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Based on review of the hospital policies entitled, "Surgical Counts", and "Universal Protocol: Verification of the Patient's Identity, Surgical Procedure and Surgical Site/Side" section for Debriefing, the Medical Event Reporting System, Surgical Executive Committee Meeting Minutes, Surgical Occurrence Reports, medical record review, and staff interviews, it was determined the hospital failed to maintain an effective hospital wide quality assessment and performance improvement program that is data driven. Performance improvement activities, and actions taken involving surgical services program data, are not incorporated into the Hospital Wide Quality Assessment Performance Improvement Plan.

Findings include the following:

1. Evidence of failure to set priorities for performance improvement activities that focus on high-risk, high-volume areas. (Refer to A 285).

2. Evidence of failure to analyze causes of adverse patient events. (Refer to A 287)

3. Evidence of failure to implement corrective actions and provide feedback related to surgical occurrences. (Refer to A 288).

4. Evidence of failure to ensure corrective actions are achieved and/or sustained. (Refer to A 291)

5. Evidence of failure to ensure performance improvement procedures for patient safety are implemented, and the reduction of medical errors for surgical services. (See A 311)

6. Failure to ensure corrective actions taken to address prior deficient practices related Medical Records are sustained. (See A 450).

Based on staff interview and review of the hospital's Operating Room Policies and Procedure Manual, specifically the hospital policy entitled "Surgical Counts", it was determined that the hospital failed to set priorities for high-risk, high-volume areas by using data obtained to improve patient safety.

Findings are as follows:

The hospital policy entitled, "Surgical Counts", Section V, Protocols/Standards, under "Procedural Guidelines-General Considerations", states:

"When additional items are added to the field, they should be counted and recorded on the count sheet."

A review of the occurrences for surgical services from 1/1/10 through 10/1/10 included instances where extra sharps/instruments were noted during the counts that were unexplained, with no follow-up to determine causal factors in order to determine priorities for performance improvement.

Occurrence examples include:

9/29/10 "... incorrect needle count and instrument count. More needles on field than on count pad"

8/19/10 " ... three (3) Bovie tips on the field but the documentation indicates only two (2)"

7/22/10 "... one (1) more needle holder on field"

6/8/10 " ... extra retractors found while doing the instrument count"

4/14/10 "... incorrect needle holder count. Count was over by one (1) needle holder"

2/24/10 "... incorrect instrument count. Extra pieces to Thompson Retractor on field, and not accounted for on the count sheet"

2/2/10" ... incorrect instrument count. Towel clips on field not on count sheet"

1/27/10 "... sponge count incorrect. Surgical field had one more sponge than on count pad"

1/26/10 "... incorrect count. Extra instrument on the field"

Another example includes a 4/15/10 Occurrence Report revealing "numerous needles put out on the field at various times by different employees." On 10/6/10, the Risk Manager was asked to provide a copy of the hospital's investigation related to this occurrence report. In response, an interview on 10/6/10, with the Administrative Director of Perioperative Services was conducted. She confirmed that no investigation was done, and she could not explain the occurrence report or why there was no follow up.
During an interview on 10/6/10 at 8:25 AM with both the Administrative Director of Perioperative Services and the Director of Quality/Patient Safety Perioperative Services, it was reported that when the count is incorrect and extra instruments/sharps/sponges are found, the Circulating Nurse is responsible to add it to the count. There was no evidence that this occurred for the above occurrences, and no evidence of remedial actions.

Based on medical record review, review of Surgical Occurrence Reports, MERS (Medical Event Reporting System) reports that include areas for Event Registration Report and Event Discovery Report, and staff interviews, it was determined that the hospital failed to analyze adverse patient events for relevant sample patient ID #24, and for 10 other unidentified patients.

Findings are as follows:

1. A review of the clinical record for patient ID #24 revealed an admission to the hospital on 8/3/10 with a diagnosis of abdominal aneurism without rupture. Surgery was performed on 8/4/10. A review of the hospital discharge summary revealed that the procedure was "tolerated well", and a surgical post-op note dated 8/4/10 at 2200 hours revealed "no complications".

