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Based on staff interviews, review of the facility's code of regulations, review of medical staff bylaws, review of physicians' personnel files, and review of meeting minutes of the credentialing committee, board of governors, and board of directors, the facility failed to ensure its governing body (the Board of Directors) appointed members of the medical staff and failed to ensure it adopted medical staff bylaws that complied with Medicare hospital Conditions of Participation.
Findings:
See A46, A47

Based on staff interviews, review of the facility's Code of Regulations, review of medical staff bylaws, review of physicians' personnel files, and review of meeting minutes of the credentialing committee, board of governors, and board of directors, the facility failed to ensure its governing body appointed members of the medical staff. This has the potential to affect all patients treated at the facility.
Findings:
A review of the facility's Code of Regulations, as amended on 05/03/10 stated, "The Board of Directors shall have general charge of the business and financial affairs of the (facility) and shall possess all powers in the management and control of its business and property ...". The review of the facility's Code of Regulations also revealed the Board of Governors is to make recommendations regarding appointments of the professional staff to the Board of Directors.
A review of the medical staff bylaws completed on 02/23/12, revealed under Article III, Section 1, "For initial appointments and granting of privileges, reappointment and renewal or modification of privileges, the (Board of Governors') delegates authority to render such decisions to the (Board of Governors') Credentialing Committee." Section 1 also stated, "The reappointment of Medical Staff Members is subject to ratification by the Board of Directors."
Review of a document entitled, "Brief Description of Governance of the Cleveland Clinic," was presented to the survey team by the Director of Accreditation on 02/22/12 at 10:30 A.M. and reviewed. The document stated the Board of Governors can delegate certain matters to the Credentialing Committee.
On 02/23/12 at 9:00 A.M. in an interview, the Chief Legal Officer stated the Board of Directors meets Centers for Medicare and Medicaid Services standard. "It's the governing body," he/she said.
The personnel/credential files for Physician #1, #2, #3, and Institute Chairman #1 was completed on 02/23/12. The review revealed each received letters dated 06/30/11 that stated they had been privileged from 07/01/11 to 06/30/13.
A review of the minutes of the credentialing board of the Board of Governors to their June 28, 2011 meeting revealed the board did recommend their re-privileging.
A review of the minutes of the Board of Governors meeting of 07/27/11 (27 days after Physician #1, #2, #3, and Institute Chairman #1 were reprivileged) was completed on 02/23/12. The review revealed the minutes to state, "The minutes of the Credentialing Board Meetings on June 28, July 1, July 12, July 15, and July 18, 2011 were reviewed and accepted by the Board of Governors."
A review of the Board of Directors meeting minutes of their meetings on 05/02/11, and 06/06/11, and 09/12/11, did not reveal any discussion of any physician's re-privileging or re-credentialing.
On the morning of 02/23/12, in an interview, the Credentialing Manager confirmed the letters of re-privileging were sent prior to their confirmation by the Board of Governors and that the Board of Directors did not discuss the reprivileging because he/she said the Board of Governors had the final say on who got re-privileged. He/she explained the privileges for Physicians #1, #2, #3, Institute Chairman #1 and Chief of Staff were approved by the Credentialing Committee/Board, but their recommendations for approval were not ratified by the Board of Directors, nor by the Board of Governors because an "expedited process" for privileging and credentialing was used.

Based on staff interviews, review of medical staff bylaws, and review of medical staff policy, the facility failed to ensure its governing body assured the medical staff bylaws complied with Medicare hospital Conditions of Participation in regard to the governing body's reapproving physicians' privileges and reappointment to the medical staff. This has the potential to affect all patients treated at the facility.
Findings:
A review of the medical staff bylaws as approved on 10/11/10 was completed on 02/23/12. The review revealed under Article III, Section 1, "For initial appointments and granting of privileges, reappointment and renewal or modification of privileges, the (Board of Governors) delegates authority to render such decisions to the (Board of Governors') Credentialing Committee." Section 1 also stated, "The reappointment of Medical Staff Members is subject to ratification by the Board of Directors."
On the morning of 02/23/12, in an interview, the Credentialing Manager stated that the Board of Directors did not discuss privileging and re-privileging of physicians because he/she said the Board of Governors had the final say on who got re-privileged. He/she explained the privileges for Physicians #1, #2, #3, Institute Chairman #1 and Chief of Staff were approved by the Credentialing Committee/Board, but their recommendations for approval were not ratified by the Board of Directors, nor by the Board of Governors because an "expedited process" for privileging and credentialing was used.
Review of medical staff policy entitled, "Expedited Credentialing Policy," effective 10/05, and last reviewed on 01/12, was completed on 02/23/12. The review revealed, "The Board of Governors authorizes a sub-committee named the Credentialing Board to review and approve final credentialing and recredentialing actions."

