HospitalInspections.org

Based on record review, interview, policy review, and medical staff by-laws review, the provider failed to ensure applicable policies, bylaws, rules, and regulations were followed to:
*Prevent a visitor from taking a photograph with a personal cell phone during a scheduled surgical procedure for one of one sampled patient (5).
*Ensure staff documented, conducted a comprehensive investigation, and follow-up for a reportable incident for one of one sampled patient (5) who had a photograph taken with a personal cell phone during a scheduled surgical procedure.
Findings include:

1. Review and interview on 9/21/15 at 11:05 a.m. with health information registered nurse I of patient 5's complete medical record revealed:
*The patient had been admitted on 8/11/15 for a surgical procedure.
*There was a visitor allowed to observe during the surgical procedure.
*There was no patient signed consent form located in the patient's complete medical record for permission to photograph.

Interview on 9/22/15 at 7:20 a.m. with surgeon A regarding the surgical procedure for patient 5 performed on 8/11/15 revealed:
*The hospital was a teaching institution.
*Visitors were allowed to observe surgical procedures in the operating room (OR) such as physical therapy students, nursing students, and pre-med (medical) students.
*Visitors would contact surgeons scheduled to perform surgical procedures and request permission to observe procedures they had an interest in.
*Visitors spoke with the administrative staff of the hospital to receive final approval to observe surgical procedures.
*The consent was part of obtaining the approval for a visitor in the OR.
*The surgeon:
-Would know ahead of time who would have been visiting and observing a surgical procedure in the OR.
*Would have to approve any visitor who was not there for training purposes.
-Would not have taken photographs during surgical procedures unless the photograph would have been used in an educational presentation.
*The photograph could not have any identifying marks that would have made it easy to identify that patient.
*There had been a visitor request to observe patient 5's total knee surgery. During the procedure the visitor used his personal cell phone to take a picture of the implant in the patient's knee.
*He was unaware of the process needed to obtain consent for the photographing of the patient.
*He felt there would have been no way to identify the patient in the photograph taken on 8/11/15 by the visitor in the OR.

Interview on 9/22/15 at 7:50 a.m. with circulating OR registered nurse (B) regarding patient 5's surgical procedure on 8/11/15 revealed:
*All visitors that would be observing during a surgical procedure would go through the hospital's education office.
*He knew when there was going to be a visitor in the OR.
*The visitor had come into the OR where the surgical procedure was going to be performed.
*During the surgical procedure the visitor took a personal cell phone out and had taken a picture of patient 5's surgical site where an implant was being inserted.
*After the photograph had been taken he had instructed the visitor that he could not take a picture. Surgeon A stated that it was "okay" for the visitor to have taken the picture.
*It was his understanding that no pictures were to have been taken with a personal cell phone by any one including staff.
*After the incident he called his immediate supervisor and told him what had taken place.
*There was a process in place to take pictures if there was a consent form signed by the patient. Photographs were not to have been taken for personal use.

Interview on 9/22/15 at 8:40 a.m. with director of surgical services E regarding the photograph taken of patient 5 on 8/11/15 during a surgical procedure revealed:
*Visitors in the OR have no privileges to take pictures during a surgical procedure.
*He had received a call from the OR staff regarding the photograph taken on 8/11/15.
*Administrative staff were going to speak with the visitor about the photograph that had been taken.
*Surgeon A should have spoken with the visitor to find out what was on the photograph.
*The administrative staff were vice president of surgical and digestive health D and vice president of orthopedics F.
*Photographs were taken but for educational purposes only.
*The surgeon had to approve the visitor who would have been observing in the OR.
*He was unsure as to what had happened to the photograph of patient 5's knee.
*The education team would have been involved in educating the visitor as to what could and could not have been done in the OR during the surgical procedure.
*Photographs should not have been taken by the visitor.
*If a visitor would have asked the staff about taking a photograph during a surgical procedure the OR staff would have said "no."
*He was unsure if the picture of patient 5 had been deleted or not.
*His assumption of the incident was surgeon A had taken care of speaking with the visitor about the photograph taken on 8/11/15.

