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.

SSM HEALTH ST CLARE HOSPITAL - FENTON 1015 BOWLES FENTON, MO 63026 May 3, 2013
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on interview and record review, the hospital's Surgical Service staff and surgeons failed to follow the facility's Universal Protocol (a safety process to prevent events that should never occur in surgery) for one patient (#23) which resulted in a wrong-site brain surgery. The Surgical Services staff and surgeons also failed to make department-wide changes in the surgical site marking procedures and re-educate all surgical staff after a wrong site surgery in December 2012 for one patient (#24). See tag number A-0951.

The cumulative effect of these deficient practices has the potential to place all patients who undergo a surgical procedure at the hospital at risk to their health and safety (also known as immediate jeopardy - IJ). The average number of surgical patients for 2012 was 517 per month (6,204 for the year). Facility staff implemented actions to abate the IJ and provided an acceptable plan of correction to prevent further immediate risk to patients by the end of the survey.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure:

-Surgical Services staff and surgeons followed the facility's Universal Protocol (UP) procedure (a safety process to prevent events that should never occur in surgery, such as wrong site, wrong procedure and/or wrong person) for one (#23) of one patient who had surgery to the brain of the 27 medical records reviewed of patients who had a surgical procedure;

-Accurate collection and monitoring of Quality Assessment Performance Improvement (QAPI) data and implementation of actions to prevent reoccurrence after a wrong-site surgery on Patient #24 in December 2012. Inaccurate data resulted in the facility not identifying failures in time out procedures during surgery, which put this patient as well as other patients at risk for wrong-site surgery (such as Patient #23 who had wrong-site surgery in April 2013). (QAPI is a process that identifies a problem, selects and implements solutions, then monitors to ensure the problem is resolved and continues to be resolved); and

-All surgical staff (rather than just those involved in an instance of wrong-site surgery for Patients #23 and #24) were educated on the facility UP procedure and the procedures were accurately monitored after a wrong-site surgery in December of 2012 and again in April of 2013.

These deficient practices and lack of implementation of consistently followed time out procedures have the potential to cause an adverse outcome for all patients who undergo a surgical procedure at the hospital.

("Time out" is a procedure implemented in some hospitals where staff conducting surgery stop and check to make sure everything is as it should be to, a practice to keep patients safe.)

Surveyors reviewed 27 Surgical Services patients and additionally observed seven "time outs", four surgical-site markings, and one neurosurgical procedure during the survey.

Findings included:

1. Record review of the facility's policy titled, "Universal Protocol", dated 08/10, directed the following:

-In order to reduce the probability of harm, every surgery/invasive surgery/procedure will include a system of verification of the correct person, site/side, and procedure. This verification prior to an invasive procedure or surgery is critical to assuring patient safety. (This process is called a "time-out.")

-A verification process applies to all invasive procedures and surgeries performed in the operating room, diagnostic and interventional service areas.

-Pre-procedure Verification and Time Out prior to Invasive/Surgical Procedures directed staff to verify the patient, procedure and the surgical site;

-Site marking is required in cases involving right or left distinction (such as right or left side of the brain, left or right hip, etc.) and levels (such as the place/level of the spine).

-Time out is a final verification process prior to an invasive procedure or operation that occurs in the procedure or operating room. It is initiated by a member of the procedural/surgical team, but all members are required to participate.

-A visual (actually looking and seeing information such as the history and physical (H&P), procedure name, surgeon's note, and diagnostic testing must be verified as matching) is to be used to verify the critical elements of the time out.

-The immediate members of the team involved in the time out will be the proceduralist (practitioner performing the surgery), the anesthesia provider, if applicable, the circulating nurse, the operating room technician, and other active participants appropriate for the procedure, who will be participating in the procedure at its inception.

-Confirmation will include, at a minimum, the following critical elements:
a. The Correct Patient identity (using 2 patient identifiers)
b. Confirmation that the correct site/side are marked on the patient
c. An accurate procedural consent form has been signed by the patient or patient's representative (that clearly shows the specific surgical procedure that will be performed)
d. Agreement on the procedure to be performed
e. Correct patient position

-During the "Time Out', the primary source verification (which was the H&P), procedure, surgeon's note, and diagnostic testing must be verified as matching in addition to validation of the other critical elements.

