Charleston Area Medical Center

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 38282 Based on document review, medical record review and staff interview, the physician failed to ensure patient safety by not following protocols during a chest tube placement on a patient (patient #21), resulting in chest tube placement on the wrong side. This failure has the potential to affect any patient needing chest tube placement at the hospital. Findings include: The “Medical Staff Bylaws, Policies, and Rules and Regulations of Charleston Area Medical Center: Medical Staff Rules and Regulations”, version: 005, effective date 03/26/22, was reviewed and stated in part, “An operative procedure report is also required for any procedure requiring moderate sedation outside of the surgical setting (e.g., endoscopy, chest tubes, etc.)...The operative procedure report shall include:..(c) the name of the attending surgeon(s)/proceduralist(s) and assistants or other practitioners who performed surgical tasks (even when performing those tasks under supervision);...(h) description of those surgical tasks that were conducted by practitioners other than the primary surgeon/practitioner ...” The delineation of privileges (DOP) for staff #41, a pulmonologist, was reviewed and contained chest tube placement. The DOP for staff #47, a mid level provider, was reviewed and did not include chest tube placement. The DOP stated, “Assists Supervising physician(s) with all bedside procedures he/she is credentialed to perform at CAMC as requested, and under direct supervision of the physician. There was a process for getting certified to insert chest tubes through a proctor, but staff #47 had not requested certification for inserting chest tubes. A review of the medical record for patient #21 was conducted. Patient #21 was admitted on 06/20/26, to 5 South Room 576, from the emergency department (ED) with a complaint of shortness of breath and was diagnosed with a renal mass with metastasis to the right rib, lung, adrenal gland, and right renal vein and a right pleural effusion. A chest x-ray was taken on 07/20/26 at 12:13 p.m., with the Impression: “Frontal and lateral views of the chest reveal cardiomediastinal silhouette to be within normal limits. Elevated right hemidiaphragm. Right basilar atelectasis or infiltrates. Bilateral pulmonary nodules. Correlate with chest CT.” A computed tomography angiography (CTA) scan was taken on 07/20/26 at 2:48 p.m., with the impression: “1. No pulmonary embolus. Large layering right-sided pleural effusion with compressive atelectasis / consolidation 2. Diffuse pleural based nodules throughout the right hemithorax. Bilateral pulmonary parenchymal nodules. Findings are compatible with metastatic disease. 3. Right hilar adenopathy. 4. Lytic posterior right seventh rib lesion. Metastatic disease suspected.” A consult was made to Pulmonology, staff #41, for the placement of a chest tube. A consent for the placement of a chest tube was signed by patient #1 and staff #41, and witnessed by staff #43 on 07/21/26 at 11:43 a.m. The Procedure Note dated 07/21/26 at 12:59 p.m. and signed by staff #41 stated in part, “Indication: Large right-sided pleural effusion ...Technique: Patient was sterilely cleansed and draped. Topical lidocaine was placed as anesthesia. Finder needle was placed and serous fluid was obtained Guidewire was placed and area was dilated. Chest tube was then placed via Seldinger technique. Fluid was sent for laboratory evaluation ...Complications: Originally chest tube was attempted on contralateral location.” An addendum was added to the note on 07/22/26 at 2:54 p.m. by staff #41 that stated, “Procedure was started with the assistance of APP [advanced practice provider], [staff #47], CRNP [certified registered nurse practitioner]. We both viewed the ultrasound on the left side. The APP started the procedure and got as far as placing the guide needle when it was realized that it was the wrong side. Procedure was terminated. I was present throughout the procedure.” The remainder of the note was the same as the previous. A chest x-ray taken on 07/21/26 at 2:04 p.m. to check chest tube placement with the impression: “Approximately 2 cm diameter left pneumothorax new since prior exam. Right pigtail pleural drainage catheter with resolution of right pleural effusion and minimal right apical pneumothorax. Mild bibasilar atelectasis and stable upper lobe nodules. The Intake and Output documentation revealed that on 07/21/26, there was three thousand one hundred forty milliliters (3140 ml) of drainage from the chest tube in the first twenty-four (24) hours.” It should be noted the addendum was not made until after entrance for this survey. An interview was conducted on 07/23/26 at 10:00 a.m. with staff #48. Regarding staff #41 and staff #47, staff #48 stated, “I received a call on 07/22/26 in the morning from [staff #46] regarding an incident involving them attempting to place a chest tube on the wrong side of a patient [patient #21], and allowing a NP [staff #47] to do the procedure. We went over what happened and looked at the patient’s medical record. We felt that the documentation was incomplete, so we instructed [staff #41] to write an addendum. A progress note of the procedure must be made immediately after the procedure and include who was in the room and their roles. The NP had no privileges to insert chest tubes. The DOP [delineation of privileges] states that a NP may assist with any procedure the physician is certified to do. If a NP or PA [physician assistant] want to be certified in chest tubes they can, but there is a process they have to follow. [Staff #41] stated [he/she] allowed [staff #47] to perform the insertion because [he/she] was observing in the room, and thought that was ok because [he/she] personally was certified to insert them; but that is wrong. The mid-level provider must be certified, and was not. We have already been looking at the DOP and are working on tightening up the wording.””

