The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

CLEVELAND CLINIC 9500 EUCLID AVENUE CLEVELAND, OH 44195 May 17, 2013
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on interview, review of clinical records, review of informed consent policy, review of surgical policies, and review of medical staff bylaws, the facility failed to ensure all staff within surgical services are aware when surgeons' privileges have been modified, reduced, or eliminated altogether (A941), failed to maintain a list of surgeons whose privileges have been suspended or restricted in the surgical suite (A945), failed to ensure surgical polices were followed (A951) failed to include the use of robotics as part of the informed consent process (A955), and failed to ensure each operative report included all necessary elements (A 959). The cumulative effect of these systemic practices resulted in the facility's inability to ensure safe surgical services. This had the potential to affect all patients in the facility. The facility's census was 998 patients.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview, review of policies, medical staff bylaws, and code of regulations, the facility's governing body failed to ensure the medical staff bylaws were followed (A044) or the medical staff bylaws complied with the Medicare Conditions of Participation (A047). The governing body failed to approve surgical policies (A048), and failed to ensure the bylaws and written criteria for privileging are followed (A050) and failed to manage the hospital's informed consent process (A057). The cumulative effect of these systemic practices resulted in the inability of the governing body to ensure the medical staff is accountable for patient care. This has the potential to affect all patients who receive services at this hospital. The facility's census was 998 patients.
VIOLATION: MEDICAL STAFF Tag No: A0044
Based on review of medical staff bylaws and staff interview it was determined the hospital's governing body failed to grant privileges based on specific criteria, and they failed to ensure the medical staff bylaws had a clear process for granting privileges, without a temporary period. This potentially affects all patients who receive services at this hospital. The hospital performs approximately 1,961 surgical procedures per week and the hospital's census was 998 patients.

Findings include:

Review of the privileging files for Physician #1 and #2 was completed on 05/17/13. The review revealed a urology clinical privileges form, each dated 04/01/13 that stated each had been granted the privilege to use a robotic assisted system for Urological procedures. The criteria to grant the form included a requirement for previous experience. This previous experience included "evidence of the performance of an adequate volume of robotic-assisted procedures the past 12 months ..." The form did not state what an "adequate volume" was.

On 05/16/13 at 2:00 P.M. in an interview, Kidney and Urological Institute Department Chair #1 did not define what an "adequate volume" was, but did say the robots are frequently utilized and the physicians get plenty of experience.

Interview with the chairman of the Digestive Disease Institute was conducted on 05/15/13 at 2:45 PM. The chairman was interviewed to determine the criteria used to grant clinical privileges to practitioners. The chairman revealed the practitioner is evaluated against the criteria established by the American Board of the specialty for which they are applying. The chairman was unable to ascertain that the hospital had established written criteria used to grant clinical privileges to practitioners.

Review of the medical staff bylaws was completed on 05/17/13. Article III, Section 1, Paragraph G reveals the circumstances in which the medical staff would recommend granting temporary clinical privileges.

Review of Medical Staff policy titled, "Temporary and Emergency Privileges," approved 06/04/12, stated, "In accordance with The Medical Staff Bylaws of The Cleveland Clinic Foundation (CCF), the Chief Executive Officer of CCF (or his or her designee), with the concurrence of the department chairperson concerned, may grant temporary clinical privileges to a new applicant with a complete, clean application...".




On 05/17/13 at 2:08 PM, in an interview, the Director of Credentialing confirmed temporary privileges would be granted by the CEO if an applicant had a complete package ready with no deficiencies prior to the governing body meeting. He/she stated there has been approximately four occurrences of temporary privileges being granted in the past four years.

Review of the Medical Staff Bylaws adopted 06/01/12 and approved by the Board of Directors on 06/04/12, was completed on 05/17/13. Article IV, Organization of Medical Staff, Section 5, Institute Duties, duty # 6 reads, "to establish written criteria for the granting of clinical privileges within the Institute."
VIOLATION: MEDICAL STAFF - BYLAWS Tag No: A0047
Based on interview and review of the medical staff bylaws the facility failed to ensure the bylaws complied with the Medicare Hospital Conditions of Participation by granting temporary privileges to surgeons. This has the potential to affect all patients who receive services at this hospital. The facility's census was 998 patients.

Findings include:

Review of the medical staff bylaws adopted 06/01/12 and approved by the Board of Directors on 06/04/12, was completed on 05/17/13. Article III, Section 1, Paragraph G revealed the circumstances in which the medical staff would recommend granting temporary clinical privileges.

Review of Medical Staff policy, "Temporary and Emergency Privileges," approved 06/04/12, stated, "In accordance with The Medical Staff Bylaws of The Cleveland Clinic Foundation (CCF), the Chief Executive Officer of CCF (or his or her designee), with the concurrence of the department chairperson concerned, may grant temporary clinical privileges to a new applicant with a complete, clean application...".

Review of the facility's code of regulations as amended 06/04/12, was completed on 05/17/13. The review revealed under Article 7, Section 6, "The Board of Governors, in conjunction with the Board of Directors, shall have ultimate responsibility for standards of medical care within the clinic." Section continued, "The Board of Governors shall have the following responsibilities and duties..." The list included 24 items, including "to comply with the professional requirements of the Joint Commission on Accreditation of Hospitals." The list did not include compliance with Medicare Conditions of Participation.

On 05/17/13 at 2:08 PM, the Director of Credentialing stated no physicians currently have temporary privileges. The governing body meets eight times a year. The Director of Credentialing stated temporary privileges would be granted by the CEO if an applicant had a complete package ready with no deficiencies prior to the governing body meeting. He/she stated there have been approximately four occurrences of temporary privileges being granted in the past four years.
VIOLATION: MEDICAL STAFF - BYLAWS AND RULES Tag No: A0048
Based on policy review and interviews, the facility failed to ensure the Governing Body approved the facility's policies and procedures and failed to ensure the bylaws organized surgical services to ensure notification of staff of when privileges of clinicians have been changed. This has the potential to affect all patients who receive services at this hospital. The facility's census was 998 patients.

