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Based on interview and record review, the facility's Governing Body (GB) failed to ensure the facility's operation was conducted in an effective, safe, and organized manner by failing:

1. To ensure there was documented evidence that surgical site marking was performed in accordance with the facility policies and procedures and standards of practice (Refer to A940).

2. To ensure there was documented evidence that needle, sponge and instrument counts were performed as needed for the surgical case in accordance with the facility policies and procedures and standards of practice (Refer to A940).

3. To ensure there was documented evidence the surgical time out (a stopped period of time when all members of the surgical/procedure team participate in the positive identification of the patient, the intended procedure and the visualization of the marked site of the procedure) was performed in accordance with the facility policies and procedures and standards of practice (Refer to A940).

4. To ensure there was documented evidence a second surgical "time out" and a second needle, sponge, and instrument counts were performed when two surgical procedures with laterality were performed by the same surgeon on the same patient in accordance with the facility policies and procedures and standards of practice (Refer to A940).

5. To ensure the facility's Quality Assessment and Performance Improvement (QAPI) program identified issues related to surgical counts, surgical "time out," and validation of the surgical side/site marking were consistent with the facility policies and procedures and standards of practice (Refer to A263).

The cumulative effect of these systemic problems resulted in failure of the Governing Body to ensure patients were receiving quality care in a safe and effective manner.

Findings:

The services provided in the surgery department were not consistent with facility policies and procedures and standards of practice (Refer to A940).

In addition, the facility QAPI program did not identify issues related to surgical counts, surgical "time out," and validation of the surgical side/site marking were consistent with facility policies and procedures and standards of practice (Refer to A263).

An interview was conducted with members of the Governing Body on January 9, 2013, at 3 p.m. The Governing Body members stated they had not been informed regarding the failure of the facility to ensure staff performed and documented the surgical counts, the surgical "time out," and the validation of the surgeon's surgical site marking were consistent with the facility policies and procedures and standards of practice.

Based on interview and record review, the facility failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven Quality Assessment and Performance Improvement (QAPI) program, in which the Governing Body (GB) ensured that the program focused on indicators in improving health outcomes by failing:

To have an ongoing quality appraisal and performance improvement program that addressed and monitored the complexity and scope of Surgical Services. This resulted in failure to identify issues related to surgical counts, surgical "time out," and validation of the surgical side/site marking were consistent with the facility policies and procedures and standards of practice (Refer to A273, A309, and A940).

The cumulative effect of these systemic problems resulted in the failure for the facility quality assurance, performance improvement program to ensure high quality healthcare and a safe environment for all patients.

Based on interview and record review, the facility failed to identify opportunities for improvement that would ensure surgical services provided to patients were consistent with facility policies and procedures and standards of practice. This failure had the potential to result in unsafe surgical practices to continue without immediately being detected.

Findings:

The services provided in the surgery department were not consistent with facility policies and procedures and standards of practice (Refer to A940 and A951).

On January 9, 2013, at 2 p.m., facility staff responsible for the Quality Assessment and Performance Improvement (QAPI) program were interviewed. The Director Risk Management/Surgical Services (DRM) stated the facility had identified "time-out" concerns not being performed outside the surgery department, in the patient care units for procedures such as central catheter insertions (PICC - Peripherally Inserted Central Catheter; intravenous access). The DRM stated the facility had not identified surgical counts, surgical "time-out," and surgical site marking validation as issues of concern.

Based on interview and record review, the facility's Governing Body, through the Quality Assessment and Performance Improvement (QAPI) program, failed to identify opportunities for improvement that would ensure surgical services provided to patients were consistent with facility policies and procedures and standards of practice. This failure had the potential to result in unsafe surgical practices to continue without immediately being detected.

Findings:

The services provided in the surgery department were not consistent with facility policies and procedures and standards of practice (Refer to A273, A940, and A951).

On January 9, 2013, at 3:10 p.m., members of the Governing Body were interviewed. The members were not aware of any concerns in the surgery department specific to the practices of surgical counts, surgical "time-out," and surgical site marking validation as issues of concern.

Based on observation, interview, and record review, the facility failed to ensure outdated; opened and not dated; opened, dated but expired drugs and biologicals were not available for patient care use. This had the potential to result in patients receiving drugs and biologicals that were expired or contaminated.

Findings:

On January 7, 2013, at 8:55 a.m., a tour of the Operating Room (OR) was conducted with OR Charge Nurse (ORCN) 1.