Interview on 9/22/15 at 9:02 a.m. with clinical manager of the patient center C regarding the preoperative (pre-op) care of patients revealed:
*The staff in pre-op area would verify if an informed consent was explained to the patient by the physician.
*If photographs were to have been taken and the staff had known ahead of time: the consent would have been signed by the patient, and it would have been obtained by the pre-op staff.
*If photographs were to have been taken it usually was if the patient had a pressure ulcer. There were dedicated cameras for taking those pictures.
*No cell phone photographs were allowed.

Interview on 9/22/15 at 9:10 a.m. with vice president of surgical and digestive health D regarding the incident with patient 5 on 8/11/15 revealed:
*The director of surgical services E would have a conversation with the visitor who had taken the photograph of patient 5.
*Director of surgical services E had called her per telephone on 8/11/15 regarding the photograph taken during the surgical procedure.
*There had been no formal paperwork completed after she had become aware of the incident, because she had been notified verbally of the incident.
*They decided surgeon A would talk to the visitor who had taken the photograph of patient 5.
*She stated surgeon A had validated the picture taken during the surgical procedure to make sure there were no identifying marks regarding patient 5.
*Cell phones were not used for photographing patients.
*Prior to the procedure the visitor had met with the OR educators, and the OR process was explained.
*Cell phone photographs were not permitted by the staff or visitors.
*Photographs were only taken for educational purposes.

Interview on 9/22/15 at 9:25 a.m. with vice president of orthopaedics F in regards to the incident with patient 5 on 8/11/15 revealed:
*He had received a phone call from vice president of surgical and digestive health D in regards to the above incident.
*He had called surgeon A regarding the photograph taken in the OR by the visitor.
*The visitor wanted to take a photograph of the surgical knee implant, because the visitor had a similar surgery completed.
*He stated surgeon A told him he had seen the photograph, and there were no identifying marks that would have identified the patient in the photograph.
He stated surgeon A had personally reviewed the photograph taken by the visitor.
*He was unaware what the picture contained.
*It would have been very uncommon for a visitor to have taken a photograph with a personal cell phone.
*The only reason the visitor was in the OR that particular day was to observe a total knee, because the visitor had the same surgery.
*No administrative staff would have accompanied non-medical, non-professional staff into the OR.
*There had been no formal paper work completed that he had been aware of that documented incident on 8/11/15.

Interview on 9/22/15 at 9:45 a.m. with enterprise executive director of patient access G regarding patient rights revealed:
*The patient would receive the Patient Rights and Responsibilities information upon admission.
*All patients would receive the Patient Rights and Responsibilities information.
*They would not be responsible for any other consents that would have been required during the patient's hospital admission.

Interview on 9/22/15 at 10:00 a.m. with surgeon A regarding patient 5's photograph taken during a surgical procedure revealed:
*It was an educational photograph involving the patient's knee with the implant.
*His focus was not on the visitor taking the photograph but on the surgery he had been performing on patient 5.
*He had not viewed the photograph taken by the visitor.
*He had not asked the visitor to delete the photograph.
*There was no way to identify the patient from the photograph taken by the visitor.
*He had been caught by surprise with the visitor taking a photograph with a personal cell phone.

Interview on 9/22/15 at 10:20 a.m. with director of surgical services E regarding escorts of visitors to the OR revealed:
*The clinical coordinators would perform teaching on OR policy with individuals prior to them observing a procedure.
*RN I was with the visitor on 8/11/15 at the beginning of the surgical procedure of patient 5.

Interview on 9/22/15 at 10:30 a.m. with education and training RN H regarding OR visitors revealed:
*The visitor has to obtain approval from the hospital.
*Her job was to explain the sterile field, where the visitor could touch, and what the visitor could not touch.
*On the 8/11/15 incident she had educated the visitor and had gone over the waiver and agreement that had been signed by the visitor.
*She had not checked to see if the visitor had brought a cell phone into the OR.