Findings include:

A. Review of the facility's code of regulations as amended 06/04/12, was completed on 05/17/13. The review revealed under Article 7, Section 6, "The Board of Governors, in conjunction with the Board of Directors, shall have ultimate responsibility for standards of care within the Clinic" and "shall have the following responsibilities and duties..." Among the duties the listed included, "The medical staff shall establish bylaws, rules and regulations, which shall be approved (sic) Board of Directors." Review of the Medical Bylaws adopted 06/01/12 and approved by the Board of Directors on 06/04/12, Section 5. Insttitute Duties includes "...to institute and implement the administrative policies necessary for the efficient operation of the Institute..."

On 05/17/13 at 8:00 A.M. in an interview, the CEO confirmed not every hospital policy was approved by the facility's governing body.

The following interviews and review of policies validate the CEO's interview:




1. On 05/16/13 at 11:11 AM, the Senior Director of Surgical Nursing was interviewed. The Director stated the facility does not have policies and procedures; the facility follows the "Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings" (AORN) manual. All of the surgical staff have completed the AORN modules. The Director stated "there is no approval document for the AORN manual". He/she was not aware if the book has been presented to the Board of Directors. The Director stated the book was approved by the department chairs.

2. On 05/13/13, the facility's Preventative Maintenance policy was reviewed. The policy was approved by the Clinical Executive Director.

3. On 05/15/13, the facility's Surgical Site Preparation policy was reviewed. The policy was approved by Surgical Operations and Executive Committee.

4. On 05/17/13, the facility's Dress Code: Surgical Services and Special Procedure Areas policy was reviewed. The policy was approved by the Nursing Institute Practice Council, the Nursing Institute Counsel, the Medical Operations Council and the Operating Room Affinity Group.

5. On 05/17/13, the facility's Hand Hygiene policy was reviewed. The policy was approved by the Infection Prevention Committee.

B. The medical staff bylaws adopted 06/01/12 and approved by the Board of Directors on 06/04/12, failed to organize surgical services to ensure an organized way of notifying staff when a clinician's privileges have been changed based upon the following findings

1. On 05/14/13 at 3:00 PM, a surgical coordinator was interviewed. The coordinator stated he/she alters the surgery schedule for add-on surgeries or emergency surgeries and receives the surgical schedule from the Registered Nurse First Assist. The coordinator stated he/she does not have a list of suspended physicians and has never received a list of suspended physicians.

2. On 05/13/13, a tour of the surgical unit (J4) was conducted. The scheduling coordinator stated he/she does not check to see if physicians are active or suspended.

3. On 05/16/13 at 12:23 PM, the Senior Director of Surgical Nursing was interviewed. The director stated physician privileges can be verified by an electronic system (EPRIV) or by calling the department chair. He/she stated suspension of privileges is activated via phone call or list. Scheduling doesn't report to nursing. He/she reported the surgeon roster is incomplete and is updated at reappointment.

See A941 for further details.
VIOLATION: MEDICAL STAFF - SELECTION CRITERIA Tag No: A0050
Based on staff interview and review of medical staff bylaws it was determined the hospital board of directors failed to ensure the application of written criteria for the granting of clinical privileges to individual practitioners established by the medical staff bylaws was complete. This potentially affects all patients who receive services at this hospital. The hospital performs approximately 1,961 surgical procedures per week and the hospital's census was 998 patients.

Findings include:

Review of the Medical Staff Bylaws was completed on 05/17/13. Article IV, Organization of Medical Staff, Section 5, Institute Duties, duty # 6 reads, "to establish written criteria for the granting of clinical privileges within the Institute."

The following examples show where the applied written criteria was lacking:

1. Review of the privileging files for Physician #1 and #2 was completed on 05/17/13. The review revealed a urology clinical privileges form, each dated 04/01/13 that stated each had been granted the privilege to use a robotic assisted system for Urological procedures. The criteria to grant the form included a requirement for previous experience. This previous experience included "evidence of the performance of an adequate volume of robotic-assisted procedures the past 12 months ..." It did not state what an "adequate volume" is.

On 05/16/13 at 2:00 P.M. in an interview, Kidney and Urological Institute Department Chair #1 did not define what an "adequate volume" was, but did say the robots are frequently utilized to where the physicians get plenty of experience.

2. Interview with the chairman of the Digestive Disease Institute was conducted on 05/15/13 at 2:45 PM. The chairman was questioned as to the criteria used to grant clinical privileges to practitioners. The chairman revealed the practitioner is evaluated against the criteria established by the American Board of the specialty for which they are applying. The chairman was unable to ascertain that the hospital had established written criteria used to grant clinical privileges to practitioners.
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on interview the hospital Chief Executive Officer failed to manage the hospital's informed consent process, the hospital's publication of physician privileges, the hospital's credentialing process to prohibit the use of the granting of temporary privileges, and the hospital's policies being approved by its governing body. This has the potential to affect all patients who receive services at this hospital. The facility's census was 998 patients.

Findings include:

On 05/17/13 at 8:00 A.M. in an interview, the Chief Executive Officer (CEO) confirmed the use of robots do not necessarily need to be included in the informed consent for surgery process. He/she said it was a tool like any other in the operating room. Using the heart/lung machine as an example, the CEO said he/she also would not expect its usage to be included in the informed consent process because it has been accepted as a tool.

The CEO also confirmed the policies for the operating rooms were not approved by the hospital's governing body, i.e.,, the Board of Directors, stating he/she would only expect policies that cover all staff to be approved by the Board of Directors.

The CEO also stated transparency is an "important thing" at the hospital. The CEO stated driving physician behavior at the hospital was putting physician names to surgical outcomes. However, he/she was unable to explain how a current list of surgeons suspended from surgical privileges was not maintained in the surgical areas and locations except to indicate the possibility of a surgeon doing a procedure he/she did not have privileges was low.