The following was observed in Surgical Services and available for patient use:
1. One three-fluid ounce bottle of Povidone-Iodine Paint, opened not dated.
2. One 8-fluid ounce bottle of Hibiclens, opened not dated.
3. Two purple top laboratory tubes with an expiration date of December 2012.
4. Three packages of Uncuffed Tracheal Tubes sizes 5.0, 5.5, and 6.0 were opened, and the size 5.5 had a stylus inside the tube.
5. Three size 4.5 tracheal tubes with an expiration date of May 2012.
6. One 30-milliliter vial of Bupivacaine which was opened and dated November 29, 2012.
7. One vial of Humulin Insulin which was opened and dated December 8, 2012.
8. One Lidocaine HCL (hydrochloride) 1.5% with an expiration date of January 1, 2013.
9. One Epinephrine 1:10,000 with an expiration date of December 2012.

During a concurrent interview with ORCN 1, she stated the bottles of Povidone-Iodine Paint and Hibiclens should have been discarded once opened. She stated once a product package, such as the uncuffed tracheal tubes, had been opened, the product would need to be discarded immediately if not used. The ORCN 1 stated the surgical technicians check for outdates once a month, and expired products were removed. She stated for multiple dose medications, once a drug was opened, the date the drug was opened was marked on the bottle and the medication was good for 30 days from that date. In addition, the ORCN 1 stated pharmacy was responsible to check for outdated drugs.

During an interview with the Director of Pharmacy on January 9, 2013, at 11:10 a.m., he stated the Povidone-Iodine Paint and Hibiclens solutions were multiple dose products and should be dated once opened, and if opened but not dated would need to be discarded. The Director of Pharmacy stated once a multiple dose vial of medication was opened, the medication was good for 28 days. In addition, he stated if the Humulin Insulin was opened on December 8, 2012, it should have been discarded on January 5, 2013. The Director of Pharmacy stated the pharmacy and surgery staff were jointly responsible to check for expired/non-usable drugs and biologicals.

The facility policy and procedure titled "Multiple Dose Vials" revised September 2011, revealed "... The multiple dose vial will be dated and initialed when opened. The vial will be discarded 28 days from the day it is opened unless other discard information is printed on the medication label. ..."

The facility policy and procedure titled "Storing, Handling and Monitoring Sterile Supplies" reviewed September 2011, revealed "... If there is an expiration date on the package, dispose of the item no later than the expiration date. If there is no date, consider the item sterile unless the integrity of the package is compromised. ..."

The facility policy and procedure titled "Expired Laboratory Reagents and Collection Tubes" dated,January 2012, revealed "... we will not use reagents that have expired, nor collection tubes or items that are expired. ..."

Based on observation, interview, and document review, the facility failed to ensure two pieces of equipment in the Operating Room (OR) were maintained per the facility's policy and procedure to ensure an acceptable level of safety and quality.

Findings:

During a tour of OR 1 on January 7, 2013, at 9:15 a.m., a suction pump was observed with a preventive maintenance (P.M.) sticker that indicated the last inspection was 5/11 (May 2011) and the next inspection was due on 5/12 (May 2012). Adjacent to the suction pump was an irrigation pump that was observed to have no evidence of a P.M. sticker.

An interview with ORCN 2 was conducted on January 7, 2013, at 9:15 a.m. She acknowledged that the suction pump P.M. sticker indicated it should have been inspected by the bio med engineers by May 2012, and the suction pump was past due for preventive maintenance inspection. She also acknowledged that the irrigation pump did not have a P.M. sticker. She could not provide documentation that the suction or irrigation pumps had received recent P.M. inspections.

A review of the facility's policy and procedure titled "Facilities Management" was conducted on January 9, 2013, at 11 a.m. The policy indicated "All mechanical equipment will be checked at least yearly for optimum functioning and safety capacity. Each piece of equipment will have a sticker to denote the date equipment was serviced."

Based on observation, interview, and record review, the facility failed to ensure it provided an organized surgical service to all patients by failing:

1. To ensure there was documented evidence/validation the surgical site was marked by the physician as needed, based on the surgical procedure to be performed, in accordance with facility policy and procedure and standards of practice.

This had the potential to result in patients being transferred to the Operating Room (OR) prior to the surgical site being marked by the physician and/or the surgical site not being marked as needed based on the surgical procedure to be performed, which may lead to wrong site surgery (Refer to A951).

2. To ensure there was documented evidence the surgical sponge, needle, and instrument counts were performed as needed for the surgical case in accordance with facility policy and procedure and standards of practice.

In addition, there was no documented evidence the surgeon was informed of the count results, being correct or incorrect, in accordance with facility policy and procedure and standards of practice.

This had the potential to result in a needle, sponge, and/or surgical instrument being retained inside a patient's body (Refer to A951).