“MEDICAL STAFF QUALIFICATIONS CFR(s): 482.22(c)(4) [The bylaws must:] (4) Describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body. This Standard is not met as evidenced by: 38282 Based on document review, medical record review and staff interview, the hospital failed to ensure patient safety by allowing a mid-level provider to attempt to insert a chest tube, a procedure they were not certified to perform, on one (1) of one (1) patients with a wrong site(patient #21). This procedure was attempted on the wrong side, which caused the patient increased pain and a new pneumothorax. This failure has the potential to adversely affect all patients receiving a chest tube procedure at the hospital. Findings include: A review of the credentialing files for staff #41, a pulmonologist, was completed. The delineation of privileges (DOP) contained chest tube placement. A review of the credentialing files for staff #47, a mid level provider, was completed. The DOP did not include chest tube placement. The DOP contained the statement, “Assists Supervising physician(s) with all bedside procedures he/she is credentialed to perform at CAMC as requested, and under direct supervision of the physician.” The mid level provider could request to be credentialed for a number of procedures, “Special Requests: Procedures: Training Experience/Requirements: (1) Must have completed formal training in the procedure(s) being requested during an Advanced Practice Registered Nurse Practitioner or Physician Assistant program or clinical rotation. (2) Verification of training must be provided with application - OR - Practice-Based Pathway: (1) Must have performed a minimum of ten (10) procedures proctored by the supervising physician who holds clinical privileges to perform the procedure. Proctoring requirement may increase based on type of procedure. (2) Proctor must assess competence and certify satisfactory completion of procedure proctoring requirements ...Chest Tube Placement: Perform a minimum of five (5) proctored cases.” A review of the medical record for patient #21 was conducted. Patient #21 was admitted on 06/20/26, to 5 South Room 576, from the emergency department (ED) with a complaint of shortness of breath and was diagnosed with a renal mass with metastasis to the right rib, lung, adrenal gland, and right renal vein and a right pleural effusion. A chest x-ray was taken on 07/20/26 at 12:13 p.m., with the Impression: “Frontal and lateral views of the chest reveal cardiomediastinal silhouette to be within normal limits. Elevated right hemidiaphragm. Right basilar atelectasis or infiltrates. Bilateral pulmonary nodules. Correlate with chest CT.” A computed tomography angiography (CTA) scan was taken on 07/20/26 at 2:48 p.m., with the impression: “1. No pulmonary embolus. Large layering right-sided pleural effusion with compressive atelectasis / consolidation 2. Diffuse pleural based nodules throughout the right hemithorax. Bilateral pulmonary parenchymal nodules. Findings are compatible with metastatic disease. 3. Right hilar adenopathy. 4. Lytic posterior right seventh rib lesion. Metastatic disease suspected.” A consult was made to Pulmonology, staff #41, for the placement of a chest tube. A consent for the placement of a chest tube was signed by patient #1 and staff #41, and witnessed by staff #43 on 07/21/26 at 11:43 a.m. The Procedure Note dated 07/21/26 at 12:59 p.m. and signed by staff #41 stated in part, “Indication: Large right-sided pleural effusion ...Technique: Patient was sterilely cleansed and draped. Topical lidocaine was placed as anesthesia. Finder needle was placed and serous fluid was obtained Guidewire was placed and area was dilated. Chest tube was then placed via Seldinger technique. Fluid was sent for laboratory evaluation ...Complications: Originally chest tube was attempted on contralateral location.” An addendum was added to the note on 07/22/26 at 2:54 p.m. by staff #41 that stated, “Procedure was started with the assistance of APP [advanced practice provider], [staff #47], CRNP [certified registered nurse practitioner]. We both viewed the ultrasound on the left side. The APP started the procedure and got as far as placing the guide needle when it was realized that it was the wrong side. Procedure was terminated. I was present throughout the procedure.” The remainder of the note was the same as the previous. A chest x-ray taken on 07/21/26 at 2:04 p.m. to check chest tube placement with the impression: “Approximately 2 cm diameter left pneumothorax new since prior exam. Right pigtail pleural drainage catheter with resolution of right pleural effusion and minimal right apical pneumothorax. Mild bibasilar atelectasis and stable upper lobe nodules. The Intake and Output documentation revealed that on 07/21/26, there was three thousand one hundred forty milliliters (3140 ml) of drainage from the chest tube in the first twenty-four (24) hours. It should be noted the addendum occured after entrance for this survey. An interview was conducted on 07/23/26 at 10:00 a.m. with staff #48. Regarding staff #41 and staff #47, staff #48 stated, “I received a call on 07/22/26 in the morning from [staff #46] regarding an incident involving them attempting to place a chest tube on the wrong side of a patient [patient #21], and allowing a NP [staff #47] to do the procedure. I immediately contacted both providers via telephone and pulled them out of the clinical environment until we met with them. The NP had no privileges to insert chest tubes. The DOP states that an NP may assist with any procedure the physician is certified to do. It means assist with, not perform the procedure. If a NP or PA [physician assistant] want to be certified in chest tubes they can. There is a process they have to follow. First they fill