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Based on interview, policy review, review of complaint document labeled "File ID: 71310," and review of the complaint log, the facility failed to show evidence that the hospital took appropriate and reasonable actions to resolve Patient #32's complaint. Although the facility sent patient #32 a letter stating the results of the review, the facility declined to provide all information related to their investigation of Pt #32's allegations so that a determination could be made as to whether the investigation addressed each allegation made by the complainant. The sample size was five complaints of five sampled patients who had filed a complaint with the facility: (Patients #32, #33, #34, #35, and #36.)

Findings:
On 01/21/10 a review of the facility's grievance policy was completed on 01/21/10. The review revealed the policy stated, "It is the policy of the [facility] that all patients and families have a right to voice a complaint or grievance ...." The policy stated the facility's ombudsman department has the authority to address and resolve grievances. The policy stated, "Any concern regarding the patient's care ... requires investigation and resolution to the complainant." The facility's document titled Ombudsman Department Process Map indicates that one of the processes is to interview all parties involved.

Review of the complaint as entered into the log and labeled "File ID: 71310" revealed patient
#32 complained (in an e-mail dated 03/18/09) that, among other things, he felt Surgeon #16 had a resident partially or completely perform the surgery. The review of the file revealed he also complained on 07/27/09 via telephone that he wanted to know what Surgeon #30 did during the surgery.

Review of File ID: 71310 revealed a note by Ombudsman #35 dated 07/27/09, stating a phone call was made to patient #32 explaining Surgeon #16 did the nerve sparing part and all other critical points of the surgery. The review of the file also revealed a letter dated 08/04/09 that was sent to the patient #32 referencing their conversation of 07/27/09.

File ID: 71310 revealed no notes indicating any interviews with personnel present in the operating room at the time of patient #32's surgery, other than Surgeon #16 and Surgeon #31. The content of the interview with Surgeons #16 and #31 were unavailable for review.

In the afternoon on 01/19/10 in an interview, Director of Consumer Affairs #34 stated Ombudsman #35, who had managed the complaint, was no longer with the facility. She stated Ombudsman #35 did keep notes on the complaint and that the facility mails acknowledgement of receipt of the grievance to its author within seven days. Patient #32 was mailed an acknowledgement within 7 days per hospital policy.

On 01/20/10 at 3:30 P.M. Surgeon #16 was interviewed. Surgeon #16 stated an ombudsman did speak with him regarding Patient #32's complaint. He declined to state what they spoke about.

When requested by the surveyor, the facility failed to provide evidence that the hospital made appropriate and reasonable attempts to resolve patient #32's complaint. On 01/21/10 at 1:05 P.M. in an interview, the Chief Quality Officer declined to allow the surveyor to see all the notes of File ID: 71310.

This deficiency substantiates complaint OH00051578.

Based on facility policy and clinical record review, the facility failed to ensure that 28 of 28 sampled surgical patients signed a written patient consent that included the name of the specific procedure, the name of the responsible practitioner who is performing the procedure, and a statement that the procedure's anticipated benefits and material risks were explained. The review of the facility's policies on consent and review of the clinical records for Patients
#1-15 and patients #20-25 support this finding. In addition, the facility failed to ensure that seven of nine patient medical records (patients 11, 12, 13, 15, 29, 31 and 32) included a completed procedure attestation document as required by hospital policy

Findings include:

Based on policy and clinical record review the facility failed to ensure patients signed a consent form that included the name of the specific procedure, name of the responsible practitioner who is performing the procedure, and a statement that said procedure's anticipated benefits and material risks were explained. This affected 28 of 28 patients whose clinical records were reviewed for surgical consent: Patients #1 to #15, and Patients #20 to #32.
See A466

Based on clinical record review and staff interview, the hospital failed to maintain a complete and accurately written inpatient record for seven of nine patients that included a procedure attestation document completed by the primary surgeon performing their surgical procedure. These included Patient #11, #12, #13, #15, #29 , #31 and #32.
See A438

Based on medical record review and staff interview, the hospital failed to maintain a complete and accurately written inpatient record for seven of nine patients that included a procedure attestation document completed by the primary surgeon performing their surgical procedure. These included Patient #11, #12, #13, #15, #29 , #31 and #32.

Findings include:

Per interview with Accreditation Staff #6 on 01/21/10 at 10:05 AM, a document called the procedure attestation form is a required document and is found in the hard copy medical record. It has not been replaced in the electronic medical record.

Per medical record review, Patient #11 had a robotic assisted radical prostatectomy completed on 01/19/10. The procedure attestation for Patient #11 did not include any detail regarding the extent of involvement by this physician. This was verified by Accreditation Staff #4 and #6 on 01/21/10 when providing the surveyor with a copy of this document.

Per medical record review on 01/20/10, Patient #12 had urologic surgery on 01/02/08. The procedure attestation form included in the hard copy of the patient medical record did not include details regarding the extent of involvement in this surgery by the surgeon. This was verified by Accreditation Staff #4 and #6 on 01/21/10 when providing the surveyor with a copy of the document.

Per medical record review on 01/20/10, Patient #13 had urologic surgery on 01/03/08. The procedure attestation form included in the hard copy medical record did not include details regarding the extent of involvement in this surgery by the surgeon. This was verified by Accreditation Staff #4 and #6 on 01/21/10 when providing the surveyor with a copy of the document.

Per medical record review on 01/20/10, Patient #15 had urologic surgery on 01/04/08. The procedure attestation form included on the hard copy medical record did not include details regarding the extent of involvement in this surgery by the surgeon. This was verified on 01/21/10 by Accreditation Staff #4 and #6 when providing the surveyor with a copy of the document.

