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Based on interview and medical record review, the facility failed to comply with California Health and Safety code when it failed to report two adverse events within five days of the events being detected and failed to notify at least one patient of the adverse event as required before reporting to the California Department of Public Health.

Findings:

1. On 3/17/09, the hospital self-reported to the California Department of Public Health a wrong site surgery performed 10/30/09 on Patient A, a delay in reporting of almost five months.

According to Patient A ' s medical record, Patient A came to the hospital for elective cervical spine surgery on 10/30/09. The planned procedure for which an informed consent was obtained on 10/22/09 was " Cervical 6-7 laminectomy and foramenotomies " . A second informed consent was obtained on 10/30/09 at 12:35 P.M. This listed the procedure to be performed: " Cervical laminectomy with right foramenotomies C6-7, C7-T1.

The Ambulatory History and Physical by MD 1, dated 10/22/09, read in part, " Procedure of C6-7 cervical laminectomy with right foramenotomies at C6-7 and C7-T1 was discussed in detail with ...patient and wife. "

The anesthesia record revealed that Patient A underwent general anesthesia at 1:30 P.M. on 10/30/10. The operative procedure listed on the Intraoperative Anesthetic Record was, " posterior cervical decompression R (right)" .

According to the operative report, dictated by MD 1, on 10/30/09 at 6 P.M., a laminectomy was performed at C6-7 and foramenotomies performed at C6-7 and C7-T1, bilaterally (both sides).

According to the medical record for Patient A, post-operative right C8 paresthesia (tickling, numbness, abnormal sensations) after decompression surgery was noted. A CT scan was performed on 11/1/09. This revealed evidence of " Post-surgical changes of laminectomy at C7-T1. The report did not indicate any surgical intervention at C6-C7, as had been planned and noted in the informed consent.

MD 1 was interviewed on 3/22/10 at approximately 10:35 A.M. and stated that MD 1 became aware of the wrong site outcome of the surgery the following week and discussed it with the patient and colleagues. MD 1 did not report the wrong site surgery and indicated having no knowledge of an obligation for reporting the adverse event to the facility.

The facility medical staff Rules and Regulations were reviewed, and Section V-F read, " All Professional Staff shall support and participate in the identification, reporting and investigation of suspected significant Events and other patient safety improvement and prevention activities " .

The facility policy, Event Management, Reviewed 12/09, section 4.4.1 was reviewed and read, " Events meeting the definition of a Joint Commission SE (Significant Event) should be reported to the designated local administrative, operational and professional staff by the medical center risk manager, or designee within 24 hours of identification of the event.

The California Health and Safety Code section 1279.1 (a) read, " A health facility ...shall report an adverse event to the department no later than five days after the adverse event has been detected ... "


2. During a review of the medical records of Patient A's hospital stay for the 10/30/09 surgery by MD 1 and post-surgical care by MD 2, there was no record of the adverse event being disclosed to Patient A.

During an interview with MD 1 on 3/22/10 at 10:35 A.M., she stated that she became aware of the CT scan (which showed the wrong site result of the 10/30/09 surgery) and disclosed it to Patient A in clinic the following week.

During an interview with the hospital Administrative Staff 1 on 6/16/10 at 3 P.M., the outpatient record of Patient A was requested to determine whether disclosure to the patient was documented. Administrative Staff 1 refused to supply the outpatient clinic records of Patient A.

The hospital ' s internal document, " Reporting of Adverse Events/Event Review/CDPH Report " form supplied by the hospital included the following information: " On Mon Nov 16, 2009 a telephonic message from the patient to the neurosurgeon asking " what level was cut? " The neurosurgeon responded to the patient, " We did C7-T1, so also did foramenotomies at T1-2. It is not uncommon to have some pain as you describe for 1-2 months. I would expect it to slowly improve. " The document indicated that the patient was in pain, and that he sent a message to MD 1 seventeen days after the surgery asking what had happened during the surgery and why he was in pain.

There was no documentation presented that Patient A was told that surgical errors had occurred, and no documentation to indicate that he had been able to deduce that errors had occurred from information that he was presented with.

According to the California Health and Safety Code, the facility has the responsibility to patient of the adverse event prior to reporting it to the California Public Health Department, 1279.1(c) The facility shall inform the patient or the party responsible for the patient of the adverse event by the time the report is made.