3. To ensure there was documented evidence the surgical "time out" (a stopped period of time when all members of the surgical/procedure team participate in the positive identification of the patient, the intended procedure, and the visualization of the marked site/side of the procedure) was performed immediately prior to the starting of the surgical case in accordance with facility policy and procedure and standards of practice.

This had the potential to result in surgery being performed on the incorrect patient and/or incorrect side/site (Refer to A951).

4. To ensure there was documented evidence a second surgical "time out" and a second needle, sponge, and instrument counts were performed when two surgical procedures with laterality were performed by the same surgeon on the same patient.

This had the potential to result in the incorrect procedure being performed on the wrong leg; and a needle, sponge, and/or instrument being retained inside the patient's body (Refer to A951).

5. To ensure outdated; opened and not dated; opened, dated but expired drugs and biologicals were not available for patient care use.

This had the potential to result in patients receiving drugs and biologicals that were expired or contaminated when in surgery (Refer to A505).

The cumulative effects of these systemic problems resulted in the failure of surgical services to ensure care was being provided in a safe and effective manner.

Based on interview and record review, the facility failed:

1. To ensure there was documented evidence/validation the surgical site was marked by the physician as needed, based on the surgical procedure to be performed, in accordance with facility policy and procedure and standards of practice for 12 of 31 sampled patients (Patient 2, 3, 4, 6, 7, 8, 10, 22, 24, 25, 27, and 30).

This had the potential to result in patients being transferred to the Operating Room (OR) prior to the surgical site being marked by the physician and/or the surgical site not being marked as needed based on the surgical procedure to be performed, which may lead to wrong site surgery.

2. To ensure there was documented evidence the surgical sponge, needle, and instrument counts were performed as needed for the surgical case in accordance with the facility policy and procedure and standards of practice for 18 of 31 sampled patients (Patient 2, 3, 4, 5, 6, 7, 8, 10, 11, 22, 24, 25, 26, 27, 28, 29, 30, and 31).

In addition, there was no documented evidence the surgeon was informed of the count results, being correct or incorrect, in accordance with facility policy and procedure and standards of practice for 14 of 31 sampled patients (Patient 2, 3, 4, 5, 6, 7, 8, 10, 22, 24, 25, 26, 30, and 31).

This had the potential to result in a needle, sponge, and/or surgical instrument being retained inside a patient's body.

3. To ensure there was documented evidence the surgical "time out" (a stopped period of time when all members of the surgical/procedure team participate in the positive identification of the patient, the intended procedure, and the visualization of the marked site/side of the procedure) was performed immediately prior to the starting of the surgical case in accordance with facility policy and procedure and standards of practice for eight of 31 sampled patients (Patient 2, 3, 6, 10, 26, 27, 28, and 29).

This had the potential to result in surgery being performed on the incorrect patient and/or incorrect side/site.

4. To ensure there was documented evidence a second surgical "time out" and a second needle, sponge, and instrument counts were performed when two surgical procedures with laterality were performed by the same surgeon on the same patient (Patient 6).

This had the potential to result in the incorrect procedure being performed on the wrong leg; and a needle, sponge, and/or instrument being retained inside the patient's body.

Findings:

1a. The record for Patient 2 was reviewed on January 7, 2013. Patient 2 was admitted to the facility on November 28, 2012, for a right knee replacement.

The "Pre-Procedure Checklist" dated, November 28, 2012, at 9:39 a.m., did not indicate the surgical site had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dated, November 29, 2012, did not indicate the surgical site had been marked.

b. The record for Patient 3 was reviewed on January 7, 2013. Patient 3 was admitted to the facility on November 28, 2012, for a left knee replacement.

The "Pre-Procedure Checklist" dated, November 28, 2012, at 9:28 a.m., did not indicate the surgical site had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dated, November 29, 2012, did not indicate the surgical site had been marked.

c. The record for Patient 4 was reviewed on January 7, 2013. Patient 4 was admitted to the facility on November 28, 2012, for a left hip replacement.

The "Pre-Procedure Checklist" dated, November 28, 2012, at 9:43 a.m., did not indicate the surgical site had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dated, November 29, 2012, did not indicate the surgical site had been marked.

d. The record for Patient 6 was reviewed on January 7, 2013. Patient 6 was admitted to the facility on December 5, 2012, for a left knee replacement and a right knee manipulation with debridement.

The "Pre-Procedure Checklist" dated, December 5, 2012, at 10:35 a.m., did not indicate the surgical sites had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dated, December 5, 2012, did not indicate the surgical sites had been marked.

e. The record for Patient 7 was reviewed on January 7, 2013. Patient 7 was admitted to the facility on December 5, 2012, for a right knee replacement.