Based on staff interviews, review of clinical records, review of physicians' personnel files, review of the the facility's code of regulations, review of medical staff bylaws, and review of the meeting minutes of the facility's board of directors, board of governors, and credentialing committee, the facility failed to ensure its medical staff operated under bylaws that contained all criteria used to evaluate a prospective physician for medical staff membership, such as where the physician received his/her medical education, failed to apply bylaws equally, such as considering a physician's gender as a criterion for medical staff membership, and failed to make sure its medical staff made recommendations for membership to its governing body, the Board of Directors.
Findings:
See A340, A341, A357, and A363.

This substantiates complaint number OH00064169.

Based on interviews and review of personnel files, the facility failed to ensure Institute Chairman #2 and the Chief of Staff underwent a periodic review. This has the potential to affect all patients seen at the facility.
Findings:
A review of the facility's Major Policies for the Professional Staff, dated 2009, was completed on 02/23/12. The review revealed a section entitled, "Annual Professional Review Process." The section stated: "Once each year, on a quarterly basis, every member of the Professional Staff is scheduled for an annual professional review."
Review of the reappointment credentials for Institute Chairman #2 on February 22, 2012 at 5:00 p.m. revealed the absence of a reviewer for the evaluation component of the reappointment. This finding was verified with the Credentialing Manager on February 23, 2012 at 12:10 p.m.
Review of the reappointment credentials for the Chief of Staff on February 22, 2012 at 5:05 p.m. revealed the absence of a reappointment packet without evidence of a letter of approval or review. During interview with the Credentialing Manager on February 23, 2012 at 12:10 p.m., he/she stated that the Chief of Staff's "last reappointment ended on 4/1/09."
This substantiates complaint number OH00064169.