On 05/14/13 at 9:30 A.M. in an interview, the Chairman of Surgical Operations stated to some degree there is a reliance on a surgeon to act ethically and withdraw himself from a surgery he/she's not privileged for.

On 05/17/13 at 2:08 P.M., the Director of Credentialing stated temporary privileges could be granted by the Chief Executive Officer if an applicant had a complete package ready with no deficiencies prior to the governing body meeting.
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on interview and review of medical staff bylaws, the facility failed to ensure privileges were granted that were not temporary and criteria for privileging were written (A357) and applied to physicians (A363). This has the potential to affect all patients who receive services at this hospital. The hospital's census was 998 patients.
VIOLATION: MEDICAL STAFF QUALIFICATIONS Tag No: A0357
Based on interview and review of the medical staff bylaws the facility failed to ensure privileges were granted to physicians in accordance with the Medicare Conditions of Participation by either granting or denying privileges, without a temporary period, to physicians. This deficient practice had the potential to affect all patients who receive services at this hospital. The facility's census was 998 patients.

Findings include:

Review of the medical staff bylaws adopted 06/01/12 and approved by the Board of Directors on 06/04/12, was completed on 05/17/13. Article III, Section 1, Paragraph G revealed the circumstances in which the medical staff would recommend granting temporary clinical privileges, stating "The President of the Medical Staff designates to the Chief of Staff of CCF ... the authority to recommend practitioners seeking temporary privileges to the Chief Executive Officer who ratifies granting temporary clinical privileges...". The Bylaws fail to make these privileges accountable to the Governing Body.


On 05/17/13 at 2:08 PM, the Director of Credentialing was interviewed. The Director stated temporary privileges would be granted by the CEO if an applicant had a complete package ready with no deficiencies prior to the governing body meeting. The Director stated there have been approximately four occurrences of temporary privileges being granted in the past four years.
VIOLATION: CRITERIA FOR MEDICAL STAFF PRIVILEGING Tag No: A0363
Based on staff interview, review of physician credentialing file and review of medical staff bylaws it was determined the hospital failed to follow written criteria for the granting of clinical privileges to individual practitioners. This potentially affects all patients serviced by the hospital. The hospital performs approximately 1,961 surgical procedures per week, and the hospital's census was 998 patients.

Findings include:

Interview with the chairman of the Digestive Disease Institute was conducted on 05/15/13 at 2:45 PM. The chairman was questioned as to the criteria used to grant clinical privileges to practitioners. The chairman revealed the practitioner is evaluated against the criteria established by the American Board of the specialty for which they are applying. The chairman was unable to ascertain that the hospital had established written criteria used to grant clinical privileges to practitioners.

The credentialing file for a staff surgeon in the Digestive Disease Institute was reviewed on 05/17/13. This staff surgeon requested privileges for the use of robotic-assisted system for general surgical procedures. The required previous experience includes the performance of "an adequate volume" of robotic-assisted procedures in the past 12 months. The reappointment requirements includes the performance of "an adequate volume" of robotic assisted procedures in the past 24 months. No specific amount of procedures was indicated as having been performed by the practitioner and the department chairman for general surgery recommended all requested privileges on 02/10/13 and privileges were granted.





On 05/15/13 at 1:15 P.M. the chairman of the orthopaedic and rheumatologic institute was interviewed. The chairman was also questioned as to the criteria used to grant clinical privileges to physicians. The chairman revealed board certification also plays a major role in determining whether to grant physicians privileges in the institute; however, the chairman was unable to articulate the facility's own, established written criteria for the granting of privileges to physicians in the orthopaedic and rheumatologic institute.
Review of the Medical Staff Bylaws was completed on 05/17/13. Article IV, Organization of Medical Staff, Section 5, Institute Duties, duty # 6 reads, "to establish written criteria for the granting of clinical privileges within the Institute."

Review of the privileging files for Physician #1 and #2 was completed on 05/17/13. The review revealed a urology clinical privileges form, each dated 04/01/13 that stated each had been granted the privilege to use a robotic assisted system for Urological procedures. The criteria to grant the form included a requirement for previous experience. This previous experience included "evidence of the performance of an adequate volume of robotic-assisted procedures the past 12 months ...". It did not state what an "adequate volume" was.

On 05/16/13 at 2:00 P.M. in an interview, Kidney and Urological Institute Department Chair #1 did not define what an "adequate volume" was, but did say the robots are frequently utilized to where the physicians get plenty of experience.
VIOLATION: ORGANIZATION OF SURGICAL SERVICES Tag No: A0941
Based on interviews, the facility failed to demonstrate the relationship between the operating room services to other services (for example, nursing), to ensure all are aware of when a surgeon's privileges have been modified, reduced, or eliminated altogether, and to ensure surgical policies were approved by the hospital's governing body. The hospital's census was 998 patients.

Findings include:

Review of the facility's organizational chart was completed on 05/17/13. The review revealed a line of authority that, through interviews, was not practiced and/or apparent by staff within the facility for determining which physicians had privileges reduced or revoked, which physicians needed proctored, which surgical policies were approved and how other services such as nursing were made aware of all of it.

Further review of the organizational chart revealed within surgical operations there is a chairman and medical director on the same level. The chart revealed the chairman and medical director report to the chief of medical operations who reports to the Chief Executive Officer; however, review of a sample of surgical policies revealed they were approved by differing entities. The scrub personnel responsibility policy was approved by the "OR Affinity Group," the scheduling and notification of emergent/urgent surgical cases policy was approved by the chairman of surgical operations, and the OR humidity control and surgical site preparation policies were approved by the surgical operations executive committee. None of these policies were approved by the hospital's governing body.

On 05/16/13 at 2:00 P.M. in an interview, kidney and Urological Institute Department Chair #1 stated he/she knew of a physician who needed to be proctored, i.e., not to conduct surgery alone. Department Chair #1 stated he/she notified his/her superior, the institute chair, but that the fact the physician was not to conduct surgery alone was not published in an area near the surgical suite and, hence, other services, like nursing, were not notified.