The "Pre-Procedure Checklist" dated, December 5, 2012, at 8:43 a.m., did not indicate the surgical site had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dated, December 5, 2012, did not indicate the surgical site had been marked.

f. The record for Patient 8 was reviewed on January 7, 2013. Patient 8 was admitted to the facility on December 5, 2012, for a right hip replacement.

The "Pre-Procedure Checklist" dated, December 5, 2012, at 11:14 a.m., did not indicate the surgical site had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dated, December 5, 2012, did not indicate the surgical site had been marked.

g. The record for Patient 10 was reviewed on January 7, 2013. Patient 10 was admitted to the facility on December 5, 2012, for a right knee replacement.

The "Pre-Procedure Checklist" dated, December 5, 2012, at 7:43 a.m., did not indicate the surgical site had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dated, December 5, 2012, did not indicate the surgical site had been marked.

h. The record for Patient 22 was reviewed on January 7, 2013. Patient 22 was admitted to the facility on December 19, 2012, for a left total knee replacement.

The "Pre-Procedure Checklist" dated, December 19, 2012, at 9:22 a.m., did not indicate the surgical site had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dated, December 19, 2012, did not indicate the surgical site had been marked preoperatively.

i. The record for Patient 24 was reviewed on January 7, 2013. Patient 24 was admitted to the facility on December 31, 2012, for a left colectomy completed on January 4, 2013.

The "Pre-Procedure Checklist" dated, January 4, 2013, at 2:09 a.m., did not indicate the surgical site had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dated, January 4, 2013, did not indicate the surgical site had been marked preoperatively.

j. The record for Patient 25 was reviewed on January 7, 2013. Patient 25 was admitted to the facility on January 2, 2013, for a right lower extremity incision and drainage (I&D).

The "Pre-Procedure Checklist" did not indicate the surgical site had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dictated January 5, 2013, did not indicate the surgical site had been marked preoperatively.

k. The record for Patient 27 was reviewed on January 7, 2013. Patient 27 was admitted to the facility on January 4, 2013, for a laparoscopic incisional hernia.

The "Pre-Procedure Checklist" dated, January 4, 2013, at 9:25 a.m., did not indicate the surgical site had been marked by the physician and validated by the nurse.

The surgeon's "Operative Report" dictated January 4, 2013, did not indicate the surgical site had been marked preoperatively.

l. The record for Patient 30 was reviewed on January 7, 2013. Patient 30 was admitted to the facility on January 4, 2013, for a right wrist scaphoid pinning.

The "Pre-Procedure Checklist" dated, January 4, 2013, at 9:22 a.m., did not indicate the surgical site had been marked by the physician and validated by the nurse. In addition, the document indicated, "Procedure: ORIF (open reduction and internal fixation) wrist (right)." The procedure listed on the "Pre-Procedure Checklist" was different from the procedure performed.

The surgeon's "Operative Report" dictated January 5, 2013, did not indicate the surgical site had been marked preoperatively.

During an interview with Preoperative Registered Nurse (PRN) and OR Charge Nurse (ORCN) 2, on January 7, 2013, at 2 p.m., they reviewed the computer generated "Pre-Procedure Checklist" and were unable to find where the nurse would validate the surgical site marking by the surgeon. They stated the "downtime Pre-Operative Check List" had spaces where the nurse would verify the surgical site and would verify that the surgical site had been marked when appropriate for laterality surgeries, but since going to the computerized documentation system two years ago, the documented side/site marking validation has not occurred.

During an interview with the Director Risk Management/Surgical Services (DRM), on January 7, 2013, at 4 p.m., she reviewed the "Pre-Procedure Checklist" and was unable to find documented evidence that the surgical sites were being marked by the surgeon as appropriate for the surgical case. The DRM stated the facility had made a mistake when the computer documentation system was set-up by not including a validation that the surgical site had been marked by the surgeon. The DRM stated without the documentation of surgical site marking/validation the facility would not be able to verify that the surgical site had been marked preoperatively by the surgeon.

The facility policy and procedure titled "Immediate Preoperative Nursing Assessment" reviewed September 2011, revealed "... Complete the Preoperative Checklist: ... Validate the marking of the surgical site on the Preoperative Checklist. ..."

According to the Association of periOperative Registered Nurses (AORN; 2012 Edition - a nationally recognized professional organization), "Recommended Practices for Transfer of Patient Care Information:

Recommendation I.d. Contents of the transfer-of-patient-information process for each perioperative phase should include, but not limited to, the following:

Preoperative Phase...evidence of site marking, if applicable..."

2a. The record for Patient 2 was reviewed on January 7, 2013. Patient 2 was admitted to the facility on November 28, 2012, for a right knee replacement.

