HospitalInspections.org

Based on interviews and documentation review the Hospital was not in compliance with the Condition of Participation. Please see Standard A-0275, A-0276, and A-0290.

Based on interviews and documentation review the Hospital failed to ensure that education provided to staff was effective and that Universal Protocol practices were being appropriately carried out by staff.

Findings included:

Complaint #10-0346:
It was reported that on 3/29/10 Patient #6 was scheduled for a left Video Assisted Thoracotomy (VAT; surgical incision into the chest wall) with a possible biopsy. The Cardiovascular Surgeon saw Patient #6 in the Holding Area and informed consent was obtained for the left VAT. The Surgeon marked Patient #6's left shoulder (side) and not the left chest (site). Patient#6 was brought to the assigned OR, was intubated, and then the Surgeon, Resident, Circulating Nurse, and Scrub Tech turned Patient #6 to a left lateral decubitus position (left side down, right side up). The Certified Registered Nurse Anesthetist (CRNA) deflated Patient #6's left lung as planned. Patient #6 was shaved by the Surgeon then prepped and draped by the Circulating Nurse and Scrub Tech. The Circulating Nurse initiated the Time-Out and the team agreed all the elements were correct including Patient #6's position. The Surgeon made 2 incisions into the right chest wall, reached in and felt the lung was still inflated and it was at that point the error was realized. One incision was closed and a chest tube was inserted into the remaining incision. Patient #6 was repositioned and the surgery was performed on the correct side.

Review of the Hospital's Policy titled Universal Protocol and Identification of Side and Site, effective 12/4/09, indicated that a final Time-Out performed in the OR must be conducted in the location of the procedure, must occur just before starting the procedure, must involve the entire team, must be active, and must be documented on the Verification Checklist. One of the elements of the final Time-Out include the correct site/side marking.

The Holding Area Nurse who assisted the Cardiovascular Surgeon was interviewed on 4/7/10 at 9:30 A.M. and the Circulating Nurse was interviewed on 4/6/10 at 2:30 P.M. The Holding Area Nurse reported handing the marker to the Circulating Nurse who handed the marker to the Surgeon and both observed the Surgeon mark Patient #6's left shoulder. The Circulating Nurse confirmed being present for the marking.

The Resident who observed the surgery was interviewed on 4/6/10 at 1:15 P.M., the Circulating Nurse was interviewed, and the Scrub Technician was interviewed on 4/8/10 at 1:25 P.M. The Resident, the Circulating Nurse, and the Scrub Technician conformed the marking was not visible once Patient #6 was draped.

The Cardiovascular Surgeon was interviewed on 4/6/10 at 1:15 P.M. The Surgeon reported having performed VAT surgery previously both at the Hospital and another out-of-state Hospital. The Surgeon reported that prior to this incident it was his/her practice to mark the shoulder and not the chest when performing VATs. The Surgeon said that the marking was not visible once the patient was draped however; no one had ever identified that as a problem.

The Cardiovascular Surgeon and the Resident were asked by the Surveyor if education had been provided prior to this incident regarding Universal Protocol. The Surgeon reported receiving education related to documentation requirements but not the Policy. The Resident reported being provided a book with various policies/procedures in it to read that included Universal Protocol. The Resident reported reading only parts of manual/policy.

Review of the OR Orientation Checklist indicated that staff are asked to sign they have received and read the Universal Protocol Policy/Procedure.

Review of electronic transmissions provided by the Hospital indicated that on 10/16/08 an electronic transmission was sent out to regarding updates made to the Verification Checklist. On 12/9/09 an electronic transmission was sent out to notify surgical staff of updates made to the Universal Protocol Policy.

The Director of Surgery was interviewed on 4/6/10 at 2:15 P.M. with the Director of Risk Management present and throughout the survey. The Director reported informally observing the Time-Out process during rounds and did not observe any concerns.

Review of the Hospital's Peri-Operative Committee Meeting Minutes that contained quality data collected from 9/09 to 3/10 indicated that documentation of side/site markings and Time-Outs was monitored. There was no indication that observations were performed to ensure practice was in accordance with the Hospital's requirements.

Based on interview and documentation review the Hospital failed to identify all opportunities for improvement during a review of an incident involving the Time-Out process.

Findings included:

Complaint #10-0334:
Review of medical record documentation and the Surgical Log, dated 3/18/10, indicated that Patient #1 presented to the Hospital for cataract surgery of the left eye. Patient #1 was to have a nerve block (induction of anesthesia into the nerve to prevent sensory nerve impulses, such as blinking with the eye) performed prior to the surgery.