Per medical record review on 01/20/10, Patient #29 had urologic surgery on 01/04/08. The procedure attestation form was signed by the surgeon, but nothing was checked regarding the surgeon's presence in the operating room during the patient's procedure. This was verified by Surgeon #16 on 01/20/10 at 3:45 PM who stated this form was not an integral part of the medical record and had been replaced by a computer form.

Per medical record review on 01/21/10, Patient #31 had urologic surgery on 01/08/08. The procedure attestation form did not contain information relating to what extent the surgeon was present during the surgical procedure. This was verified by Accreditation Staff #4 and #6 on 01/21/10 when providing the surveyor a copy of the document.

Per interview on 01/21/10 at 11:45 AM with the Chief Quality Officer, who is a surgeon, it is the responsibility of the primary surgeon to complete the procedure attestation and to include the extent to which the surgeon was present during the surgery. If the physician has been present during the entire surgery, this is to be documented and if present during only the critical portions, the critical portions are to be delineated in the attestation statement.


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The clinical record review for Patient #32 was completed on 01/21/10. The clinical record review revealed the patient had a transperitoneal robotic prostatectomy on 01/08/08. Review of the Patient #32's clinical record revealed a form entitled "Procedure Attestation". Review of that form revealed text that read:

"I was present during the critical portion of the above procedure and another teaching physician or I was immediately available for the entire procedure. The critical portion is as follows:"

The text is preceded by a check box, and followed by lines. The form was signed by Surgeon #16 and dated 01/08/08, but the section where critical portions are to be delineated was blank.

On 01/21/10 at 11:45 AM , in an interview with both the Chief Quality Officer and surgeon #16, it was determined that it is the responsibility of the primary surgeon to complete the procedure attestation and to include the extent to which the surgeon was present during the surgery. If the physician has been present during the entire surgery, this is to be documented and if present during only the critical portions, the critical portions are to be delineated in the attestation statement. During this interview it was confirmed Patient #32's procedure attestation form did not include this.

This deficiency substantiates complaint OH00051578.

Based on policy and clinical record review the facility failed to ensure that 28 of 28 surgical patients signed a written consent that included the name of the specific procedure, the name of the responsible practitioner who is performing the procedure, and a statement that the procedure's anticipated benefits and material risks were explained. Review of the facility's policies on consent and review of the clinical records for Patients #1 to #15, and Patients #20 to #32 support this finding.

Finding:

The clinical record review for Patient #32 as presented in both electronic and paper form, was completed on 01/21/10. The electronic clinical record review revealed an encounter screen that indicated the Patient #32 had an office visit with Surgeon #16 on 12/06/07. Review of that office visit documentation revealed a new patient history and physical exam. The history and physical stated a final diagnosis of mild to moderate chronic prostatitis to the right prostate, and infiltrating adenocarcinoma to the left prostate. The history and physical stated "discussed at length regarding treatment (sic) options including radiation brachy (sic), and surgery. Risks, benefits, alternatives and personnel discussed with patient who consents to proceed with surgery Transperitoneal robotic prostatectomy" The documentation indicated this was digitally signed by Surgeon #16 and Surgeon #30 however there was no evidence that the patient signed a consent acknowledging the information as described above by the physician.

A printout of electronic documentation entitled "Consent Form" stated:

"The risks, benefits and anticipated outcomes of the procedure, the risks and benefits of the alternatives to the procedure and the roles and tasks of the personnel to be involved were discussed with the patient and the patient consents to the procedure and agrees to proceed.

I verify that I personally obtained the patient's consent.
Jihad H. Kaouk, MD"

The electronic documentation did not show evidence of a patient signature.

Additionally, further review of the medical record revealed a document titled "surgical episode". This document contained a section that states the "Surgeon affirms Risks/Benefits/Alternatives/Personnel/Consent discussed; patient agrees to proceed: Please circle: YES/NO" Surgeon #16 signed and dated the document, but did not affirm by indicating yes or no the patient consented to the surgery.

Further review of the clinical record revealed a "Patient Acknowledgment and Consent" form signed by patient #32 and was dated 01/07/08. Patient #32's signature acknowledged "By signing below, I am indicating that I have reviewed and consent to the terms described above." This consent signed prior to surgery consisted of information of the patient's financial responsibility, assignment of benefits/third party payers, acknowledgment of receipt of Medicare/TRICARE information, uses and disclosures of health information, teaching facility/clinical studies and valuables/limitation of liability. This consent did not include the type of procedure, name of the specific procedure, the name of the responsible surgeon who was performing the procedure, a statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient, and the time the informed consent form was signed by the patient.

The facility was unable to locate any other consent forms either in paper or in electronic format.

Review of the facility's "Essentials of Informed Consent" was completed on 01/21/10. This policy stated, "Patients don't sign Consent Forms (sic), unless specifically required by law".

Review of the facility's informed consent and policy and procedure (03/09/04 revision) stated:
"Written Informed Consent forms, signed by patients, are not utilized at Cleveland Clinic unless specifically required by law."

And,

"To comply with Cleveland Clinic's policy for documenting Informed Consent (sic), whether in the paper chart or in the electronic medical record, a summary statement which references (1) risks, (2) benefits, (3) alternatives, and (4) the agreement or consent is acceptable."

The clinical record reviews for Patients #1 - #15, and Patients #20 - #32, show there were no forms with patient signatures regarding consent for surgery. A summary statement in the medical record which references patient consent or agreement is not sufficient to comply with this requirement.