out an application, then get a proctor and insert five [5] chest tubes with the proctor, then complete some trainings and take a test. It then goes to the credentialing team for approval. [Staff #41] stated [he/she] allowed [staff #47] to perform the insertion because [he/she] was observing in the room and thought that was ok because [he/she] was certified to insert them. [Staff #47] has not applied for certification for placing chest tubes. We have already been looking at the DOP and are working on tightening up the wording. We went over what happened and looked at the patient ’ s medical record. We felt that the documentation was incomplete, so we instructed [staff #41] to write an addendum. A progress note of the procedure must be made immediately after the procedure and include who was in the room and their roles. They have twenty-four (24) hours to complete the operative report. Original notes cannot be deleted or altered and there is no time frame to add addendums. We have already been looking at the DOP and are working on tightening up the wording. [Staff #41] and [staff #46] took voluntary refrain from working until the investigation into the matter is settled.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 32177 Based on policy review, document review and staff interview, it was determined the charge nurse failed to conduct daily checks of the code blue crash carts in one (1) of one (1) crash carts not checked daily. This failure has the potential to affect all patients who receive care in this facility. Findings include: A policy titled “Crash Cart Policy and Procedure” with a last revised date of 02/26 states in part,” ... K. Nursing personnel will conduct daily checks of the Code Blue carts to assess equipment availability, cart readiness and that carts do not contain out-of-date items ...” A tour of the post-partum unit was conducted on 07/20/26 at approximately 11:45 a.m. in the presence of staff #46 and staff #54 . During the tour a review of the “Crash Cart/Defibrillator Check” log revealed daily code blue crash cart checks were not completed on July 13th, 15th, 16th, and 17th. Staff #46 and staff #54 concurred with the findings.”

“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: 38282 Based on document review, medical record review and staff interview, the physician failed to follow policy to perform a time out prior to the insertion of a chest tube at the bedside for a patient (patient #21), resulting in an attempt being made to the wrong side and causing additional pain and a new pneumothorax. This failure has the potential to adversely affect all patients having a procedure at the hospital. Findings include: A policy titled “Time Out (CMS Universal Protocol) Policy and Procedure”, effective 04/2026, was reviewed and stated in part, “Responsibility: All healthcare team members involved in surgical and invasive procedure interventions ...PROCEDURE: C.2.c. Site is verified by patient/family. d. Site is verified by the RN. e. Site is verified by the physician ...C.1.ll. For bedside procedures, site marking performed by the proceduralist must occur prior to beginning the time out ...Documentation of the Time Out is recorded in the patient’s EHR [electronic health record] by a licensed staff member participating in the procedure.” A review of the medical record for patient #21 was conducted. Patient #21 was admitted on 06/20/26, to 5 South Room 576, from the emergency department (ED) with a complaint of shortness of breath and was diagnosed with a renal mass with metastasis to the right rib, lung, adrenal gland, and right renal vein and a right pleural effusion. A consult was made to Pulmonology, staff #41, for the placement of a chest tube. A consent for the placement of a chest tube was signed by patient #1 and staff #41, and witnessed by staff #43 on 07/21/26 at 11:43 a.m. The Procedure Note dated 07/21/26 at 12:59 p.m., and signed by staff #41, stated in part, “Indication: Large right-sided pleural effusion ...Technique: Patient was sterilely cleansed and draped. Topical lidocaine was placed as anesthesia. Finder needle was placed and serous fluid was obtained Guidewire was placed and area was dilated. Chest tube was then placed via Seldinger technique. Fluid was sent for laboratory evaluation ...Complications: Originally chest tube was attempted on contralateral location.” An addendum was added to the note on 07/22/26 at 2:54 p.m., by staff #41, that stated, “Procedure was started with the assistance of APP [advanced practice provider], [staff #47], CRNP [certified registered nurse practitioner]. We both viewed the ultrasound on the left side. The APP started the procedure and got as far as placing the guide needle when it was realized that it was the wrong side. Procedure was terminated. I was present throughout the procedure.” There was no documentation in the records of a time out prior to the procedure. An interview was conducted on 07/23/26 at 12:30 p.m. with staff #46, who stated, “There is no time out documented in the record prior to [patient #21s] procedure. The time out procedure is documented by the RN assisting with the procedure, but all staff in the room, including the physician and the patient, are involved in the time out. The chest tube insertion was at the bedside, and the physician turned the RN away and stated that the nurse practitioner was assisting. There was a nurse extern who asked to observe the procedure, but they would not have been assisting or documenting the time out. We trained all of the RNs on that floor yesterday [07/22/26]. We did an SBAR [situation background action recommendation] training regarding assisting with procedures at the bedside and performing a time out prior to the procedure, and had all of the nurses on the unit sign it.””

“PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING CFR(s): 482.13(b)(1) The patient has the right to participate in the development and implementation of his or her plan of care. This Standard is not met as evidenced by: 38282 Based on document review, medical record review and staff interview, the facility included the healthcare surrogate (HCS) of a patient (#1) who lacked capacity in the initiation of the development of the discharge plan, but failed to document notification of the accepting skilled nursing facility (SNF) and when they were discharged. This failure has the potential to adversely affect the rights of all patients who lack capacity and are in need of discharge planning. Findings include: A policy titled “Patient Discharge (Nursing)”, publication date 05/27/25, was reviewed, and stated in part, “PROCEDURE: A. Discharge: 1. RN receives discharge order from attending physician/designee ...I. Determine if the patient is discharged to home or another facility. II. For those patients who lack mental capacity at the time of discharge, consult with the surrogate/MPOA/guardian regarding into whose physical custody the patient should be placed to ensure his/her safety. Under no circumstances shall an incapacitated patient be discharged other than to the direct physical custody of an appropriate caregiver/facility as approved by the patient’s surrogate/MPOA/guardian. III. Determine if transportation has been arranged. For those patients who lack mental capacity at the time of discharge, and who require transportation, such transportation shall be accomplished via appropriate medical transport to ensure the patient is safely and directly delivered to the physical custody of the patient’s surrogate/MPOA/guardian or an appropriate caregiver/facility as approved by patient’s surrogate/MPOA/guardian ...” A medical record review was completed for patient #1, dates of admission 01/16/26 to 02/12/26, with diagnoses that included hypothermia, hypotension, and edema of spinal cord. Patient #1 had developmental delay and a history of seizures, followed commands, but speech was garbled. There was a determination of lack of capacity, and the MPOA was appointed as healthcare surrogate (HCS #1), and signed all consentsThere was no documented evidence in the medical records of notification of HCS #1 of the discharge to the skilled nursing facility by case management or nursing. A telephone interview was conducted on 03/03/26 at 12:45 p.m. with HCS #1, who stated, “The problem I had was when they discharged [patient #1]. I had no idea that [he/she] was being transferred on [02/12/26] to [SNF]. The last I heard from case management was that [he/she] was being transferred to [area snf] as soon as a bed was ready. One of our staff called to check on [him/her] the next day [02/13/26] and were told about the transfer to the [SNF], or I would not have known. That was upsetting.” It should be noted the patient was transfered to a different SNF than the HCS was told the patient was being transfered to. An interview was conducted on 03/02/26 at 12:27 p.m. with staff #4 regarding patient #1. When asked if [he/she] notified HCS #1 of the pending transfer to [SNF], staff #4 stated, “I’m pretty sure I did. We stayed in close contact.” When staff #4 reviewed the medical records, [he/she] concurred that there was no documented evidence of any notification. An interview was attempted with staff #5, but they were unavailable for interview. An interview was conducted on 03/03/26 at 9:20 a.m. with staff #14 regarding patient #1’s discharge. Staff #14 stated, “I do not remember this patient or incident.” After reviewing the medical records, staff #14 stated, “This happened after hours, so I must have been on call. I would have received a call from the liaison or the [SNF] that the bed was ready. I then enter a standard note. Nursing picks it up from there and makes all arrangements and calls all involved parties. I would not have notified the HCS, that’s up to nursing to make that courtesy call.” A telephone interview was conducted on 03/03/26 at 9:30 a.m. with staff #10 regarding speaking with patient #1’s HCS. Staff #10 stated, “I remember speaking with [HCS #1] that morning, but I don’t remember what we talked about exactly, and I didn’t document it. I was aware that [patient #1] was being discharged that day.” A telephone interview was conducted on 03/03/26 at 9:10 a.m. with staff #9 regarding patient #1’s discharge. Staff #9 stated, “I did the discharge to [SNF]. [He/she] left around 10:30 p.m. I did not call the HCS when [he/she] left. I was told that case management was in touch with the HCS and that [he/she] was aware of the discharge, and it was late.””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 32177 Based on document reviews, medical record reviews, and staff (EMP) interviews, it was determined that the hospital failed to have an effective governing body as evidenced by failing to ensure the hospital’s Organ, Tissue and Eye Donation program was integrated into the Quality Assurance/Performance Improvement Program (A-308) Cross-Reference: §482.21 QAPI: Quality Assessment and Performance Improvement Program”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 32177 Based on document reviews and staff (EMP) interviews, it was determined that the hospital failed to ensure the hospital had a system-wide Quality Assurance/Performance Improvement (QA/PI) that included the hospital’s Organ, Tissue and Eye Donation program (A-308). Cross Reference: §482.21 QAPI: Governing Body”

