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Based on observation, interview, and record review, the Medical Staff failed to implement the Medical Staff bylaws (describes the roles, rights and responsibilities of the medical staff and members) when the Medical Staff failed to:

1. Conduct periodic appraisal/reappraisal (evaluation of physician's clinical practice by another qualified physician) for nine of nine sampled medical providers (Medical Doctor [MD] 1, MD 2, MD 3, MD 4, MD 5, MD 6, Certified Registered Nurse Anesthetist [CRNA] 7, MD 8, and MD 9). This failure resulted in physician practices not being evaluated for standard of practice and the potential for undesired patient outcomes. (Refer to A0340).

2. Ensure one of five medical providers (MD 3) performed surgical procedures under fluoroscopy (a real time video x ray) without a fluoroscopy license and clinical privilege for four of four patients (Patient 26, Patient 27, Patient 28, and Patient 24). This failure had the potential to place patients at risk for excess radiation from fluoroscopy. (Refer to A0341).

3. Follow the Medical Staff Rules and Regulations and implement their Policies and Procedures to investigate concerns within 14 days for one of nine medical providers (MD 2)'s practice and behavior. This failure resulted in a delayed investigation and the potential for incomplete or inaccurate findings. (Refer to A0341).

5. Verify one of nine medical providers (MD) 9 met the medical staff membership and privileging criteria. This failure had the potential for unsafe medical care. (Refer to A0341).

6. Ensure nurses had the ability to verify eight of nine medical providers' (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 8, and MD 9) clinical privileges. This failure had the potential for unsafe medical care and undesired patient outcomes. (Refer to A0341).

The cumulative effects of these systemic failures had the potential to negatively impact health and safety of all patients seeking medical care at the facility.

Based on interview and record review the Medical Staff failed to conduct periodic appraisal/reappraisal (evaluation of physician's clinical practice by another qualified physician) for nine of nine sampled medical providers (Medical Doctor [MD] 1, MD 2, MD 3, MD 4, MD 5, MD 6, Certified Registered Nurse Anesthetist [CRNA] 7, MD 8, and MD 9). This failure resulted in physician practices not being evaluated for standard of practice and the potential for undesired patient outcomes.

Findings:

During a record review on 5/12/22, at 10:09 AM, with Medical Staff Coordinator (MSC), MD 1's medical credential (verification of education, qualifications, experience, and professional records) was reviewed. The medical credential file indicated, "The Governing Body initially appointed MD 1 to the Medical Staff on 1/31/20. The Governing Body reappointed MD 1 to the Medical Staff on 3/10/22." Medical Staff Coordinator was unable to provide documentation of MD 1's reappraisal prior to reappointment.

During a record review on 5/12/22, at 10:15 AM, with Medical Staff Coordinator, MD 2's medical credential was reviewed. MD 2's medical credential file indicated, "The Governing Body initially appointed MD 2 to Medical Staff on 7/24/19. The Governing Body reappointed MD 2 on 7/24/21. Medical Staff Coordinator was unable to provide documentation of MD 2's performance-based reappraisal prior to reappointment.

During a record review on 5/12/22, at 10:20 AM, with Medical Staff Coordinator, MD 3's medical credential file was reviewed. MD 3's medical credential file indicated, the Governing Body granted MD 3 initial clinical privilege on 3/10/22. Medical Staff Coordinator was unable to provide documentation the Medical Staff performed an assessment/appraisal of MD 3's general competencies prior to MD 3's initial appointment and being granted clinical privileges (authorization to a medical staff member to provide medical services granted by a governing authority or according to medical staff bylaws).

During a record review on 5/12/22, at 10:25 AM, with Medical Staff Coordinator, MD 4's medical credential file was reviewed. MD 4's medical credential file indicated, the Governing Body granted initial clinical privileges to MD 4 on 3/10/22. Medical Staff Coordinator was unable to provide documentation the Medical Staff performed an appraisal and assessment of the general competencies prior to MD 4's initial appointment and being granted clinical privileges.

During a record review on 5/12/22, at 10:30 AM, with Medical Staff Coordinator, MD 5's medical credential file was reviewed. MD 5's medical credential file indicated, the Governing Body granted initial clinical privileges to MD 5 on 3/10/22. Medical Staff Coordinator was unable to provide documentation the Medical Staff performed an appraisal/assessment of MD 5's general competencies prior to MD 5's initial appointment.

During a record review on 5/12/22, at 10:35 AM, with Medical Staff Coordinator, MD 6's medical credential file was reviewed. The medical credential file indicated, the Governing Body initially appointed MD 6 to the Medical Staff on 7/24/19. The Governing Body reappointed MD 6 to the Medical Staff on 6/5/20. Medical Staff Coordinator was unable to provide documentation the Medical Staff performed an appraisal/assessment of MD 6's general competencies prior to MD 6's initial appointment.

During record review, on 5/12/22, at 10:40 AM, with Medical Staff Coordinator, Certified Registered Nurse Anesthetist (CRNA) 7's credential was reviewed. CRNA 7's credential file indicated, the Governing Body granted CRNA's initial appointment to the Medical Staff, as a non-physician practitioner, on 3/10/22. Medical Staff Coordinator was unable to provide documentation the Medical Staff performed an appraisal/assessment of CRNA 7's general competencies prior to CRNA 7's initial appointment.

During record review, on 5/12/22, at 10:45 AM, with Medical Staff Coordinator, MD 8's medical credential file was reviewed. MD 8's medical credential file indicated, the Governing Body's initial appointment was 11/18/10. The Governing Body reappointed MD 8 to the Medical Staff on 7/24/21. Medical Staff Coordinator was unable to provide documentation the Medical Staff performed an appraisal/assessment of MD 8's general competencies prior to MD 8's reappointment.

During a concurrent interview and record review, on 5/12/22, at 11 AM, MD 9's medical credential file was reviewed. MD 9's medical credential file indicated, the Governing Body initially appointed MD to the Medical Staff with Provisional with Proctor status on 8/29/18. MD 9's medical credential file indicated, MD 9 applied for reappointment on 10/15/20. Medical Staff Coordinator was unable to provide documentation MD 9 had a performance-based reappraisal. Medical Staff Coordinator stated, Medical Staff privileging was granted every two years. Medical Staff Coordinator stated, MD 9's reappointment to Medical Staff was granted on 12/3/21.

During a review of the facility's current "Medical Staff By-Laws," dated 2017, the Medical Staff By-Laws indicated, "Basis for Appointment:. . .Recommendations for appointment to the Medical Staff and for granting privileges shall be based upon appraisal of all information provided in the application, including but not limited to,
health status and written peer recommendations regarding the practitioner's current proficiency with respect to the hospital's general competencies as further described at Bylaws Section 5.2, the practitioner's training, experience and professional performance at this hospital. . .Recommendations from peers in the same professional discipline as the practitioner, and who have personal knowledge of the applicant. . .Article Vll. Performance Evaluation Monitoring: 7.1. The credentialing and privileging processes described in Bylaws, Article 4, Procedure for Appointment and Reappointment, and Article 5, privileges, require that the Medical Staff develop ongoing performance evaluation and monitoring activities to ensure that decisions regarding appointment to membership on the Medical Staff and granting or renewing of privileges, are detailed, current, accurate, objective and evidenced-based. . ."

During a review of the facility's current "Medical Staff Rules and Regulations," dated 2/29/17, the Medical Staff Rules and Regulations indicated, "Verification shall encompass, but is not limited to, written verification of peer references, licensure status, training and education, current proficiency with respect to the hospital's general competencies. . .and health status. . ."

Based on interview and record review, the Medical Staff failed to:

1. Ensure one of five medical providers (MD 3) performed surgical procedures under fluoroscopy (a real time video x ray) without a fluoroscopy license and clinical privilege for four of four patients (Patient 26, Patient 27, Patient 28 and Patient 24). This failure had the potential to place patients at risk for harm for excess radiation from fluoroscopy.

2. Follow the Medical Staff Rules and Regulations and implement their Policies and Procedures to investigate concerns within 14 days for one of nine medical providers(MD 2)'s practice and behavior. This failure resulted in a delayed investigation and the potential for incomplete or inaccurate findings.

3. Ensure one of nine medical providers (MD 9) met the medical staff privileges met the medical staff membership and privileging (authorization to a medical staff member to provide medical services granted by a governing authority or according to medical staff bylaws) criteria. This failure resulted in medical provider practices not being evaluated for standards of practice and the potential for undesired patient outcomes.