On 05/14/13 at 9:30 A.M. in an interview, the chairman of surgical operations stated if a physician had surgical privileges eliminated, he/she would receive a phone call from the physician's institute chair, and he/she would in turn disseminate that information to the operating room staff.

On 05/13/13 at 1:20 P.M. in an interview, Surgery Scheduler #1 did not indicate he/she would look for this information. Surgery Scheduler #1 said the scheduling software would not let him/her schedule a case unless the physician had the privilege to do it.

On 05/15/13 at 1:15 P.M. the chairman of the institute for Orthopaedics and rheumatology was interviewed. the chairman stated it was his/her responsibility to notify others when a surgeon's privileges have been eliminated. The chairman also stated he/she did not know what parts get switched in the electronic system, but said he/she expected when he/she told a physician not to go into the operating room, the physician was expected not to go in.
VIOLATION: SURGICAL PRIVILEGES Tag No: A0945
Based on staff interviews and review of medical staff by-laws, it was determined the hospital failed to maintain a current roster in the surgical suites of surgical practitioners that included those whose privileges had been modified, reduced or eliminated. This potentially affected all patients receiving surgical services from the hospital. The hospital performs an average of 1,961 procedures per week, and the hospital's census was 998 patients.

Findings include:

Interview with the Chairman of the Digestive Disease Institute was conducted on 05/15/13 at 2:45 PM. During interview the Chairman was questioned on several occasions if there was a list of surgical practitioners for the Digestive Disease Institute and the specific privileges of each practitioner. The Chairman could not ascertain that such a list existed. The Chairman was also asked if there was a list of surgical practitioners whose privileges were currently suspended. The Chairman revealed there was no list as there were currently no surgical practitioners whose privileges were suspended.

Interview with the Medical Director of Surgical Operations was conducted on 05/16/13 at 2:40 PM. The medical director revealed his duties include that of liaison between nursing, surgeons and anesthesia. In addition, he oversees the surgical schedulers and the logistics of the operating rooms, i.e.; what practitioner will be assigned to which operating room, what equipment is needed in the room and what time each room will be available. During interview the medical director was questioned if there was a list of surgical practitioners and the specific privileges of each practitioner. The medical director responded, "I don't have a list of every practitioner and their specific privileges. If I have a question about a certain surgeon I go to the department chairman of the surgical specialty and ask."

Review of the Medical Staff Bylaws adopted 06/01/12 and approved by the Board of Directors on 06/04/12, was completed on 05/17/13. Article IV, Organization of Medical Staff, Section 5, Institute Duties, duty # 5 reads, "Each clinical institute shall have the duty to provide such call lists, staff lists and other lists or rosters for medical coverage of clinical services as are necessary for compliance with applicable law, the efficient provision of quality care in the Foundation Facilities." Section 6 of the medical staff bylaws reveals the duties of the institute chairs to include, (3) "to transmit to the appropriate authorities, as required by these Bylaws, the Institute's recommendations concerning appointment and classification, reappointment, delineation of clinical privileges or specified services, corrective action with respect to practitioners in the Institute, and recommendations for the sufficient number of qualified and competent persons to provide care, treatment and services, and to recommend to the Medical Staff the criteria for clinical privileges that are relevant to the care provided in the Institute and the departments within the Institute."





On 05/14/13 at 9:30 A.M. in an interview, the chairman of surgical operations stated he/she would expect the scheduler of surgeries to realize a physician is scheduled to do a surgery for which he/she does not have privileges.

On 05/13/13 at 1:20 P.M. in an interview, Surgery Scheduler #1 said the scheduling software would not let him/her schedule a case unless the physician had the privilege to do it.

On 05/13/13 at 3:15 P.M. in an interview, Operating Room Nurse Manager #1 said he/she wasn't sure the scheduling software would not allow scheduling a surgery for which the physician was not privileged. He/she did utilize a software program called (E-priv) to determine what surgical privileges the physician had.

On 05/14/13 at 9:30 A.M. in an interview, the Chairman of Surgical Operations stated he/she would expect staff to look up in a computer program called "(E-priv)" to determine whether a physician had a surgical privilege pulled.

On 05/15/13 at 10:00 A.M. in an interview, the Director of Credentialing stated the protocol from stopping a physician from performing surgery after his/her privileges have been revoked lay within their institute. He/she said (E-priv) does list what surgical privileges a physician has, but does not alert staff to which ones he/she recently lost. He/she said those physicians who are still to be reprivileged in 2013 would not have their privileges listed in (E-priv) until those physicians had been reprivileged. In other words, until a physician is reprivileged in 2013, his/her privileges are not published in a computer program, (E-priv), where staff look to verify them.

On 05/14/13 at 9:30 A.M. in an interview, the Chairman of Surgical Operations stated if the scheduler did not realize a privilege had been revoked, and staff did not realize a privilege was no longer listed for a surgeon in (E-priv)), then to some degree there is a reliance on the surgeon in question to act ethically and withdraw himself from a surgery he/she's not privileged for.





Interview with the scheduling manager (Staff V) 05/14/13 at 2:10 PM when questioned how determined the privileges and credentials of surgeons prior to scheduling procedures replied "we just know. The schedule is primarily made by the ten individual departments such orthopedics, gastrointestinal, etc. that this office was responsible for about a month in advance. The hospital's main institute chairmen and department surgeons have been pre-allotted specific days which they can schedule their surgeries on. The individual department surgeons along with the chairmen then schedule their own surgeries approximately one month in advance. The main scheduling office received this tentative surgery schedule 48 hours prior to the surgery date. This office's responsibility was to schedule any add on cases due to cancellations or emergent cases into any vacant operating rooms. The scheduling office received electronic notification of surgeries that needed to be scheduled into any open operating rooms. Staff V verbalized they were familiar with all the surgeons and just knew their privileged status for procedures. He/she verbalized if there were concerns with a surgeon's privileges they had access to the facility's intranet (E-priv) site or could call the nurse on call hotline number, which also had access to facility physicians and their credentials and privileges.