3. On 1/12/10 the facility reported to the California Department of Public Health a spinal wrong site surgery that occurred on 12/01/09 on Patient B, over a month after the spinal wrong site surgery on Patient A.

According to the closed medical record for Patient B, Patient B came to the hospital on 12/01/09 for elective cervical spine surgery. The planned procedure was for a C6-C7 anterior disc fusion. The informed consent dated 11/30/09 obtained at 2:24 PM, revealed "Anterior (front) Cervical 6-7disc excision and interbody fusion with donor bone graft and internal fixation with anterior cervical plate and screws. "

Following the surgical procedure, MD 2 ordered x-rays on 12/1/09 that revealed post-surgical changes with a metallic surgical clip and a few small surgical screws projecting, fixing and connecting between the anterior vertebral bodies of C7-T1 and an ill defined radio-opaque disc prosthesis within the disc space between C7-T1. This report documented that the surgical procedure was performed at one level too low, at C7-T1 rather than the planned C6-C7.

During an interview with MD 2 on 6/16/10 at 12:46 PM, he stated that he reported the error to the facility OR and his service chief (MD 4) before a second surgery was performed on Patient B on 12/3/09. During an interview with MD 4 on 6/16/10 at 1 PM, he did not recall being informed of the 12/1/09 surgical error by MD 2. During an interview with the Director of Risk Management on 6/16/10 at 10:20, he stated that regarding the surgery of Patient B, " the physician did not report " and that the facility became aware on 1/11/10 of the wrong site surgery done on Patient B on 12/1/09.

The facility medical staff Rules and Regulations were reviewed, and Section V-F read, " All Professional Staff shall support and participate in the identification, reporting and investigation of suspected significant Events and other patient safety improvement and prevention activities " .

The facility policy, Event Management, Reviewed 12/09, section 4.4.1 was reviewed and read, " Events meeting the definition of a Joint Commission SE (Significant Event) should be reported to the designated local administrative, operational and professional staff by the medical center risk manager, or designee within 24 hours of identification of the event.

The California Health and Safety Code section 1279.1 (a) read, " A health facility ...shall report an adverse event to the department no later than five days after the adverse event has been detected ... "

Based on interview and review of the medical record review the hospital failed to ensure that Patient A was given the right to make informed decisions about his care. Patient A had surgery was performed on areas of his body where he had not consented to have surgery.

Findings:

According to Patient A ' s medical record, Patient A came to the hospital for elective cervical spine surgery on 10/30/09. The planned procedure for which an informed consent was obtained on 10/22/09 was " Cervical 6-7 laminectomy and foramenotomies " . A second informed consent was obtained on 10/30/09 at 12:35 P.M. This listed the procedure to be performed: " Cervical laminectomy with right foramenotomies C6-7, C7-T1.

The Ambulatory History and Physical by MD 1, dated 10/22/09, read in part, " Procedure of C6-7 cervical laminectomy with right foramenotomies at C6-7 and C7-T1 was discussed in detail with ...patient and wife. " There was no mention of left sided foramenotomies.

The anesthesia record revealed that Patient A underwent general anesthesia at 1:30 P.M. on 10/30/10. The operative procedure listed on the Intraoperative Anesthetic Record was, " posterior cervical decompression R (right)" .

According to the operative report, dictated by MD 1, on 10/30/09 at 6 P.M., a laminectomy was performed at C6-7 and foramenotomies performed at C6-7 and C7-T1, bilaterally (both right and left sides). There was no indication on the report that an emergent condition was identified that required surgery at locations other than those consented to by Patient A.

According to Patient A ' s medical records, the patient underwent surgery at a spinal level that he had not consented to, and on the left side, when the foramen surgery that was discussed with him and that he specifically consented to was the right side.