4. Ensure nurses had the ability to verify eight of nine medical providers' (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 8, and MD 9) clinical privileges. This failure had the potential for unsafe medical care and undesired patient outcomes.

Findings:

1. During a concurrent interview and record review on 5/11/22, at 9:57 AM, with Surgery Coordinator (SC), SC stated, an Ash Catheter Placement (Implanted device which allows access to patient's veins) was one of the procedures done under fluoroscopy.

During a concurrent interview and record review, on 5/11/22, at 10 AM, with Interim Chief Nursing Officer (ICNO), the surgery schedule dated 3/9/22, 3/14/22, 3/21/22, and 4/27/22 were reviewed. ICNO stated, MD 3 placed an Ash Catheter for Patient 26 on 3/9/22, Patient 27 on 3/14/22, Patient 28 on 3/21/22, and Patient 24 on 4/27/22.

During a concurrent interview and record review on 5/11/22, at 10:05 AM with ICNO, Patient 26's Operative Procedure Note, dated 3/9/22 was reviewed. The Operative Procedure Note indicated, "[MD 3] inserted a central venous catheter [tube surgically inserted into a large vein for long-term access] in Patient 26's right neck under fluoroscopy." ICNO stated, MD 3 performed the procedure under fluoroscopy. ICNO was unable to provide documented evidence of a radiology supervising physician in the procedure room with MD 3 during the use of fluoroscopy.

During a concurrent interview and record review, on 5/11/22, at 10:10 AM, with ICNO, Patient 27's Operative Procedure Note, dated 3/14/22, was reviewed. The Operative Procedure Note indicated, "MD 3 inserted a central venous catheter for dialysis [procedure to remove waste products and excess fluids from the blood] under fluoroscopy." ICNO stated, MD 3 performed the procedure under fluoroscopy. ICNO was unable to provide documented evidence of a radiology supervising physician in the procedure room with MD 3 during the use of fluoroscopy.

During a concurrent interview and record review, on 5/11/22, at 10:15 AM with ICNO, Patient 28's Operative Procedure Note, dated 3/21/22 was reviewed. The Operative Procedure Note indicated, "MD 3 inserted a central venous catheter under fluoroscopy. Fluoroscopy confirmed adequate placement of the wire. . ." ICNO stated, MD 3 performed the procedure under fluoroscopy. ICNO was unable to provide documented evidence of a radiology supervising physician in the procedure room with MD 3 during the use of fluoroscopy.

During a concurrent interview and record review, on 5/11/22, at 10:25 AM with ICNO, Patient 24's Operative Procedure Note, dated 3/21/22 was reviewed. The Operative Procedure Note indicated, "MD 3 inserted right central venous catheter and removal of left central venous catheter; Confirmed to be in the right ventricle (chamber of the heart) under fluoroscopy." ICNO stated, MD 3 performed the procedure under fluoroscopy. ICNO was unable to provide documented evidence of a radiology supervising physician in the procedure room with MD 3 during the use of fluoroscopy.

During a record review, on 5/12/22, at 11:21 AM, with Medical Staff Coordinator (MSC), MD 3's medical credential file was reviewed. The Medical Credential file did not indicate, MD 3 had fluoroscopy certification. The Medical Staff Coordinator was unable to provide documented evidence for MD 3's Fluoroscopy certification, request for fluoroscopy privilege, or MD 3's granted privileges for performing procedures under fluoroscopy.

During an interview on 5/20/22, at 10:45 AM, with MD 3, MD 3 stated, he performed procedures under fluoroscopy. MD 3 stated, he did not have fluoroscopy certification. MD 3 stated, he should have documented MD 4 was in the room supervising during fluoroscopy.

During a review of MD 4's "Fluoroscopy Certificate," dated expires 12/31/23, MD 4's fluoroscopy certificate did not indicate "x-ray supervisor or operator."

During a review of the facility's policy and procedure (P&P) titled, "Operating Room Procedure for Radiology," dated 3/10/22, the P&P indicated, "B. A qualified Radiology Technologist will operate X-ray equipment in the Operating Room. Operation of the Mobile Fluoroscopy Unit (C-Arm) requires a valid Fluoroscopy certificate issued by the Department of Health Services. This includes both the Radiology Technologist and the Physician."

During a review of the facility's policy and procedure (P&P) titled, "C-Arm (Mobile Fluoroscopy), dated 3/10/22, the P&P indicated, "1. A current certified x-ray Supervisor and Operator certificate along with Fluoroscopy certificate issued by the Department of Health Services and the Radiologic Bureau of Health and privileges granted by the Medical Staff are required of any Physician who personally activates fluoroscopic equipment including the C-Arm."

2. During a concurrent interview and review of the complaint report, on 5/12/22, at 10:30 AM with Medical Staff Coordinator, a complaint report, dated 1/13/22 was reviewed. The complaint report alleged MD 2 violated patients' rights, issues with informed consents, and exhibited disruptive conduct. Medical Staff Coordinator stated, the Medical Executive Committee received the complaint on 2/3/22. Medical Staff Coordinator stated, an internal investigation was conducted but she had not received the result of the investigation. At 4:30 PM, Medical Staff Coordinator presented the completed facility investigation report dated 4/14/22.

During an interview with Medical Staff on 5/18/22, at 2:45 PM, Medical Executive Committee Chairperson (MD) 10, MD 10 stated, he was not able to interview MD 2. MD 10 stated, he did not start his investigation for two months. MD 10 stated, the Risk Management Department led the investigative process.

During an interview on 5/18/22, at 5 PM, with Quality/Risk Manager (QRM), QRM stated, physician complaints were reported to Medical Staff Coordinator. QRM stated, she handled all complaints, except for physician concerns.

During a review of the facility's policy and procedure (P&P) titled, "Practitioner Complaint Process," dated 12/18/16, the P&P indicated, "The facility will appropriately and promptly manage and resolve any concerns brought forth from the Medical Staff. . .1. Practitioners with concerns, complaints, or issues are encouraged to call the Quality Officer for immediate assistance. 2. Hospital employees who learn of a physician concern, complaint, or issue are to contact the Quality Officer. . .5. The Quality Officer or designee will be responsible for sending a summary of the complaint to the appropriate person in the organization within 24 hours of notification. . .7. If resolution of the complaint is expected to take more than seven working days, the Quality Officer must be informed. . ."

During a review of the current "Medical Staff Rules and Regulations," dated 3/29/17, the Medical Staff Rules and Regulations indicated, "Standards of Conduct 3.3.1 Reporting: The medical Staff Office or other appropriate recipient of a disruptive conduct complaint shall submit each report to the Chief of Staff and Chief Executive Officer for investigation. . .3.3.2 Investigation: The Chief of Staff and Chief Executive Officer or designated committee shall ensure that appropriate documentation of each incident of disruptive conduct is acquired in order to facilitate the investigative process. . .4. The investigation shall take place within 14 calendar days from receipt of a report of inappropriate conduct.

3. During a record review on 5/12/22, at 2:30 PM, with Medical Staff Coordinator, MD 9's medical credential file was reviewed. MD 9's medical credential file indicated the following:
The Governing Body initially appointed MD 9 to the Medical Staff on 8/29/18 with Provisional Status with Proctor.
MD 9 applied for reappointment on 10/15/20.
The Governing Body reappointed MD 9 to the Medical Staff on 12/3/20.
The National Practitioner Data Bank (NPDB-repository of adverse actions reports on health care practitioners) indicated MD 9's license was placed on probation for a period of five years beginning 10/1/20. The Medical Staff Coordinator provided no further information.

During an interview on 5/18/22, at 2:30 PM with Medical Staff, MD 10 stated, "We don't have a copy of the Board of California's decision."

During a review of the current "Medical Staff's Rules and Regulations," dated 3/29/17, the Medical Staff's Rules and Regulations indicated, "2.5 Verification of Information: Verification shall encompass, but is not limited to written verification of peer references, licensure status, training and education, current proficiency with respect to the hospital's general competencies, health status. . .The application will be deemed complete when all necessary verifications have been obtained, including, but not limited to, current license, licensing board disciplinary records, specially board certification status, National Practitioner Data Bank information, Drug Enforcement Administration certificate. . ."