Review of the provider's September 2014 Patient Right and Responsibilities revealed: "You have the right to privacy. Privacy is an important part of your care. You have the right to: Privacy and security with your personal, written, telephone and electronic communication while a patient."

Review of the provider's undated Student/Individual Observation Experience Waiver and Agreement revealed: "[Name of the facility] may take immediate corrective action in any situation in which my behavior and/or performance adversely affect the best interests of the facility or its clients."

Review of the provider's September 2013 Notice of Privacy Practices revealed: "We are required by law to maintain the privacy and security of your health information. We will let you know promptly if a breach occurs that may have compromised the privacy and security of your health information. We will not share your information other than as described here unless you tell us in writing."

Review of the provider's April 2014 Patient Rights and Responsibilities revealed:
*The purpose of the policy was to:
-Assure that certain rights were preserved for all patients.
-Assure that each patient was informed on his/her rights and responsibilities as a patient.
*The right to expect that all communications and other records pertaining to the patient's care be treated as confidential.

Review of the provider's April 2013 Photographs and Videotaping policy revealed:
*The purpose was to provide a means for ensuring confidentiality and to protect staff, patients, and visitors within reasonable limits from invasion of privacy that might occur from the use of photographs during patient care or other health systems activities.
*The use of the term "photograph" in this policy refers to traditional film photographs, digital images, camera cell phones, videotapes, or other images used to capture the image of the patient or procedure.
*No cell phone photographs may be taken during any procedure.
*An authorization would have been obtained from the patient or their representative for any subsequent release of the photograph to parties outside of the hospital accept when used for treatment, payment, or hospital operations.
*A consent will be obtained prior to photographing using the authorization form (name of the form) when photographs do not meet the purposes of medical documentation and the patient was identifiable.
*Photographs of patient conditions, wounds, or injuries etc. might be taken for internal education, process improvement, or continuing patient care.
*The health care professional has the right and responsibility to ensure consent was obtained for non-medical photographs.
*It was the responsibility of all personnel to safeguard patient information in accordance with the HIPAA (Health Insurance Portability and Accountability Act of 1996) Privacy regulations.

Review of the provider's May 2015 Events Reporting of Staff Concerns and Events revealed:
*The purpose of the policy was to:
-Inform the administration and the concerned department directors, CNO (chief nursing officer)/DON (director of nursing) of any unusual staff concerns of events.
-To allow proper analysis of the concerns and events by the appropriate committees (Risk Management and Administration).
-To provide a uniform system of reporting concerns and events.
-To provide a base of information for the proper study of risk management.
*A concern or event was defined as a health system related occurrence not consistent with the desired operation of the facility, the care of the patient, or the intended use of equipment.
*An on-line report would have been filled out by any employee for all concerns and events meeting the definition above.
*Events and concerns would have been reviewed by the department director, CNO/DON or his/her designee immediately as well as Risk Management.
*All departments and facilities would have been responsible for implementing the Event Reporting System within their area.

Review of the provider's July 2015 Code of Conduct-Compliance policy revealed:
*Respect the confidentiality of patients and information about patients, as well as all other confidential (name of the facility) business information.
*Report suspected violations of all applicable laws, regulations, and (name of the facility) policies, including but not limited to the Code of Conduct.
*As part of (name of facility), you were expected to have been honest, act ethically, and demonstrate integrity in all situations. It was further expected that you take responsibility to become familiar with (name of facility) Corporate Compliance Program and the policies and procedures that were specific to the job.
*Common sense and good judgement provide excellent guidelines in almost every situation.
*(name of the facility) was dedicated to patient privacy. Our relationship with (name of facility) patients and customers was a private one. You must protect this personal information and kept it confidential.
*Respecting patient privacy includes protecting what you have seen while at work.
*If you suspect or know that someone has violated the Code of Conduct, (name of the facility) policies, or any applicable laws or regulations, you must report such activity in accordance with the reporting options set forth below:
-"You are encouraged to report suspected misconduct to your direct supervisor.
-You may contact the Corporate Compliance Officer."
*If an investigation revealed a violation of the Code of Conduct or other (name of the facility) policy had occurred, (name of the facility) would take corrective action. Depending on the infraction consequences might include implementing systemic changes or imposing disciplinary action to avoid similar violations in the future.