According to the hospital Rules and Regulations, 2009, Section II-F 1: " The competent patient is entitled to be informed about the nature of the proposed diagnostic and therapeutic procedures, possible benefits, risks, potential complications and alternative approaches available. It is the Professional Staff member ' s responsibility to convey the necessary information appropriate to the patient and the circumstances, in language which the patient is likely to understand, and to document this discussion in a separate entry in the medical record " and " 2: Except in emergencies, when the patient is unable to consent and consent is implied by law, no patients shall be subjected to any surgical, diagnostic, or therapeutic procedure that involves a significant risk of bodily harm unless an informed consent is obtained from the patient or his or her legally recognized representative and all other persons, if any, from whom consent is required by law. The medical record should indicate the emergent reason for not obtaining consent. "

An interview was conducted with the hospital's compliance officer on 6/16/10 at 11 AM. She confirmed that the consent for surgery for Patient A did not match the surgery that was performed on the patient.

Based on interviews and review of facility documents and policies, medical records and the medical staff bylaws, the medical staff failed to be responsible for the quality of care provided to patients in the hospital because it:

1. Failed to obtain consent for surgical procedures performed for Patient A (refer to A-347);
2. Failed to ensure that the facility policy for site marking was fully implemented during the procedures of Patients A and B, resulting in two wrong site surgeries (refer to A-347);
3. Failed to recognize in a timely fashion that a wrong site surgery had occurred for Patient A (refer to A-347) and
4. Failed to report the wrong site surgeries to the hospital, as required by the medical staff bylaws (refer to A-353).

The cumulative effect of these failings was the inability of the medical staff to ensure high quality medical care at the hospital.

Based on interviews and review of the medical record for Patient A, the medical staff failed to ensure quality and appropriateness of quality of care and its responsibility to the Governing Body when it failed to:

A. ensure that the surgery performed was the one to which Patient A consented,
B. verify the exact surgical level for Patient A and Patient B,
C. promptly recognize the surgical error made in the case of Patient A.

Findings:

1. According to Patient A ' s medical record, Patient A came to the hospital for elective cervical spine surgery on 10/30/09. The planned procedure for which an informed consent was obtained on 10/22/09 was " Cervical 6-7 laminectomy and foramenotomies " . A second informed consent was obtained on 10/30/09 at 12:35 P.M. This listed the procedure to be performed: " Cervical laminectomy with right foramenotomies C6-7, C7-T1.

The Ambulatory History and Physical by MD 1, dated 10/22/09, read in part, " Procedure of C6-7 cervical laminectomy with right foramenotomies at C6-7 and C7-T1 was discussed in detail with ...patient and wife. " There was no mention of left sided foramenotomies.

The anesthesia record revealed that Patient A underwent general anesthesia at 1:30 P.M. on 10/30/10. The operative procedure listed on the Intraoperative Anesthetic Record was, " posterior (back) cervical decompression R (right)" .

According to the operative report, dictated by MD 1, on 10/30/09 at 6 P.M., a laminectomy was performed at C6-7 and foramenotomies performed at C6-7 and C7-T1, bilaterally (both right and left sides).

According to Patient A ' s medical records, the patient went through surgery at a spinal level that he had not consented to, and on the left side, when the foramen surgery that was discussed with him and that he specifically consented to was the right side.

According to the hospital Rules and Regulations, 2009, Section II-F 1: " The competent patient is entitled to be informed about the nature of the proposed diagnostic and therapeutic procedures, possible benefits, risks, potential complications and alternative approaches available. It is the Professional Staff member ' s responsibility to convey the necessary information appropriate to the patient and the circumstances, in language which the patient is likely to understand, and to document this discussion in a separate entry in the medical record. " And " 2: Except in emergencies, when the patient is unable to consent and consent is implied by law, no patients shall be subjected to any surgical, diagnostic, or therapeutic procedure that involves a significant risk of bodily harm unless an informed consent is obtained from the patient or his or her legally recognized representative and all other persons, if any, from whom consent is required by law. The medical record should indicate the emergent reason for not obtaining consent. "

2A. On 3/17/09, the hospital self-reported a wrong site surgery performed 10/30/09 on Patient A.

According to Patient A ' s medical record, Patient A came to the hospital for elective cervical spine surgery on 10/30/09. The planned procedure for which an informed consent was obtained on 10/22/09 was " Cervical 6-7 laminectomy and foramenotomies " . A second informed consent was obtained on 10/30/09 at 12:35 P.M. This listed the procedure to be performed: " Cervical laminectomy with right foramenotomies C6-7, C7-T1.