Based on staff interviews, review of the medical staff bylaws, review of the facility's code of regulations, review of physicians' personnel files, and review of meeting minutes of the facility's credentialing board, board of governors, and board of directors, the facility failed to make recommendations to its governing body, the Board of Directors, on the re-privileging of all physicians and the Chief of Staff in particular. This has the potential to affect all patients treated at the facility.
Findings:
Review of the reappointment credentials for the Chief of Staff on February 22, 2012 at 5:05 p.m. revealed the absence of a reappointment packet without evidence of a letter of approval or review.
During interview with the Credentialing Manager on February 23, 2012 at 12:10 p.m., he/she stated that the Chief of Staff's "last reappointment ended on 4/1/09."
Review of the Medical Staff Bylaws, The Cleveland Clinic Foundation, Section C, Qualification, states, "Each Officer of the Medical Staff shall be a Member of the Medical Staff, qualified by training, experience, and demonstrated ability for their respective position. All Officers must remain in good standing as Members of the Medical Staff during their term of office."
The Medical Staff Bylaws, The Cleveland Clinic Foundation, Section D, Duties of Officers, Chief of Staff, states "The Chief of Staff shall serve as the Chief Medical Officer of CCF. In that capacity, he or she shall perform such functions as are typically performed by a chief executive officer for clinical affairs. The Chief of Staff shall perform the duties described specifically in these Bylaws and the Code of Regulations of CCF. . ."
The Medical Staff Bylaws, The Cleveland Clinic Foundation, Section E, Removal of Officers, states, "The Chief of Staff shall be removed by the BOG/MEC for failure to remain a Member of the Medical Staff in good standing." There was no evidence that the Chief of Staff remained in good standing as a member of the Medical Staff.
A review of the document entitled "management structure" was presented to the survey team by the Director of Accreditation on 02/22/12 at 8:00 A.M. and reviewed. It described a board of trustees as, "Either directly or through delegation ...responsible for the operations of the (facility)." The document also stated, "The Board of Governors also acts as the credentialing committee for the Medical Staff and serves as a liaison between the Medical Staff and the Board of Trustees."
A review of the facility's Code of Regulations, as amended on 05/03/10 stated, "The Board of Directors shall have general charge of the business and financial affairs of the (facility) and shall possess all powers in the management and control of its business and property ...". The review of the facility's Code of Regulations also revealed the Board of Governors is to make recommendations regarding appointments to the professional staff to the Board of Directors (not the Board of Trustees).
A review of the medical staff bylaws completed on 02/23/12, revealed under Article III, Section 1, "For initial appointments and granting of privileges, reappointment and renewal or modification of privileges, the (Board of Governors) delegates authority to render such decisions to the (Board of Governors) Credentialing Committee." Section 1 also stated, "The reappointment of Medical Staff Members is subject to ratification by the Board of Directors."
Review of a document entitled, "Brief Description of Governance of the Cleveland Clinic," was presented to the survey team by the Director of Accreditation on 02/22/12 at 10:30 A.M. and reviewed. The document stated the Board of Governors can delegate certain matters to the Credentialing Committee.
On 02/23/12 at 9:00 A.M. in an interview, the Chief Legal Officer stated the Board of Directors meets Centers for Medicare and Medicaid Services standard. "It's the governing body," he/she said.
Review of the personnel/credential files for Physician #1, #2, #3, and Institute Chairman #1 was completed on 02/23/12. The review revealed each received letters dated 06/30/11 that stated they had been privileged from 07/01/11 to 06/30/13.
A review of the minutes of the credentialing board of the Board of Governors to their June 28, 2011, meeting revealed the board did recommend their re-privileging.
A review of the minutes of the Board of Governors meeting of 07/27/11 (27 days after Physician #1, #2, #3, and Institute Chairman #1 were reprivileged) was completed on 02/23/12. The review revealed the minutes to state, "The minutes of the Credentialing Board Meetings on June 28, July 1, July 12, July 15, and July 18, 2011 were reviewed and accepted by the Board of Governors."
A review of the Board of Directors meeting minutes to their meetings on 05/02/11, and 06/06/11, and 09/12/11, did not reveal any discussion of anybody's re-privileging or re-credentialing.
On the morning of 02/23/12, in an interview, the Credentialing Manager confirmed the letters of re-privileging were sent prior to their confirmation by the Board of Governors, and that the Board of Directors did not discuss the reprivileging because the Board of Governors had the final say on who got re-privileged. He/she explained the privileges for Physicians #1, #2, #3, Institute Chairman #1 and Chief of Staff were approved by the Credentialing Committee/Board, but their recommendations for approval were not ratified by the Board of Directors, nor by the Board of Governors because an "expedited process" for privileging and credentialing was used.
A review of the medical staff policy entitled, "Expedited Credentialing Policy," effective 10/05, and last reviewed on 01/12 was completed on 02/23/12. The review revealed, "The Board of Governors authorizes a sub-committee named the Credentialing Board to review and approve final credentialing and recredentialing actions."

Based on staff interviews and review of the medical staff bylaws, the facility failed to describe all qualifications, such as type and quality of medical education each physician must have, and apply said bylaws equally to each practitioner in each professional category. This has the potential to affect all patients treated at the facility.
Findings:
On 02/22/12 at 2:00 P.M. in an interview with Institute Chairman #1, he/she stated he/she looked for a robotic surgeon that was a young woman to place on the medical staff.
The review of the facility's medical staff bylaws revealed, "Appointment as a Member of the Medical Staff shall be without regard to color, race, religion, national origin, age, sex ...."
On the morning of 02/22/12, in an interview, Department Chairman #1 discussed how candidates are nominated to the medical staff from his/her department. When asked what kind of characteristics Department Chairman #1 and those who assist him/her look for in a candidate to nominate to the medical staff, Department Chairman #1 stated, "I don't have a checklist" and "to some extent it's intangible" and the "checklist is a mental, a gestalt of many different factors." Department Chairman #1 stated he/she likes to select candidates from certain medical education programs, because they know which programs are good ones; however, Department Chairman #1 said he/she did not have a list of said programs, and said the credentialing committee did not provide him/her with a list of programs.
On 02/22/12 at 3:20 P.M., in an interview, Institute Chairman #2 stated he/she forwarded people for medical staff membership based on people he/she knew personally and on criteria that he/she "had ... all up here" and pointed to his/her temple. Institute Chairman #2 also stated a person for prospective membership was declined because he/she knew the person and just didn't think they would fit into the facility.
Institute Chairman #2 also stated that he/she had been chairman of the institute for the past three years and had not received any criteria from his/her predecessor on the selection for nominating candidates to the medical staff.
On 02/22/12 at 9:10 A.M., in an interview, the Chief of Staff also said he/she expected candidates for the medical staff to come from top medical education programs.
A review of the medical staff bylaws confirmed education as a criterion for medical staff membership, but did not list any specific programs, or what academic ranking and/or status a program had to have for a candidate to be credentialed and privileged. Other listed criteria include references who can attest to the applicant's reputation and character, prior criminal convictions, and pending or previous malpractice judgments.