Review of the provider's August 2015 Medical Staff By-Laws revealed:
*"Whereas, the Board of Directors ("the Board") recognizes that each physician and dentist appointed to the Medical Staff has responsibility for the exercise of professional judgement in the care and treatment of patients.
*The Physician Executive Council is delegated authority over activities related to the functions of the Medical Staff and performance improvement activities regarding the professional services provided by individuals with clinical privileges.
*The Physician Executive Council is responsible for the following:
-Provide for continuous assessment and improvement of the quality of care, treatment, and services provided.
-Development and implementation of policies and procedures that guide and support the provision of services.
-Receiving and acting on reports and recommendations from Medical Staff committees, Clinic and other respective groups as appropriate.
-Performing such other functions as are assigned to it by those Bylaws, the Procedural Policy or other applicable policies.
*Medical Staff involved in the care of patients, evaluation and improvement of the quality of patient care, and/or credentialing activities will have access to very sensitive and confidential information. All such information and any and all discussions and deliberations regarding the same will be maintained in strict confidence.
*Any breach of confidentiality may result in a professional action and/or appropriate legal action.
*All reports, variance/incident reports, recommendations, actions, and minutes made or taken by Peer Review Committees are confidential and covered by the provision of South Dakota law and/or the corresponding provisions of any subsequent federal or state statute providing protection to peer review or related activities.
*Medical Staff Rules and Regulations may be necessary to implement more specifically the general principles of conduct found in these Bylaws. Rules and Regulations shall set standards of practice that are to be required of each individual exercising clinical privileges in the Medical Center, and shall act as an aid to evaluating performance under, and compliance with, these standards. Rules and Regulations shall have the same force and effect as the Bylaws."

Based on record review, interview, and policy review, the provider failed to ensure privacy and confidentiality had been maintained during a surgical procedure for one of one sampled patient (5) when a visitor took a photograph with a personal cell phone for their own personal use. Findings include:

1. Review and interview on 9/21/15 at 11:05 a.m. with health information registered nurse I of patient 5's complete medical record revealed:
*The patient had been admitted on 8/11/15 for a surgical procedure.
*A visitor had observed the surgical procedure.
*There was no patient signed consent form located in the patient's complete medical record for permission to photograph.
-The patient had not signed for permission to photograph during the procedure.

Interview on 9/22/15 at 7:20 a.m. with surgeon A regarding the surgical procedure for patient 5 performed on 8/11/15 revealed:
*The hospital was a teaching institution. There were several visitors allowed to observe surgical procedures in the operating room (OR) such as physical therapy students, nursing students, and pre-med (medical) students.
*Visitors would contact surgeons scheduled to perform surgical procedures and request permission to observe procedures they had an interest in.
*Visitors spoke with the administrative staff of the hospital to receive final approval to observe surgical procedures.
*The surgical consent form signed by the patient provided approval for a visitor in the OR.
*The surgeon:
-Would know ahead of time who would have been visiting and observing a surgical procedure in the OR.
*Would have to approve any visitor who was not there for training purposes.
-Was aware whenever there was a visitor in his OR during a surgical procedure.
-Would not have taken photographs during surgical procedures unless the photograph would have been used in an educational presentation.
*The photograph could not have any identifying marks that would have made it easy to identify that patient.
*There had been a visitor request to observe patient 5's total knee surgery. During the procedure the visitor used his personal cell phone to take a picture of the implant in the patient.
*He was unaware of the process needed to obtain consent for the photographing of the patient.
*He felt there would have been no way to identify the patient by the photograph taken by the visitor in the OR.