The Ambulatory History and Physical by MD 1, dated 10/22/09, read in part, " Procedure of C6-7 cervical laminectomy with right foramenotomies at C6-7 and C7-T1 was discussed in detail with ...patient and wife. "

The anesthesia record revealed that Patient A underwent general anesthesia at 1:30 P.M. on 10/30/10. The operative procedure listed on the Intraoperative Anesthetic Record was, " posterior cervical decompression R (right) " .

According to the operative report, dictated by MD 1, on 10/30/09 at 6 P.M., a laminectomy was performed at C6-7 and foramenotomies performed at C6-7 and C7-T1, bilaterally (both the right and left sides).

According to the medical record for Patient A, post-operative right C8 paresthesia (tickling, numbness, abnormal sensations) after decompression surgery was noted. A CT scan was performed on 11/1/09. This revealed evidence of " Post-surgical changes of laminectomy at C7-T1. The report did not indicate any surgical intervention at C6-C7 had occurred, as had been planned and noted in the informed consent.

MD 1 was interviewed on 3/22/10 at approximately 10:35 A.M. MD 1 stated that somehow in marking the spinous processes (the portion of the back bones that protrude along the center of the back), MD 1 counted down two levels instead of one level. MD 1 stated that the surgery that was actually performed was a laminectomy at C7-T1 and C7-T1 and T1-T2 foramenotomies.

2B. On 1/12/10 the facility reported a spinal wrong site surgery that occurred on 12/01/09 on Patient B.

According to the closed medical record for Patient B, Patient B came to the hospital on 12/01/09 for elective cervical spine surgery. The planned procedure was for a C6-C7 anterior (front) disc fusion. The informed consent dated 11/30/09 obtained at 2:24 PM, read " Anterior Cervical 6-7disc excision and interbody fusion with donor bone graft and internal fixation with anterior cervical plate and screws. "

Following the surgical procedure, MD 2 ordered x-rays on 12/1/09 that showed post-surgical changes with a metallic surgical clip and a few small surgical screws projecting, fixing and connecting between the anterior vertebral bodies of C7-T1 and an ill-defined radio-opaque disc prosthesis within the disc space between C7-T1. This report documented that the surgical procedure was performed at one level too low, at C7-T1 rather than the planned C6-C7.

3. Patient A had surgery on 10/30/09, performed by MD 1. According to the consent and operative note, the surgery performed on Patient A was to have included a laminectomy at C6-C7. After the surgery, Patient A received follow-up care in the hospital by MD 2.

On 11/1/09 at 12:01 P.M., MD 2 ordered a CT scan of the cervical spine, with the reason for the scan noted on the order, " post op right C8 paresthesias after decompression " (post operative right side cervical nerve 8 abnormal sensation after surgery). The result of the CT scan performed 11/1/09 was, " Postsurgical changes of laminectomy at C7-T1 " . MD 3, the assistant surgeon for Patient A ' s surgery on 10/30/09, wrote in an addendum to a progress note on 11/1/09 at 4:32, " CT C (cervical) spine reviewed with MD 2 " . According to an electronic medical record tracking document provided by the hospital on 6/18/10, MD 2 reviewed the CT scan on 11/2/09 at 1:50 P.M.

During an interview with MD 2 on 6/17/10 at 12:45, he denied any recollection of Patient A ' s case. He stated that he would not usually order a CT scan postoperatively, and he did not believe that he had reviewed the CT scan with MD 3, nor discussed the possibility of a wrong site surgery with MD 3. He stated that in following the patient post-operatively, he was " just doing wound care " and "may not have reviewed the details of the case".

During an interview with MD 4, the chief of the neurosurgery service, he stated that when a surgeon was filling in for another surgeon, " all necessary and appropriate attention should be given " to the patient. MD 4 stated that the surgery of Patient A had been reviewed by the physicians in the department.

Patient A had a wrong site surgery performed by MD 1 on 10/30/09. The error was evident on a CT scan ordered and reviewed by MD 2, and the CT results were discussed between MD 2 and MD 3, but there was no evidence that MD 2 recognized that a wrong site surgery had occurred, and no evidence that he informed the patient about the surgical error. Although MD 4 stated that the case had been reviewed by the physicians in the department, MD 2 denied any recollection of the case.

