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Based on review of hospital policy, medical staff bylaws, rules and regulations, record review, operating room log review and physician and staff interviews, the hospital failed to ensure an informed consent form for surgery was obtained for 2 of 2 non-scheduled, non-emergent surgical procedures performed (Patients #1, #8).
Review of the hospital's policy, "Informed Consent", revised 02/2013, revealed, "Policy It is the policy of (Name of Hospital) that a form should be procured prior to every substantial medical or surgical procedure beyond routine treatment. Use of such a form will satisfy the requirements of an informed consent. The form should not be completed in the Admitting Office of the hospital. It is meant to serve as a record of the full and complete discussion between the patient and the physician, and should not be completed in advance of such discussion. Generally, the involved physician involved in the procedure should take responsibility for completing the special consent form and having it executed by the patient. The consent should be in writing and signed by the patient (when possible) or the legally authorized representative according to the law as outlined in policy. Interpretation 1. Informed consent refers to an affirmative duty of disclosure on the part of the physicians. 2. Informed consent is a shared decision making process made between the patient ...and the physician. The consent should be based upon the principal that competent individuals are entitled to make healthcare decisions based upon their own personal values and goals. 3. To adequately inform a patient, a physician should disclose the patient ' s condition, the nature and purpose of the proposed procedure, risks of treatment, side effects of the proposed care, treatment and services, the likelihood of the patient achieving his or her goals, the alternatives to the procedure, and any potential problems that may occur during recuperation. The physician should also disclose the risks, benefits and side effects related to the alternatives and not receiving the proposed care, treatment and services. The informed consent should be contained in the patient's medical record and documented either on the Informed Consent form, progress notes, or in the practitioner's notes. In all cases, it should be clearly stated which practitioner informed the patient for purposes of obtaining consent, and it should be indicated that the patient understood the information provided. ...The hospital ' s role in the consent process is to verify that the responsible practitioner has obtained the patient ' s informed consent before the practitioner performs the procedure. An Informed Consent form should be executed by the patient or the legally recognized representative of the patient before any of the following types of procedures are performed: 1. Major or minor surgery involving any entry into the body through either an incision or a natural body opening. 2. All procedures in which regional or general anesthesia is used. ...7. All other procedures that the Medical Staff determines require a specific explanation to the patient. (Any doubts as to the necessity of obtaining a special consent form from the patient for procedures should be resolved in favor or procuring the consent) ... " .
Review of the hospital's Medical Staff Bylaws, Rules and Regulations, effective 11/19/2013, revealed, " ...VI. MEDICAL RECORDS ...B. Medical Records of Inpatients and Outpatients Scheduled Procedures Requiring General and Regional Anesthesia and Sedation ...3. Consent for Procedure a) A properly executed consent form for the procedure must be in the patient ' s chart prior to the procedure except in emergencies. b) A properly executed consent form contains at least the following information: (1) Name of patient ...(2) Name of hospital; (3) Name of procedure; (4) Name of practitioner(s) performing the procedure(s) or important aspects of the procedure(s), as well as the name(s) and specific surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner. (Significant surgical tasks include: opening and closing, harvesting grafts, dissecting tissues, removing tissue, implanting devices, altering tissues); (5) Risks; (6) Alternative procedures and treatments; (7) Signature of patient ...(8) Date and time consent is obtained; (9) Statement that procedure was explained to patient ...(10) Signature of professional witnessing the consent; and (11) Name/signature of person who explained the procedure to the patient ...c) The practitioner performing the procedure is responsible for obtaining the consent. ... " .