Interview on 9/22/15 at 7:50 a.m. with circulating OR registered nurse (B) regarding the surgical procedure performed on patient 5 on 8/11/15 revealed:
*All visitors that would have observed surgical procedure would go through the hospital's education office.
*He knew when there was going to be a visitor in the OR.
*This visitor had come into the OR where the surgical procedure was going to be performed.
-He was instructed by the OR staff to stay at least two feet from the operating table.
*During the surgical procedure the visitor used his personal cell phone and took a picture of patient 5's surgical site where an implant was being inserted.
*After the photograph had been taken he had instructed the visitor that he could not take a picture.
-Physician/surgeon A stated that it was "okay" for the visitor to have taken the picture.
*It was his understanding that no pictures were to have been taken with a personal cell phone by any one.
*After the incident he called his immediate supervisor and told him what had taken place.
*There was a process in place to take pictures if there was a consent signed by the patient.
-Photographs were not to have been taken for personal use.

Interview on 9/22/15 at 8:40 a.m. with director of surgical services E regarding the photograph of patient 5 on 8/11/15 during a surgical procedure revealed:
*Visitors in the OR have no privileges to take pictures during a surgical procedure.
*He had received a call from the OR staff regarding the photograph taken on 8/11/15.
*Administrative staff were going to speak with the visitor about the photograph that had been taken.
*Surgeon A should have spoken with the visitor to find out what was on the photograph.
*The administrative staff were vice president of surgical and digestive health D and vice president of orthopedics F.
*Photographs were taken for educational purposes only.
*The surgeon had approved the visitor in the OR.
*He was unsure as to what had happened to the photograph of patient 5.
*The education team would have been involved in educating the visitor as to what could and could not have been done in the OR during the surgical procedure.
*Photographs should not have been taken by the visitor.
*If a visitor would have asked the staff about taking a photograph during a surgical procedure the OR staff would have said "no".
*He was unsure if the picture of patient 5 had been deleted or not.
*His assumption of the incident was surgeon A had taken care of speaking with the visitor about the photograph taken on 8/11/15.

Interview on 9/22/15 at 9:02 a.m. with clinical manager of the patient center C regarding the preoperative (pre-op) care of patients revealed:
*The staff in pre-op area would verify if an informed consent had been explained to the patient by the physician.
*If photographs were to have been taken and the staff had known ahead of time: the consent would have been signed by the patient and it would have been obtained by the pre-op staff.
*If photographs were to have been taken it usually was if the patient had a pressure ulcer. There were dedicated cameras for taking those pictures.
*No cell phone photographs were allowed.

Interview on 9/22/15 at 9:10 a.m. with vice president of surgical and digestive health D regarding the incident with patient 5 on 8/11/15 revealed:
*The director of surgical services E would have a conversation with the visitor who had taken the photograph of patient 5.
*Director of surgical services E had called her per telephone on 8/11/15 regarding the photograph taken during the surgical procedure.
*There had been no formal paperwork completed after she had become aware of the incident, because she had been notified verbally of the incident.
*They decided surgeon A would talk to the visitor who had taken the photograph of patient 5.
*She stated surgeon A had validated the picture taken during the surgical procedure to make sure there were no identifying marks regarding patient 5.
*Cell phones were not used for photographing patients.
*Prior to the procedure the visitor had met with the OR educators, and the OR process was explained.
*Cell phone photographs were not permitted by the staff or visitors.
*Photographs were only taken for educational purposes.

