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Based on review of the Association of peri-Operative Registered Nurses (AORN) Journal, review of the American College of Radiology (ACR) Practice Parameters, hospital policy review, hospital document review, medical record review, and interview, the hospital failed to provide surgical services in accordance with acceptable standards of practice to ensure the health and safety of surgical patients for four (4) of four (4) (Incident #1, #2, #3, and #4) hospital reported incidents reviewed involving retained surgical items (RSI).

The findings included:

1. The hospital failed to ensure a qualified registered nurse (RN) performed circulating duties in the operating room during surgical procedures in three (3) of four (4) (Incident #1, #3, and #4) hospital reported incidents involving retained RSI.
Refer to A 944

2. The hospital failed to ensure surgical staff members performed surgical counts and delivered surgical services in accordance with acceptable standards of practice and hospital policies to prevent RSI for four (4) of four (4) (Incident #1, #2, #3, and #4) hospital reported incidents of RSI. The hospital's failure to ensure surgical staff members adhered to facility policies and standards of practice resulted in three (3) of four (4) (Patient #2, #3, and #4) surgical patients reviewed requiring additional surgical procedures to remove the RSI. The hospital also failed to ensure one (1) of three (3) (Registered Nurse (RN) #1) agency nurses and one (1) of seven (7) (Surgical Technologist (Scrub Tech) #7) scrub techs received additional training on the new interventions implemented following three (3) of four (4) (Incident #1, #2 and #3) hospital reported incidents involving retained surgical items.
Refer to A 951.

Based on hospital policy review, review of the hospital's job descriptions, review of hospital incident reports, personnel file review, medical record review, and interview, the hospital failed to ensure a qualified registered nurse (RN) performed circulating duties in the operating room (OR) during surgical procedures in three (3) of four (4) (Incident #1, #3, and #4) hospital reported incidents involving retained surgical items (RSI).

The findings included:

1. Review of the hospital's Job Description for the Registered Nurse Category three (3) position revealed, "...Responsible for the nursing care of patients requiring specialized judgement and skill. This judgement and skill is based on knowledge of the natural, behavioral and nursing sciences and humanities as the basis for application of the nursing process in wellness and illness care...Responsibilities: Provides Practice Excellence through specialized nursing assessment, care, evaluation and education to patients and families in accordance with established policies and procedures....Demonstrates Role Clarity through professional competence, expertise, and knowledge..." The hospital did not provide a Job Description that was specific for the Operating Room Registered Nurse.

2. Review of the hospital's "Initial Competency Assessment Form Perioperative Adult and Pediatric OR [operating room] RN [registered nurse]" revealed, "During Associate orientation period, the Associate should carefully read each competency required for their role and perform a self-evaluation...The Associate and preceptor will review this self-assessment and together, create the Associate's development plan. Throughout the Associate's orientation period, s/he will work to complete all required competency validations according to required methods of validation...Validator: may be a preceptor, clinical educator, advanced practice nurse, patient care coordinator, clinical director, or developmental specialist..."

3. Review of the hospital's "OR Agency Information" tool revealed, "...All counts must be written and maintained on Whiteboard...Must Use sponge holder bags for all cases! Non-negotiable...Final sponge count is done from the holder. No sponges may be on the field (including Wet/Dry)...Have surgeon or remaining resident visually confirm all sponges are in holder..."

4. Review of the hospital reported Incident #1, which was identified by the hospital on 8/6/2019, revealed a surgical needle was retained inside a surgical patient who had a Coronary Artery Bypass Graft (CABG) procedure completed on 8/5/2019. (A CABG is a surgical procedure to restore normal blood flow to obstructed blood vessels in order for oxygen to be delivered to the heart). After being informed of the risks and benefits of having the needle surgically removed, the patient and his wife chose to leave the needle in place.

Review of the hospital's investigation of the incident revealed the hospital determined surgical staff members failed to follow the policy for the surgical procedure counts titled "Invasive Procedure Count" policy.

RN #1, an agency nurse, was the circulating nurses working in the OR when Incident #1 occurred.

Review of the hospital's personnel file for RN #1 revealed the RN completed a self assessment of her skills as a circulating nurse with the staffing agency she worked for on 7/26/2019. RN #1 indicated she had experience working as a nurse circulator for CABG procedures on the self assessment.

There was no documentation RN #1 received hospital orientation, OR specific training, or verification from a preceptor to determine she was competent to perform her duties in the hospital.