Based on interviews and medical record and medical staff bylaws review, the medical staff failed to ensure the medical staff bylaws were enforced to carry out its responsibilities. This failure resulted in two physicians, who performed wrong-site surgeries, failed to report the events as required by the medical staff Rules and Regulations.

Findings:

1. On 3/17/09, the hospital self-reported a wrong site surgery performed 10/30/09 on Patient A, a delay in reporting of almost five months.

According to Patient A ' s medical record, Patient A came to the hospital for elective cervical spine surgery on 10/30/09. The planned procedure for which an informed consent was obtained on 10/22/09 was " Cervical 6-7 laminectomy and foramenotomies " . A second informed consent was obtained on 10/30/09 at 12:35 P.M. This listed the procedure to be performed: " Cervical laminectomy with right foramenotomies C6-7, C7-T1.

The Ambulatory History and Physical by MD 1, dated 10/22/09, read in part, " Procedure of C6-7 cervical laminectomy with right foramenotomies at C6-7 and C7-T1 was discussed in detail with ...patient and wife. "

The anesthesia record revealed that Patient A underwent general anesthesia at 1:30 P.M. on 10/30/10. The operative procedure listed on the Intraoperative Anesthetic Record was, " posterior cervical decompression R (right) " .

According to the operative report, dictated by MD 1, on 10/30/09 at 6 P.M., a laminectomy was performed at C6-7 and foramenotomies performed at C6-7 and C7-T1, bilaterally (both left and right sides).

According to the medical record for Patient A, post-operative right C8 paresthesia (tickling, numbness, abnormal sensations) after decompression surgery was noted. A CT scan was performed on 11/1/09. This revealed evidence of " Post-surgical changes of laminectomy at C7-T1. The report did not indicate any surgical intervention at C6-C7, as had been planned and noted in the informed consent.

MD 1 was interviewed on 3/22/10 at approximately 10:35 A.M. and stated that MD 1 became aware of the outcome of the surgery the following week and discussed it with the patient and colleagues. MD 1 stated that somehow in marking the spinous processes (the portion of the back bones that protrude along the center of the back), MD 1 counted down two levels instead of one level. MD 1 stated that the surgery that was actually performed was a laminectomy at C7-T1 and C7-T1 and T1-T2 foramenotomies.

MD 1 indicated having no knowledge of an obligation for reporting the adverse event to the facility.

2. On 1/12/10 the facility reported a spinal wrong site surgery that occurred on 12/01/09 on Patient B, over a month earlier.

According to the closed medical record for Patient B, Patient B came to the hospital on 12/01/09 for elective cervical spine surgery. The planned procedure was for a C6-C7 anterior disc fusion. The informed consent dated 11/30/09 obtained at 2:24 PM, revealed " Anterior (front) Cervical 6-7disc excision and interbody fusion with donor bone graft and internal fixation with anterior cervical plate and screws. "

Following the surgical procedure, MD 2 ordered x-rays on 12/1/09 that revealed post-surgical changes with a metallic surgical clip and a few small surgical screws projecting, fixing and connecting between the anterior vertebral bodies of C7-T1 and an ill defined radio-opaque disc prosthesis within the disc space between C7-T1. This report documented that the surgical procedure was performed at one level too low, at C7-T1 rather than the planned C6-C7.

During an interview with MD 2 on 6/16/10 at 12:46 PM, he stated that he reported the error to the facility OR and his service chief (MD 4) before a second surgery was performed on Patient B on 12/3/09.

During an interview with MD 4 on 6/16/10 at 1 PM, he did not recall being informed of the 12/1/09 surgical error by MD 2.

During an interview with the OR Director on 6/16/10 at 2:05 PM, she stated that when Patient B presented to the OR for a second surgery, the OR Manager talked with the surgeon, and was told that Patient B ' s first surgery was not a wrong level surgery. According to the hospital's interview with the OR Manager, the surgeon whom she spoke with was MD 2.

During an interview with the Director of Risk Management on 6/16/10 at 10:20 AM, he stated that regarding the surgery of Patient B, " the physician did not report " and that the facility became aware on 1/11/10 of the wrong site surgery done on Patient B on 12/1/09.