“QAPI GOVERNING BODY, STANDARD TAG CFR(s): 482.21 ... The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement) ... The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Standard is not met as evidenced by: 32177 Based on document review and staff (EMP) interview, it was determined the hospital’s Governing Body failed to ensure that the hospital had a system-wide Quality Assurance/Performance Improvement (QA/PI) that included the hospital’s Organ, Tissue and Eye Donation program. Findings include: Review of facility document, titled “Amended and Restated Bylaws by Charleston Area Medical Center, Inc,” dated November 21, 2024, revealed “ ...ARTICLE V THE BOARD OF TRUSTEES OF THE CORPORATION 5.1 Powers of Board of Trustees. The affairs of the Corporation shall be managed and conducted by a Board of Trustees. Subject to the Reserved Powers of the Voting Member, the Board of Trustees shall be the governing body and have general charge and supervision of the business of the Corporation, including the operation and management of its hospitals and all other activities or facilities....” Review of facility document, titled “QMS Performance Improvement Plan,” dated July 8, 2024, revealed, “Quality Management System Scope: The quality Management System covers all aspects and facets of achieving CAMC’s Mission: Striving to provide the best healthcare to every patient every day. The Scope of CAMC services consists of four acute care hospitals and ambulatory sites. Quality Management System Policy: Charleston Area Medical Center, Inc. (CAMC) will develop, implement, and maintain a Quality Management System (QMS) for managing patient safety and quality. The Quality Management System will promote the mission of CAMC by providing services to meet the needs of patients in its community...Goals of Performance Improvement (QA/PI/PS) The QMS Performance Improvement Plan outlines the organization’s performance improvement strategies: integrating performance improvement into all aspects of our work ...All departments are expected to have quality and safety improvement initiatives and report in-process and outcomes measures to their Administrative Staff, Quality Improvement Committees and other committees as assigned ...Quality Management System Performance Improvement Priorities Performance Improvement priorities are determined annually through Strategic Planning Process, and approved by the Administrative Leadership, Medical Executive Committee, Board of Trustees Committee on Quality and Board of Trustees ....” Review of the QA/PI documentation, dated April 2024 through April 2025, revealed no documentation that the hospital’s Organ,Tissue and Eye Donation program was presented at the monthly meetings. Review of email from EMP15 to EMP1, dated April 28, 2025, at 12:33 PM, revealed, “I have reviewed the Jan-Dec 2024 [QA/PI] and there were no reports or issues presented for [Organ, Tissue and Eye Donation program].” Interview on April 28, 2025, at 1:40 PM, EMP1 indicated there had been no reports from the hospital’s Organ, Tissue and Eye Donation program in QA/PI meetings. Interview on April 30, 2025, at 7:15 AM, EMP1 indicated the hospital’s Organ, Tissue and Eye Donation program were not reported to QMS. Interview on April 30, 2025, at 10:20 AM, EMP9 indicated the Donor Advisory Group [part of the hospital’s Organ, Tissue and Eye Donation program] did not report to the QMS. Interview on May 2, 2025, at 9 AM, EMP12 indicated the hospital’s Organ, Tissue and Eye Donation Program was not reported to the QA/PI.”

“FORM AND RETENTION OF RECORDS CFR(s): 482.24(b) The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. This Standard is not met as evidenced by: 32177 Based on document reviews, medical record reviews, and staff (EMP) interviews, it was determined the hospital failed to ensure there was documentation of the information provided to patients and Health Care Surrogates (HCS) required to make an informed decision about the patient’s care. Findings include: Review of facility policy titled “Informed Consent,” with a publication date of August 23, 2024, revealed “Charleston Area Medical Center, Inc, (CAMC) recognizes the right of patients, their surrogate decision-makers, or their Medical Power of Attorneys (MPOAs) to give informed consent or refusal to proposed treatment and procedures. To give informed consent or refusal, patients, surrogate decision-makers, and MPOAs should receive sufficient information from the physician or Advance Practice Professional (APP) performing the treatment or procedure...Informed Consent - voluntary authorization of a patient to proceed with a treatment or procedure after having received sufficient information regarding the risks, benefits, purpose, alternatives, risks of the alternatives, and consequences of refusal of the proposed treatment or procedure...The physician or treating APP is responsible for insuring [sic] that written documentation of informed consent as set forth below is contained in the patient’s medical record prior to initiating any of the following treatments or procedures ...10.Withholding or withdrawing life sustaining treatment i.e., providing comfort care only ...” Review of facility document, titled “Patient Bill of Rights and Responsibilities,” dated July 27, 2023, revealed “...The American Hospital Association (AHA) has developed a “Patient Bill of Rights” with the expectation that observance of these rights will contribute to more effective patient care and greater satisfaction for patients, physicians, and hospitals. CAMC models its Patient’s Bill of Rights and Responsibilities on that of the AHA ...Procedure: Patient Rights ...3. The patient has the right to have a family member or representative of his/her choice and his/her physician to be notified promptly of his/her admission to the hospital. 4. The patient has the right to and is encouraged to obtain from physicians and other direct caregivers relevant, current, and understandable information concerning diagnosis, treatment, and prognosis ...The patient has the right to participate in the development and implementation of his/her plan of care and make informed decisions regarding his/her care. The patient’s rights include being informed of his/her health status, being involved in care planning and treatment, and being able to request or refuse treatment ...6. The patient has the right to have an advance directive (such as a living will or medical power of attorney) concerning treatment or designating a surrogate decision-maker with the expectation that Hospital will honor the intent of that directive to the extent permitted by law and Hospital policy.” Review of Patient 1 (P1) medical record revealed the patient was transferred from another hospital after a motor vehicle accident with multiple cervical fractures and injuries. The patient was admitted to Surgical Trauma Intensive Care Unit (STICU), was intubated and placed on a ventilator. On March 20, 2025, the physician documented that due to sedation, P1 did not have capacity to make medical decisions, and a HCS was appointed. On April 6, 