5. Review of the hospital reported Incident #3, which was identified by the hospital on 12/16/2019, revealed a laparotomy (surgical) sponge was retained inside a surgical patient during a laparoscopic assisted hemi-colectomy that was completed on 12/6/2019. (A hemi-colectomy is a surgical procedure in which a portion of the bowel is removed). The retained sponge was surgically removed on 12/16/2019.

Review of the hospital's investigation of the incident revealed the hospital determined surgical staff failed to follow the invasive procedure count policy by not using a lap pad holder and failed to complete a final count. The hospital also determined the circulating nurse failed to accurately document those in attendance during the procedure.

RN #4, an agency nurse, was the circulating nurse working in the OR when Incident #3 occurred.

Review of the hospital's personnel file for RN #4 revealed the RN completed an "Operating Room-Circulate Checklist" with the staffing agency he worked for on 7/8/2019. RN #4 indicated he was experienced working as a nurse circulator in general and laparoscopic surgeries on the checklist.

There was no documentation RN #4 received hospital orientation, OR specific training, or verification from a preceptor to determine she was competent to perform her duties in the hospital.

6. Review of the hospital reported Incident #4, which was identified by the hospital on 9/24/2020 before the patient left the OR, revealed a laparotomy pad was retained inside a surgical patient during a CABG procedure.

Review of the hospital's investigation of the incident revealed the hospital determined Surgeon #4 failed to stop closing the patient's chest after being notified of the missing laparotomy pad which led to the patient's chest being completely closed before the pad was identified inside the patient's chest.

RN #6, an agency nurse, was 1 of 2 circulating nurses working in the OR when Incident #4 occurred.

Review of the hospital's personnel file for RN #6 revealed the RN completed a self assessment of her skills as a circulating nurse with the staffing agency she worked for. The completion date was not noted on the assessment. RN #6 indicated she had no experience working as a nurse circulator for CABG procedures on the self assessment.

There was no documentation RN #6 received hospital orientation, OR specific training, or verification from a preceptor to determine she was competent to perform her duties in the hospital.

In an interview with the Clinical Director of Perioperative Services on 11/5/2020 at 11:20 AM, she verified the hospital had no documentation RN #1, #4, and #6 had completed hospital orientation, OR specific training or competency verification from a preceptor.

Refer to A 951.

Based on review of the Association of peri-Operative Registered Nurses (AORN) Journal, review of the American College of Radiology (ACR) Practice Parameters, hospital policy review, hospital document review, medical record review, and interview, the hospital failed to ensure surgical staff members performed surgical counts and delivered surgical services in accordance with acceptable standards of practice and hospital policies to prevent retained surgical items (RSI) for four (4) of four (4) (Incident #1, #2, #3, and #4) hospital reported incidents of RSI. The hospital's failure to ensure surgical staff members adhered to facility policies and standards of practice resulted in three (3) of four (4) (Patient #2, #3, and #4) surgical patients reviewed requiring additional surgical procedures to remove the RSI. The hospital also failed to ensure one (1) of three (3) (Registered Nurse (RN) #1) agency nurses and one (1) of seven (7) (Surgical Technologist (Scrub Tech) #7) scrub techs received additional training on the new interventions implemented following three (3) of four (4) (Incident #1, #2 and #3) hospital reported incidents involving retained surgical items.

The findings included:

1. Review of AORN Journal February 2012 section titled, Implementing AORN Recommended Practices for Prevention of Retained Surgical Items revealed, "...The National Quality Forum includes RSIs [retained surgical items] on its list of serious reportable events, the Centers for Medicare & [and] Medicaid Services has referred to an RSI as a 'never event,' and RSI is on the list of hospital-acquired conditions that could reasonably have been prevented...The RN circulator and scrub person should follow a standardized procedure for counting, as indicated by the health care's policy, because errors typically result from a deviation in routine practice...The RN circulator should be an active participant in the counting process and should be observant of activities at the sterile field throughout the procedure..."

2. Review of the ACR Practice Parameter for Communication of Diagnostic Imaging Findings revised 2020 revealed, "...Effective Communication is a critical component of diagnostic imaging. Quality patient care can only be achieved when study results are conveyed in a timely fashion to those responsible for treatment decisions...An official interpretation (final report) by the interpreting physician must be generated and archived following any examination, procedure, or officially requested consultation...The report should include a description of the studies and/or procedures performed...The final report is the definitive documentation of the results of an imaging examination or procedure..."