The Anesthesiologist who performed the nerve block was interviewed on 4/2/10 at 2:00 P.M. with the Director of Risk Management present, medical record documentation was reviewed, and the Hospital's investigation was reviewed. Interview and documentation review indicated the following: the Anesthesiologist evaluated Patient #1; identified the left eye as the surgical eye and consent was obtained; the side/site verification process was interrupted when the Anesthesiologist was asked to see another patient who was having difficulty coming out of anesthesia; the Anesthesiologist was gone approximately 12-15 minutes; when the Anesthesiologist returned to Patient #1 the Anesthesiologist did not start the side/site verification process from the beginning; the equipment to perform the nerve block had been placed on the right side of Patient #1's bed, and the Anesthesiologist performed the nerve block on Patient #1 ' s right eye .

The Anesthesiologist said there was nothing unusual about the day, there were no issues with staffing, and the caseload was not increased.

The Chief of Anesthesiology was interviewed on 4/6/10 at 9:25 A.M. The Chief of Anesthesiology reported being on vacation the day of the incident but was sent a message regarding the incident. The Chief reported returning the following Monday, 3/22/10, and immediately meeting with the Anesthesiologist, reviewing the Universal Protocol Policy, and telling the Anesthesiologist there would be no exceptions to the process. The Chief reported spending all week meeting with each Anesthesiologist and Certified Registered Nurse Anesthetist to review the Policy, to inform them violation of Policy would not be tolerated, and a violation would result in disciplinary action.

The Director of Risk Management was interviewed on 4/2/10 at 2:15 P.M. and throughout the survey. The Director said an interdisciplinary evaluation of the incident was scheduled for 3/30/10 to involve leadership and the individuals involved in the incident.

Review of the analysis conducted on 3/30/10 indicated that the following opportunities for improvement were identified: 1). the Anesthesiologist documented but did not mark the side/site of the nerve block prior to performed in the blocking; 2). the Anesthesiologist did not follow the verification process; 3). the Anesthesiologist relied on placement of equipment as a prompt for the side of the block; 4). there was a need for education related to the Time-Out process and side/site marking and the reliance on equipment placement; 5). Anesthesiology needed a documented prompt to perform an active Time-Out with nerve blocks; 6). there was a need to look at staff accountability for patients in the Holding Area, and 7). the Universal Protocol Policy needed to be revised to include necessity of active Time-Out in the Holding Area with 2 staff members.

The Director of Risk Management said a medical record review was conducted and identified that the Eye Surgeon had not appropriately completed Patient #1's Verification Checklist which was going to be addressed however; the focus was on addressing the verification process.

The analysis did not identify that the Consent Forms were not appropriately completed for 5/5 patients (Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5), and the Eye Surgeon signed, but did not complete the verification check-off list for 4/5 records (Patient #2, Patient #3, Patient #4, and Patient #5).

Based on interview and documentation review the Hospital failed to ensure that peri-operative quality data was acted upon and/or that actions taken were documented.

Findings included:

Complaints #10-0334 and #10-0346:
1). Review of the Universal Protocol Verification Checklist indicated that it is a preprinted form with 6 sections. Each section contained a check-off list of items to be reviewed and completed by the staff member assigned to that section. Each person signed their assigned section to indicate the check-off list was verified. Section #1 was pre-procedural and was completed by Preadmission Testing if applicable and/or by the nurse on the unit (if an inpatient or from Same Day Surgery). Section 2 was completed pre-procedural by the physician performing the surgery/procedure. Section 3 was completed by the Anesthesiologist. Section 4, the final confirmation check, was completed by the Holding Area nurse (if applicable). Section 5, the active Time-Out, was completed by the nurse in the location of the procedure just prior to the start of the procedure. Section 6 was completed by the nurse following the procedure.

Review of Verification Checklists for 6 Patients (Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, and Patient #6) indicated the following:
-On 3/18/10 Patients #2, #3, #4, and #5 had cataract surgery by the same Eye Surgeon. Prior to the surgeries the Eye Surgeon signed, but did not do the check-off list for Section 2.
- On 3/29/10 Patient #6 had a left-sided Video Assisted Thoracotomy by the Cardiothoracic Surgeon. Prior to the surgery the Cardiothoracic Surgeon signed, but did not do the check-off list for Section 2.