Interview on 9/22/15 at 9:25 a.m. with vice president of orthopedics F in regards to the incident with patient 5 on 8/11/15 revealed:
*He had received a phone call from vice president of surgical and digestive health D in regards to the above incident.
*He had called surgeon A regarding the photograph taken in the OR by the visitor.
*The visitor wanted to take a photograph of the surgical knee implant, because the visitor had a similar surgery completed.
*He stated surgeon A told him he had seen the photograph, and there were no identifying marks that would have identified that patient in the photograph.
*He stated surgeon A had personally reviewed the photograph taken by the visitor.
*He was unaware what the picture contained.
*It would be very uncommon for a visitor to have taken a photograph with a personal cell phone.
*The only reason the visitor was in the OR that particular day was to observe a total knee replacement, because the visitor had the same surgery.
*No administrative staff would have accompanied non-medical, non-professional staff into the OR.
*There had been no formal paper work completed that he had been aware of for the cell phone incident on 8/11/15.

Interview on 9/22/15 at 10:00 a.m. with surgeon A regarding patient 5's photograph taken during a surgical procedure revealed:
*It was an educational photograph with the patent's knee with the implant.
*His focus was not on the visitor taking the photograph but on the surgery he had been performing on patient 5.
*He had not viewed the photograph taken by the visitor.
*He had not asked the visitor to delete the photograph.
*There was no way to identify the patient from the photograph taken by the visitor.
*He had been caught by surprise when the visitor took the photograph with his personal cell phone.

Interview on 9/22/15 at 10:20 a.m. with director of surgical services E regarding escorts of visitors to the OR revealed:
*The clinical coordinators would perform the teaching with individuals prior to the procedure.
*RN I was with the visitor on 8/11/15 at the beginning of the surgical procedure of patient 5.

Interview on 9/22/15 at 10:30 a.m. with education and training RN H regarding OR visitors revealed:
*The visitor has to obtain approval from the hospital.
*Her job was to explain the sterile field, where the visitor can touch, and what the visitor can not touch.
*She had educated the visitor on 8/11/15 reviewing the waiver and agreement prior to the procedure.

Review of the provider's September 2014 Patient Right and Responsibilities revealed: "You have the right to privacy. Privacy is an important part of your care. You have the right to: Privacy and security with your personal, written, telephone and electronic communication while a patient."

Review of the provider's undated Student/Individual Observation Experience Waiver and Agreement revealed: "[Name of the facility] may take immediate corrective action in any situation in which my behavior and/or performance adversely affect the best interests of the facility or its clients."

Review of the provider's September 2013 Notice of Privacy Practices revealed: "We are required by law to maintain the privacy and security of your health information. We will let you know promptly if a breach occurs that may have compromised the privacy and security of your health information. We will not share your information other than as described here unless you tell us in writing."

Review of the provider's April 2014 Patient Rights and Responsibilities revealed:
*The purpose of the policy was to:
-Assure that certain rights were preserved for all patients.
-Assure that each patient was informed on his/her rights and responsibilities as a patient.
*The right to expect that all communications and other records pertaining to the patient's care be treated as confidential.

Review of the provider's April 2013 Photographs and Videotaping policy revealed:
*The purpose was to provide a means for ensuring confidentiality and to protect staff, patients, and visitors within reasonable limits from invasion of privacy that might occur from the use of photographs during patient care or other health systems activities.
*The use of the term "photograph" in this policy refers to traditional film photographs, digital images, camera cell phones, videotapes, or other images used to capture the image of the patient or procedure.
*No cell phone photographs may be taken during any procedure.
*An authorization would have been obtained from the patient or their representative for any subsequent release of the photograph to parties outside of the hospital accept when used for treatment, payment, or hospital operations.
*A consent will be obtained prior to photographing using the authorization form (name of the form) when photographs do not meet the purposes of medical documentation and the patient was identifiable.
*Photographs of patient conditions, wounds, or injuries etc. might be taken for internal education, process improvement, or continuing patient care.
*The health care professional has the right and responsibility to ensure consent was obtained for non-medical photographs.
*It was the responsibility of all personnel to safeguard patient information in accordance with the HIPAA (Health Insurance Portability and Accountability Act of 1996) Privacy regulations.