Based on staff interviews, clinical record review, and review of physicians' personnel files, the facility failed to include in its bylaws all criteria used to determine whether to grant privileges to physicians and/or follow what criteria are listed, such as the irrelevance of a physician's age or sex. This has the potential to affect all patients treated at the facility.
Findings:
A review of the facility's documentation entitled, "Criteria for Privileges in Robotically Assisted Gynecologic Surgery", as reviewed and approved by Institute Chair #1, stated two pathways are available for physicians applying for privileges to perform robotically assisted gynecologic surgery at the facility. The document describes the first pathway to privileges to include, among other things, having been proctored for a minimum of seven cases as the console surgeon, and five cases as the bedside surgeon. The document describes the second pathway to privileges to include, among other things, "evidence of at least twenty procedures using the robotic surgical system within the prior 12 months ...."
A review of Physician #1's personnel file was completed on 02/23/12. The review revealed that he/she had his/her privileges granted from 07/01/11 to 06/30/13. A review of the kinds of privileges that could be granted revealed there wasn't a line to include robotically assisted gynecologic surgery.
The clinical record review for Patient #1 was completed on 02/23/12. The review revealed Physician #1 conducted a robotic laproscopic total hysterectomy on the patient.
A review of Physician #2's personnel file was completed on 02/23/12. The review revealed Physician #2's privileges were granted from 04/01/11 to 03/31/13. A review of the kinds of privileges that could be granted revealed there wasn't a line to include robotically assisted surgery.
On the morning of 02/23/12, in an interview, the Credentialing Manager stated the kind and number of robotic surgeries a candidate for privileges has done is kept by the candidate's chairperson. He/she said who can and who cannot perform robotic surgeries is known by the department chairpersons. The Credentialing Manager confirmed that that information is not kept in their credentialing file.
A review of the facility's medical staff bylaws was completed on 02/23/12. The review revealed, "The Institute/Department Chair shall review the applicant's qualifications and shall submit a written report of his/her recommendation to (the Office of Professional Staff Affairs) including a recommendation for the delineation of specific clinical privileges at the (facility)."
On 02/22/12 at 2:00 P.M. in an interview with Institute Chairman #1, he/she stated he/she looked for a robotic surgeon that was a young woman to place on the medical staff.
The review of the facility's medical staff bylaws revealed, "Appointment as a Member of the Medical Staff shall be without regard to color, race, religion, national origin, age, sex ...."
On the morning of 02/22/12, in an interview, Department Chairman #1 discussed how candidates are nominated to the medical staff from his/her department. When asked what kind of characteristics Department Chairman #1 and those who assist him/her look for in a candidate to nominate to the medical staff, Department Chairman #1 stated, "I don't have a checklist" and "to some extent it's intangible" and the "checklist is a mental, a gestalt of many different factors." Department Chairman #1 stated he/she likes to select candidates from certain medical education programs, because they know which programs are good ones; however, Department Chairman #1 said he/she did not have a list of said programs, and said the credentialing committee did not provide him/her with a list of programs.
On 02/22/12 at 3:20 P.M. in an interview, Institute Chairman #2 stated he/she forwarded people for medical staff membership based on people he/she knew personally and on criteria that he/she "had ... all up here" and pointed to his/her temple. Institute Chairman #2 also stated a person for prospective membership was declined because he/she knew the person and he/she didn't think they would fit into the facility.
Institute Chairman #2 also stated that he/she had been chairman of the institute for the past three years and Institute Chairman #2 had not received any criteria from his/her predecessor on the selection for nominating candidates to the medical staff.
Institute Chairman #2 also stated there wasn't a set number of times the applicant must do a procedure under supervision before being given full privileges to do it.
A review of the medical staff bylaws confirmed education as a criterion for medical staff membership, but did not list any specific programs. Other listed criteria include references who can attest to the applicant's reputation and character, prior criminal convictions, and pending or previous malpractice judgments.
This substantiates complaint number OH00064169.