During a review of the current "Medical Staff Bylaws," dated 2017, the Medical Staff Bylaws indicated, "Basic Qualifications: A practitioner must demonstrate compliance with all basic standards. . .to have an application for Medical Staff membership accepted for review. . .a. Physicians must be licensed to practice medicine by the Medical Board of California or the Board of Osteopathic Examiners of the State of California."

4. During an interview on 5/16/22, at 5:30 PM, with Registered Nurse (RN) 4, RN 4stated she was not aware of a process to determine if a physician has clinical privilege to perform a procedure.

During an interview on 5/17/22, at 3:37 PM, with Medical-Surgical Nurse Manager (MSNM), Medica Surgical Nurse Manager stated, the facility installed a software application yesterday but we can only see the face of the physician but unable to see the clinical privileges.

During an interview on 5/17/22, at 3:42 PM, with RN 3, RN 3 stated, "I don't know how to find the information if the physician has clinical privilege to perform certain procedures at the bedside.

During an interview with MSC on 5/17/22, at 4 PM, MSC stated there is a software application called EPriv the nurses can view to look at physician clinical privilege but it may not have been installed yet.

During a review of the current "Medical Staff Bylaws," dated 2017, the Medical Bylaws indicated, "5.8 Dissemination of Privilege List: Documentation of current privileges (granted, modified, or rescinded) shall be disseminated to the hospital admission/registration office and such other scheduling and health information services personnel as necessary to maintain an up-to-date listing of privileges for purposes of scheduling and monitoring to assure that practitioners are appropriately privileged to perform all services rendered."

Based on observation, interview, and record review, the hospital failed to ensure Radiologic Services met the professionally approved standards for safety and personnel qualifications as evidenced by:

1. The hospital failed to implement safety precautions against radiation hazards for patients receiving ionizing radiation (x-rays, gamma rays which may damage tissue at high levels of exposure), in the operating room. This failure had the potential to result in unintended radiation exposure to patients and staff. (Refer to A0535).

2. The hospital failed to provide dosimetry (measures dose of radiation) badges to monitor the operating room staff for radiation exposures. This failure resulted in the operating room staff not being tracked, and monitored for the amount of radiation exposure. (Refer to A0538).

3. The hospital failed to ensure the Director of Radiology Services met the Medical Staff credentialing and privileging (authorization to a medical staff member to provide medical services granted by a governing authority or according to medical staff bylaws) criteria and/or the contractual agreement. This failure had the potential to result in unsafe medical care. (Refer to A0546).

4. The hospital failed to ensure the Director of Radiology Services provided the required supervision for the radiology technicians, the use of equipment, safety hazards, supervision for the use of ionizing radiation, and performed administrative duties monthly as per the contractual agreement. This failure had the potential to result in radiology services being compromised, which could be detrimental to patient care. (Refer to A0546).

The cumulative effects of these systemic failures had the potential to negatively impact health and safety of all patients seeking medical care at the facility.

Based on interview, and record review, the facility failed to ensure radiation safety measures were being implemented when:

1. Radiation safety shields were not available and being utilized to protect body parts of patients not being radiated during ionizing radiation procedures in the operating room

2. Radiation safety signs were not posted outside operating rooms during radiation procedures.

These failures had the potential for unintended radiation exposure to patients and staff.

Findings:

1. During a concurrent observation and interview, on 5/17/22, at 11:30 AM, with Surgery Coordinator (SC) and Radiology Manager (RM), in the operating room hallway, SC stated, there were no personal protective lead shields in the operating room to protect patients during fluoroscopy (procedure that makes a real-time video of the movements inside a part of the body through x-rays passed over a period of time) procedures.

2. During a concurrent observation and interview on 5/17/22, at 11:30 AM, with SC and RM, outside the operating rooms, SC stated, there were no radiation safety signs posted outside the operating rooms indicating a radiation procedure was in progress.

During a review of the facility's policy and procedure (P&P) titled, "Radiation Safety" dated 3/10/22, the P&P indicated, ". . .Ensure that all individuals who work with or in the vicinity radiation producing equipment have the education. . .all imaging procedures are conducted safely and in accordance with regulations and license conditions. . .Monitor and ensure radiation safety in and (sic) for the patients, personnel, and the public in the department.

Based on observation, interview and record review, the facility failed to ensure operating room staff were monitored for radiation exposure during surgical cases. This failure resulted in operating room staff being exposed to unknown amounts of radiation and the potential to adversely impact employee health.

Findings:

During a concurrent observation and interview, on 5/11/22, at 1:25 PM, with Surgery Coordinator (SC), in the operating room storage area, multiple lead aprons (protective garment designed to shield the body from harmful radiation) were noted. SC stated, there were no dosimetry badges (device that detects and measures radiation exposure) available for the operating room staff. SC stated, "they [surgical staff] weren't being monitored."

During an interview on 5/11/22, at 1:40 PM, with Circulator Nurse (CN) 1, CN 1 stated, during fluoroscopy (real-time x-rays) cases, she wore a lead apron and a thyroid shield (a lead collar wrapped around one's neck to block radiation from X-rays). CN 1 stated, "We had not been provided a dosimetry badge."

During an interview on 5/17/22, on 10:40 AM, with Radiology Manager (RM), RM stated, he was told monitoring of radiation exposure in the operating room was not needed as it was done so infrequently.

During a review of the facility's policy and procedure (P&P) titled, "Radiation Safety Dosimetry Badge" dated 3/10/22, the P&P indicated, "1. All employees operating an X-ray generating equipment and others as determined by the Radiology Manager will wear a dosimetry badge: 1. The dosimetry badge will be worn at all times while working in an area of possible radiation exposure."

Based on interview, and record review, the hospital failed to:

1. Ensure the Director of Radiology Services met the Medical Staff credentialing and privileging (authorization to a medical staff member to provide medical services granted by a governing authority or according to medical staff bylaws.) criteria and/or the contractual agreement. This failure resulted in medical provider practices not being evaluated for standards of practice and the potential for undesired patient outcomes.

2. Ensure the Director of Radiology Services provided monthly administrative duties (supervision for the radiology technicians, the use of equipment, safety hazards, supervision for the use of ionizing radiation (x-rays, gamma rays which may damage tissue at high levels of exposure), review dosimetry (device that detects and measures radiation exposure) reports, review safety standards, radiation surveillance activities. This failure had the potential to result in radiology services being compromised, and the potential for undesired patient outcomes.

Findings:

1. During a concurrent interview and record review, on 5/17/22, at 1:50 PM, with Medical Staff Coordinator (MSC), MD 9's medical credential file was reviewed. The medical credential file indicated, "MD 9 was initially granted appointment on 8/29/18 with provisional (initial appointee) status with proctoring (written evaluation by another qualified physician) requirements. MD 9 applied for reappointment on 10/15/20. MD 9 was granted reappointment on 12/3/20." MSC stated, the Medical Staff did an Ad-hoc (focused, unplanned meeting) review on 12/3/20.

During a record review on 5/17/22, at 2 PM, with MSC, MD 9's reports from the National Practitioner Data Bank (NPDB-repository of adverse actions reports on health care practitioners) was reviewed. The NPDB indicated, "MD 9's license was placed on probation (disciplinary action) for a period of five years beginning 10/1/20. MSC was unable to provide any additional information regarding MD 9's probation requirements.

During a concurrent interview and record review on 5/17/22, at 2 PM, with MSC, MSC stated, MD 9 had been doing telemedicine. MSC was unable to provide documentation MD 9 had approved clinical privilege for telemedicine. MSC was unable to provide documented evidence MD 9 had requested and been granted telemedicine privileges. MSC stated, "I don't have anything to show a request for telemedicine."

During an interview on 5/18/22, at 2:30 PM with Medical Executive Committee Chairperson (MD) 10, MD 10 was not aware of the Medical Board's action to put MD 9's license on probation. MD 10 stated, "We don't have a copy of the [Medical] Board of California's decision."

During a review of the current "Medical Staff Bylaws," dated 2017, the Medical Staff Bylaws indicated, "Basic Qualifications: A practitioner must demonstrate compliance with all basic standards. . .to have an application for Medical Staff membership accepted for review. . .a. Physicians must be licensed to practice medicine by the Medical Board of California or the Board of Osteopathic Examiners of the State of California."