3. Review of the hospital's policy titled, "Counts for Invasive Procedures" revealed, "...Surgical counts will be performed on all procedures where there is the likelihood that an item may be retained. Counting is a mandatory standard identified by the Association of Operating Room [OR] Nurses...Counts are performed to account for all items and to lessen the potential for injury to the patient as a result of a retained foreign body...All countable items will be counted audible, and concurrently viewed by persons fulfilling the scrub and the circulating positions of the case...Closing counts will be completed on all procedures where there is likelihood that items may be retained in a cavity or incisions...When unable to perform a count for any reason an x-ray will be obtained...Prior to closure on any cavity or cavity within a cavity...an additional cavity count of sharps and sponges will be completed and documented...A final count of sponges, towels and sharps will be completed when the skin is being closed....The status of all counts is communicated to the surgeon by the circulator...When additional countable items, including instruments, are added to the field, they will be counted at the time and recorded as part of the count documentation to keep the count current...Sponges (Raytex)/Laps...All Raytex/laps will be counted and added to field in groups of 10...During the procedure the scrub person should discard soiled Raytex/laps into the kick bucket lined with a clear plastic bag which allows the circulator to then place sponges into the sponge holder...All Raytex/laps used in the sterile field will be x-ray detectable...All Raytex/laps will be placed in sponge holder with x-ray detectable string visible from the clear side of sponge holder...Before closing count the consenting physician (surgeon/resident) will perform a methodical wound exam...At the time of final count, all Raytex/laps will be thrown off the field and placed into the sponge holder. The circulator and scrub nurse will validate all slots in sponge holder are full...Before surgeon leaves room, the circulator will show the surgeon/or his designee that all sponge holder slots are full...Needles/Sharps... Initially, suture packs will be counted according to the number marked on the outer wrapper. When opened, they should be counted audibly and concurrently viewed one by one, by the scrub person and the circulator...Needles and/or sharps will be placed in a needle counter and discarded in a sharps container after all counts are completed...Unresolved Surgical Counts: An unresolved count is defined as a shortage or overage of any counted item or an emergency situation where a count is not possible...If a counted item cannot be found the surgeon should be informed as soon as it is noted...Radiology will be alerted that an x-ray is needed. The circulator will inform the radiology technician what type of item is missing...A radiologist will interpret the x-rays and immediately communicate results to the surgical team before patient is extubated or moved from the OR [operating room] table. The radiologist performs a final x-ray report. The circulator should document the following in the OR Clinical Record. Surgeon's awareness of count. Specific type of unresolved count. X-ray results.. Who read the x-ray...If the case ends with an incorrect count and a medical decision has been made to leave the missing item in the patient, the surgeon must disclose the information to the patient, document count as unresolved and disclose in operative report...When the surgeon requests that counted sponges are used as packing and patient leaves the Operating/Procedural Room the number and type sponge retained will be documented on the Clinical Record..."

4. Review of the hospital's policy titled, "Serious Reportable Event Principles" revealed, "Serious Reportable Event (SRE): An adverse event that reaches our patient, is serious and causes harm, and, is generally considered preventable. Serious Reportable Events include "never events", sentinel events, the National Quality Forum-endorsed list of serious reportable events, and events that require reporting to State Agencies or CMS. Examples of SREs included...Surgical events may include procedures performed on wrong patients, wrong site/body part, wrong procedure, and unintended retained foreign objects after surgery...When a serious reportable event is identified...an occurrence report must be completed in accordance with the Occurrence Reporting Process...Report the event to the appropriate agency (accrediting organization, CMS, or State Agency...) within the required timeframe...If the initial investigation determines that the event meets criteria for reporting to an external agency, then Clinical Risk Management will ensure the event report is submitted to the appropriate external agency within 15 business days, or the required timeframe of the reporting agency which may be sooner..."

5. Review of the hospital's policy titled, "Occurrence Reporting Process" revealed, "...An "occurrence" is defined as any incident or event which is not consistent with the expected operation of the facility or care of a patient. Occurrences include events where there is unexpected patient medical intervention, and/or unexpected outcome, unusual or risk associated behavior or practice...Reportable occurrences include but are not limited to the following Event types...General Invasive Procedure/Surgery (...Retained Foreign Object)..."