The "Surgical" record dated, November 28, 2012, revealed "Final Needle and Sponge Counts Correct" was checked and "Final Instrument Count Correct" was checked.

There was no indication in the record that the initial surgical counts were performed, the skin closure surgical counts were performed, and the surgeon was informed of the surgical count results.

b. The record for Patient 3 was reviewed on January 7, 2013. Patient 3 was admitted to the facility on November 28, 2012, for a left knee replacement.

The "Surgical" record dated, November 28, 2012, revealed "Final Needle and Sponge Counts Correct" was checked and "Final Instrument Count Correct" was checked.

There was no indication in the record that the initial surgical counts were performed, the skin closure surgical counts were performed, and the surgeon was informed of the surgical count results.

c. The record for Patient 4 was reviewed on January 7, 2013. Patient 4 was admitted to the facility on November 28, 2012, for a left hip replacement.

The "Surgical" record dated, November 28, 2012, revealed "Final Needle and Sponge Counts Correct" was checked and "Final Instrument Count Correct" was checked.

There was no indication in the record that the initial surgical counts were performed, the skin closure surgical counts were performed, and the surgeon was informed of the surgical count results.

d. The record for Patient 5 was reviewed on January 7, 2013. Patient 5 was admitted to the facility on January 6, 2013, for active labor and a repeat cesarean section (abdominal delivery of an infant).

The "Surgical" record dated, January 6, 2013, revealed "Final Needle and Sponge Counts Correct" was checked and "Final Instrument Count Correct" was checked.

There was no indication in the record that the initial surgical counts were performed, the beginning of the uterine cavity closure surgical counts were performed, and the skin closure surgical counts were performed.

The surgeon's "Operative Report" indicated the surgeon was informed of the sponge and needle count results twice, but did not indicate which of the required three counts the surgeon was informed of being correct. The record did not indicate the surgeon was informed of the instrument counts.

e. The record for Patient 6 was reviewed on January 7, 2013. Patient 6 was admitted to the facility on December 5, 2012, for a left knee replacement and a right knee manipulation with debridement.

The "Surgical" record dated, December 5, 2012, revealed "Final Needle and Sponge Counts Correct" was checked and "Final Instrument Count Correct" was checked.

There was no indication in the record that the initial surgical counts were performed, the skin closure surgical counts were performed, and the surgeon was informed of the surgical count results.

f. The record for Patient 7 was reviewed on January 7, 2013. Patient 7 was admitted to the facility on December 5, 2012, for a right knee replacement.

The "Surgical" record dated, December 5, 2012, revealed "Final Needle and Sponge Counts Correct" was checked and "Final Instrument Count Correct" was checked.

There was no indication in the record that the initial surgical counts were performed, the skin closure surgical counts were performed, and the surgeon was informed of the surgical count results.

g. The record for Patient 8 was reviewed on January 7, 2013. Patient 8 was admitted to the facility on December 5, 2012, for a right hip replacement.

The "Surgical" record dated, December 5, 2012, revealed "Final Needle and Sponge Counts Correct" was checked and "Final Instrument Count Correct" was checked.

There was no indication in the record that the initial surgical counts were performed, the skin closure surgical counts were performed, and the surgeon was informed of the surgical count results.

h. The record for Patient 10 was reviewed on January 7, 2013. Patient 10 was admitted to the facility on December 5, 2012, for a right knee replacement.

The "Surgical" record dated, December 5, 2012, revealed "Final Needle and Sponge Counts Correct" was checked and "Final Instrument Count Correct" was checked.

There was no indication in the record that the initial surgical counts were performed, the skin closure surgical counts were performed, and the surgeon was informed of the surgical count results.

i. The record for Patient 11 was reviewed on January 7, 2013. Patient 11 was admitted to the facility on December 26, 2012, for a diagnosis of pelvic pain and a dilatation and curettage (widening of the cervix and surgical removal of part of the lining of the uterus).

The "Surgical" record dated, December 26, 2012, revealed there were no surgical counts performed.

During an interview with the Director Risk Management/Surgical Services (DRM), on January 8, 2013, at 1:30 p.m., she reviewed the record and was unable to find documentation of surgical counts being performed on the "Surgical" record. She stated there should have been documentation on the "Surgical" record of the surgical counts.

j. The record for Patient 22 was reviewed on January 7, 2013. Patient 22 was admitted to the facility on December 19, 2012, for a left total knee replacement.

The "Surgical (Intraoperative)" record dated, December 19, 2012, revealed "Final Needle and Sponge Counts Correct and Final Instrument Count Correct" sections were checked, but did not indicate who performed the counts.