During a review of the contractual agreement titled, "Administrative Services and Coverage Agreement for Radiology Services," dated 9/1/18, the contractual agreement indicated, "e. Professional Qualifications: i. Hold an unrestricted license to practice medicine in the State of California. . .iii Be a member of good standing of Hospital's Medical Staff in accordance with Hospital's Medical Staff Bylaws and maintain active privileges. . .f. Representations and Warrants: ii. Physicians' license to practice medicine in the State of California or in any other jurisdiction has never been denied, suspended, revoked, terminated, voluntarily relinquished under threat of disciplinary action, or restricted in any way. . ."

2. During an interview on 5/17/22, at 10:16 AM, with Radiology Manager (RM), RM stated, the last time he saw the Director of Radiology was nine months ago. RM stated, he had been managing the department himself.

During a concurrent interview and record review, on 5/17/22, at 10:27 AM, RM was unable to provide documentation of any surveillance activities conducted on the use of personal protective shields, the use of dosimetry for the operating room staff, radiation safety. RM stated, he ensured the radiology staff had their radiology technician license and fluoroscopy certificates. RM stated, he did not keep records of the medical doctors' training for radiological procedures. RM stated, the Director of Radiology Services was responsible for making sure the medical doctors have their training and certification. RM stated, the department has not conducted any emergency drills, or staff training for any adverse events (injury caused by medical management, rather than the disease, which resulted in longer hospital stay, harm or death to the patient). RM stated, the Director of Radiology Services has not been present in the hospital to provide the direction and supervision the radiology staff needed.

During a review of the facility's policy and procedure (P&P) titled, "Radiation Safety,-ALARA (As Low As Reasonably Achievable) Reports," dated 3/10/22, the P&P indicated, "The Radiology Manager with the Radiology Medical Director will review the radiation exposure reports to determine that all exposures are in accordance with ALARA limits."

During a review of the facility's policy and procedure (P&P) titled, "Radiation Safety," dated 3/10/22, the P&P indicated, "The Radiology Manager with the direction of the Radiology Medical Director should address the following: a. Familiarize themselves with pertinent regulations, license terms, and documents, submitted in support of the request for the license and its amendments. b. Monitor and ensure radiation safety for the patients, personnel, and the public. . .d. Establish a program to ensure occupational radiation exposures will be as low as reasonably achievable (ALARA)."

During a review of the contractual agreement titled, "Administrative Services and Coverage Agreement for Radiology Services," dated 9/1/18, the contractual agreement indicated, "b. Availability: . . Physicians will devote adequate time per month to perform services as Medical Director of Radiology Services. . ."

Based on observation, interview and record review, the facility failed to ensure;

1. Clean and sanitary environment in the operating room clean linen closet.

2. Staff immunization reports were up to date for one of one sampled staff.

These failures had the potential to result in the spread of infectious disease to patients, staff, and visitors.

Findings:

1. During an observation on 5/11/22, at 2:46 PM, in the operating room clean linen storage area, the following items were noted:
A white towel with a brown substance was on top of several bags of clean, unused microfiber mops.
A posted sign indicated, "Clean rags only, Thank you."

During an interview on 5/11/22, at 2:48 PM, with Circulator Nurse (CN 1), CN 1 stated, the dirty towel should not have been placed inside the gray bin with the microfiber mops.

During a review of the facility's policy and procedure (P&P) titled, "Soiled Linen Pickup and Disposal" dated 03/10/2022, the P&P indicated, "1. Containers: All soiled linen will be contained, stored, and transported in containers labeled "SOILED LINEN", and containers securely closed as to prevent airborne contamination of patients, staff, visitors, or public corridors, rooms and other areas. The containers will prevent contamination of clean linen."

2. During a record review, on 5/12/22, at 2:10 PM, with Human Resource Manager (HRM), the Director of Plant Operations (DPO) employee file was reviewed. HRM was unable to provide documented evidence of a Varicella (highly contagious infection causing itching, blister-like rash on the skin) titers (a measurement of the amount or concentration of a substance in a solution) for DPO.

During a concurrent interview and record review, on 5/20/22, 10:34 AM, with Infection Control Manager (ICM) and Employee Health Coordinator (EHC), DPO employee file was reviewed. Neither ICM nor EHC were able to provide documented evidence of a Varicella titer for DPO. Both ICM and EHC both stated, DPO's Varicella titer had not been completed. EHC stated, "I think we should have done one [Titer]."

Based on observation, interview, and record review, the hospital failed to ensure Surgical Services met the professionally approved standards for safety and personnel qualifications as evidenced by:

1. The hospital failed to implement their policy and procedure for a qualified Registered Nurse (RN) to effectively lead the Surgical Services Department. This failure resulted in inadequately trained staff, and had the potential to affect the quality of patient care and increased infections in all surgical patients. (Refer to A-0942).

2. The hospital failed to implement their policy to assure the competency of two registered nurses Circulator Nurse (CN) 1 and Interim Chief Nursing Officer (ICNO) in their roles as operating room circulating nurses prior to working independently in the operating room. This failure had the potential to impact the ability of staff to provide safe patient care. (Refer to A-0944)

3. The hospital failed to ensure staff accurately completed the Pre-Operative/Surgical check list (check list, designed to improve the safety of surgical procedures) for five of 30 sampled patients (Patient 6, Patient 4, Patient 9, Patient 10, and Patient 11) before outpatient surgical procedures. This failure had the potential of an unanticipated (wrong patient, wrong procedure, wrong site) surgery on the patient. (Refer to A-0951)

4. The hospital failed to ensure staff obtained physician orders for surgical consents for four of 30 sampled surgical patients (Patient 6, Patient 26, Patient 27, and Patient 29). This failure had the potential for staff to consent the patient for a wrong procedure. (Refer to A-0951)

5. The hospital failed to develop and implement a policy and procedure (P&P) for temperature and humidity monitoring in the surgical critical areas. This failure had the potential to result in decreased shelf life and product integrity of surgical supplies, equipment malfunction, and increased risk for fire in the surgical areas. (Refer to A-0951)

6. The hospital failed to develop and implement a policy and procedure (P&P) for calling a code blue (life saving emergency procedure) in the operating room (OR). This failure had the potential to result in a delay of life saving procedures to patients during an emergency when staff was unaware of how to call for assistance. (Refer to A-0951)

7. The hospital failed to ensure Pre (before) and Post (after) OP (operative) Progress Record completed for two of 30 sampled surgical patients (Patient 15 and Patient 5). This failure resulted in incomplete patient information and had the potential to affect patients' continuity of care. (Refer to A-0951)

8. The hospital failed to develop and implement policies and procedures to obtain Informed Consents (written consent by a patient/responsible party for a procedure after receiving all material information regarding risk, benefits and alternatives) for two of two incapacitated sampled patients (Patient 13 and Patient 14). This failure had the potential of Patient 13 and Patient 14's wishes for care not to be honored.(Refer to A-0955)

9. Follow hospital policies and procedures on "Informed Consents, Obtaining and Documenting," for seven of ten sampled patients (Patient 22, Patient 24, Patient 26, Patient 27, Patient 28, Patient 29, and Patient 30). This failure had the potential patient/responsible party were not aware of the surgical procedure, risk and benefits or alternative therapy. (Refer to A-0955).

The cumulative effects of these systemic failures had the potential to negatively impact health and safety of all patients seeking medical or surgical services care at the facility.

Based on interview and record review, the hospital failed to implement their policy and procedure for a qualified Registered Nurse (RN) to effectively lead the Surgical Services Department. This failure resulted in inadequately trained staff, and had the potential to affect the quality of patient care and increased infections in all surgical patients.

Findings:

During an interview on 5/11/22, at 9:48 AM, with Surgery Coordinator (SC), SC stated, she was new and she was hired to be the Coordinator of Surgery. SC stated, she was a surgical technician. SC stated, "I don't have any credentials but I have a lot of experience. I have been working closely with the Interim Chief Nursing Officer (ICNO)."

During an interview on 5/12/22, at 9:07 AM with Circulator Nurse (CN)1, CN 1 stated, "I am new to the OR [operating room]. I am being trained by SC. She is my preceptor. I don't feel I am getting the right training. I don't feel safe. [ICNO] has not really overseen my training. When [SC] first arrived, she introduced herself as our manager."

