariatric wheelchair or any other mobilization assistance, like hoyer lift. She believed a hoyer lift would have been indicated for safe discharge planning to home, given the patient’s degree of deficits and habitus. She stated durable medical equipment that is needed for an inpatients discharge home would be discussed by therapists and case managers prior to discharge planning for home discharges. Interview with Case Management Director Staff ID # 75 on 12/1/23 at 11:15 am. She stated patient ID #1 caregiver refused to participate in education and training. She stated she “watched” at the bedside. She confirmed the case managers failed to document the patient’s caregiver refusal to participate in teaching with discharge education. Staff ID #75 stated that case managers had attempted to locate charity inpatient rehabilitation beds for Patient ID #1 at 4 facilities owned by the acute care hospital corporation via telephone call. She was unable to locate the documentation which stated the date, time, or personnel involved in these telephone referrals and denials. Staff ID #75 stated the patient’s caregiver had refused to accept bariatric wheelchair, hoyer lift or equipment necessary for safe discharge and had refused education on the equipment. She was unable to locate this documentation in the medical record. Staff ID #75 stated the patient was supposed to follow up with Harris Health doctors when the patient’s Gold Card application was accepted. She was unable to identify in the medical record which primary care clinic or which specialty offices/services that patient should follow-up with after discharge as this was omitted from the discharge instructions. Interview with Neuroscience Director Staff ID #66 on 12/1/23 at 12:10 pm, she confirmed that the discharge instructions for the Patient ID #1 stated “follow-up with PCP in 2-3 weeks” and “consultant follow-up.” She confirmed that the instructions failed to state which primary care physician or clinic and consultant(s) the patient should follow-up with and how to reach them for an appointment.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 37490 Based on record review and interview the facility failed to ensure surgical services were consistent with needs by: a.) failing to perform preventative maintenance on washers and sterilizers per manufacturers guidelines. b.) follow surgical instrumentation instructions for use (IFU) for decontamination. Findings include: a.) Interview with sterile processing (SPD) manager (ID#88) on 11/30/23 at 1135am he stated that the IFUs are what is used to determine equipment is maintained and instruments are processed properly. All staff have access to IFUs via OneSource on the computer. Record review of Operator Manual for Amsco Steam Sterilizer showed the following: Weekly Maintenance: Flush Chamber Drain Record Review of operator Manual for Vision 1300 Series Washer/ Disinfector showed the following: Preventative maintenance is essential in keeping this equipment in optimal working condition. ONCE PER DAY: clean debris screen in chamber ONCE PER WEEK: Inspect traveler spray arm assemblies for clogged holes, Clean if necessary. While cycle is in progress, look through chamber door window to verify traveler spray arm assembly for free movement. Verify if DECONTAMINATION Cycle warning message is displayed on control.. Clean washer/disinfector exterior. Inspect all spray arms ... ONCE PER MONTH: Brush each door gasket to clean, then disinfect using germicidal detergent. Verify door gasket ... Record review of Operator Manual for Reliance Synergy washer/disinfector showed the following: Maintenance procedures described in this section must be performed as required at the suggested frequency. The indicated frequencies are minimums ... Daily Cleaning: Each day, clean the washer as follows ... Weekly Cleaning: Clean unit exterior as outlined. Clean wash chamber rotary spray arm assembly as follows. Clean rotary spray arm as follows ... Record review of SPD Maintenance logs were not in accordance with manufacturers owner manual guidelines. Interview with SPD staff (ID# 89) on 11/3023 at 1205 pm stated that she is not aware of daily or weekly maintenance of machines. b.) Record review of IFUs for Stryker Triathlon total knee loaner instrumentation for surgical cases 11/22/23 provided by SPD staff (ID# 89) showed the following: Pre-Cleaning: Equipment required: Ultrasonic bath large enough to allow complete immersion of the reusable instrument. (A frequency of 25-50 kHz is recommended ...). Interview with SPD staff (ID# 89) on 11/3023 at 1208 pm stated that the ultrasonic cleaner/disinfector was not currently working. When asked if instrument specific IFUs require the use of ultrasonic equipment, what is done., she replied “we just skip that step.” Interview with Stryker (vendor) Representative (ID# 100) on 11/30/23 at 4:25pm confirmed the IFUs were correct for Triathlon knee instrumentation. She also stated that any information printed in the IFUs are mandatory steps. Work order for Ultrasonic cleaner showed the machine broke 11/14/23.”