2025, P1’s HCS made the decision to withdraw the patient’s life support and proceed with organ donation. There was no documentation indicating what information the HCS had received about the risks, benefits, purposes, alternatives, risks of alternatives to make an informed decision to withdraw life support. Further review of P1’s medical record revealed that on April 7, 2025, at 11:59 AM, the physician discontinued all paralytics and sedation except Precedex (medication used for sedation). At 5:27 PM, the physician documented P1 nodded their head appropriately to questions and indicated they would not want to live on ventilator, understood they would pass away if the ventilator was removed and agreed to organ donation. The “General Main Operative Record,” dated April 7, 2025, at 6:00 PM, revealed that in the OR, P1 did not want to proceed with withdrawal of life support or organ donation. On April 8, 2025, at 7:08 PM, the physician documented P1 wanted to proceed with withdrawal of life support the following day. On April 9, 2025, at 10 AM, the physician documented asking P1 if they wanted withdrawal of life support and understood withdrawal of life support would be fatal, P1 indicated yes. P1’s life support was withdrawn and P1 passed. Interview on April 28, 2025, at 12:40 PM, EMP1 indicated there was no documentation of the physician’s assessment of capacity or the information the HCS received to make an informed decision. Interview on April 29, 2025, at 8:30 AM, EMP2 indicated P1 was alert, blinking yes and no appropriately to questions, and could nod their head. EMP2 indicated P1 indicated they did not want to live paralyzed, with a tracheostomy, on a ventilator in a nursing facility. Conversations with P1 were discussed with the HCS, and the HCS wanted to honor P1’s wishes. There was no documentation of EMP2’s assessment of P1’s capacity, or the information P1 received regarding risks, benefits, purposes, alternatives, risks of alternatives to make an informed decision to withdraw life support.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 32177 Based on document reviews, observations, and staff (EMP) interviews, it was determined the hospital failed to ensure the staff hydration stations were separated from the patient nutrition area. Findings include: A observation was conducted of the Surgical Trauma Intensive Care Unit (STICU) on April 30, 2025, at 11:25 AM, with EMP1 and EMP14. Observation revealed a hydration station in the patient’s nutrition area that had multiple open containers that were touching the patients ice machine and open cups and water bottles touching the rim to the nutrition sink. Review of facility document, titled “Bloodborne Pathogens Exposure Control Plan,” dated January 9, 2025, revealed “...Covered drinks are permissible in locations designated as “hydration stations”. Hydration stations are defined areas within a department or unit in which covered drinks may be kept for employee consumption during their work shift. Departments may designate hydration stations using the following requirements: a. Area must be at least 12 inches away from sinks. If designated area is 12 inches from a sink a splash guard must be in place...G. Drinks must be in a covered container...” Review of facility document, titled “Rounds Findings and Action Plan 2022,” revealed that on August 8, 2022, the hydration station was to be placed in the employee lounge. Interview on May 1, 2025, at approximately 1 PM, EMP11 indicated when infection control issues were discovered during rounding, they report the concern to the unit manager and administration. EMP11 further indicated it was not acceptable for employee drink containers to touch the patient nutrition areas and patient ice machine.”

“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: 32177 Based on document review, observations, and staff [EMP] interviews, it was determined that the hospital failed to maintain a clean environment in the clean supply storage rooms on the Surgical Trauma Intensive Care Unit (STICU). Findings include: Review of facility document, titled “Equipment Cleaning,” dated February 3, 2025, revealed “...Clean and Sterile Supply Storage...All departments providing care to patients or providing products/services must apply appropriate cleaning/disinfection practices to prevent transmission of infectious and potentially infectious agents or conditions. Routine and terminal cleaning are done to minimize hazards associated with contamination of equipment...Clear labeling and segregation of clean and dirty items or equipment will be maintained in utility and/or storage areas...Shelving: Choose shelving with cleanable surfaces. Unsealed wood or cardboard are not acceptable cleanable surfaces...Bottom shelf must be at least 6 [six] inches off the floor. Maintain a solid bottom shelf....” Observation of the STICU on April 30, 2025, at 11:25 AM, with EMP1 and EMP14. There were two clean supply rooms on Pod B. Observation of clean supply room #1 (supplies purchased under the STICU budget) revealed items touching the clean supplies including two Christmas trees, paint supplies, drinks, and five boxes of Christmas supplies. Observation of clean supply room #2 revealed a large amount of dust on the floor, dried spills, and a mattress on the floor in open packaging. In addition, the following items were observed on the floor: three infection control Personal Protective Equipment (PPE) containers- one PPE container held an open box of gloves; canister tops for vacuum suction (used for removing fluids and secretions from the airway, surgical sites, and wounds, as well as for assisting with various medical procedures like wound drainage, chest drainage, and gastric emptying); seven containers of blood tubing; three boxes of syringes; lancets for blood sugar testing; and multiple blood collection tubes. EMP14 observed the clean supply rooms and indicated they were aware of the supplies being on the floor, “Because that is where materials puts them if there isn’t enough space where they go.” Interview on May 1, 2025, at approximately 1 PM, EMP11, indicated they believed the last environmental rounding had been conducted in March, it was performed every quarter, and if there are problems found when rounding they report it to the unit manager and administration.”