Further interview of Staff V revealed this main surgical scheduling office would receive notification of surgeons whose privileges were revoked or suspended and the medical director for surgical operations would receive that information and notify scheduling staff of the necessity to remove a surgeon from the schedule. Staff V verbalized "that has never happened in the three years I ' ve been here. " When Staff V was asked if the surgery scheduling office maintained a roster of physicians and surgeons with their credentials and privileges, Staff V again referred that the information was available through the facility's intranet (E-priv) site. The institute department chairmen are knowledgeable of their physicians and surgeons and know who was privileged for what procedures and scheduled their surgeries accordingly. When asked if the scheduling office maintained a current roster of credentialed physicians and surgeons and their individual privileges, and expectations of any new staff in the scheduling office would be in regards to scheduling physicians they were unfamiliar with, Staff V verbalized the expectation would be for the staff member to check a surgeon's privileges prior to putting on the surgery schedule. Again, Staff V was unable to provide a current and comprehensive roster or a list of surgeons who had privileges suspended or revoked and again referred to staff use of the (E-priv) data base or the facility nurse on call hot line telephone number. When asked what the procedure was for electronic down time Staff V replied there was a policy and procedure and it basically reverted back to the paper process. Staff V reiterated that the system would not permit the scheduling of a physician who was not credentialed or privileged in the E-priv data base.





On 05/16/13 at 12:23 PM, the Senior Director of Nursing was interviewed. The Director stated physician privileges can be verified by E-priv or by calling the department chair. He/she reported the surgeon roster is incomplete and is updated at the surgeons' reappointment.

On 05/14/13, a Registered Nurse First Assist was observed in his/her office. The nurse was responsible for the scheduling of surgeons with the appropriate surgeries. He/she was asked to demonstrate how he/she identifies surgeon's privileges when scheduling surgeries. The nurse went to the Ohio License Search website and entered a surgeon's name in the search space. She stated the above method determines what specific surgeries the surgeons are allowed to perform.

A tour of surgical unit J4 was conducted with Staff Y, nurse manager, on 05/13/13. The unit had three scheduling coordinators. One scheduling coordinator stated the unit has a call number located on a pink sticker to verify surgical privileges of doctors. Another scheduling coordinator reported he/she does not check to see if physicians are active or suspended.

On 05/14/13 at 3:00 PM, a surgical coordinator was interviewed. The coordinator stated he/she alters the surgery schedule for add-on surgeries or emergency surgeries. The coordinator stated he/she receives the surgical schedule from the Registered Nurse First Assist and he/she does not have a list of suspended physicians and has never received a list of suspended physicians.

On 05/14/13, 3:10 PM, the Clinical Manager for Thoracic and Cardiovascular Surgery was interviewed. The clinic manager stated the department chair signs off on surgeons' privileges annually. He/she stated no surgeons have had privileges suspended since 2010. He/she stated a face to face meeting would occur if a physician's privileges were suspended.

On 05/13/13 at 8:17 AM, the Heart and Vascular Institute Chairman was interviewed. The Chairman stated the Heart and Vascular Institute has approximately 200 doctors. He/she stated the department chairman is responsible for the surgeons and non-surgeons. The program director signs-off when the surgeons have been trained to do selected items. After one year, if the facility believes the physician is competent, the facility privileges the physician based on the American Board of Thoracic Surgery. He/she reported "it is not the responsibility of a scrub tech to determine if a physician is competent to complete a surgery". He/she stated the scheduling of surgeries is completed by a nurse. The nurse makes the schedule based on the individual surgeons' reports of their patients' needs. If a surgeon request to perform a surgery questionable to the scheduler, the scheduler would call the department chairman or the Heart and Vascular Institute Chairman for authorization. The heart and vascular institute chairman went on to say the suspension of physician privileges is "handled at the doctor level" and the institute has "never needed or felt they needed to surrender someone's privileges for surgery". He/she stated nurses are "not expected to stop the physician from any surgery."
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations and interviews and policy review, it was determined the hospital failed to ensure patient safety by having expired supplies in crash carts, anesthesia supply carts and operating rooms, storage of supplies on the floor, not ensuring preventative maintenance was completed as scheduled, not having policies addressing surgical services, allowing equipment connected to a patient to drag on the floor, not identifying equipment in need of repair or replacement, overfilling crash carts, not following the facility's Surgical Site Preparation policy for (Patient # 2) and allowing patient divider curtains to hang in a used bio-hazard container. This potentially affects all patients receiving services in the surgical area. The hospital performs approximately 1,961 surgical procedures per week. The total sample size was 15 surgical medical records with a census of 998 patients.

Findings include:




1. Patient #2 was admitted to the hospital on [DATE] with a preoperative diagnosis of [DIAGNOSES REDACTED].

Observations on 05/14/13 from 10:05.13 until 10:05.45 A.M. of the pre-operative surgical scrub revealed an operating room staff member performed a one time surgical scrub of the patient's urogenital area prior to performance of the cystoscopy. The staff member performed an approximate thirty second scrub of the patient's entire genital area with Hibiclens (a commercially prepared antiseptic/antimicrobial skin cleanser). The operating room staff then immediately draped the still wet patient's genital area in sterile surgical cloth drapes. There was no patting to dry of the urogenital area prior to the pre-surgical draping of the patient in accordance with the manufacturer's printed directive. The physician immediately began cystoscopic procedure with no additional pre-surgical preparations.

Review of the Hibiclens manufacturer's printed directive under the product warnings directed this product was not to be used in the genital area. Additionally, the manufacturer's preoperative skin preparation directed to apply Hibiclens liberally to the surgical site and swab for at least two minutes. Dry with a sterile towel. Repeat. Dry with a sterile towel.