Review of the Peri-Operative Improvement Committee Meeting Minutes, dated 10/15/09, 12/17/09, 2/18/10, and 3/18/10, indicated that physician, Anesthesia, and the Holding Areas documentation were monitored for compliance. A number of records were audited each month and based on compliance the targeted areas were given a percentage to indicate the level of compliance. Under the data discussion regarding the numbers and recommended actions was documented. The Minutes also contained an area to document action plans.

Review of the Meeting Minutes indicated that physician compliance with documentation declined from 100% in 11/09 to 68% in 12/09, 51.67% in 1/10, and 58.33% in 2/10. The 2/18/10 Meeting Minutes (which reviewed the 11/09 to 1/10 data) indicated that the surgeons were not completing the Verification Checklist and that an action plan needed to be developed. The 3/18/10 Meeting Minutes (which reviewed the 11/09 to 2/10 data) indicated that the Chief of Surgery wanted to know why the drastic change in physician compliance and was told that the Verification Checklist now separated the Anesthesiologist and physician documentation. The recommendation continued to be the need to develop an action plan.

Even though documentation was audited and deficient practice was identified there was no evidence that an action plan had been developed and/or implemented .

2). Review of the Meeting Minutes, dated 10/15/09, 12/17/09, 2/18/10, and 3/18/10, indicated that Holding Area level of compliance with documentation tended to fluctuate between approximately 82% and 93%. The 10/15/09 and 12/17/09 Meeting Minutes indicated that there needed to be a second nurse in the Holding Area; documentation indicated that an action plan needed to be developed. The 2/18/10 Meeting Minutes discussion indicated there needed to be a second nurse in both Holding Areas in the Hospital; documentation indicated that an action plan needed to be developed. The 3/18/10 Meeting Minutes indicated that there was a consistent need for a second nurse in both Holding Areas especially in the morning; documentation indicated that an action plan needed to be developed.

The Director of Quality Management was interviewed on 4/8/10 at 9:30 A.M. The Director said it was identified that the beginning of the day was busy in the Holding Area because of the influx of the first cases of the day. The Director said as a result a second nurse was scheduled in the Holding Areas.

Review of the 3/18/10 staffing schedule and observation on 4/2/10 and 4/7/10 indicated that there were 2 nurses scheduled for the Holding Areas.

The Director of the PACU/Holding Areas was interviewed on 4/6/10 at 8:50 A.M. The Director said 2 nurses were being scheduled in the Holding Areas of the Hospital.

The Meeting Minutes did not reflect any actions identified and/or implemented to address the identified concern.

3). Review of the Anesthesia Performance Improvement Committee Meeting Minutes, dated 10/7/09, 10/28/09, 12/23/09, 1/20/10, and 3/31/10, indicated that there was a monthly evaluation of compliance with obtaining witness signatures on Informed Consents. The compliance rate for time period reviewed was variable between 58.3 to 95.4%.

The Hospital's Policy/Procedure titled Informed Consent, effective 11/30/06, indicated that completion of the informed consent included the signature of a witness.

The Hospital's Policy/Procedure titled Universal Protocol, effective 12/4/09, indicated that the witness signature was optional.

The Director of Risk Management was interviewed on 4/2/10 at 2:15 P.M. and throughout the survey. The Director said when the Universal Protocol Policy was updated research was done and it was determined that a witness signature was not required. The Director said the change in policy was entered into the updated Universal Protocol Policy and implemented before the Informed Consent Policy was updated.

Although the data was reviewed at the Meetings there was no documented evidence of actions taken to address the level of compliance. The Hospital implemented an action plan to not require witness signatures however; the current Policies were opposing. Although the Universal Protocol Policy had been updated to consider witness signatures as optional the Hospital continued to evaluate the level of compliance regarding witness signatures.

Based on interviews and documentation review the Hospital failed to ensure that 1). the policies related to informed consent were not consistent, and 2). informed consents were properly completed for 6 of 6 patients (Patient #1, Patient #6, Patient #3, Patient #4, Patient #5, and Patient #6).

Findings included:

Complaint #10-0334 and Complaint #10-0346
1). The Hospital's Policy/Procedure titled Informed Consent, effective 11/30/06, indicated that completion of the informed consent included the signature of a witness. A witness was a professional who personally observed a patient or legally authorized person signing a consent form. The purpose of the witness signature was to affirm that the signature belonged to the person signing the form. The physician performing the procedure was responsible for providing sufficient information too enable the patient to make a decision.