During a concurrent interview and record review on 5/11/22, at 3:07 PM, with Human Resources Manager (HRM), the Job Description for the Surgery Coordinator and Lead Surgical Coordinator were reviewed. SC signed both Job Descriptions on 2/17/22. The Surgery Coordinator Job Description indicated, "Under the general direction of the Chief Nursing Officer, the Surgery Coordinator assumes responsibility for the efficient functioning in Surgical Services. . In collaboration with the Chief of Surgery, this individual is responsible for the ongoing assessment of the quality of patient care services provided in these areas. . .Essential functions: Assesses requirements of patient care and department needs to coordinate assignment of nursing staff to meet required services. . .Provides continuous employee assessment with written evaluations. . .as required based on employee performance . . .Develops, interprets, implements operational standards for the surgery department to promote maintenance of good quality patient care. . .possesses sound knowledge of nursing techniques and procedures. . .to assist the nursing staff when needed. Demonstrates knowledge and skills necessary to provide direct patient care. . ." HRM stated, "SC is not a Registered Nurse. A surgical technician cannot supervise nurses, cannot orient registered nurses, and cannot do a performance evaluation for a registered nurse."

During an interview on 5/12/22, at 3:31 PM, with ICNO, ICNO stated, SC did not meet the qualifications and could not be a manager for Surgery Services.

During a review of the facility's policy and procedure (P&P), titled, "Standards of Nursing in the Operating Room," dated, 7/24/19, the P&P indicated, "Standard lll: A Registered Nurse shall be authorized with administration accountability and responsibility for the Operating Room services. The Registered Nurse shall have the experience and education necessary to effectively lead the department in all Peri-Operative phases. Standard lV: The Registered Nurse Administrator shall be accountable and responsible for developing mechanisms that ensure optimal patient care. The Registered Nurse has responsibility for fiscal management, policy and procedure development, coordination of all personnel, and management of services.

Based on interview and record review, the hospital failed to implement their policy to assure the competency of two registered nurses Circulator Nurse (CN) 1 and Interim Chief Nursing Officer (ICNO) in their roles as operating room circulating nurses prior to working independently in the operating room. This failure had the potential to impact the ability of staff to provide safe patient care.

Findings:

During an interview on 5/12/22, at 1:15 PM, with CN 1, CN 1 stated, the hospital hired her at the end of March 2022 to work in the operating room as a circulating nurse. CN 1 stated, she had one year of experience working in the Emergency Department. CN 1 stated, she had one day of hospital orientation, and one additional day of a hospital wide job fair. CN 1 stated, she did not feel competent in her role as a circulator in the operating room. CN 1 stated, she did not recall any specific competencies or checklist of job functions that had been reviewed with her during her orientation. CN 1 stated, the prior circulating nurse (CN) 2 trained her, but that nurse quit soon after she (CN 1) started in the operating room.

During an interview on 5/18/22, at 11:10 AM, with Human Resource Manager (HRM), HRM stated, CN 1's start date was 3/23/22, and CN 2's last day of work was 4/7/22. HRM stated, CN 1 should be with a preceptor (instructor) until CN 1 felt competent in her role as a circulating registered nurse.

During a review of Patient 1's "Intraoperative Flow Record," dated 4/11/22, the "Intraoperative [during the operation] Flow Record" indicated, "Circulator - [CN 1]."
During a review of Patient 3's "Intraoperative Flow Record," dated 4/11/22, the "Intraoperative Flow Record" indicated, "Circulator - [CN 1]."
During a review of Patient 5's "Intraoperative Flow Record," dated 4/11/22, the "Intraoperative Flow Record" indicated, "Circulator - [CN 1]."
During a review of Patient 20's "Intraoperative Flow Record," dated 4/11/22, the "Intraoperative Flow Record" indicated, "Circulator - [CN 1]."

During a concurrent interview and record review on 5/19/22, at 11:08 AM, with ICNO and Quality/Risk Manager (QRM), CN 1's competencies, dated 4/25/22 were reviewed. QRM stated, she thought Circulator 2 worked until the end of April. ICNO stated, she reviewed CN 1's competencies verbally in one day, (4/25/22). ICNO stated, "Under normal circumstances, each day we would teach, show, and assess the competencies during training with a preceptor."

During a concurrent interview and record review, on 5/19/22, at 11:08 AM, with ICNO, Patient 1, Patient 3, Patient 5, and Patient 20's "Intraoperative Flow Record," dated 4/11/22 were reviewed. ICNO stated, "I thought, [CN 2] trained [CN 1] by this time "4/11/22]." ICNO stated, "I am in error that I did not check to see if [CN 1] was competent prior to her performing her job functions independently.


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During a concurrent interview and record review on 5/18/22, at 8:51 AM, with HRM, ICNO personnel file was reviewed. ICNO's Personnel File indicated the following:
Education: Associate Degree of Nursing
Supervisory/Leadership Training: None
PeriOperative (before, during and after surgical period) Services Competency completed 10/31/19;
Performance Evaluation; last completed 4/19.

HRM was unable to provide written documentation of current PeriOperative Services competencies. HRM stated, the PeriOperative Services competencies, dated 4/18 and 4/19 were not signed by an evaluator. HRM stated, ICNO should have current competencies in her file, and the competencies should be verified by an evaluator. HRM stated, "The hospital does not have an education department. The managers were responsible for providing staff education and ensuring competencies were completed." HRM stated, "For Performance Evaluations, I email the managers/supervisors to inform and remind them of the employees who will require performance evaluations to be completed. Performance evaluations are to be done annually. HRM stated, ICNO personnel file was not up-to-date."

During a review of the facility's policy and procedure (P&P) titled, "Assessment of Competency" dated, 10/21, the P&P indicated, "It is the responsibility of the Hospital to assure the competence of each staff member, student, volunteer and job trainee. It is the supervisors' and department managers' responsibility to follow the guidelines set forth by the policy."

During a review of the facility's policy and procedure (P&P) titled, "Delivery of Care Methodology, " dated 7/24/19, the P&P indicated, "2 A. Functions of the Circulating Nurse: The Circulating Nurse plays a role that is vital to the smooth flow of the events before, during, and after the operation. . .The surgeon is in charge at the operating table, but he or she relies upon the circulating nurse to take care of the activities in the room outside the sterile field and to manage the nursing care for each patient. . .The Circulating Nurse must always be a Registered Nurse. . ."

During a review of the facility's policy and procedure (P&P) titled,"Evaluation Period," dated 7/24/19, the P&P indicated, "Employee Annual Performance Evaluation: The annual performance evaluation for each employee shall be performed by the department manager and maintained in the employee personnel record. . .Periodic appraisals required: All performance appraisals must be documented on the appropriate Employee Performance Appraisal Form and shall be submitted annually on review date or employment date. . ."

Based on observation, interview and record review, the hospital failed to:

1. Ensure staff accurately completed the Pre-Operative/Surgical check list (check list, designed to improve the safety of surgical procedures) for five of 30 sampled patients (Patient 6, Patient 4, Patient 9, Patient 10, and Patient 11) before outpatient surgical procedures. This failure had the potential of an unanticipated (wrong procedure, wrong patient, wrong site) surgery on the patient.

2. Ensure staff obtained physician orders for surgical consents for four of 30 sampled surgical patients (Patient 6, Patient 26, Patient 27, and Patient 29). This failure had the potential for staff to consent the patient for a wrong procedure.

3. Develop and implement a policy and procedure (P&P) for temperature and humidity monitoring in the surgical critical areas. This failure had the potential to result in decreased shelf life and product integrity of surgical supplies, equipment malfunction, and increased risk for fire in the surgical areas.

4. Develop and implement a policy and procedure (P&P) for calling a code blue (life saving emergency procedure) in the operating room (OR). This failure had the potential to result in a delay of life saving procedures to patients during an emergency when staff was unaware of how to call for assistance.

5. Ensure Pre (before) and Post (after) OP (operative) Progress Record completed for two of 30 sampled surgical patients (Patient 15 and Patient 5). This failure resulted in incomplete patient information and had the potential to affect patients' continuity of care.

Findings:

1. During an observation, on 5/16/22, at 1:55 PM, in the pre-op holding area, Patient 6 was being prepared for her surgical procedure.

During an interview and record review, on 5/16/22, at 2 PM , with Registered Nurse (RN) 2, in the pre-op holding area, Patients 6's medical record was reviewed. RN 2 stated, Patient 6's medical record did not contain a completed pre-operative check list. RN 2 stated, the hospital did not use pre-operative check lists outpatient surgical patients.