According to the Operating Room Policy & Procedure Manual, Section V, the "Surgical Counts" Protocol, "the first count is done before closure and the final count is done at skin closure or at the end of the procedure".

A review of the patient's Intraoperative Report revealed that the first count for sharps and instruments was "incorrect", and the final sharps and instrument counts remained "incorrect".
A Surgical Occurrence Report was completed on 8/4/10. Event Description reveals that sharps first and final counts were "incorrect". The instrument count was partially completed, then aborted by the Surgeon.

During an interview with the Director of Quality/Patient Safety Perioperative Services on 10/6/10 at 9:30 AM, she was questioned regarding the incorrect counts. It was reported that the "Surgeon was in a hurry" and had told the Operating Room team to "stop the count". When asked why, it was reported that "there must have been a lot going on in the suite".

The MERS Event Registration Report identified factors involved with this event that included "inadequate/absent communication; staff related clinical judgment/skill/competence and distraction/interruption/inattention". Although this report also identified that the event "probably" could have been prevented or could be prevented in the future, it failed to provide actions. This report, under Manager's comments, stated, "team should have stopped to complete count." The Event Discovery Report area indicated, "when closing, the Scrub Tech was prompted to begin surgical counts and refused. Although the surgical counts began too late in the procedure, the Circulating Nurse made every attempt to redirect the Scrub Tech to complete the instrument count. X-ray taken...."

Although during an interview with the Director of Quality/Patient Safety Perioperative Services on 10/6/10 at 9:30 AM, she reported that the only actions taken had been to "re-educate staff", and that the Surgeon was "spoken to", she was unable to provide any supporting evidence. It was further stated that the hospital encourages the reporting of "good catches", and the actions taken are usually re-education so good catch reporting is not reduced.

During an interview, on 10/7/10, with the Surgical Director of the Perioperative area, due to the unavailability of the Surgeon in this case, he reported that if the counts were not done, the medical record should indicate why protocol was not followed. The medical record failed to contain this information.

2. Refer to A 285

For all above cases, the hospital failed to analyze the causes for the unreconciled counts.

Based on review of Surgical Executive Committee minutes, the Medical Error Reporting System (MERS), and staff interview, it was determined that the hospital failed to ensure that adverse events are analyzed for causes and corrective actions taken, and that feedback from the information is used for learning opportunities.

Findings are as follows:

1) A review of the MERS revealed that on 9/21/10, an Anesthesiologist had "another incident" of entering a sterile operating room without being appropriately attired. The Occurrence Report indicated that this Anesthesiologist had "on numerous times" been told to put the (surgical) mask up. On 9/21/10, the Anesthesiologist "made like he held his breath" and walked through the Operating Room, again being told not to do so. The Anesthesiologist at that time "made a joke about it and continued on".

Although the occurrence report also indicated this should go to his Chief, and the Surgical Executive Committee (SEC), review of the SEC meeting minutes revealed no evidence that this occurrence was presented/discussed. Also, during an interview with the Chief of Anesthesia on 10/7/10 at 9:05 AM, he reported that "this was the first time he had heard of the situation", although he did report that actions taken regarding the Anesthesiologist included being "pulled aside and spoken to". When asked to provide any written evidence of the action taken, the response was that "nothing had been documented".

A review of the MERS Event Discovery Report identified concerns in the Anesthesia Department related to infection control and aseptic technique. Case summary indicated that as a "result of the event-no additional action taken" and the section for comments by the Manager was blank. During an interview on 10/6/10 at 8:00 with the Administrative Director of the Perioperative area, she indicated that the Manager should have completed the review, was unable to state how many times the Anesthesiologist may not have followed standards of aseptic technique, and could not explain what "numerous" meant in the report.

2) Refer to A 287.

The hospital failed to ensure that adeverse events, as stated above, are used for feedback and learning.