There was no indication in the record that the initial surgical counts and the skin closure surgical counts were performed. The record did not indicate the surgeon was informed of the surgical counts results.

k. The record for Patient 24 was reviewed on January 7, 2013. Patient 24 was admitted to the facility on December 31, 2012, for a left colectomy completed on January 4, 2013.

The "Surgical (Intraoperative)" record dated, January 4, 2013, revealed "Final Needle and Sponge Counts Correct and Final Instrument Count Correct" sections were checked.

There was no indication in the record that the initial surgical counts, the cavity closure count, and the skin closure surgical counts were performed. The record indicated the surgeon was informed of the sponge and instrument count results twice, but did not indicate which of the required three counts the surgeon was informed of being correct. The record did not indicate the surgeon was informed of the needle counts.

l. The record for Patient 25 was reviewed on January 7, 2013. Patient 25 was admitted to the facility on January 2, 2013, for a right lower extremity incision and drainage (I&D).

The "Surgical (Intraoperative)" record dated January 4, 2013, revealed "Final Needle and Sponge Counts Correct, Final Instrument Count Correct, and Instruments Not Counted" sections were checked.

There was no indication in the record that the initial surgical counts and the skin closure surgical counts were performed. The record did not indicate the surgeon was informed of the surgical count results.

m. The record for Patient 26 was reviewed on January 7, 2013. Patient 26 was admitted to the facility on January 4, 2013, for a repair of left inguinal hernia.

The "Surgical (Intraoperative)" record dated January 4, 2013, revealed "Final Needle and Sponge Counts Correct; and Final Instrument Count Correct" sections were checked.

There was no indication in the record that the initial surgical counts and the skin closure surgical counts were performed. The record did not indicate the surgeon was informed of the surgical count results.

n. The record for Patient 27 was reviewed on January 7, 2013. Patient 27 was admitted to the facility on January 4, 2013, for a laparoscopic incisional hernia.

The "Surgical (Intraoperative)" record dated January 4, 2013, revealed "Final Needle and Sponge Counts Correct; and Final Instrument Count Correct" sections were checked.

There was no indication in the record that the initial surgical count was performed.

o. The record for Patient 28 was reviewed on January 7, 2013. Patient 28 was admitted to the facility on January 4, 2013, for a laparoscopic cholecystectomy.

The "Surgical (Intraoperative)" record dated, January 4, 2013, revealed "Final Needle and Sponge Counts Correct; and Final Instrument Count Correct" sections were checked.

There was no indication in the record that the initial surgical count was performed.

p. The record for Patient 29 was reviewed on January 7, 2013. Patient 29 was admitted to the facility on January 3, 2013, for a laparoscopic cholecystectomy.

The "Surgical (Intraoperative)" record dated, January 4, 2013, revealed "Final Needle and Sponge Counts Correct; and Final Instrument Count Correct" sections were checked.

There was no indication in the record that the initial surgical count was performed.

q. The record for Patient 30 was reviewed on January 7, 2013. Patient 30 was admitted to the facility on January 4, 2013, for a right wrist scaphoid pinning.

The "Surgical (Intraoperative)" record dated, January 4, 2013, revealed there were no surgical counts performed. There was no documented evidence that the surgeon was informed of the surgical count results.

r. The record for Patient 31 was reviewed on January 7, 2013. Patient 31 was admitted to the facility on January 4, 2013, for a laparoscopic fulguration of oviduct (LFO).

The "Surgical (Intraoperative)" record dated, January 4, 2013, revealed "Final Needle and Sponge Counts Correct, Final Instrument Count Correct, and Instruments Not Counted" sections were checked.

There was no indication in the record that the initial surgical counts and the skin closure surgical counts were performed. The record did not indicate the surgeon was informed of the surgical count results.

On January 7, 2013, at 2:05 p.m., the ORCN 2 was interviewed. She stated the facility's practice was to document only the final count. She stated if the final count was documented then, "...the first count must have been done..." She stated the circulator nurse did not document any other counts performed in the record except for the final count. She stated, "If we do that (document all counts performed), then we would be documenting 14 counts..."

On January 7, 2013, at 4 p.m., the DRM was interviewed and stated the facility's practice was to conduct the surgical counts, but only documented the final count. The DRM stated, without the documentation of surgical site marking/validation, the facility could not verify that the surgical site had been marked preoperatively by the surgeon.

The facility policy and procedure titled "Sponge, Needle and Instrument Counts" reviewed June 2012, revealed "... Initial counts establish a baseline for subsequent counts. ... Counts are done in the operating rooms by the scrub personnel and the circulating nurse prior to the surgical prep at the beginning of the operation, at the beginning of a cavity closure and when the skin closure is started. An additional sponge count is done after closure before the drapes are removed. ... Sponge counts are performed: When either the scrub and/or circulator are relieved, a count is taken. ... The circulator is responsible for ... Documenting the count results on the operative record and informing the surgeon of the count results. ..."