During a concurrent interview and record review on 5/18/22, at 10:20 AM, with Quality/Risk Manager (QRM), Patient 4, Patient 9, Patient 10, and Patient 11's medical records were reviewed. QRM stated, none of these patients (Patient 4, Patient 9, Patient 10, and Patient 11) had a pre-operative check list in their medical record as these were all outpatient surgeries.

During a review of the facility's policy and procedure (P&P) titled, "Peri-Operative [before, during and after surgery] Nursing Record," dated 7/24/19, the P&P indicated, "d. Pre-Operative check list 1. All lines are to be filled in or N/A written in the appropriate areas and signed by the pre-operative nurse as well as the circulating nurse."

During a review of the facility's P&P titled, "Operative Nursing Assessment", dated 7/24/19, the P&P indicated Purpose: To ensure a process is in place to assure the safety of the patient as the patient is processed from preoperative area to the operating room table ...The circulating nurse will ...a. Check identification band ...b. Check allergies ...c. Ask patient procedure site and side d. Assures that the anesthesiologist has spoken to the patient and anesthesia consent has been signed e. Review the patient's chart for correct procedure, correct side, correct site, appropriate surgeon; consent signed and witnessed ..."

2 a. During an observation, on 5/16/22, at 2:03 PM, in the pre-op holding area, Patient 6 was waiting to be taken to the operating room.

During a review of Patient 6's "Consent for Surgery and Procedure" (CSP), dated 5/16/22, the CSP indicated, "Removal of staples, stitches to groin, Perineum (area between buttocks and genitals) buttocks, under the R (right) breast Laparoscopic (minimally invasive surgical procedure) sigmoid colostomy (piece of colon is diverted to opening in the abdominal wall) creation possible open."

During an interview and record review, on 5/16/22, at 2:07 PM, with Interim Chief Nursing Officer (ICNO), Patient 6's "Pre-Surgical Orders," dated 5/16/22, at 1:15 PM were reviewed. ICNO was unable to provide written documentation of a physician order for Patient 6's procedure. ICNO stated "we cannot take her (Patient 6) back (to operating room) until we put in an order (for the surgical procedure)." ICNO stated, "there is a failure in the process."

2 b. During a record review, on 5/19/22, at 3:20 PM, with Physician Scribe (PS), Patient 26's Consent for Surgery/Procedure, dated 3/8/22, at 9:08 PM was reviewed. The Consent for Surgery/Procedure indicated, Patient 26 signed the "Ash Catheter Placement [implanted device which allows access to patient's veins]" consent. PS was unable to written documentation of physician's order for Patient 26's procedure.

2 c. During a record review on 5/19/22, at 4:07 PM, with PS, Patient 27's Consent for Surgery/Procedure, dated 3/14/22, was reviewed. The Consent for Surgery/Procedure indicated, Patient 27 signed the "Insertion of Permanent Ash Catheter for Dialysis [mechanical removal of waste and excess fluid]," at 1:05 PM. The Physician's Order, dated 3/6/22, indicated, "Consult the surgeon (MD 3) for Ash Cath Placement." PS was unable to written documentation of physician's order for Patient 27's procedure.

2 d. During a record review, on 5/19/22, at 4:30 PM, with PS, Patient 29's "Consent for Surgery/Procedure," dated 12/6/21, indicated, Patient 29 signed the "EGD - Esophagogastroduodenoscopy (a procedure that examines upper digestive tract)" consent. PS was unable to written documentation of physician's order for Patient 29's procedure.

3. During an interview on 5/11/22, at 9:25 AM, with Medical Director/President Board, Medical Director/President Board stated, there were issues with the humidity in the operating rooms, the hospital was old, and canceling surgery was ideal.

During a concurrent interview and record review, on 5/11/22, at 10:50 AM, with Surgery Coordinator (SC), Temperature and humidity log for 5/22 was reviewed. The log indicated, Clean work area: Temp 68-73 degrees Humidity 30-60%. The log indicated, on:
5/1/22 no readings (Surgical Services closed)
5/2/22 Clean Work Area Temperature 68 Humidity 28% "Plant opps (operations) called."
5/3/22 Clean Work Area Temperature 68 Humidity 29% "Plant opps (operations) called."
5/4/22 Clean Work Area Temperature 68 Humidity 27% "Plant opps (operations) called."
5/5/22 Clean Work Area Temperature 69 Humidity 26% "Plant opps (operations) called."
5/6/22 Clean Work Area Humidity 30%
5/7/22 no readings (Surgical Services closed)
5/8/22 no readings (Surgical Services closed)
5/9/22 Clean Work Area Temperature 65 Humidity 26% "Plant opps (operations) called."
5/10/22 Clean Work Area Temperature 63 Humidity 26% "Plant opps (operations) called."
5/11/22 Clean Work Area Temperature 61 Humidity 27% "Plant opps (operations) called."
5/12/22 Clean Work Area Temperature 64 Humidity 25% "Plant opps (operations) called."
SC stated, the action taken was to call plant operations when temperature of humidity were out of range. SC stated, there were no indications of any corrective action by plant operations, or if the action taken resulted in corrective result.

During a review of the facility policy and procedure (P&P) titled, "Temperature and Pressure Monitoring in Operating Room/Critical Areas," dated 3/10/22, the P&P indicated, "It is the policy of Good Samaritan Hospital to monitor and maintain pressure relationships in the Surgical Suites and designated high-risk areas defined by Infection Prevention and Control...C. Thermostat for Operating Room will be locked/controlled, so that no one other than authorized personnel can adjust it. D. In the event of a change in pressure, Plant Operations will be notified. Infection Prevention Coordinator or designees will conduct an investigation to eliminate the root cause, and document corrective actions taken."

4. During a concurrent observation and interview, at 10:32 AM, with SC in OR 1, a white telephone was noted on the wall. SC stated, staff used the white telephone to call for emergencies such as a code blue. SC picked up the telephone and stated, I don't know (the telephone number to call), I thought we all knew how the telephone number for code blue, I'll need to get the number. "I guess we would step out [of the room] and yell out."

During a concurrent observation and interview on 5/12/2022, at 10:34 AM, with Surgical Technician (ST 1) and SC in OR 2. No telephone to call a code blue was noted in OR 2. ST 1 stated, "I don't know how to call a code from the telephone." SC stated, OR 2 did not have a telephone available for staff to call for assistance during a code blue.

During an interview on 5/19/2022, at 9:56 AM, with ICNO, ICNO stated, "If you didn't have a telephone, we would send a runner, it would depend on who is in the room. I would step out a yell out into the hall." The facility policy and procedure was requested, none was provided.

5. During a concurrent interview and record review, on 5/19/22, at 10:34 AM, with QRM, Patient 15's "Pre and Post OP (operative) Progress Record" dated 4/1/22, was reviewed, the top pre-op section and bottom post-op section were incomplete. QRM stated, the OP progress record was not complete.

During a concurrent interview and record review on 5/19/22, at 4:10 PM, with SC, Patient 5's "Pre and Post OP (operative) Progress Record," dated 3/23/22, was reviewed. The Pre and Post Operative Progress Record indicated, "Immediate Post-Op Notes to include, Pre-Op Diagnosis, Post-Op Diagnosis, Procedure, Anesthesiologist [doctors who specialize in giving patients anesthesia, medicine that controls pain and may put you to sleep during surgery, and monitoring people while they are still under the effects of these drugs after surgery], Surgeon, Estimated Blood Loss, Specimen removed/disposition, Complications, and Anesthesia [pain medications] Type. Patient 5's "Pre and Post OP Progress Record" did not indicate a physician signature, date, and time. SC stated, "The top of the form is completed before and the bottom half should be completed after the procedure, this [OP Progress Report] is incomplete."

During a review of the facility's policy and procedure (P&P) titled "Operating Room Guidelines: date 7/24/19, the P&P indicated, "PREOPERATIVE DIAGNOSIS, The preoperative diagnosis must be placed on the patient's chart, written or co-signed by the attending physician. POSTOPERATIVE ORDERS, immediately after the operative procedure, the attending surgeon or resident must place a brief descriptive note of the operation in the hospital chart, including at least the name of the surgeon, the type of anesthesia used, name of the operation performed, essential operative findings, descriptive of drains, and immediate postoperative condition of the patient and scanned into the patients electronic medical record (EMR)."

Based on interview and record review the hospital failed to:

1. Develop and implement policies and procedures to obtain Informed Consents for two of two incapacitated sampled patients (Patient 13 and Patient 14). This failure had the potential of Patient 13 and Patient 14's wishes for care not to be honored.