Based on review of the hospital policy entitled, "Medical Record Documentation Requirements", and medical record review, it was determined that the hospital failed to follow corrective actions for previously cited deficient practices dated 4/7/2010. Compliance has not been achieved as evidenced by re-citation of A 450, regarding incomplete records, for 12 of 16 relevant sample patient records (ID#'s 2, 12, 13, 14, 15, 16, 17, 18, 20, 21, 22, 24 ).

Findings are as follows:

Refer to A 450.

Based upon review of medical records, staff interview, and review of the hospital policy entitled, "Verification Protocol: Verification of the Patient's Identity, Surgical Procedure and Surgical Site/Side" relevant to the Debriefing Process, it was determined that the hospital failed to provide evidence that this Debriefing Process was accomplished for 4 of 4 relevant sample patients (ID #'s 20, 21, 22, and 23).


Findings are as follows:

A review of the hospital policy entitled, "Verification Protocol: Verification of the Patient's Identity, Surgical Procedure and Surgical Site/Side" states, under Item #4, Debriefing Process:

"The attending surgeon will initiate a debriefing prior to leaving the operating room. ALL team members are to be actively involved in this process. The surgeon initiates the debriefing by saying, 'Let's begin the debriefing' The debriefing must include the confirmation of the procedure performed and specimen labeling and destination communicated."

1. Medical Record review for patient ID #20 revealed an admission to the hospital for a surgical procedure in December, 2009. Review of the Perioperative Verification Checklist revealed there is no place on the form for date, time or signature and there is no evidence in the medical record that indicated the surgical debriefing was done according to policy.

The patient was readmitted on 4/7/10 for another surgical procedure. This readmission also failed to contain any evidence that the debriefing was conducted.

2. A review of the medical record for patient ID #21 revealed a hospital admission on 4/27/10. The Perioperative Verification form revealed no evidence that a surgical debriefing was conducted.

3. A review of the medical record for patient ID #22 revealed that the patient was admitted to the hospital on 1/11/10. The Perioperative Verification Form revealed no evidence that the a surgical debriefing was conducted.

4. Review of the medical record for patient ID #23 revealed that the patient was admitted on 9/17/10. The Perioperative Verification form revealed no evidence that a surgical debriefing was conducted.

During an interview 10/7/10 at 8:15 AM with the Administrative Director of Perioperative Services, she was unable to provide evidence that the Debriefing Process was documented, anywhere, as being conducted.

5. Refer to A 450

6. Refer to A 951

Based on record review, and review of the hospital policy entitled, "Medical Record Documentation Requirements", it was determined that the hospital continues to fail to ensure that medical records are consistently dated and/or timed by the individual responsible for the service for 12 of 16 relevant sample patient records (ID#'s 2, 12, 13, 14, 15, 16, 17, 18, 20, 21, 22, 24 ).

Findings are as follows:

A review of the hospital policy entitled, "Medical Record Documentation Requirements", under "Procedure", states:

"Every clinical record entry must be dated, timed, its author identified and authenticated."

1) A review of the medical record for patient ID #2 revealed an admission to the hospital on 8/2/10. A Progress Note dated 8/4/10, and a Neurology note dated 8/5/10 did not include the time of the entry. Additionally, a Pre-op Assessment note and a Surgical Prep Checklist failed to include the time of entry.

2) A review of the medical record for patient ID #12 revealed an admission to the hospital on 8/16/10 . Progress Notes dated 8/17/10, 8/18/10, and 8/23/10, an Anesthesia note dated 8/17/10, and a "Brief Operative Note" dated 8/18/10 did not include a time of entry.

3) A review of the medical record for patient ID #13 revealed an admission to the hospital on 8/17/10. Progress Notes dated 8/17/10, 8/19/10, 8/20/10, 8/21/10, 8/22/10, 8/23/10, 8/24/10, and 8/25/10, a Cardiology note dated 8/18/10, and a Case Management note dated 8/26/10 did not include a time of entry.