-Active communication techniques will be used by all members of the team. Active communication requires oral confirmation of the above. During the time out, all other activities are suspended to the extent possible without compromising patient safety so that all relevant members of the team are focused on the active confirmation of the critical elements.

-If at any time during the "Time Out" any member of the team has a question or concern about the accuracy of the critical element, the procedure will be suspended until such time as all members are comfortable with the safety of the plan.

-For Time Outs Prior to Invasive Procedures:
1. Verify that you have the correct patient.
2. Verify that you have the correct documents and/or (radiology) films for the patient.
a. Verify that H&P and Advance Directives (legal documents that allow a person to convey their decisions about end-of-life care ahead of time) are available prior to the procedure.
3. Verify that you have the correct site for the procedure.
b. Be sure the mark (the correct site is marked with indelible pen) remains visible after skin prep and drape (the process to drape towels so only the site of the surgery is exposed).
4. Verify that the patient is in the correct position needed to do the procedure.

-Conduct a final time out prior to the incision or start of the procedure and after the patient is draped and the procedural physician is present. Everyone in the procedural room needs to actively agree about both the patient and the procedure.


2. Record review of Patient #23's medical record showed the patient needed surgery on the left side of the brain to increase blood flow.

-Record review of the operative report dated [DATE] showed both the Pre-operative and Post-operative Diagnosis was left hemispheric ischemia (a stroke of the left brain). The patient was brought to the operating room and placed in the Mayfield head holder (a metal clamp with pins that hold the head stable) and turned to the left with the right side up. [Note: The left side of the patient should have been facing up so the surgery could be done on the left side of the brain as was originally planned.]

-Record review of the Anesthesia Report dated 04/04/13 showed no time out documented.

-Record review of the Brief Op Note (Brief Operative Note is documentation by the physician after a surgery is completed), dated 04/04/13 at 1:57 PM, showed a preop diagnosis of [DIAGNOSES REDACTED]], a disease in which certain arteries in the brain are constricted. Blood flow is blocked by the constriction and also by blood clots).
[Physician's] Note: Right craniotomy [surgical removal of part of the bone from the skull to expose the right-side of the brain] done by the surgeon.
However, the surgery was originally to be an operation on the left side of the brain.


3. Record review of the facility's document titled "Root Cause Analysis (RCA, a structured process that uncovers the physical, human and latent causes of any undesirable event in the workplace) Checklist and Action Plan", dated 04/04/13, which reviewed the wrong site surgery for Patient #23 showed the following:
-Wrong site Craniotomy (surgical removal of part of the skull to expose the brain) was performed on 04/04/13.
-Staff QQ, Medical Doctor (MD), Neurosurgeon (a specialized field of surgery for the treatment of diseases or conditions of the brain and spine).
-Sentinel Event (unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof) was documented as determined by the facility (the event was identified as a major problem after their investigation as directed by hospital policy) on 04/05/13.
-RCA due 05/05/13 (one month after the wrong site brain surgery).
-RCA determination: "[Surgical] Team did not comply with [surgical] site marking and time out [STO- "surgical time out" which is a pre-procedural active pause to verify patient identity and intended-site operations conducted before an incision/cut for the actual surgical procedure] because they trusted each other."
- The CRNA (Certified Registered Nurse Anesthetist) taped the tubing to the wrong side of the patient's [Patient #23] head when it should have been taped to the opposite side of the operative site.
- Gaps in the STO included no H&P in the patient's chart, two procedural identifiers were not used (H&P and the consent form), surgical site marking was not in the operative field and correct positioning of the patient was not verified. (Surgical marking is where the site of the surgical incision is visibly written on the patient's body as one method to ensure the proper site of surgery.)
- The Patient was sent to post-anesthesia care unit where Staff QQ noted the surgical bandage was on the right side of the patient's head and Staff QQ's initials (as directed by the UP, the surgeon wrote his initials on the patient to confirm where the surgery was to be done), written with a purple marker were still visible on the left [side] of the patient's head.