2. Follow hospital policies and procedures on "Informed Consents, Obtaining and Documenting," for seven of ten sampled patients (Patient 22, Patient 24, Patient 26, Patient 27, Patient 28, Patient 29, and Patient 30). This failure had the potential patient/responsible party were not aware of the surgical procedure, risk and benefits or alternative therapy.

Findings:

1 a. During a review of Patient 14's "General Surgery Consultation," dated 4/19/22, the General Surgery Consultation indicated, "This is a 77-year-old male from a nursing home with advanced dementia (disorder of the mental processes caused by brain disease) and multiple stage IV [severe - exposed muscle and bone] sacral (bottom of spine) decubitus ulcers (bed sores), who was brought in from the facility for workup for fecal diversion (creation of opening between surface of the skin and small intestines). [Patient 14] was previously seen in the hospital for this similar issue. However, we had difficulties obtaining consent. Ethics committee did agree to our recommendation to proceed with fecal diversion. [Patient 14] is a poor historian and nonverbal at baseline, and history is obtained from the medical records."

During an interview and record review, on 5/17/22, at 3:40 PM, with Physician Assistant (PA), Resident 14's Ethics Committee Meeting notes, undated, was reviewed. The Notes indicated, "On 4/5/22 at 2:20 PM a meeting was called about patient [Patient 14] ... After antibiotic therapy he will return to hospital for diverting colostomy (fecal diversion) for patient comfort and wound healing of multiple wounds, as patient is contorted. The following personnel were in attendance: [PA], [Pharmacy Director], [Interim Chief Nursing Officer], [Health Information Manager/ Utilization Review]." Resident 14's Ethics Committee Meeting notes did not indicate any discussion of other alternative treatment. PA stated, "There were only a few of us present, not a formal ethics meeting regarding Patient 14." PA stated, ethics committees should have an established group of individuals such as two physician providers, clergy, case managers, and administration when making decisions for patients.

1 b. During a review of Patients 13's "Consent for Surgery/Procedure" (Consent), dated 2/22/22, at 4 PM, the Consent indicated, operation or procedure to be performed "Debridement [removal of dead or infected tissue to aid in wound healing] of multiple decub [decubitus] of buttock, coccyx [tailbone]." The consent was signed by the Chief of Staff , and Physician Assistant [PA])."

During a review of Patient 13's "Consent for Surgery/Procedure", dated 2/22/22, [untimed], the Consent for Surgery/Procedure indicated, operation or procedure to be performed "PEG (percutaneous endoscopic gastrostomy -feeding tube inserted through the skin and the stomach wall) tube placement." The consent had one unwitnessed signature.

During a review of Patient 13's Ethic Committee Meeting notes, dated 2/24/22, Patient 13's Ethic Committee Meeting Notes indicated, the plan was to place a PEG tube for nutrition and return Patient 13 to previous skilled nursing facility. Patient 13 "will receive selective treatment as described on POLST [physician orders for life sustaining treatment] form (nutrition, hydration, pain management, treating complicating illnesses and conditions). Resident 13's Ethics Committee Meeting notes did not indicate any discussion of other alternative treatment.

During a review of Patient 13's Patient "Addendum of Ethics Committee Meeting Minutes" (Addendum), dated 5/6/22, the Addendum indicated, "I affirm I was present and discussed patient [Patient 13] on 2/24/22 regarding both peg tube placements and debridement of decubitus ulcer (bedsore) of the buttocks, coccyx's (tailbone) and that the original documentation from the ethics committee omitted some documentation due to a clerical error. I affirm that the ethics committee discussed both the peg tube (percutaneous endoscopic gastrostomy -feeding tube insertion through the skin and the stomach wall) placement and debridement of sacral (lower spine) decubitus ulcer and that the benefits of surgery outweighed the risk."

During an interview on 5/17/22, at 3:30 PM, with Quality/Risk Manager (QRM), QRM stated, she was unable to find ethics committee policies and procedures or committee meeting minutes. QRM stated, the hospital was revising the ethics committee process for obtaining informed surgical consents. QRM was unable to provide ethics committee policies and procedures in effect for February 2022.

During an interview on 5/19/22, at 3:34 PM, with QRM, QRM stated, the hospital did not have a structured process for obtaining surgical consent from incapacitated patients.

During an interview on 5/20/22, at 11:18 PM with Chief Of Staff, Chief Of Staff stated, two physician providers should be present when making medical decision for patients.

During a review of the facility policy and procedure (P&P) titled, "Ethics Committee," dated 5/15/22, the P&P indicated, "The Ethics Committee will also serve to evaluate healthcare decisions on behalf of patients that are unable to weigh [decide risk and benefit] decisions for themselves ...Attendees should include a wide range of individuals from multiple disciplines in order to provide a wide variety of opinions. Attendance should include, but is not limited to: CNO [Chief Nursing Officer], CAO [Chief Administrative Officer], Chaplin [spiritual advisor], Pharmacy Director, MedSurg [medical surgical unit] PA [physician Assistant], Applicable physician, D/C [discharge] planner / Social Worker, Any additional person(s) with special expertise or interest in the presenting problem (Family or friends. In cases involving care options for a singular patient all efforts will be made to find the most appropriate decision making body on the patients behalf, such as; Power of attorney, Conservators, Guardians, Advance Directives [written document of patient's wishes for care], Do Not Resuscitate orders, Family, or Friends."

During a review of the facility's policy and procedure (P&P) titled, "Informed Consent, Obtaining & Documenting," dated 7/24/19, the P&P indicated, "1. General Rule-Consent to Treatment: The hospital shall not permit any treatment unless the patient or person legally authorized to act on the patient's behalf, has consented to the treatment. . .e. The physician and hospital staff do not sign a consent form on behalf of the patient. Unless an ethics committee meeting has been held and 2 providers, 2 clinical staff, 2 non-clinical staff have determined the procedure or surgery to be essential for quality of life/or life saving for the patient"



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2 a. During a concurrent interview and record review on 5/11/22, at 3:30 PM, with Interim Chief Nursing Officer (ICNO), Patient 24's History and Physical (H&P), dated 4/26/22, was reviewed. The H&P indicated, "Patient 24 was a 53-year old female, from a local nursing home, admitted for management of malfunctioning dialysis [mechanical filtration of body waste and excess fluids] catheter [tube inserted into vein for dialysis].

During a concurrent interview and record review, on 5/11/22, at 3:40 PM, with ICNO, Patient 24's "Consent for Surgery/Procedure," dated 4/27/22 and Surgical Procedure Note, dated 4/27/22 were reviewed. The Consent for Surgery/Procedure indicated, "Ash Catheter (implanted device for long term vein access) Placement. Patient 24's Surgical Procedure Note, indicated, "Insertion of right subclavian [collar bone] central venous [vein] catheter for dialysis (permacath [tube inserted into vein for dialysis]) and Removal of left internal jugular [neck] vein tunneled central venous catheter (permacath)." ICNO stated, the consent obtained was not exactly the same as the surgical procedure performed. ICNO stated, the doctor should order the procedure correctly and the consent should indicate "Insertion of a tunneled dialysis catheter and removal of a tunneled dialysis catheter." ICNO was unable to provide documentation the surgeon (MD) 3 wrote a pre-operative order to consent the patient for the procedure. ICNO stated, the admitting physician wrote the order to obtain consent for ash catheter placement.

During a concurrent interview and record review on 5/12/22, at 8:49 AM, with ICNO, Patient 24's "Consent for Administration of Anesthesia," dated 4/27/22, and the Consent for Surgery/Procedure, dated 4/27/22, was reviewed. ICNO stated, the signature of the patient on the consent for anesthesia was not the same patient signature on the consent for surgery/procedure. The initials on the consent, dated 4/26/22, were not of the patient. ICNO stated, 'It is reprehensible! It's falsification!" ICNO described the patient signature to be unsteady, wobbly, and written with shaky hands. ICNO recognized Patient 24 was unable to connect her letters to complete her last name. The altered signature was written clearly and the spelling of the patient's last name was wrong.

During a concurrent interview and record review. on 5/12/22, at 9:17 AM, with Circulator Nurse (CN) 1, Patient 24's Consent for Surgery/Procedure, dated 4/27/22 and Consent for Administration of Anesthesia, dated 4/26/22, were reviewed. CN 1 stated, "I am certain [Patient 24] did not sign the consent on anesthesia form."