4) A review of the medical record for patient ID #14 revealed an admission to the hospital on 8/2/10. Progress Notes dated 8/2/10, 8/3/10, 8/4/10, 8/5/10 and 8/6/10, and a Surgical Procedure Record dated 8/3/10 did not include a time of entry.

5) A review of the medical record for patient ID #15 revealed an admission to the hospital on 9/10/10. Progress notes dated 9/10/10, 9/13/10, 9/15/10, and 9/25/10, an "OP" note dated 9/15/10, and Clinical Nutrition note dated 9/24/10 did not include a time of entry.

6) A review of the medical record for patient ID #16 revealed an admission to the hospital on 8/17/10. An Operative Note dated 8/17/10, Progress notes dated 8/18/10, 8/19/10, 8/20/10 and 8/22/10, and a Case Management note dated 8/21/10 did not include a time of entry.

7) A review of the medical record for patient ID #17 revealed an admission to the hospital on 8/25/10. An Operative note dated 8/25/10, Progress Notes dated 8/26/10, 8/28/10, 8/29/10 and 8/30/10, and a Case Management note dated 8/30/10 did not include a time of entry.

8) A review of the medical record for patient ID #18 revealed an admission to the hospital on 8/31/10. The Perioperative Verification Checklist, the Holding Unit Assessment, the Surgical Procedure Record, and the Operative Note, all dated 8/31/10, failed to reveal times of entry. In addition, Progress notes dated 9/1/10 and 9/2/10, and a Case Management note dated 9/3/10 did not include a time of entry.

9) A review of the medical record for patient ID #20 revealed an admission to the hospital on 12/12/09. Progress notes dated 12/12/09 and 12/14/09 were not timed. A Perioperative note failed to have the date or time recorded. An Ambulatory PACU (Post Anesthesia Care Unit) order failed to have the date or time recorded A readmission Progress note dated 1/9/10 was not timed. Additionally a Surgical note dated 4/8/10 had no date, time, or signature of the individual writing the note.

10) A review of the medical record for patient ID #21 revealed an admission to the hospital on 4/27/10. Progress notes dated 4/28/10 and 4/29/10 did not include the time of the entry. Additionally there was no time on the Colon Rectum Staging Form.

11) A review of the medical record for patient ID #22 revealed an admission to the hospital on 1/11/10. Physician orders on the Surgical Procedure Record did not include the time, and the discharge order to home failed to include the time. The Ambulatory PACU order failed to have time recorded.

12) A review of the medical record for patient ID #24 revealed an admission to the hospital on 8/3/10. An Emergency Room Physician Record had no physician signature, date or time. A Progress note dated 8/3/10, a Cardiology attending note dated 8/4/10 had no time, progress notes dated 8/5/10, 8/6/10 and 8/7/10, and a Vascular Attending note dated 8/8/10 did not include the time of entry.

The hospital was previously cited (April 2010) for failure to ensure complete medical records

Based on record review, staff interview, and review of hospital policies, it was determined that the hospital failed to ensure compliance with the hospital policies entitled, "Surgical Counts", and "Universal Protocol: Verification of the Patient's Identity, Surgical Procedure and Surgical Site/Side", for relevant sample patient (ID #2).

Findings are as follows:

The hospital policy entitled, "Surgical Counts", under "Instruments" states:

"Members of the surgical team should account for disassembled or broken instruments in their entirety, including all parts of the instruments."

Under "Incorrect Counts" it states:

"If the count is incorrect and not reconciled after two counts and the item cannot be located, an X-ray will be taken in the OR...."

Additionally, the hospital policy entitled, "Universal Protocol: Verification of the Patient's Identity, Surgical Procedure and Surgical Site/Side", under item 4 "Debriefing Process" states:

"The attending surgeon will initiate a debriefing prior to leaving the Operating Room. All team members are to be actively involved in this process......Identification of any instrument or equipment concerns ....Request by the attending surgeon for any questions, comments from the team."