4. During an interview on 05/01/13 at 11:35 AM, Staff O, Registered Nurse (RN), stated that:
-She had 39 years of nursing experience.
-She currently worked in the Pre-Op (pre-operative) area.
-She routinely moved patients from Pre-Op area into procedure rooms.
-She stated that time outs were done in the Pre-Op area but have become such a routine that nobody took it seriously.
-She stated staff "just go through the motions" for time outs.


5. Staff V was a Surgical Technician (ST), also called "scrub tech," "surgical technician," or "operating room technician", who is an unlicensed assistive personnel who work under the supervision of a surgeon, RN or other surgical personnel to help ensure that the operating room or environment is safe, that equipment functions properly, and that the operative procedure is conducted under conditions that maximize patient safety. STs have knowledge and skills in sterile and aseptic techniques. They handle the instruments, scrubs, medications, and other supplies and equipment necessary during the surgical procedure.

During an interview on 05/01/13 from 2:10 PM through 2:50 PM, Staff V stated that:
-She had been employed with the facility since 02/18/13. However, she had surgical technician experience at another facility in another state.
-She was currently in orientation (for her newly acquired position of ST).
-She was in the room during Patient #23's wrong site surgery.
-She had not realized the wrong site was operated on until after 04/04/13.

Staff V stated:
-We (the team) were not rushed.
-We started somewhere between 8:30 AM or 9:30 AM.
-Other staff positioned the patient and applied the Mayfield (head holder) to the head and Staff QQ, Neurosurgeon, shaved the head of the patient himself, the physician's preference.
-Staff QQ doppled (measured the velocity of blood flow through the patient's brain's blood vessels) the vessels for twenty minutes.
-Staff QQ started the time out.
-Staff I, agency RN, stated the name of the surgery and Staff QQ corrected her pronunciation of the name of the surgery.
-Staff I did not flip the tabs over (manually change the board to show presence or absence of a specific item such as H&P, identification, procedure name) on the (surgical time out) board (used to track progress of the surgery).
-None of us realized it was the wrong site.
-The team was called into the board room the next day, but Staff V wasn't included.
-The team was suspended, but Staff V was not included in the suspension. (Suspension means the individual was not allowed to work at the hospital for a period of time.) The surgeon was not suspended by the facility.
-Staff QQ did have another craniotomy scheduled for that following Saturday (04/06/13) and he requested the same team, but they were all suspended.
-Time outs were done but there is so much information on it (numerous items were covered).
-In my opinion we should have done a time out when the Mayfield was placed but we didn't do one.
-I didn't see Patient #23's medical record prior to the procedure.
-I saw Staff QQ and Staff T, Registered Nurse First Assist (RNFA), place a shoulder roll under the patient's shoulder and I know they doppled the patient's head for twenty minutes.
-I have read the policy and procedure on Universal Protocol that includes time outs, but it was during my first week when I read all the policies and procedures, so I don't remember it specifically.
-I wasn't included in the suspension because I was an orientee and I did not receive any re-education on the STO.
-I am not aware of any Quality Assessment/Performance Improvement (QAPI) projects on anything prior to the wrong site surgery.
-Since the wrong site surgery (after 04/04/13), the Surgery Department started a QAPI committee to look at time outs, but no changes have been made.


6. During an interview on 05/01/13 at 2:55 PM Staff W, RN, Surgical Team Circulator (the circulating nurse serves as the patient advocate while the patient is least able to care for him or herself while anesthetized during the surgical procedure. The RN Circulator ensures the patient's safety during this period of vulnerability).

Staff W stated that:
-She has had eleven years of experience as a circulator.
-She routinely interviewed the patients before the surgical procedure for allergies, their understanding of the procedure, and other identification.
-She would routinely move the patient from the pre-procedure room into the surgical procedure room.
-She came in at the end of Patient #23's case so she was only involved with moving the patient to the Recovery Room.
-She was not aware of any QAPI projects done in the Surgery Department.
-She was not part of the re-education after the wrong site surgery. The re-education was only given to the surgical team involved. No changes to the STO have been made.


7. During an interview on 05/01/13 at 3:15 PM Staff S, Certified Surgical Technician (CST), stated that she had been a CST for three years. She stated that she was in the room for the time out for Patient #23 and "lots went wrong".