1. Closed record review of Patient #1 revealed an 80 year-old male admitted to the hospital on 02/07/2014 with bladder cancer. Further record review revealed a H&P (History and Physical) dictated by Physician A, a urologist, on 01/24/2014, "...To undergo radial cystectomy (bladder removal) for invasive bladder cancer and left nephrectomy (kidney removal) for atrophic kidney. ...Abdomen: Palpation: Abdominal palpation revealed no abnormalities. No mass was palpated in the abdomen ... " . Further record review revealed a statement on the last page of the H&P, "I have examined the patient and reviewed the H&P ". Review revealed the box was checked "No Changes" and was signed by Physician A on 02/07/2014 at 0715. Further record review revealed an "Informed Consent for Surgery, Anesthesia and/or Special Procedure" with the name of Hospital A, "I authorize the performance upon myself, (Patient #1) the following procedure(s)/treatment(s)/operation(s): Left Nephrectomy, radical cystectomy with ileal loop to be performed by Dr. (Physician A) and/or such assistants as may be selected by him/her to perform such surgery or procedure ... " . Further review revealed Patient #1's signature, dated 01/24/2014 at 1315, and Physician A's signature dated 02/05/2014 at 1445. Further record review revealed an Intraoperative Record dated 02/07/2014. Review of the intraoperative record revealed, " ...Procedure: Cystectomy, ileo conduit, left nephrectomy and left hernia repair by (Physician B, a general surgeon) " . Further review of the intraoperative record revealed, " ...Operative Procedure Site Verified By: Patient, Staff, Consent, MD ... Personnel: Surgeon: (Physician A) Assistants: (Physician B- urologist) ... " . Review of the intraoperative record revealed no documentation that Physician C was the surgeon performing the left inguinal hernia repair. Further record review revealed an operative report handwritten by Physician A on 02/07/2014 at 1200 that a left nephrectomy, radical cystectomy and ileal loop was performed on Patient #1. Record review revealed a dictated operative report dated 02/07/2014 at 1824 by Physician C that a left inguinal hernia repair was performed on Patient #1. Further record review revealed no documentation of an informed consent signed by Patient #1 for Physician C to perform a left inguinal hernia repair.
Review of the hospital's operating room log for 02/07/2014 revealed Patient #1 was scheduled for a left nephrectomy and radical cystectomy with ileo loop in Operating Room #7 with Physician A as the surgeon, with Physician B as the assistant. Review of the log revealed Patient #1 was scheduled for the surgery on 01/23/2014 at 0821. Review of the log revealed no hernia repair for Patient #1by Physician C was scheduled.
Inteview on 04/23/2014 at 0905 with Registered Nurse (RN) #1 revealed the RN was the circulating nurse in Operating Room #7 on 02/07/2014 when Patient #1 had surgery. Interview revealed, "(Physician A) told me to call (Physician C) in for the hernia repair. We did not have a consent signed for the hernia repair. I thought until yesterday (04/22/2014), the hernia was found during surgery. I know now that they already knew about the hernia before the patient came to surgery". Interview further revealed, "If I had known, I would definitely had asked about the consent. The hernia repair was done by (Physician C) after (Physician A and B) had finished their surgery".
Interview on 04/23/2014 at 1215 with Physician C revealed he was Physician A's partner and assisted with him the left nephrectomy, cystectomy and ileo conduit loop for Patient #1 on 02/07/2014. Interview further revealed, "we knew (Physician C) was coming in to repair the inguinal hernia when we were finished. I didn't know an informed consent had not been done".
Interview on 04/23/2014 at 1445 with RN #2 revealed the RN was the charge nurse in the operating room on 02/07/2014. Interview revealed, "I was not made aware that (Physician C) was coming in to do a hernia repair on (Patient #1)".
Inteview on 04/23/2014 at 1420 with Administrative Surgery Staff revealed, "An informed consent should have been done with (Patient #1's) hernia repair. Surgery add ons should only be those that are incidental or emergent, like an inflammed appendix or unanticipated bleed".
Interview on 04/24/2014 at 1030 with Physician A revealed he and Physician C had talked about Patient #1's hernia repair prior to surgery. Interview revealed, "I got consent for my surgery. I assumed (Physician C) had gotten his".
Interview on 04/24/2014 at 0850 with Physician C revealed he was a general surgeon on had seen Patient #1 on several occasions in his office. Interview revealed, "I saw him the end of 2013 and sometime in January 2014. We talked about scheduling the hernia repair. He had many medical issues and needed medical clearance before surgery. He needed to talk with (Physician A). The informed consent was done in my office. I did not schedule any portion of (Patient #1's) surgery. I got a call from (Physician A) in the OR wanting to know if I could come look at (Patient #1). (Patient #1) clearly wanted the hernia fixed". Interview confirmed there was no documented informed consent available for Patient #1's hernia repair.
Interview on 04/23/2014 at 1445 with the hospital's Chief Medical Officer revealed, "any seperate procedure should be consented by the patient". Interview further revealed, "I am very concerned about this incident. (Physician C) has been educated".