6. Review of the hospital's training tool titled, "No Thing Left Behind Sponge Accounting Practice" revealed, "...Actions to Take If There is an Incorrect Count...If the nurses respond back there is a missing sponge, STOP closing the wound...Place a sterile drape or non-radiopaque towel over the wound and call Radiology to obtain an x-ray...Unless the object is found, wait to see the film before reclosing the site...Rationale...In cases where there has been a retained sponge in the setting of an incorrect count, the most frequent error is the surgeon has failed to stop closing the wound and do a thorough exploration. Surgeons are often sure the sponge is NOT in the wound and this perception affects their ability to actually find the sponge. Often the sponge is "right there" but the surgeon doesn't feel it..."

7. Review of 3 of 4 hospital reported incidents involving retained surgical items revealed, Incident #1, was identified by the hospital on 8/6/2019, Incident #2, was identified by the hospital on 10/7/2019, and Incident #3, was identified by the hospital on 12/16/2019. The incidents were not reported to the State Agency (SA) or the Centers for Medicaid and Medicare (CMS) until 10/19/2020. The patients involved in Incident #2 and #3 required additional surgical procedures for removal of the retained item.

8. Review of the hospital reported Incident #1 identified by the hospital on 8/6/2019 and Patient #1's medical record revealed Patient #1 was admitted on 8/5/2019 for a scheduled Coronary Artery Bypass Grafting (CABG) procedure (A CABG is a surgical procedure to restore normal blood flow to an obstructed coronary artery). The patient had a past medical history of Coronary Artery Disease, Congestive Heart Failure, Diabetes, and End Stage Renal Disease.

Patient #1's surgery was completed on 8/5/2019 and both the closing and final counts of needles and surgical sponges were documented as "correct" by agency nurse RN #1 and Scrub Tech #1. Surgeon #1 also documented, "All needle and sponge counts were correct" on his operative report.

A chest x-ray (CXR) completed on 8/6/2019, the day after Patient #1's surgery, revealed a metallic object with the appearance of a needle was visible in the patient's chest. The patient and his wife were informed of the retained needle and the risk involved in leaving the needle in place or surgically removing it. Both the patient and his wife chose to leave the needle in place. Patient #1 was discharged home in stable condition on 8/16/2019.

Review of the hospital's investigation for Incident #1 revealed post-surgery it was determined the needle count was incorrect. After the surgical staff searched the OR for the needle, a needle was found, and the agency circulating nurse, RN #1, deemed the count to be correct; however, the scrub tech did not think that the needle that was found was the same size as the needle that was missing, but did not report his concerns. The hospital determined surgical staff members failed to follow the policy for the surgical procedure counts titled "Invasive Procedure Count" policy.

Following Incident #1, the hospital re-educated surgical staff on the Invasive Procedure Count policy.

Review of the training logs dated 8/19/2019 through 10/14/2019 titled, "Just in Time Training Unintentional Retained Object Educational Board" revealed RN #1, Scrub Tech #1, and Surgeon #1 completed the training along with other surgical staff members which included RN #2, #3, #4, and #5; Scrub Tech #2, #3, #4, #5, and #6; and Surgeon #2 and #3. The training logs did not include the actual dates the employees completed the training.

In an interview with Risk Manager (RM) #1 on 10/19/2020 at 3:34 PM, the RM verified staff failed to follow the Invasive Procedure Count policy and stated education was posted on the board and personal onsite instruction was given to all staff and physicians in order to ensure comprehension and training was completed regarding the Invasive Procedure Count policy.

In a telephone interview with RN #1 on 11/3/2020 at 9:48 AM the RN stated, "A needle was dropped during the [surgical] procedure and I found one on the floor, so my needle count was correct."
The RN was asked what measures the hospital had put in place after the incident to prevent future occurrences. RN #1 stated, "We had to wait until everything was closed on the body before we did a final count."

9. Review of the hospital reported Incident #2 identified by the hospital on 10/7/2019 and Patient #2's medical record revealed Patient #2 was admitted on 9/29/2019 for a scheduled liver transplant procedure. Patient #2 had a past medical history of Autoimmune Hepatitis Cirrhosis, a condition in the liver that occurs when the immune system attacks the liver resulting in scarring of the liver.