According to AORN, the "Recommended Practices for Prevention of Retained Surgical Items (RSI):

Purpose...Counts for soft goods (e.g. radiopaque sponges, radiopaque towels); sharps; and instruments are performed to account for all items used on the surgical field and to lessen the potential for injury to the patient as a result of an RSI...

Recommendation IX - Measures taken for the prevention of RSIs should be documented in the patient's medical record. Documentation of all nursing activities performed is legally and professionally important for clear communication and collaboration between health care team members and for the continuity of patient care.

IX.a. Sponge, sharp, and instrument counts should be documented on the patient's intraoperative record by the RN circulator.

IX.b. Documentation of measures taken for the prevention of RSIs should include, but not be limited to,
- types of counts (eg. radiopaque sponges, sharps, instruments, miscellaneous);
- number of counts;
- names and titles of personnel performing the counts;
- results of surgical item counts;
- surgeon notification of count results..."

3a. The record for Patient 2 was reviewed on January 7, 2013. Patient 2 was admitted to the facility on November 28, 2012, for a right knee replacement.

The "Surgery" record dated, November 28, 2012, revealed the surgical "time out" was done at 10:59 a.m., Patient 2 entered the OR at 11 a.m., and the surgical cut time was 12:10 p.m. (The surgical "time out" was 71 minutes prior to the surgery cut time.)

b. The record for Patient 3 was reviewed on January 7, 2013. Patient 3 was admitted to the facility on November 28, 2012, for a left knee replacement.

The "Surgery" record dated, November 28, 2012, revealed the surgical "time out" was done at 7:59 a.m., Patient 3 entered the OR at 8 a.m., and the surgical cut time was 9 a.m. (The surgical "time out" was 61 minutes prior to the surgery cut time.)

c. The record for Patient 6 was reviewed on January 7, 2013. Patient 6 was admitted to the facility on December 5, 2012, for a left knee replacement and a right knee manipulation with debridement.

The "Surgery" record dated, December 5, 2012, revealed the surgical "time out" was done at 9:59 a.m., Patient 6 entered the OR at 10 a.m., and the surgical cut time was 10:59 a.m. (The surgical "time out" was 60 minutes prior to the surgery cut time.)

d. The record for Patient 10 was reviewed on January 7, 2013. Patient 10 was admitted to the facility on December 5, 2012, for a right knee replacement.

The "Surgery" record dated, December 5, 2012, revealed the surgical "time out" was done at 7:54 a.m., Patient 10 entered the OR at 7:55 a.m., and the surgical cut time was 8:47 a.m. (The surgical "time out" was 53 minutes prior to the surgery cut time.)

e. The record for Patient 26 was reviewed on January 7, 2013. Patient 26 was admitted to the facility on January 4, 2013, for a repair of left inguinal hernia.

The "Surgical (Intraoperative)" record dated, January 4, 2013, revealed the surgical "time out" was done at 1:34 p.m., Patient 26 entered the OR at 1:35 p.m., and the surgical cut time was 2:14 p.m. (The surgical "time out" was 40 minutes prior to the surgery cut time.)

f. The record for Patient 27 was reviewed on January 7, 2013. Patient 27 was admitted to the facility on January 4, 2013, for a laparoscopic incisional hernia.

The "Surgical (Intraoperative)" record dated, January 4, 2013, revealed the surgical "time out" was done at 10:11 a.m., Patient 27 entered the OR at 10:12 a.m., and the surgical cut time was 10:56 a.m. (The surgical "time out" was 45 minutes prior to the surgery cut time.)

g. The record for Patient 28 was reviewed on January 7, 2013. Patient 28 was admitted to the facility on January 4, 2013, for a laparoscopic cholecystectomy.

The "Surgical (Intraoperative)" record dated, January 4, 2013, revealed the surgical "time out" was done at 7:49 a.m., Patient 28 entered the OR at 7:50 a.m., and the surgical cut time was 8:33 a.m. (The surgical "time out" was 44 minutes prior to the surgery cut time.)

h. The record for Patient 29 was reviewed on January 7, 2013. Patient 29 was admitted to the facility on January 3, 2013, for a laparoscopic cholecystectomy.

The "Surgical (Intraoperative)" record dated, January 4, 2013, revealed the surgical "time out" was done at 1:39 p.m., Patient 29 entered the OR at 1:40 p.m., and the surgical cut time was 4:03 p.m. (The surgical "time out" was 2 hours and 24 minutes prior to the surgery cut time.)