The Hospital's Policy/Procedure titled Universal Protocol, effective 12/4/09, indicated that the witness signature was optional.

Review of the Consent for Medical, Surgical, and Diagnostic Procedures form indicated that the bottom of the form were areas for the patient's, witness, and the physician signature. The form did not indicate the witness signature was optional.

The Director of Risk Management was interviewed on 4/2/10 at 2:15 P.M. and throughout the survey. The Director said when the Universal Protocol Policy was updated research was done and it was determined that a witness signature was not required. The Director said the change in policy was entered into the updated Universal Protocol Policy and implemented before the Informed Consent Policy was updated.


2). Complaint #10-0334:
The Hospital ' s Policy/Procedure titled Informed Consent indicated that elements of the informed consent included the nature and probability of risks. Documentation must include a specific listing of major risks disclosed. If the informed consent process took place in the physician ' s office then a copy of the progress note describing the elements of informed consent may be attached as an addendum.

Review of the Consent for Medical, Surgical, and Diagnostic Procedures form indicated that there were an area to document the risks, benefits, and alternatives to treatment. There was also a check-off box to indicate if an addendum was attached to the Consent Form.

The Consent for Medical, Surgical, and Diagnostic Procedures form was reviewed for 5 Patients (Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5) who were scheduled for cataract surgery under the same Eye Surgeon on 3/18/10.

Review of Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5's Consent for Medical, Surgical, and Diagnostic Procedures forms determined that in each form the Risk/Benefits area was typed - Discussed w/pt and the addendum box was not checked off.

Review of Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5's medical records determined that there was no documentation in the records to indicate that the risks/benefits of the scheduled surgical procedure had been discussed with each patients.

A copy of the office visit note for Patient #1 was obtained and reviewed and evidenced that the risks and benefits were discussed at the office prior to the surgical procedure however; those notes were never copied and attached to the Consent Form.

Review of 6 medical records indicated that the practice for obtaining witness signatures was inconsistent. Patient #6's Consent for a Bronchoscopy procedure did not include a witness signature however; all other Consent Forms reviewed contained witness signatures.

Complaint #10-0346:
The medical record documentation for Patient #6 indicated that on 3/25/10 Patient #6 was admitted to the Hospital from the physician's office after a chest x-ray revealed a chronic left-sided pleural effusion and possible infiltrate verses a mass. Patient #6 had 3 procedures performed during the hospitalization: on 3/26/10 a Bronchoscopy with moderate sedation was performed in the Pulmonary Suite; on 3/26/10 a Thoracentesis was performed at the bedside, and on 3/29/10 left Video Assisted Thoracotomy (VAT) surgery was performed in the Operating Room (OR).

Review of Patient#6 ' s Consents for Medical, Surgical, and Diagnostic Procedures indicated the following:

The Consent for Medical, Surgical, and Diagnostic Procedures for the Bronchoscopy, dated 3/26/10, indicated that Patient #6 was consenting to a Bronchoscopy with conscious sedation.

Review of the Consent for Medical, Surgical, and Diagnostic Procedures form indicated that there was an area to consent to the use of moderate sedation, if applicable. The consent for moderate sedation included information regarding the expected results, risks, and technique.

Review of the Consent for Medical, Surgical, and Diagnostic Procedures for the Bronchoscopy, dated 3/26/10, indicated that the risk/benefits section was completed and addressed the risks/benefits for the Bronchoscopy however; the authorization for moderate sedation was not checked off to indicate the risks were reviewed with Patient #6.

Review of the Consent for Medical, Surgical, and Diagnostic Procedures for the left VAT, dated 3/29/10, indicated that the risks/benefits and alternatives to treatment were not documented as reviewed with Patient #6.

The Surgeon who performed the left VAT was interviewed on 4/6/10 at 1:15 P.M. with the Director of Risk Management present. The Surgeon said he explained the risks/benefits to the Patient prior to the procedure.

Review of Patient #6's medical record indicated that there was no documented evidence in other areas of the record that the risks/benefits related to the left VAT were reviewed with Patient #6 prior to the surgical procedure.

Based on interviews and documentation review the Hospital was not in compliance with the Condition of Paticipation for Surgical Services. Please see Standards A-0951 and A-0955.