“DISCHARGE PLANNING- PAC SERVICES CFR(s): Requirements related to post-acute care services. (c) For those patients discharged to home and referred for HHA services, or for those patients transferred to a SNF for post-hospital extended care services, or transferred to an IRF or LTCH for specialized hospital services, the following requirements apply, in addition to those set out at paragraphs (a) and (b) of this section This Standard is not met as evidenced by: 46199 Based on medical record review, documentation review, and interview, it was revealed the facility failed to notify a patient’s legal guardian prior to discharge for one (1) of ten (10) patients (Patient 1). This failure has the potential to negatively impact all patients receiving care at the facility. Findings include: A medical record review was conducted for patient #1. The patient is a newborn delivered via Caesarean section at the facility on 3/27/25 at 3:24 a.m. The record contains an entry titled “History and Physical” completed on 3/27/25 at 11:49a.m. by staff 14 which includes a section titled “Assessment/Plan” which states, in part, “ ...Social: SW [Social Work] consult placed, appreciate recommendations ...” The medical record has an external document titled “Department of Health and Human Resources” (DHHR) dated 3/28/25. This document states the biological parents are to have no visitation or contact with [states patient 1’s name]. The document names the foster parents and states that they are allowed contact and visit with patient 1. The medical record has an external document titled “West Virginia Department of Human Services” (DHS) dated 4/1/2025. This document outlines that the West Virginia Department of Human Services has legal custody of patient 1 and outlines the rights, responsibilities, and limitations of the foster parents’ rights concerning patient 1. The medical record has a section titled “Case Management (CM) Transition Planning Follow Up ...” this section contains the following entries: an entry titled “Narrative Note” completed on 4/3/25 at 8:21a.m. by staff 5 states, in part, “Comment: ...CM asked if [cps 1] received a call from [staff 13] yesterday, [cps 1] stated, ‘no, I did not have any missed calls.’ “An entry titled “CM Narrative Note” completed on 4/2/25 at 9:54a.m. by staff 13 states, “SW [Social Worker] called [cps1], left VM [voice mail]. Waiting on a return call.” An entry titled “CM Narrative Note” completed on 3/31/25 at 9:06a.m. which states, in part, “CM received call from [cps1] ...asking for an update on pt [patient]. CM spoke with NBN [newborn nursery] staff who stated pt could possibly dc [discharge] tomorrow, but nursery staff is waiting on doctor’s recommendations during rounds. CM will follow up with [cps 1] after NBN rounds.” May it be noted, there are no “CM Narrative Notes” dated 4/1/25, which is patient 1’s date of discharge. An email was reviewed titled “Handoff” dated Monday March 31, 2025, at 3:55p.m. This document was sent to staff 6, 10, 13 and others. The document contains a section titled “Newborn Nursery [NBN]” which states, in part, “ ... [patient 1 parent] ... [cps 1] ...called stating [patient 1] should not be with parents. Letter on chart. Possible discharge (DC) tomorrow as long as [patient 1] does not need any medication for withdraw, [cps 1] asked that we call [him/her] in the morning if patient will be ready for DC so [he/she] can send over petition.” An interview was conducted with staff 12 on 4/8/25 at 3:00p.m. Staff #12 was asked about the process of discharging a patient in DHHR custody. Staff #12 stated, “If we have a social work consult, [he/she] makes the CPS referral if necessary. If CPS takes custody of the patient, we need a ratification letter. The previous social worker had said that the initial letter was okay. We make a copy of foster parent identification but there is no policy about this process. In a perfect world, the social worker should be rounding, looking at who is going home.””

“EMERGENCY SERVICES CFR(s): 482.12(f)(2) If emergency services are not provided at the hospital, the governing body must assure that the medical staff has written policies and procedures for appraisal of emergencies, initial treatment, and referral when appropriate. This Standard is not met as evidenced by: 42792 Based on review a of the medical records [MR] and facility documentation. It was determined the facility failed to comply with 482.23 (b) by failing to following policies and procedures for providing respectful privacy care and patient rights when completing initial assessment for treatment care plan for emergency department patients. (Refer to A0093) The policy titled: “Patient Bill of Rights and Responsibilities” Publication Date: July 27, 2023; was reviewed and stated in part: “...III. Procedure: A. Patient Rights 1. The patient has the right to receive considerate and respectful care...” The policy titled: “Admitting a Patient (Nursing)” Publication Date: December 17,2024; was reviewed and stated, in part, “Purpose: Process for all...hospital admission; Definitions... Boarder Patient: A boarder is defined as patient in the Emergency Department [ED] who has a Patient Status Order [PSO] for admission and no available bed on the appropriate unit/facility. Therefore, the patient must wait, or board, in the Emergency Department until a bed is available...Patient Status Order which determines what level of care the patient is to receive by the Admitting Provider, e.g. inpatient, outpatient, observation, outpatient in a bed...Procedures: Emergency Department: 1. The patient’s ED work is completed and the ED provider has determined the patient needs admitted to the hospital. 2. The ED provider consults the access coordinator to ensure bed is available prior to consulting admitting physician. If bed available, ED provider will consult the admitting physician for admission or observation placement of the patient...3. Admitting physician places PSO in Cerner. I. PSO will state bed type, admission status, and the name of the patient’s attending physician. 