The facility policy, Event Management, Reviewed 12/09, section 4.4.1 was reviewed and read, " Events meeting the definition of a Joint Commission SE (Significant Event) should be reported to the designated local administrative, operational and professional staff by the medical center risk manager, or designee within 24 hours of identification of the event.

The facility medical staff Rules and Regulations were reviewed, and Section V-F read, " All Professional Staff shall support and participate in the identification, reporting and investigation of suspected significant Events and other patient safety improvement and prevention activities " .

Based on interview and medical record and facility policy review, the hospital failed to ensure that a facility policy regarding intra-operative site verification was implemented to prevent surgical errors, resulting in two wrong site surgeries.

Findings:

1. On 3/17/10, the hospital self-reported a wrong site surgery had been performed on Patient A.

Patient A came to the hospital for elective cervical spine surgery on 10/30/09. According to the anesthesia record, Patient A was taken to the operating room at approximately 1:30 P.M. on 10/30/09. The planned procedure for which an informed consent was obtained on 10/22/09 was " Cervical 6-7 laminectomy and foramenotomies " . A second informed consent was obtained on 10/30/09 at 12:35 P.M.. This listed the procedure to be performed: " Cervical laminectomy with right foramenotomies C6-7, C7-T1.

The anesthesia record revealed that Patient A underwent general anesthesia at 1330 hours on 10/30/10.

According to the operative report, dictated by MD 1, on 10/30/09 at 6:00 PM, a laminectomy was performed at C6-7 and foramenotomies performed at C6-7 and C7-T1, bilaterally (both left and right sides).

According to the medical record for Patient A, post-operative right C8 paresthesia (tickling, numbness, abnormal sensations) after decompression surgery was noted. A CT scan was performed on 11/1/09. This revealed evidence of " Post-surgical changes of laminectomy at C7-T1. The report does not indicate any surgical intervention at C6-C7, as had been planned and noted in the informed consent.

MD 1 was interviewed on 3/22/10 at approximately 10:35 AM. MD 1 stated that " somehow in marking the spinous processes, MD 1 counted down two levels instead of one level.

The policy and procedure for intra-operative radiographic identification of the proper surgical level Number 2230 dated 12/08 stated: " For spinal procedures, in addition to the pre-op skin marking of the general spinal region, special intra-operative radiographic techniques are used for marking the exact vertebral level."

MD 1 stated that a radiograph revealed that the incorrect level had been marked. However, MD 1 proceeded to manually count down two spinous processes, instead of one spinous process. MD 1 did not repeat a radiograph to verify the exact spinal level.

2. According closed medical record for Patient B, Patient B came to the hospital on 12/01/09 for elective cervical spine surgery. The planned procedure was for a C6-C7 anterior disc fusion. The informed consent dated 11/30/09 obtained at 2:24 PM, revealed " Anterior (front) Cervical 6-7 disc excision and interbody fusion with donor bone graft and internal fixation with anterior cervical plate and screws. "

According to the intra-operative record, a surgical was conducted. The dictated operative report revealed that " x-ray control was used. First x-ray showed needles at C4-5 and C5-6. The second (x-ray) showed needles in C5-6 and
C6-7."

When interviewed at 12:30 noon on 6/17/10, MD 2 stated that during the radiographic identification, for the first x-ray, to verify the correct level, there was difficulty identifying the skin needle. A second x-ray was ordered and performed, however, MD 2 removed the skin marking needle prior to the results of the x-ray being obtained. MD 2 was unable to recall the location of the needle and proceeded to operate at the wrong level of the cervical spine.

Following the surgical procedure, MD 2 ordered x-rays on 12/1/09 that revealed post-surgical changes with a metallic surgical clip and a few small surgical screws projecting, fixing and connecting between the anterior vertebral bodies of C7-T1 and an ill defined radio-opaque disc prosthesis within the disc space between C7-T1. This report documented that the surgical procedure was performed at one level too low, at C7-T1 rather than the planned C6-C7.

The policy and procedure for intra-operative radiographic identification of the proper surgical level Number 2230 dated 12/08 stated: " For spinal procedures, in addition to the pre-op skin marking of the general spinal region, special intra-operative radiographic techniques are used for marking the exact vertebral level."

MD 2 stated that he did not await radiograph results to determine if the exact vertebral level had been marked prior to removing the spinal level markers and proceeding with surgery.