Staff S stated:
-Staff got the room set up. When the patient got there we prepared and we had problems getting the patient's intravenous fluid lines started.
-I cannot recall if the ventilator tubing was on the correct or incorrect site.
-The shoulder roll was on the wrong side.
-The patient was marked on the correct site but the markings were difficult to see on darker (pigmented) skin.
-The pre-operative area had a violet-colored pen and the policy and procedure says to use a permanent marker.
-I just work in the room (neurosurgical operating room) and there was a time out conducted in the procedure room.
-We all assumed it was the correct site.
-There was another surgery where a wrong level (of the spine) was done in December 2012. The surgeon involved in the December 2012 surgery did change his own procedures in his (operating) room, but the Surgical Services time out procedure for the rest of the department has not been any different for the last six months. The surgeon involved (in the December, 2012 surgery) did listen to us and he did take our input for change for his procedures in his operating room, but no changes have been made in the written Surgical Department-wide policies.


8. During an interview on 05/01/13 from 3:35 PM to 4:18 PM Staff T, Registered Nurse First Assistant (RNFA, is a perioperative - or the period of time before, during and after the surgery, Registered Nurse - who functions in an expanded role, working in collaboration with the surgeon and health care team members to achieve optimal patient outcomes. During the time beginning with the patient's transfer to the operating room, through the surgical procedure, and until the patient is transferred to the recovery room, the RNFA practices at the direction of the surgeon. Staff T stated that she had been in position for the last four years. She confirmed the team prepared the night before for the procedure on Patient #23.

Staff T stated:
-We made sure we had the correct equipment and the room was prepared.
-The patient arrived and we found she was a "hard stick" (had difficulty getting an intravenous line started).
-Staff QQ, Neurosurgeon, placed the Mayfield to hold the head in place and I left the room for ten minutes, something I never do. I had to go to the bathroom.
-Staff QQ mapped the patient's head, shaved the head and marked the head with black marker.
-I never second guessed Staff QQ. I don't know why. I just didn't.
-Staff QQ asked me to help place the shoulder roll. He lifted the patient's right shoulder and I placed the shoulder roll underneath, which was the wrong side and it still didn't occur to me that it was the wrong side.
-After I was suspended, I returned to work and reviewed the Universal Protocols.
-The Circulator (Staff I, RN) documented Patient #23's history and physical was on the medical record, but it wasn't.
-One of the issues was time out was conducted after the patient was draped (patient was covered with sheets to the floor, exposing only a 6 inch by 6 inch square window of skin of the head).
-My suggestion of time out prior to draping was rejected by Surgery Department supervisory staff.
-I was part of the surgical team that was suspended and we were required to attend some education on STO, but none of the other surgical teams or surgical services were required to do that.
-No changes have been made to STO except that we are now taking it very seriously.


9. During an interview on 05/02/13 at 9:05 AM Staff QQ, Neurosurgeon, stated the following:
-There were two basic reasons for the wrong site surgery on Patient #23. The first reason was there was a breakdown in the "fail-safe" procedure (following the Universal Protocol steps). The second was the surgeon (referring to himself) made a mistake.
-Time outs are important.
-We were not rushed. We were not tired.
-I did the History and Physical (H&P) in the holding area but I did not document it (even though he was in the room when the Circulating Nurse said the H&P was on the chart).
-I marked the correct site in the prep area.
-We did not follow the spirit of the time out process. (We were just going through the steps/motions and not really doing the steps as intended.)
-I can request a specific Circulator but this is not an environment of infinite supply and demand so, I don't.
-My new philosophy is that I have made time outs a living breathing thing.
-I've always considered it important, but now I will bully my colleagues (other surgeons) into doing them.
-I am not safe to operate on people at this time.
-I have done five or six craniotomies since the wrong-site surgery on Patient #23.
-The procedure of time out pre-draping has changed in my room.
-I feel there needs to be a general Universal Protocol plus variations specific to each service line (each surgical sub-specialty).
-Policies and procedures for UP have not changed and the surgical team involved was suspended and had some education, but no other surgical teams or services were re-educated or made any changes.