2 b. During a record review on 5/19/22, at 10:05 AM, with Physician Scribe (PS), Patient 22's "Consultation Notes, dated 2/6/22, was reviewed. The Consultation Notes indicated, "Patient 22 has dementia and a poor historian. [Patient 22] has a stepdaughter, who has the power of attorney (POA). The patient has infection on the left foot. The power of attorney agreed to proceed with surgical management of the left foot."

During a concurrent interview and record review, on 5/19/22, at 10:10 AM, with PS, Patient 22's "Consent for Surgery/Procedure," was reviewed. The consent for surgery/procedure indicated, "Incision & drainage of soft tissue and bone irrigation & debridement with application of tissue graft to left foot. The signature line on the consent form was blank. It was not signed by the person with the power of attorney, but witnessed by two people. The consent form was not dated, and timed. PS stated, the consent was not signed by the POA, but was witnessed by two people.

During a concurrent interview and record review on 5/19/22, at 10:12 AM with PS, Patient 22's Consent for Anesthesia was reviewed. The Consent for Anesthesia indicated, patient signature line was blank. PS stated, the consent was not signed.

During a concurrent interview and record review, on 5/19/22, at 10:15 AM, with PS, Patient 22's Consents for Conditions of Admission, Blood Transfusion Administration, and Acknowledgement of Notice of Privacy were reviewed. The consents all indicated, under the patient signature line, the statement, "Emergency Contact gave consent to sign." PS stated, she was certain that was not how the consent forms should be signed.

During an interview on 5/20/22, at 11:15 AM, with Admissions Clerk (AC), and QRM, AC stated, she was not aware she had to put the person's name who consented and who had the power of attorney on the signature line.

2 c. During a concurrent interview and record review, on 5/19/22, at 3:20 PM, with PS, Patient 26's Consent for Surgery/Procedure, dated 3/8/22, at 9:08 PM, and Patient 26's Consent for Administration of Anesthesia, dated 3/9/22, at 1:20 PM, were reviewed. The consent for surgery/procedure indicated, Patient 26 signed the consent for "Ash Catheter Placement." PS stated, the signatures are not the same, someone signed the Consent for Anesthesia for the patient."

During a concurrent interview and record review on 5/19/22, at 3:40 PM, with PS, Patient 26's Operative Report, dated 3/9/22, indicated, "Insertion of tunnel central venous catheter through the right internal jugular vein. PS stated, the consent for surgery/procedure signed by the patient was not the same verbiage as the procedure performed by the surgeon. PS was unable to provide written documentation of a physician order to consent Patient 26 for the procedure.

2 d. During a record review on 5/19/22, at 4:07 PM, with PS, Patient 27's Consent for Surgery/Procedure, dated 3/14/22, was reviewed. The Consent for Surgery/Procedure indicated, Patient 27 signed the consent for "Insertion of Permanent Ash Catheter for Dialysis," PS was unable to provide documentation of a physician's order to obtain consent for insertion of permanent ash catheter.

During a review of the Physician's Order, dated 3/6/22, indicated, "Consult the surgeon (MD) 3 for Ash Cath Placement."

During a concurrent interview and record review, on 5/19/22, at 4:10 PM, with PS, Patient 27's "Procedure Note," dated 3/9/22, was reviewed. The Procedure Note indicated, "Procedure Performed: Insertion of tunnel central venous catheter for dialysis." PS stated the surgeon's procedure note did not match the verbiage on the Consent for Surgery/Procedure as there was no order to consent the patient for the procedure. PS was unable to provide written documentation of a physician order to consent Patient 27 for the procedure.

2 e. During a concurrent interview and record review, on 5/19/22, at 4:23 PM, with PS, Patient 28's Consent for Surgery/Procedure, dated 3/20/22, at 10:46 AM, and Consent for Surgery/Procedure, dated 3/21/22, at 12:45 PM was reviewed. The Consent for Surgery/Procedure, dated 3/20/22, at 10:46 AM indicated, Patient 28 signed the consent for "Permacath Insertion." The second Consent for Surgery/Procedure, dated 3/21/22, at 12:45 PM indicated, "Hemodialysis Catheter" 'Patient is legally blind. Verbal Consent." PS stated, the consent form was not identified with the patient's name. PS stated, Patient 28 could sign for herself. The Consent for Administration of Anesthesia was not signed by the patient. On the side was written "Patient legally blind. Verbal Consent," and was witnessed by two individuals.

During a concurrent interview and record review, on 5/19/22, at 4:30 PM, with PS, Patient 28's "Physician's Order," dated 3/20/22 was written by the surgeon (MD 3). The Physician's Order indicated "Obtain consent permacath insertion." The Procedure Note, dated 3/21/22, indicated, "Insertion of right internal jugular vein tunneled central venous catheter." PS stated, the consent was not the same verbiage as the procedure performed.

2 f. During a record review, on 5/19/22, at 4:30 PM, with PS, Patient 29's "Consent for Surgery/Procedure," dated 12/6/21, indicated, Patient 29 signed the consent for "EGD - Esophagogastroduodenoscopy (examination of the upper digestive tract)." PS was unable to provide written documentation of a physician order to consent Patient 29 for the procedure.

2 g. During a concurrent interview and record review, on 5/19/22, at 4:40 PM, with PS, Patient 30's "Consent for Surgery/Procedure," dated 4/27/22, at 1 PM, and Patient 30's Consent for Surgery/Procedure, dated 4/27/22, at 4 PM, were reviewed. The Consent, dated 4/27/22, at 1 PM, indicated, "Exploratory Laparotomy [minimally invasive surgery], possible bowel resection [removal of a part of the intestines]." The Consent indicated, in handwriting "Patient is unable to consent, needs emergent surgery. The Medical Director/President of the Board (MDPB) and co-signed by the Physician Assistant (PA) both signed the Consent for Surgery, dated 4.27.11 at 1 PM.
The Consent for Surgery/Procedure, dated 4/27/22, at 4 PM, indicated Patient 30 signed the second consent for "Exploratory Laparotomy [surgery to open up the belly area], possible Bowel Resection [surgery to remove a part of one's intestines] with Hernia Repair (surgical procedure to return part of the intestines to its original position)."

During a review of Patient 30's History and Physical (H&P) dated 12:45 PM, the H&P indicated, "Physical Exam: General: Alert. . .Neuro/Psych [neurological psychology focus on how brain injuries or illnesses affect thinking and behavior: Alert and oriented x 3. CN [cranial nerves] 2-12 intact no sign of agitation or depression. Patient 30's Progress Notes were reviewed. Neither Patient 30's H&P nor Patient 30's progress notes indicated, Patient 30 was unable to consent.

During a concurrent interview and record review, on 5/19/22, at 5 PM, with PS, Patient 30's "Operative Report," dated 4/27/22, was reviewed. The Operative Report indicated, exploratory laparotomy, lysis of adhesions (surgery to cut bands of tissue that form between organs) from previous abdominal surgeries, and repair of incarcerated (trapped) ventral (abdominal) hernia. PS stated, the surgical consent obtained from Patient 30 was not the same as the procedure performed.

During a review of the facility's policy and procedure (P&P) titled, "Informed Consent, Obtaining & Documenting," dated 7/24/19, the P&P indicated, "1. General Rule-Consent to Treatment: The hospital shall not permit any treatment unless the patient or person legally authorized to act on the patient's behalf, has consented to the treatment. . .3. Exception for Emergency Treatment: d. The medical determination that an emergency exists shall be determined and documented by the physician in the patient's medical record. If the physician has obtained a consultation, the consulting physician shall also document his/her opinion in the patient's medical record. e. The physician and hospital staff do not sign a consent form on behalf of the patient. Unless an ethics committee meeting has been held and 2 providers, 2 clinical staff, 2 non-clinical staff have determined the procedure or surgery to be essential for quality of life/or life saving for the patient. . .Methods of Obtaining Informed Consent: Signature will be required of the patient or patient's legal representative. . .5. Prior to surgery or medical complex procedure, the physician responsible for administering anesthesia, or the surgeon if a general anesthetic is not to be administered, shall ascertain that a written informed consent appears in the medical record. . . The time and date on the form will reflect the time and date the form is signed by the patient or the patient's representative, not the time and date of the operation or procedure."