Based on interviews and documentation review the Hospital failed to ensure that peri-operative services were provided in accordance with acceptable standards of practice. The Hospital failed to ensure that. 1). the verification process was appropriately executed and/or documented for 6 of 6 patients Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, and Patient #6)., and 2). that staff were properly educated regarding Universal Protocol prior to Patient #6's incident.


Findings included:

1). Complaint #10-0334:
The Policy/Procedure titled Universal Protocol and Identification of Site and Side, effective 12/4/09, was reviewed. The Policy indicated that prior to surgery or a procedure, verification of the correct patient (name and date of birth), procedure, and site/side occur at the time of admission, before the patient leaves the pre-procedure area or enters the procedure room, and anytime responsibility for care of the patient is transferred to another caregiver.
-In the immediate pre-procedure area the following occurs: The provider performing the procedure verifies the patient name and DOB, the consent is completed and is accurate, the H&P is updated, signed, dated, and timed within 24 hours of the procedure, and the site/side has been marked with the provider ' s initials. The Anesthesiologist verifies the following in the immediate pre-procedure area when moderate sedation or anesthesia is planned: patient name and DOB; Anesthesia Consent is completed, dated, and timed; any sites for anesthesia procedures involving laterality are marked by the Anesthesiologist performing the procedure (such as with nerve blocks); Anesthesia pre-evaluation is completed; anticipated airway concerns are identified and communicated; correct antibiotic is available, and resuscitation status is addressed. Final confirmation of all required elements listed on the checklist is conducted by the licensed provider just prior to entering the procedure room: correct name and DOB; H&P within 30 days and updated within 24 hours; Surgical Consent signed, dated, and timed within 30 days; Anesthesia Consent signed, dated, and timed; the words right or left are spelled out on the Consent Form, if applicable, and the appropriate surgical site/side has been identified/marked by the provider performing the procedure.
-A final Time-Out performed in the OR must be conducted in the location of the procedure, must occur just before starting the procedure, must involve the entire team, must be active, and must be documented on the Verification Checklist. The elements of the final Time-Out in the OR include: the patient name and DOB; accurate and complete Consent Form; team consensus on the procedure that is consistent with the Consent and H&P, and correct site/side are marked; correct patient position. Once the Patient is draped the circulating nurse will initiate the Time-Out which will consist of a pause and each member of the surgical team will confirm each site prior to the incision. If all agree the physician will proceed. The Time-Out is documented on the Verification Checklist by the circulating nurse.

Review of the Universal Protocol Verification Checklist indicated that it is a preprinted form with 6 sections. Each section contained a check-off list of items to be reviewed and completed by the staff member assigned to that section. Each person signed their assigned section to indicate the check-off list was verified. Section #1 was pre-procedural and was completed by Preadmission Testing if applicable and/or by the nurse on the unit (if an inpatient or from Same Day Surgery). Section 2 was completed pre-procedural by the physician performing the surgery/procedure. Section 3 was completed by the Anesthesiologist. Section 4, the final confirmation check, was completed by the Holding Area nurse (if applicable). Section 5, the active Time-Out, was completed by the nurse in the location of the procedure just prior to the start of the procedure. Section 6 was completed by the nurse following the procedure.

Review of the Verification Checklist for Patient #1 determined the following: Section 1 was checked off by a nurse (unable to determine if from Same Day Surgery or from the Holding Area and was not signed; Section 4 was checked off but was not signed by licensed staff in the Holding Area.

Review of the OR Schedule for 3/18/10 determined there were 4 additional cataract surgeries scheduled (Patient #2, Patient #3, Patient #4, and Patient #5). Review of the medical records determined the Surgeon signed, but did not complete Section 2 of the Verification Checklist for 4 of 4 medical records.

Complaint #10-0346:
The medical record documentation for Patient #6 indicated that on 3/25/10 Patient #6 was admitted to the Hospital from the physician's office after a chest x-ray revealed a chronic left-sided pleural effusion and possible infiltrate verses a mass. Patient #6 had 3 procedures performed during the hospitalization: on 3/26/10 a Bronchoscopy with moderate sedation was performed in the Pulmonary Suite; on 3/26/10 a Thoracentesis was performed at the bedside, and on 3/29/10 left Video Assisted Thoracotomy (VAT) surgery was performed in the Operating Room (OR).

Review of the Verification Checklist for the Bronchoscopy indicated that only the pre-procedural sections (Sections 1, Section 2, and Section 3)were completed and signed. Sections 4, 5, and 6 were not completed.