10. Review of the corporate Performance Improvement and Patient Safety plan (PIPSP), dated 2013, showed the following direction:
-Each of the facilities in the corporation would provide quality care in a safe environment for all patients.
-Continuous Quality Improvement (CQI) principles should be used.
-CQI principles included decisions were based on facts.
-The objectives included to measure, assess and improve the quality and safety of care as evidenced by outcomes and improvement in processes.
-Each facility in the corporation was directed to include specific processes in the Performance Improvement Plan including Quality Control which was defined as the ongoing monitoring of outcomes and processes to assure that expected levels of performance were maintained. Each facility was responsible for collecting and reviewing information from a variety of sources, services and functions to monitor performance. The information may include, protocol/guidelines variance analysis; effectiveness and safety of processes/services; operative and other invasive procedures; adverse patient events and staff opinions.

Record review of the Surgical Department's Universal Protocol (UP) Audit results, dated August 2012 and through April 2013, showed the following:
-Staff included and reviewed only 12 to 18 medical records per month for surgical patients.
-Stated criteria reviewed included presence or absence of six particular factors including pre-procedure verifications, site markings, and time outs.
-Audit criteria under pre-procedure verification included presence of inpatient history and physical (H&P); presence of outpatient H&P; complete informed consent with date, time and signature; nursing assessment done; and diagnostic/radiological/blood/equipment available.
-Audit criteria under site marking included it was marked with the surgeon's initials; site marked before the patient moved to the procedure room; and alternative site marking used.
-Audit criteria under time out included activity in area stopped and all staff involved in the procedure were present and actively involved; name and birth date of the patient verified; and confirmation of the correct site marked.

Record review of the Surgical Department's UP Audit results, dated August 2012 through April 2013 (the period in which Patients #23 and #24 each had wrong-site surgery), showed the following:
-(Inaccurately reported) 100% compliance for all criteria except February, 2013 66.7% for alternate site marking (accuracy questioned because there was a wrong site surgery in 12/12 and on 04/04/13);
-Inaccurate data for March 2013 showed only 15 medical records reviewed but data for 16 records was recorded;
-Partial data for April 2013 showed 18 medical records were reviewed showing one without completed consent; one without diagnostic/ radiological/ blood and equipment present; one without site marking by the surgeon; and two without the site marked before the patient was moved to the procedure room.

During an interview on 05/02/13 at 10:10 AM Staff JJ, Nurse Director of Surgery, stated the following:
-She reviewed the data collected.
-The total number of medical records selected to audit per month was selected by the Quality Assessment department and were "set in the computer".
-Approximately 10 to 15 medical records per month were reviewed.
-The number (10-15 cases) was not a statistically significant percentage of the approximately 480 to 560 cases done per month by the Surgical Department. (10-15 cases would be approximately 1.8% to 3.1%.)
-During 2012, approximately 517 surgeries per month were done in the facility with 651 of those as neurosurgeries during the year.
-When asked if all the 100% findings could possibly be caused by the small sample size, she responded that a percentage of 10 to 15 percent should probably be reviewed (not 10 to 15 individual cases per month).
-Random auditing would be a good way to collect data.
-She confirmed she was very rarely in the surgical procedure rooms to observe the work of her staff.
-After the wrong site surgery for Patient #23 on 04/04/13, she has audited 100% of the neurosurgical cases (increased monitoring after the fact).
-There were no defined roles (of specific individuals responsible for each critical element) in the UP for the time out procedures.
-The UP policy had not changed since the wrong site surgery performed on Patient #23 and after the RCA showed problems.


11. Record review of Patient #24's H&P dated 12/17/12 showed the patient had a history of back pain and leg pain.

Record review of the Consent to Operation or Other Medical Procedures showed:
-The patient had consented to a lumbar microdecompression L 3-4, L 4-5 (surgery on the lumbar vertebrae, the lower spine).
-Record review of the Operative Report showed a "Time Out" before the incision on 12/17/12 at 11:55 AM.
-Record review of the Neurosurgery Operative Note dated 12/17/12 at 3:58 PM stated that the Post-op diagnosis was Lumbar Stenosis and the procedure was a left L 3-4, L 4-5 Microdecompression.