Review of the facility's policy and procedure entitled Surgical Site Preparation with a most recent review date of 08/26/2012 identified the facility approved two agents for surgical site preparation, an iodophore (iodine) based cleansers when no iodine allergy existed or a chlorhexidine gluconate (Hibiclens). The policy and procedure directed to scrub the surgical site with the appropriate agent, repeat the process, then cover site with open, sterile towel and pat to dry. The policy and procedure under the section entitled special considerations, directed to follow the manufacturer's guidelines.





3. A tour of surgical unit J4 was conducted on 05/13/13 and 05/14/13. A Jelly-Roll warming mattress was observed on a surgical bed. The surgical bed had tape from a previous surgery on the head rest. The Assistant Director of Heart and Vascular reported the surgical bed was ready for the operating room. He/she removed the warming-Roll mattress and head piece after the staff was notified of the above findings. A flash sterilizer tray was observed on the floor.

4. A refrigerator to hold units of blood was observed on the unit. The refrigerator had a clinical engineering label affixed to the front of the refrigerator which stated preventative maintenance was due on 10/2010. The IP/OP Clinical Engineering Manager stated no preventative maintenance was needed on the refrigerator. He/she stated a company named Rees monitors the temperatures of the refrigerator 24 hours a day seven days a week. On 05/15/13, the Clinical Engineering Executive Director wrote the facility is transferring all refrigerators' labels to read test after a repair. "This device was missed which is an error on our part."

5. A Glide scope was observed on the unit without a clinical engineering label specifying when preventative maintenance was due. The IP/OP Clinical Engineering Manager reported the Glide scopes are only tested after a repair is needed.

6. The anesthesia "ready room" was observed on 05/13/13. The room contained a monitor for training purposes which was going to replace the unit's existing GE monitors. A member of the anesthesia team reported the equipment was cleared by clinical engineering for use and a representative from the company had provided training to the staff last week. The monitor was left in the ready room for staff to familiarize themselves with the equipment. The monitor did not contain a label identifying it as a demo piece of equipment. The monitor did not contain a clinical engineering label.

7. On 05/13/13, the facility's Preventative Maintenance policy dated 01/01/12, was reviewed. The policy stated the facility uses a yellow sticker to communicate the inspection schedule for medical devices in the equipment management program to end-users and internal and external inspectors. Clinician partners are expected to review this sticker prior to device use and verify that the equipment is not in need of inspection. If the device is overdue for inspection, the clinician should remove the device from service and contact Clinical Engineering for service. Some devices represent a low risk of failure or have failure mechanisms that cannot be prevented by regular inspections. The same sticker may be used for a device that does not benefit from any preventative maintenance and is only inspected after repair.

8. An anesthesia supply cart was observed in the unit's hall. The cart was unlocked and contained and a bottle of AKWA Tears lot # 8M28A with an expiration date of 11/2011 on the bottle.

9. An EEG machine had a chlorohexidine applicator (an antibacterial compound used in antimicrobial skin cleansers for surgical scrub, preoperative skin preparation, and cleansing skin wounds) and the pre-op holding room storage cart had chlorohexidine applicators stored. The Assistant Director of Heart and Vascular reported the applicators are used in the pre-op holding area for patient arterial lines and in the operating room for Swan-Ganz catheters by anesthesia.

10. On 05/17/13, the facility's Surgical Site Preparation policy was reviewed. The policy stated CCF allows for non-alcohol-based preps or iodophors to be used in the Operating Rooms. Several antiseptic agents are available for the preoperative preparation of skin at the incision site. The agents currently approved by the Cleveland Clinic Infection Prevention Department include iodophors (e.g. providone-iodine) and chlorhexidine gluconate (Hibiclens).

11. The pre-op holding room was observed on 05/13/13. A privacy curtain was observed hanging in an opened sharps container. The Assistant Director of Heart and Vascular requested the curtain be removed for cleaning during the observation.

12. A member of the surgical staff was observed transporting a patient to the operating room. The staff member was kicking the pressure bag inflation ball attached to the patient's intravenous fluids across the floor during the transport.

13. The anesthesia clean and dirty utility room was observed on 05/13/13. An anesthesia tech's personal bag was observed on the floor of the clean utility room. A box of 3M blankets and a box of blood pressure cuffs was observed stored on the floor. A bottle of hydrogen peroxide and an uncapped bottle of Mueller Whisk Adhesive Remover was observed in the unlocked cabinet without indication as to when the bottles were opened. A bottle of Terrell Isoflurane USP Liquid for Inhalation was observed in the unlocked cabinet. Staff did not know why the cabinet was unlocked. Cleaned laryngoscopes, scissors and hemostats were observed uncovered on a cart in the clean utility room.

14. On 05/13/13, a refrigerator filled with cardioplegia solutions was observed on the unit unlocked. The refrigerator had a locking mechanism on the door. A perfusionist stated the batteries to the refrigerator died on Friday. He stated the unit did not have replacement batteries. On 05/14/13, the refrigerator was observed unlocked. A perfusionist reported the battery locking unit was not working and a work order was submitted on Friday.

15. On 05/14/13, a crash cart located in Storage B was opened. The cart contained two pairs of expired sterile gloves. Lot # 01 TS 078 and 09 TS 078 expired on ,d+[DATE]. A crash cart located in storage room C was observed to have expired supplies. The cart contained saline for injection Lot # -5E expired 03/2013 and E-Z lubricating jelly Lot # 1044 expired 2/2013. The staff had difficulty opening the bottom drawers of the cart due to the saline bags had been filled to the level that impeded the ability to open the crash cart drawers timely.

16. Operating room 67 was observed on 05/14/13. The room contained six expired blood tubes (pink top tubes Lot # 39 expired 09/2010 X2 and Lot # 13 expired 12/2012 X1 and orange top tubes Lot # 34 expired 03/2012, Lot # 66 expired 07/2012 and Lot # 82 expired 08/2012). A surgical technologist reported the anesthesia supplies are checked every week and the person assigned to check the supplies is rotated every month. Operating room 69 contained two expired blood tubes (pink tubes Lot # 27 expired 01/ ).