The Bronchoscopy Nurse was interviewed on 4/8/10 at 10:15 A.M. with the Director of Risk Management present. The Bronchoscopy Nurse said the pre-procedural sections of the Verification List (Sections 1-3) were completed however; Section 4 was not completed because patients did not come from the Holding Area of the Hospital. The Bronchoscopy Nurse reported Section 5 (the final Time-Out in the Procedural Area) and Section 6 (the Post-Procedural sections) were not completed because the Bronchoscopy Nurse was not told they were supposed to be completed. The Bronchoscopy Nurse reported documenting that a Time-Out was performed and was documented on the Flow Sheet.

Review of the Flowsheet, dated 3/26/10, confirmed the Bronchoscopy Nurse documented the Time-Out in that area.

The Verification Checklist used for the Thoracentesis was not the correct form and completed incorrectly. One person (later identified as a Resident) completed all Sections of the checklist and signed at the end of the last section (Section 6). Because the procedure was performed at the bedside a Bedside Verification Checklist form should have been used.

Review of the Verification Checklist, dated 3/29/10, indicated that the Surgeon signed, but did not complete Section 2 and Section 6 was not completed.

2). It was reported that on 3/29/10 Patient #6 was scheduled for a left Video Assisted Thoracotomy (VAT; surgical incision into the chest wall) with a possible biopsy. The Cardiovascular Surgeon saw Patient #6 in the Holding Area and informed consent was obtained for the left VAT. The Surgeon marked Patient #6's left shoulder (side) and not the left chest (site). Patient#6 was brought to the assigned OR, was intubated, and then the Surgeon, Resident, Circulating Nurse, and Scrub Tech turned Patient #6 to a left lateral decubitus position (left side down, right side up). The Certified Registered Nurse Anesthetist (CRNA) deflated Patient #6's left lung as planned. Patient #6 was shaved by the Surgeon then prepped and draped by the Circulating Nurse and Scrub Tech. The Circulating Nurse initiated the Time-Out and the team agreed all the elements were correct including Patient #6's position. The Surgeon made 2 incisions into the right chest wall, reached in and felt the lung was still inflated and it was at that point the error was realized. One incision was closed and a chest tube was inserted into the remaining incision. Patient #6 was repositioned and the surgery was performed on the correct side.

Review of the Hospital's Policy titled Universal Protocol and Identification of Side and Site, effective 12/4/09, indicated that a final Time-Out performed in the OR must be conducted in the location of the procedure, must occur just before starting the procedure, must involve the entire team, must be active, and must be documented on the Verification Checklist. One of the elements of the final Time-Out include the correct site/side marking.

The Holding Area Nurse who assisted the Cardiovascular Surgeon was interviewed on 4/7/10 at 9:30 A.M. and the Circulating Nurse was interviewed on 4/6/10 at 2:30 P.M. The Holding Area Nurse reported handing the marker to the Circulating Nurse who handed the marker to the Surgeon and both observed the Surgeon mark Patient #6's left shoulder. The Circulating Nurse confirmed being present for the marking.

The Resident who observed the surgery was interviewed on 4/6/10 at 1:15 P.M., the Circulating Nurse was interviewed, and the Scrub Technician was interviewed on 4/8/10 at 1:25 P.M. The Resident, the Circulating Nurse, and the Scrub Technician conformed the marking was not visible once Patient #6 was draped.

The Cardiovascular Surgeon was interviewed on 4/6/10 at 1:15 P.M. The Surgeon reported having performed VAT surgery previously both at the Hospital and another out-of-state Hospital. The Surgeon reported that prior to this incident it was his/her practice to mark the shoulder and not the chest when performing VATs. The Surgeon said that the marking was not visible once the patient was draped however; no one had ever identified that as a problem.

The Cardiovascular Surgeon and the Resident were asked by the Surveyor if education had been provided prior to this incident regarding Universal Protocol. The Surgeon reported receiving education related to documentation requirements but not the Policy. The Resident reported being provided a book with various policies/procedures in it to read that included Universal Protocol. The Resident reported reading only parts of manual/policy.

Review of the OR Orientation Checklist indicated that staff are asked to sign they have received and read the Universal Protocol Policy/Procedure.

Based on interviews and documentation review the Hospital failed to ensure that 1). the policies related to informed consent were not consistent, and 2). informed consents were properly completed for 6 of 6 patients (Patient #1, Patient #6, Patient #3, Patient #4, Patient #5, and Patient #6).

Findings included:


Please refer to Standard A-0466.