Record review of the Surgical department's UP Audit results dated August 2012 through April 2013 failed to show any wrong site surgeries and specifically the wrong site surgery for Patient #24.

However, record review of an Event Occurrence Executive Summary (dated 12/21/12) stated that the surgery performed on Patient #24 on 12/17/12 was the wrong site surgery. The report stated that the surgeon had made a small incision and completed L 3-4 and then proceeded to L 2-3 (rather than L 4-5). The surgeon then operated on the correct lumber region (L 4-5).

Hospital staff conducted a Root Cause Analysis, which was completed on 03/28/13. The action plan identified the need for timely event reporting and notification to leadership of potential serious/sentinel events and to develop a standardized method for site marking for spinal cases.

During an interview on 04/02/13 at 12:10 PM, Physician SS, (Neurosurgeon who performed the wrong site surgery on 12/17/12) stated that the facility had made no changes or re-educated all surgical services. He stated that his surgical team voluntarily made STO changes and decided to put the levels (of the spine) on the board and cross them out when they had been completed. He stated that the new STO changes were exclusive to his surgical procedure and had not been shared with other neurosurgeons.
VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
Based on interview and record review, the facility's Surgical Services staff failed to follow the hospital's "Universal Protocol" (UP) procedure that directed each surgical patient undergoing a procedure should have a History and Physical (H&P) on the medical record prior to surgery. This affected one (Patient #23) of 27 medical records of surgical patients reviewed.

(UP is a safety process to prevent events that should never occur in surgery.)

This deficient practice has the potential to affect the health and safety of each patient undergoing a surgical procedure at the facility since a current history and physical will include the patient's medical conditions that may affect medical decisions regarding the surgery.

Findings included:

1. Record review of the facility's document titled "Universal Protocol", dated 08/10, directed the following:

Procedural Requirements...Documentation, Pre-Procedure: Prior to the start of any non-emergent invasive procedure, the following documents must be complete and on the patient's medical record:
-A history and physical (H&P), which includes the physician's impression and plan for treatment, completed within 30 days before admission for outpatient procedures or within 24 hours of admission for inpatients. The H&P must be reviewed and updated prior to the start of the procedure.
-If the above documentation is not available, incomplete or illegible, the surgery or procedure will be canceled or postponed until documents are correct, complete and on the patient's medical record.

2. Record review of the facility's document titled "Rules and Regulations", revised 09/12, showed in Section 9.1.5 of the Bylaws that a dictated and transcribed H&P shall be completed by a Medical Staff member or his/her appropriately credentialed designee or resident for every patient no more than thirty (30) days before or twenty-four (24) hours after a patient is admitted or registered, but prior to surgery or procedures requiring anesthesia services.

3. Record review of Patient #23's Time out Type Pre-Procedure (before the surgical procedure) documentation showed a "yes" response to the H&P being present and updated on the chart. This document showed a verification date and time of 04/04/13 at 8:18 AM.

("Time out" is a procedure implemented in some hospitals where staff conducting surgery stop and check to make sure everything is as it should be. The process is usually implemented to ensure practices are conducted to keep patients safe.)

Record review of Patient #23's Time out Type Pre-Incision documentation (pre-incision meaning before surgical incision) showed a "yes" response to the H&P being present and updated on the chart. This document showed a verification date and time of 04/04/13 at 9:59 AM.

Nevertheless, record review of Patient #23's medical record showed that although the patient's surgery was in the morning on 04/04/13, the H&P was dated 04/04/13 at 8:20 PM. Therefore, the H&P was not on the chart prior to the start of the surgery as required.

During an interview on 05/02/13 at 9:05 AM Staff QQ, Neurosurgeon, stated that he did the H&P in the holding area (on 04/04/13), but he did not document it (even though he was in the room when Staff I, RN, said the H&P was on the chart).

Staff I, RN, was no longer employed at the facility and was unavailable for an interview after several attempts to contact her by phone.

See also tag A-0951, regarding Patient #23 who received surgery to the wrong side of the patient's brain and had no H&P in the patient's medical record at the time of the surgical procedure.