During an interview with the Director Risk Management/Surgical Services (DRM), on January 8, 2013, at 8:45 a.m., she stated the time the patient entered and exited the OR on the "Surgery" records were incorrect. She stated the surgery staff were told the time the patient entered and exited the OR needed to match the anesthesia start (time the anesthesiologist sees the patient pre-operatively) and stop (time anesthesiologist has completed report to the post anesthesia care staff) times which was incorrect. In addition, the DRM stated the staff told her they documented the surgical "time out" as one minute before the surgical cut time, and the DRM stated the surgical "time out" cannot be done prior to the patient being in the OR and ready for the surgical cut. The DRM also stated they had not done any monitoring of the surgical "time out," surgical counts, and validation/verification of the surgical site/side being marked by the surgeon as appropriate based on the surgical case.

During an interview with Surgery Registered Nurse (SRN) 2, on January 9, 2013, at 10:35 a.m., she stated she had misunderstood and thought the surgical "time out" was supposed to be documented as one minute prior to the anesthesia start time. SRN 2 stated she would wait for the anesthesia's record after the surgical case was completed to record the surgical "time out" as one minute prior to the anesthesia start time. The SRN 2 stated based on the documentation in the records, she was unable to verify that the surgical "time outs" had been performed immediately prior to the surgical cuts.

The facility policy and procedure titled "Universal Protocol" reviewed September 2011, revealed "... Final confirmation and verification of the site mark takes place during the 'time out.' ... Conduct final 'Time out' verification immediately before starting the procedure. This final procedure verification step is conducted prior to starting the actual procedure, in the location where the procedure will be performed, and with the patient properly positioned for the procedure. The 'time out' must be initiated in a standardized fashion and involves all the individuals of the entire procedure team who will be participating with the procedure at its inception. ..."

4. The record for Patient 6 was reviewed on January 7, 2013. Patient 6 was admitted to the facility on December 5, 2012, for a left knee replacement and a right knee manipulation with debridement.

The "Surgery" record dated, December 5, 2012, revealed the surgical "time out" was done at 9:59 a.m., Patient 6 entered the OR at 10 a.m., and the surgical cut time was 10:59 a.m.

There was no evidence in the record that a second surgical "time out" was performed before the initiation of the second procedure, right knee manipulation with debridement.

The "Surgical" record dated, December 5, 2012, revealed "Final Needle and Sponge Counts Correct" was checked and "Final Instrument Count Correct" was checked.

There was no evidence in the record that separate surgical counts were performed for the two procedures.

During an interview with Surgery Registered Nurse (SRN) 2, on January 9, 2013, at 10:35 a.m., she reviewed the record and was unable to find documentation of a second surgical "time out" and surgical
counts for the second surgical procedure performed on Patient 6. SRN 2 stated she only documents one surgical "time out" in the record when there were two surgical procedures, and there was "no way" to document the second surgical "time out." In addition, SRN 2 stated she only documented one final sponge, needle, and instrument counts in Patient 6's record even though there were two surgical procedures.

During an interview with the Director Risk Management/Surgical Services (DRM), on January 8, 2013, at 11:05 a.m., she stated there should be two surgical "time outs," and two sponge, needle, and instrument counts documented in the patient's record if two surgical procedures were being performed.

The facility policy and procedure titled "Sponge, Needle and Instrument Counts" reviewed June 2012, revealed "... Sponge counts are performed: ... When a bilateral procedure has been performed, a separate count is done for each side. ..."

The facility policy and procedure titled "Universal Protocol" reviewed September 2011, revealed "... When two or more procedures are being performed on the same patient, a 'time out' is performed to verify each subsequent procedure before they are initiated. ..."

According to AORN, the "Policy and Procedure template for use with recommended practices:

Verification of Correct Site, Correct Procedure, and Correct Patient for Invasive or Surgical Procedures...

...A time out will be performed for all cases, including those not requiring site marking...

Taking a time out - Time outs will be performed before all surgical or invasive procedures. Time outs will:

* Cause all other activities to be suspended (unless there is a threat to patient safety) during the time out;

* Be initiated by a designated team member (eg. RN circulator);

* Involve all members of the surgical team;

* Address the following standard information:
- correct patient identity,
- correct side and site are marked,
- consent form is present and accurate,
- agreement on the procedure to be done,
- correct patient position,
- confirm that relevant images and results are properly labeled and appropriately displayed,
- confirm that antibiotics have been administered,
- confirm that the skin prep has dried, and
- prosthesis is present, if applicable.

* Be performed in the location of the procedure and after the patient is prepped and draped;

* Be performed before each procedure if two procedures are being performed on the same patient...

Documentation...Record, at a minimum, the following items...the time of pause..."