4. PSO order alerts the Transfer Center that the patient needs a bed...5. The Transfer Center assigns the patient a bed. For Plateau Medical Center, Access Coordinator will assign a bed in PM office once patient arrives to receiving unit. If a bed is not available, the patient will board in the ED until a bed become available.” The policy titled: “Professionalism: Interactions with Patients and Families” which was in the additional GME Policies for Residents and fellows in CAMC program. The policy was undated was reviewed and stated, in part, “Residents/fellows are reminded that...public areas to respect the privacy concerns of patients. Hallway...are inappropriate as they may be overheard by unauthorized individuals. House staff must at all times be respectful and professional in all interaction with patients, families...in their communication to other health professional about patients. A review of the History and Physical Final; Assessment and Plan dated 12/11/24 at 7:33 p.m. completed by Staff #20 revealed the concerns for Patient #1 bowel obstruction were: Patient with several months of varying abdominal distention and ostomy output, Patient recently had been more distended and had decrease output, A computed tomography [CT] shows colon is very distend and fluid-filled. Distal small bowel is also mildly dilated. Transition point is seen at the level for the ostomy in the left lower quadrant, concerning for possible intermittent obstructions, Abdomen is significantly distended, no tibial tubercle osteotomy [TTP] or rebound/guarding, ostomy is pink and patient down to fascia, admit to surgery services, Nothing by mouth [NPO] will not place nasogastric [NG] tube at this time as patient has had no nausea and vomiting, will attempt decompression with red rubber, this was ultimately unsuccessful, on interval check, patient has emptied ostomy bag twice with good output, bowel rest maintenance intravenous fluids [mIVF].” Interview was conducted on 1/14/25 at 2:00 p.m. with Staff #6, who confirmed that, “I saw the patient a total of three (3) times. Once in the MERT area where the recliners are located. The second was when I assessed the patient in the hallway. I did a digital and when I put my finger in the stoma area of the patient. The third time was when I did a follow up to check on the patient after my first initial assessment of the stoma. The patient expressed to me that [he/she] was upset because I assessed the coloscopy bag and did the stoma examine in the hallway. I told [him/her] I would not do that again if I had to examine the patient again, I would do the examine in a private area of the ED.” Interview was conducted on 1/15/25 at 12:06 p.m. with Staff #20, who confirmed that, “I was not present at the time [Staff #6] completed the assessment on [Patient #1]. Another Resident was assigned with [Staff #6] which was [Staff #13]. Which both of these individuals are Residents. Resident can do consults, write notes/progress notes which has to be sent to the attending physician.””

“PATIENT RIGHTS: PERSONAL PRIVACY CFR(s): 482.13(c)(1) The patient has the right to personal privacy. This Standard is not met as evidenced by: 42792 Based on review of medical records [MR] and facility documentation, it was determined that facility failed to comply with 482.13 (c) (1) by failing to provide the right of personal privacy during a medical assessment. (Refer to A0143) Findings include: Review of the facility policy “Patient Bill of Rights and Responsibilities” published date: July 27, 2023, revealed and stated in part ... “The patient has the right to personal privacy. A review of the History and Physical Final; Assessment and Plan dated 12/11/24 at 7:33 pm completed by Staff #20 revealed the concerns for Patient #1 bowel obstruction were: Patient with several months of varying abdominal distention and ostomy output, Patient recently had been more distended and had decrease output, A computed tomography [CT] shows colon is very distend and fluid-filled. Distal small bowel is also mildly dilated. Transition point is seen at the level for the ostomy in the left lower quadrant, concerning for possible intermittent obstructions, Abdomen is significantly distended, no tibial tubercle osteotomy [TTP] or rebound/guarding, ostomy is pink and patient down to fascia, admit to surgery services, Nothing by mouth [NPO] will not place nasogastric [NG] tube at this time as patient has had no nausea and vomiting, will attempt decompression with red rubber, this was ultimately unsuccessful, on interval check, patient has emptied ostomy bag twice with good output, bowel rest maintenance intravenous fluids [mIVF]. An interview was conducted on 1/14/25 at 9:00 a.m. with Staff #1, who confirmed that, “[Staff #6] is a third [3rd] year resident at the hospital Interview was conducted on 1/14/25 at 2:00 p.m. with Staff #6, who stated, “I saw the patient a total of three [3] times. Once in the MERT area where the recliners are located. The second was when I assessed the patient in the hallway. I did a digital and when I put my finger in the stoma area of the patient. The third time was when I did a follow up to check on the patient after my first initial assessment of the stoma. The patient expressed to me that [he/she] was upset because I assessed the coloscopy bag and did the stoma examine in the hallway. I told him I would not do that again if I had to examine the patient again, I would do the examine in a private area of the ED. Interview was conducted on 1/15/25 at 12:06 p.m. with Staff #20, who stated, “I was not present at the time [Staff #6] completed the assessment on [Patient #1]. Another Resident was assigned with [Staff #6] which was [Staff #13]. Which both of these individuals are Residents. Resident can do consults, write notes/progress notes which has to be sent to the attending physician.””