Patient #2's surgery was completed on 9/30/2019 and the closing and final count of needles and surgical sponges were documented as "incorrect" with 1 suture needle missing by RN #3 and Scrub Tech #2. An abdominal x-ray was obtained and the report documented, "...Suspected Retained Foreign Body...Findings: No needle demonstrated. Findings discussed with nurse..."
Surgeon #2 documented, "All needle and sponge counts were correct" on his operative report.
On 10/7/2019 Patient #2 developed swelling in the abdomen and had decreased urine output. An abdominal x-ray was performed and revealed the patient had a large laparotomy sponge retained in his abdomen which had to be surgical removed on 10/7/2019 Patient #2 was discharged home in stable condition on 10/16/2019.

Review of the hospital's investigation for Incident #2 revealed post-surgery it was determined the needle count was incorrect, an x-ray was obtained and no needles were found. The investigation revealed Radiologist #1 saw the retained laparotomy sponge on x-ray; however, he did not include those findings on his report since he was told he was looking for retained needles. The hospital determined surgical staff members failed to follow the policy for the surgical procedure counts titled "Invasive Procedure Count" policy when they failed to use the lap pad holder, failed to complete a final count, and the Radiologist failed to report that he saw the laparotomy pad on the x-ray. There was no documentation the lost needle was ever found.

Following Incident #2 which occurred while the hospital was in the process of re-educating all staff members on the Invasive Procedure Count policy, the hospital ordered "No Thing Left Behind" posters for each of the operating rooms to serve as a reminder to all staff to ensure the counts were completed and correct; and began requiring all Radiologists to review all abnormal findings on x-rays for retained objects with the attending surgeon.

Review of the training logs dated 8/19/2019 through 10/14/2019 titled, "Just in Time Training Unintentional Retained Object Educational Board" revealed RN #2 and #3, Scrub Tech #2, and Surgeon #2 completed the training along with other surgical staff members which included RN #1, #3, #4, and #5; Scrub Tech #1, #3, #4, #5, and #6; and Surgeon #1 and #3. There was no documentation Scrub Tech #7 completed the training. The training log did not include the actual dates the employees completed the training.

In an interview with Risk Manager (RM) #1 on 10/19/2020 at 4:32 PM, when asked why the interventions previously put in place were ineffective in preventing the incident identified on 10/7/2019 the RM stated, "This incident occurred while the investigation and root cause analysis were being completed for the first Incident #1; therefore corrective actions overlapped and the policy had not yet been revised." She continued and reported all physicians orienting to the operating room were now required to complete "No Thing Left Behind" training.

In a telephone interview with RN #3 on 11/3/2020 at 11:09 AM the RN verified the needle count was incorrect and the lap pad holder was not used during the final count. The RN further stated the Radiologist did not inform her that a retained laparotomy sponge was seen on the x-ray.

In a telephone interview with RN #2 on 11/3/2020 at 1:38 PM the RN verified she was not in the OR when the closing and final counts were completed. The RN did inform this surveyor that following the incident the hospital reinforced the policy with the nurses and scrub techs to make sure the count bags (lap pad holders) were always used.

In a telephone interview with Radiologist #1 on 11/4/2020 at 11:08 AM the Radiologist verified a laparotomy pad was visible on the x-ray. He stated he had informed the nurse that it was visible, but she told him the lap count was correct. The Radiologist then stated, "I should have called the doctor and not taken the nurse's word for it...I didn't put it on my report...It was my fault for not following up with the doctor myself. The new process is for us to call the doctor if we see anything abnormal..."

In an interview with Scrub Tech #2 on 11/5/2020 at 10:00 AM the Scrub Tech verified she had been in the room throughout the procedure and Scrub Tech #7, who was in orientation for the transplant team, was with her. Scrub Tech #2 informed this surveyor the closing count was initially off by 1 laparotomy pad, but RN #2 and Scrub Tech #7 had recounted, and determined the pad count was correct but the needle count was off by 2, "but we found 1." Scrub Tech #2 verified she was unaware a laparotomy pad was seen on the x-ray following the procedure.

9. Review of the hospital reported Incident #3 identified by the hospital on 12/16/2019 and Patient #3's medical record revealed Patient #3 was admitted on 12/6/2019 for a scheduled Right Hemicolectomy, a surgical procedure in which a portion of the bowel is removed. The patient had a past medical history of a Right Colon Mass, Coronary Artery Disease, and Diabetes.

Patient #3's surgery was completed on 12/6/2019 and both the closing and final count of needles and surgical sponges were documented as "correct" by agency RN #4 and Scrub Tech #3; however, Scrub Tech #3 was not in the room at the time of closing and had been relieved by Scrub Tech #6.