On 05/16/13 at 11:11 AM, the Senior Director of Surgical Services was interviewed. The senior director stated the facility does not have policies and procedures; the facility follows the Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings (AORN) manual. Staff R stated "there is no approval document for the AORN manual " . He/She was not aware if the book has been presented to the Board of Directors and stated the book was approved by the department chairs.

On 05/16/13, the Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings manual 2013 Edition, was reviewed. The manual stated policies and procedures should be written, reviewed annually, and readily available within the practice setting. The manual stated a safe, clean environment should be reestablished after each surgical procedure. Mattresses should be moisture resistant and intact.

On 05/16/13, the facility's Care of Equipment and Environmental Infection Policy dated 10/26/12, was reviewed. The policy stated sterile and clean supplies should be stored in closed cabinets, carts or drawers. The supplies should be stored off the floor. Clean all, blinds, and curtains when visibly soiled and as scheduled by Environmental Services.
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on observation, staff and patient interview and medical record and policy review, it was determined the hospital failed to ensure a patient was provided the information necessary to enable the patient to evaluate a proposed surgery before agreeing to the surgery, specifically the use of robotics as part of the minimally invasive approach, for three (Patient # 1, 12 and 13) of 15 surgical patients reviewed. The hospital's census was 15 patients.

Findings include:

Patient #1 and his/her spouse were interviewed on 05/14/13 at 2:45 PM. The patient and spouse were asked if they were aware that a robot had been used during part of his/her procedure the day before. Both the patient and spouse reported no knowledge of the use of robotics during his surgery on 05/13/13. The patient's spouse revealed that he/she was present at the time the patient gave written consent for the surgery on 04/30/13 at 10:41 AM. The patient and spouse both revealed the surgeon nor the surgical resident had informed them that a robot may be used as part of the minimally invasive approach.

Review of Patient # 1's medical record was completed on 05/15/13. The surgical informed consent that was signed by the patient on 04/30/13 at 10:41 AM was noted to have no mention of the possible use of robotics as part of the patient's proposed procedure.

Interview with the surgeon who was observed using the robot on Patient # 1 on 05/13/13 was conducted on 05/15/13 at 2:05 PM. The surgeon revealed he/she does not always tell the patient he/she may use a robot, just like he/she doesn't discuss every tool used during the procedure, and the robot is just another tool. The surgeon also revealed that while obtaining consent from a patient for a surgical procedure, the surgical resident is often at the computer, preparing the electronic form for the patient to sign. "Not all residents mention the use of robotics on the surgical informed consent," the surgeon added. The surgeon reported that most of his/her patients aren't aware of the use of the robot, as the patients don't see him/her for robotic surgery, but, for his/her skill set and trust.




Review of the informed consent policy further revealed although it had been approved by the Board of Governors on 04/14/10, it had not been approved by the Board of Directors.

On 05/16/13 at 10:00 A.M. the facility's chief legal officer was interviewed. The facility's chief legal officer stated information provided during the informed consent process would vary based on particular procedures and said physicians are to be very extensive describing the alternatives and risks. The more detailed the informed consent, the better, "More is better,". He/she also stated it should be easily explained to the patient and the expectation is that the institute and department chairs decide what is discussed with the patient(s) and what is withheld.

The following findings reveal that the informed consent does not contain all aspects of the procedure to be performed was with the patients, such as the robotics:





1. The clinical record review for Patient #12 was completed on 05/16/13. The record contained a consent signed by the patient on 05/01/13. The consent listed the surgical procedure as "MVR". The operative report revealed the patient had undergone a robotically-assisted mitral valve (MVR) repair, complex repair. The record did not contain evidence of discussions of the use of a robot with the patient.

2. The clinical record review for Patient #13 was completed on 05/16/13. The record contained a consent signed by the patient on 05/01/13. The consent listed the surgical procedure as "MVR" . The post anesthesia note stated the patient had undergone a robotic mitral valve repair. The record did not contain evidence of discussions of the use of a robot with the patient.

4. On 05/14/13, cardio-thoracic surgeon was interviewed. The surgeon stated the determining factor on whether to use a robot for surgery is based on the surgeon's judgment which is based on patient safety. If a patient's heart is dilated, the patient is not a candidate for robotic surgery. The surgeons choose the method for surgery based on the safest possible outcomes. He/she stated the possibility of using a robot for surgery is discussed with the patients but not listed on the consents due to the robot is just a "tool" for the surgery. He/she stated the patients are asked for their preference on the surgery and if the patients state not to use a robot then the robot will not be used.

5. On 05/16/13, the facility's Informed Consent Policy dated 03/18/13, was reviewed. The policy stated at 3. "Patients giving informed consent shall be advised of the proposed Health Care Treatment, its material risks, the benefits or expected results, the standard alternatives to the proposed treatment, and the material risks involved with each standard alternative. In addition, the patient shall be told the name of the Responsible Practitioner and the names of others significantly involved in providing the Health Care Treatment and generally the tasks they will perform. When the names of the practitioners cannot be given with specificity, general descriptions may be provided with as much specificity as reasonably possible." The policy also states that patients must be given adequate information concerning the treatment that is to be given in order to exercise their rights to make an informed choice. The practitioner should use clear and understandable language to ensure the patient comprehends the information being discussed.
VIOLATION: OPERATIVE REPORT Tag No: A0959
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review and staff interview it was determined the hospital failed to ensure the operative note for two patients (Patient #'s 4 and 5) were immediately dictated or written by the operating surgeon. In addition the hospital failed to ensure the operative note indicated the specific tasks performed by the surgical assistants listed on the operative note for eleven patients (Patient #s 1, 3, 4, 5, 7, 8, 10, 11, 12, 13 and 14) The total sample size was 15 patients. The hospital performs an average of 1,961 surgical procedures per week, and the census was 998 patients.