A review of the medical record for patient ID #2 revealed that a right parietal craniotomy for resection of tumor was performed on 8/4/10. The Operative Report revealed that during the procedure a high-speed air drill was used to make a single burr hole in the inferior portion of the skull that had been exposed. At the conclusion of the case all sponge and needle counts were noted to be correct.

An undated/untimed addendum to the Operative Report revealed that a small fragment of drill bit was fractured during the opening of the craniotomy. The surgical procedure concluded with no evidence that the drill bit was located

The patient was admitted postoperatively to the Neurological Intensive Care Unit as planned. A physician progress note, dated 8/4/10, revealed "status post parietal craniotomy, doing well". On 8/5/10 at 0310, a routine post operative MRI (Magnetic Resonance Technology) was performed. The MRI reading was found to be "non diagnostic secondary to extensive artifact, that obscured the visualization of the resection cavity". An addendum on 8/5/10 at 8:01 PM revealed that "there is a small radiopaque foreign body which represents the artifact and Neurosurgery is aware of the findings".

On 8/5/10 at 0951, a skull Xray (2 views) was performed, and revealed that "two adjacent craniotomy defects are present in the right parietal region". At 8:01 PM, an addendum to this report noted "additional clinical information provided relative to concern that a small fragment of a drill bit cracked in the Operating Room".

On 8/6/10 the patient returned to the operating room for removal of a "metal foreign body". The patient underwent a "right cranial wound exploration for removal of foreign body". The Operative Report revealed a retained foreign body, "approximately 7 mm (millimeters) in length of broken drill bit".

During an interview on 9/30/10 at 10:45 AM with the Vice President of Risk Management, she reported that the Circulating Nurse had contacted the Assistant Clinical Manager for guidance during the initial surgery when the drill bit broke off, and was instructed to collect all pieces in a bag and complete an occurrence report. The broken drill bit piece was not obtained.

During an interview on 9/30/10 at 11:00 AM with the Director of Quality/Patient Safety Perioperative Services, it was reported that the Surgeon should have reconciled the broken drill piece either visually or by X-ray when it was not located. An X-ray was not performed prior to the cranial flap placement on the patient when the broken piece of drill bit could not be located, per hospital policy. There was no evidence that the Surgical team identified any equipment concerns during the Debriefing Process at the conclusion of the procedure, per hospital policy. Additionally, the Surgical team also failed to account for the broken piece of equipment during the Surgical Counts at the end of the procedure, in accordance with hospital policy.

During an interview on 9/30/10 at 2:00 PM with 1 of 2 Scrub Technicians, it was determined that she had been precepting the other Scrub Technician that was recently transferred to the Neurosurgery area. She reported that although she was present for the first count, she was not present for the final count nor the debriefing process. She returned to the operating room when the procedure had concluded and the patient was on a stretcher. She reported that it is the responsibility of the Scrub Tech to ensure that all equipment pieces are in place. The precepting Scrub Tech revealed that she left the orienting Scrub Tech, as he was an experienced Scrub Tech and she assumed he would ask if he had any questions.

During an interview on 9/30/10 at 2:40 PM with the Neurosurgeon, he reported that during the operative procedure on 8/4/10 the drill bit broke and a new drill bit was obtained. He indicated that he "thought that the broken piece may have been in the bone flap that was handed to the Scrub Tech". The Circulating Nurse did question him as to where the broken piece was. The procedure continued, and the scalp was closed by the Neurosurgery Resident. The Neurosurgeon did remain in the room while the sponge and needle counts were completed. He revealed that an X-ray had not been done as he "assumed that the drill bit was found". He admitted that although a debriefing was done, it did not include dialogue relative to the broken piece of equipment.

Although the hospital has policies and procedures in place to account for surgical counts and equipment, all parts of these procedures were not implemented. Specifically, the surgical team failed to account for a broken instrument (drill bit) or obtain an Xray at the time that the broken drill bit could not be located; and prior to leaving the OR, the attending surgeon failed to identify instrument or equipment concerns related to the broken drill bit during his debriefing.