Surgeon #3 documented, "All needle and sponge counts were correct" on his operative report. There were no radiology studies conducted from 12/6/2019 through 12/10/2019 when Patient #3 was discharged home in stable condition.

Patient #3 was readmitted to the hospital on 12/16/2019 with diagnoses that included "Retained foreign body and Intra-abdominal Abscess". Patient #3 underwent surgical removal of the retained lap sponge and evacuation of the abdominal abscess on 12/16/2019. The patient was discharged home on 12/22/2019.

Review of the hospital's investigation for Incident #3 revealed post-surgery, it was determined revealed surgical staff failed to follow the invasive procedure count policy by not using a lap pad holder and failing to complete a final count. The hospital completed a comparison of all three of the incidents involving retained foreign objects and identified in all three cases, the surgery staff failed to follow the Invasive Procedure Count policy by not performing final counts and not using the lap pad holder The staff also failed to share their safety concerns with peers and supervisors, and all three incidents were noted to have interruptions during the closing counts. The hospital determined their previous interventions had been ineffective in preventing retained foreign objects.

Following Incident #3, the hospital established expectations regarding the counts and safety tools with all surgical staff in which staff members would be held accountable for upholding policy requirements and expectations. The hospital also established a multidisciplinary Surgery Safety Council as a systems approach to ensure patient safety by engaging the surgery staff in shared governance to identify and overcome real and perceived barriers. Additionally, the hospital conducted "Safety Starts With Me" training specific to the operating room in January of 2020.

Review of the training logs dated 12/22/2019 titled, "Counts for Invasive Procedures" revealed RN #4 and Scrub Tech #3 completed the training along with other surgical staff members that included RN #2 and Scrub Tech #2. There was no documentation Scrub Tech #7 and RN #1 completed the training.

Review of the training logs dated 1/2/2020 and 1/27/2020 titled, "OR Specific Safety Training" revealed Scrub Tech #3 completed the training along with other surgical staff members that included RN #2, #3, and #5; and Scrub Tech #1, #2, #5, and #6. There was no documentation Scrub Tech #7 and agency nurse RN #1 completed the training.

In an interview with Risk Manager (RM) #1 on 10/20/2020 at 9:16 AM, the RM verified staff failed to follow the Invasive Procedure Count policy. The RM also stated RN #4's contract was terminated due to his failure to follow the policy, and failure to accurately document all members of the surgical team. RM #1 informed this surveyor there was no documentation that indicated Scrub Tech #3 was relieved by Scrub Tech #6 and was not present for the closing and final counts.

In a telephone interview with agency RN #4 on 11/3/2020 at 10:04 AM, the RN was asked if a lap pad holder was used when they completed the closing and final surgical counts during Patient #3's surgery and the RN stated, he couldn't remember. Agency RN #4 was asked if the surgical count was correct post surgery and the RN stated, "Apparently I marked it was correct, but it obviously wasn't." Agency RN #4 was asked what measures were put in place by the hospital following Incident #3 with Patient #3 to prevent future occurrences of RSI and RN #4 stated, "I don't know, because they terminated my contract because of the incident, so I wasn't there to see what they did."

In a telephone interview with Scrub Tech #3 on 11/3/2020 at 12:18 PM, the Scrub Tech stated he was present for the initial count of surgical items at the beginning of surgery, but was relieved by Scrub Tech #6 before the surgery was completed. Scrub Tech #3 stated the agency nurse (RN #4) didn't document that Scrub Tech #6 had relieved him from the case. Scrub Tech #3 further stated when he returned to the OR after his lunch break, the surgeon was almost finished closing the patient's skin and both the closing and final counts were reported as correct. Scrub Tech #3 was asked what measures the hospital had put in place to prevent future occurrences and Scrub Tech #3 stated, "It's mandatory to verify all laps [sponges used during surgery] are hung and accounted for and the attending surgeon or resident has to verify the laps are in the holder and counts are correct."

In a telephone interview with Scrub Tech #6 on 11/3/2020 at 12:47 PM Scrub Tech #6 verified she relieved Scrub Tech #3 during the surgical case with Patient #3. Scrub Tech #3 stated she was very busy trying to keep up with the number of lap pads the surgeon was placing in and out of the patient. The Scrub Tech stated that RN #4 was not placing the used lap pads in the holder, but was instead leaving them in the kick bucket making it difficult to visualize how many laps were used. Scrub Tech #6 stated she could not recall if she was present for the closing and final counts of the surgical items. Scrub Tech #6 was asked what measures the hospital had put in place to prevent future occurrences and Scrub Tech #6 stated, "...let fellow associates know what happens, make sure to count when we relieve someone and when you come back in the room. We have to make sure sponges are put in the counter and have to make sure things are written on the board..."