Findings include:

1. The medical record review for Patient # 1 was completed on 05/15/13. Patient #1 underwent surgery pancreaticoduodenctomy and cholecystectomy on 05/13/13 at 12:05 PM. The operative note dictated by the primary operating surgeon was dictated on 05/13/13 at 6:48 PM. The operative note contains the names of two assistants, both of which are medical doctors. Neither of the assistants were mentioned in the operative note as to what specific surgical tasks had been performed by them during the surgery. This finding was verified with the nurse manager for neurology on 05/15/13 at 12:15 PM.

2. The medical record review for Patient #4 was completed on 05/15/13. Patient # 4 underwent surgery for removal of antibiotic beads to the left distal tibia osteo[DIAGNOSES REDACTED] pocket on 05/10/13 at 4:56 PM. The operative note was completed by the surgeon on 05/13/13 at 8:23 AM, 3 days after the surgery was performed. The operative note included the names of two surgical assistants, one a medical doctor and the other a physicians assistant. Neither of the assistants were mentioned in the operative note as to what specific surgical tasks had been performed by them during the surgery. This finding was verified with the nurse manager for neurology on 05/15/13 at 12:15 PM.

3. The medical record review for Patient #5 was completed on 05/15/13. Patient # 5 underwent surgery for a laparoscopy cholecystectomy on 05/13/13 at 3:29 PM. The operative note was not yet completed by the surgeon at the time of the record review on 05/15/13 at 12:10 PM. The operative note included the names of three surgical assistants, all listed as surgeons. None of the names listed were mentioned in the operative note as to what specific surgical tasks had been performed by them during the surgery. This finding was verified with the nurse manager for neurology on 05/15/13 at 12:15 PM.

4. The medical record review for Patient #3 was completed on 05/15/13. Patient #3 underwent surgery for recurrent massive abdominal wall hernia on 05/08/13 at 12:05 PM. The operative note dictated by the primary operating surgeon was dictated on 05/08/13. The operative note contains the names of two assistants, both of which are medical doctors. Neither of the assistants were mentioned in the operative note as to what specific surgical tasks had been performed by them during the surgery. This finding was verified with the nurse manager for neurology on 05/15/13 at 12:15 PM.

5. The medical record review for Patient #7 was completed on 05/15/13. Patient #7 underwent surgery laparoscopy cholecystectomy on 05/14/13 at 08:05 AM. The operative note dictated by the primary operating surgeon was dictated on 05/14/13. The operative note contains the names of two assistants, both of which are medical doctors. Neither of the assistants were mentioned in the operative note as to what specific surgical tasks had been performed by them during the surgery.

6. The medical record review for Patient #8 was completed on 05/15/13. Patient #8 underwent surgery labaroscopic radical nephrectomy on 05/13/13 at 12:14 PM. The operative note dictated by the primary operating surgeon was dictated on 05/14/13 at 07:21 AM. The operative note contains the names of one assistant, a medical doctor. The assistant was not mentioned in the operative note as to what specific surgical tasks he/she had performed during the surgery. This finding was verified with the nurse manager for neurology on 05/15/13 at 12:15 PM.





7. The medical record review for Patient #14 was completed on 05/17/13. The clinical record review revealed Patient #14 was admitted to the facility on [DATE] for diagnosis of [DIAGNOSES REDACTED]. The operative report did not indicate what type of anesthesia was used. The operative report stated there were two surgeons involved in the procedure. The report did not indicate which surgeon did which part of the surgery, instead, frequently saying, "we". On 05/17/13 in an interview the Director of Accreditation was shown the operative report and confirmed the findings.





8. The medical record review for Patient #10 was completed on 05/16/13. Patient #10 underwent an [DIAGNOSES REDACTED] repair on 05/13/13 at 6:34 AM. The record contained an operative report. The operative report listed one surgeon and two assistants, a doctor and a physician assistant. The operative report did not list a description of the specific significant surgical tasks that were conducted by practitioners other than the primary surgeon.

9. The medical record review for Patient #11 was completed on 05/16/13. Patient #11 underwent a exploratory laparoscopy on 05/13/13 at 1:50 PM. The record contained an operative report. The operative report listed two primary surgeons and three assistants, three doctors. The operative report did not list a description of the specific significant surgical tasks that were conducted by practitioners other than the primary surgeons.

10. The medical record review for Patient #12 was completed on 05/16/13. Patient #12 underwent a robotic mitral valvoplasty repair on 05/01/13 at 9:30 AM. The record contained an operative report. The operative report listed one surgeon and one assistant, a fell ow. The operative report did not list a description of the specific significant surgical tasks that were conducted by practitioner other than the primary surgeon.

11. The medical record review for Patient #13 was completed on 05/16/13. Patient #13 underwent a robotic mitral valvoplasty repair on 05/09/13 at 3:30 PM. The record contained an operative report. The operative report listed one surgeon and one assistant, a fell ow. The operative report did not list a description of the all the specific significant surgical tasks that were conducted by practitioner other than the primary surgeon.

On 05/16/13, the facility ' s Operative/Procedure Documentation Policy dated 03/18/13, was reviewed. The policy stated the primary surgeon is responsible for complete and accurate operative / procedure documentation. Prior to a change in the level of care a Brief Op Note must be completed including the elements listed below:
- Name of Primary Surgeon
- Name of assistants
- Postoperative diagnosis
- Procedure performed
- Description of each procedure finding
- Complications
- Estimated blood loss
- Specimen removed

If the complete operative report is completed and available prior to a change in the patient ' s level of care, an interim post-operative note is not required. An Operative report must be initiated within 24 hours or less, be signed/dated/timed within 30 days and must contain the following elements:
- Patient name
- Medical Record Number
- Date
- Name of primary and other surgeons and assistants or other practitioners who performed significant surgical tasks (even when performing those tasks under supervision).
- Preoperative Diagnosis
- Postoperative Diagnosis
- Name of specific surgical procedures performed
- Type of anesthesia administered
- Complications
- Estimated blood loss
- Specimen(s) removed and tissues removed or altered
- Prosthetic devices, grafts, tissues, transplants, or devices implanted if any

Based on the above findings the hospital failed to follow their policies the operative report.