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2. Closed record review of Patient #8 revealed an 81 year-old male admitted on 03/24/2014 for a laparoscopic placement of peritoneal dialysis catheter. Review of the "Informed Consent for Surgery, Anesthesia and/or Special Procedure" revealed the patient authorized a "laparoscope peritoneal dialysis catheter placement." Review of the form revealed the patient signed as giving consent for this procedure on 03/12/2014 at 1412. Further review revealed the patient's surgeon signed a statement on the same form on 03/12/2014 at 1100 recording that he had discussed the risks and possible complications of the surgical procedure with the patient. Review of the dictated operative report revealed the patient had a "laparoscopic placement of peritoneal dialysis catheter" and a "repair of umbilical hernia" performed. Further review of the record revealed no informed consent for the umbilical hernia repair.
Interview on 04/23/2014 at 1425 with an administrative surgical staff member revealed an informed consent should have been obtained for the umbilical hernia repair. Interview revealed the surgeon informed the surgery team during "time out" (just prior to the start of the surgery) that he was going to perform an umbilical hernia repair. Interview confirmed the hernia repair was a non-scheduled and non-emergent surgical procedure and an informed consent should have been obtained.

Based on review of the hospital's medical staff bylaws, rules and regulations, medical record review and physician and staff interview, the surgeon failed to complete an immediate operative report including procedure performed, findings, type of anesthesia and/or sign the immediate operative report in 5 of 15 surgical patients reviewed (Patients #13, 14, 10, 12, 2).

The findings include:
Review of the hospital's Medical Staff Bylaws, Rules and Regulations, effective 11/19/2013, revealed, " ...VI. MEDICAL RECORDS ...B. Medical Records of Inpatients and Outpatients Scheduled Procedures Requiring General and Regional Anesthesia and Sedation ...5. Operative Reports a) An operative or other high-risk procedure progress note is entered in the medical record immediately after the procedure, if the full operative or other high risk procedure report cannot be entered into the record immediately after the procedure. b) A final operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. The operative report includes at least: (1) Name and identification number of the patient. (2) Date and times of surgery. (3) Name(s) of the surgeon(s) and assistants or other practitioners who performed surgical tasks (even when performing those tasks under supervision). (4) Pre-operative and Post-operative diagnosis; (5) Name of the specific surgical procedure performed (6) Type of anesthesia administered (7) Complications; if any; (8) A description of techniques, findings, and tissues removed or altered ... " .
1. Open medical record review of Patient #13 revealed a 30 year-old female admitted on 04/22/2014 for a laparoscopic cholecystectomy (gall bladder removal). Record review revealed the surgery started on 04/22/2014 at 1523, ending at 1538. Record review revealed an immediate operative report handwritten by Physician C on 04/22/2014 at 1200, 3 hours and 23 minutes prior to the start of surgery.
Interview on 04/24/2014 at 0925 with Physician C revealed the immediate operative report should be written immediately after surgery. Interview confirmed the immediate operative report for Patient #13 was written 3 hours, 23 minutes prior to the start of surgery.
2. Open medical record review of Patient #14 revealed a 49 year-old female admitted on 04/22/2014 for removal of left tibial hardward and left total knee arthroplasty. Record review revealed the surgery started on 04/22/2014 at 1342, ending at 1525. Record review revealed an immediate operative report handwritten by Physician Assistant #1 on 04/22/2014 at 1330, 12 minutes prior to the start of surgery.
Interview on 04/24/2014 at 1200 with Physician Assistant #1 revealed the immediate operative report should be written immediately after surgery. Interview confirmed the immediate operative report for Patient #14 was written 12 minutes prior to the start of surgery.
3. Closed medical record review of Patient #16 revealed a 54 year-old female admitted on 01/20/2014 for "CABG X 4 with LIMA (left internal mammary artery) to LAD (left anterior descending artery), saphenous vein graft to the first diagonal, saphenous vein graft to the obtuse marginal, and saphenous vein graft to the PDA (posterior descending artery)" Record review revealed no documentation of an immediate operative report.
Interview on 04/24/2014 at 1100 with Administrative Quality Staff #2 revealed no immediate operative report available for Patient #16.



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4. Open medical record review of Patient #10 revealed a 77 year old male admitted on 04/21/2014 for exploratory laporatomy, repair of perforated cecum loop, and creation of ileostomy. Record review revealed the surgery began on 4/22/2014 at 0037, ending at 0137. Record review revealed an immediate operative report handwritten by Physician D on 4/22/2014 at 1330, 12 hours and 7 minutes after completion of surgery.

Interview on 4/23/2014 at 1330 with an administrative surgery staff member revealed the immediate operative report should be written immediately after surgery. Interview revealed, "He does this all the time."

5. Closed medical record review of Patient #12 revealed a 71 year-old female admitted on 04/17/2014 for colostomy closure and incidental appendectomy (removal of appendix). Record review revealed the surgery started on 4/17/2014 at 0747, ending at 0926. Record review revealed an immediate operative report handwritten by Physician D dated and timed on 04/17/2014 at 0900, 26 minutes prior to end of surgery. Review of the operative note revealed a handwritten diagonal line noted on operative report, leaving all categories (Preoperative diagnosis, Post-operative diagnosis, Procedure, Findings, Surgeon, Assistant, Anesthesia, Complications, Specimens, Drains, EBL, Fluid) blank and without entry.

Interview on 4/23/2014 at 1330 with an administrative surgery staff member revealed the immediate operative report should be written immediately after surgery. Interview revealed, "He does this all the time."



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6. Closed medical record review of Patient #2 revealed a 73 year-old female admitted on 04/05/2013 for arterosclerotic coronary artery disease with angina pectoris. Record review revealed the patient had a three vessel coronary artery bypass graft surgical procedure on 04/08/2013. Record review revealed the surgery started at 0741 and ended at 1130. Record review revealed an immediate operative report handwritten by Physician E on 04/08/2013 at 1300, 90 minutes after the surgery ended .
Interview on 04/23/2014 at 1420 with an administrative surgical staff member revealed the immediate operative report should be written immediately after surgery. Interview confirmed the immediate operative report for Patient #2 was written 90 minutes after the surgery ended.
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