In a telephone interview with Surgeon #3 on 11/5/2020 at 9:40 AM the Surgeon stated, "Sometimes I put a lap[laparotomy pad] in when I remove a specimen. I usually will say out loud, 'lap in the belly' and will put a hemostat on my gown to remind me I put one in...I don't remember doing that with this case." Evidently, I put a lap in and for whatever reason, I didn't remove it." Surgeon #3 verified Patient #3 returned to the hospital's Emergency Department where a retained laparotomy pad which was visualized by radiology and had to be surgically removed. Surgeon #3 informed this surveyor that there were a couple of things that he thought may have contributed to the incident. The Surgeon stated Scrub Tech #3 had been working the entire procedure and was relieved very shortly before the closing and final counts of the surgical items were started. The Surgeon then stated "I was working with a travel circulator [RN #4], and I hadn't worked with him before...I don't even remember his name and haven't seen him since then. I got a verbal notice that the count was correct, but I didn't double check the Raytex/lap pad [surgical sponges used in surgery] count myself. I think the scrub tech leaving that close to closing count was a major factor...The lap got missed..."

10. Review of the hospital reported Incident #4 identified by the hospital on 9/24/2020 and Patient #4's medical record revealed Patient #4 was admitted on 9/24/2020 for a scheduled CABG and Mitral Valve Annuloplasty, a surgical procedure to repair a leaking mitral valve. The patient had a past medical history of Coronary Artery disease, Chronic Kidney Disease, Chronic Obstructive Pulmonary Disease, and Hepatitis C.

Patient #4's surgery was completed on 9/24/2020 and RN #5, #6 and Scrub Tech #4 and #5 determined the closing count was incorrect with 1 missing laparotomy pad. Surgeon #4 was informed the laparotomy pad was missing, a chest x-ray was ordered, and staff began looking for the missing pad. Surgeon #4 continued closing the surgical incision site while staff were looking for the pad and waiting for x-ray. The RNs notified the Board Runner (the person responsible for the daily management of the OR schedule and daily staffing requirements) and RN Clinical Director that the pad was missing. Surgeon #4 documented in his operative report, "...While I was preparing to close I was informed that the lap [surgical sponge] count was incorrect. An examination of the pericardial and pleural spaces [cavities surrounding the heart and lungs] did not reveal the sponge and closure was therefore continued...a chest x-ray was then performed which revealed the retained lap within...The chest was therefore reopened...the lap...was removed. The lap count was then verified to be correct...The skin was closed again. At this point all sponge, needle and instrument counts were verified as correct by nursing staff..." Patient #4 did not leave the operating room and remained under anesthesia throughout the event. Patient #4's family was informed of the event by Surgeon #4. The patient was discharged home in stable condition on 10/8/2020.

Review of the hospital's investigation for Incident #4 revealed post-surgery it was determined Surgeon #4 failed to stop closing the patient's chest after being notified of the missing laparotomy pad which led to the patient's chest being completely closed before the pad was identified inside the patient's chest. The hospital also determined there was a delay in getting the x-ray completed due to problems with pager connectivity inside the hospital. The investigation further revealed the hospital was in need of a checklist for the operating room that incorporated measures for the surgeons to follow when counts are off, as their current policy did not have measures in place for the surgeon to make the determination to stop or continuing closing when counts were off. The hospital also determined the "No Thing Left Behind" training was not included in the orientation process for Medical Staff members, and there were no alternative methods for identifying a potentially retained object when radiology was not readily available. The hospital determined all licensed providers needed additional education that included specific do's and don'ts before they begin working in the operating room.

Immediately following Incident #4, the hospital began instructing surgical team members to back away from the surgeon and stop providing them with additional supplies needed to close the incision until the surgical counts were correct or the missing items were found. This surveyor interviewed a total of 4 circulating RNs, 3 scrub techs, 1 surgical resident, and 1 surgeon on 11/5/2020 and verified staff were aware of the new process; however there was no documentation all surgical staff and surgeons had been trained on the new interventions to prevent RSI.

In a telephone interview with Surgeon #4 on 11/3/2020 at 8:55 AM, the surgeon verified he was informed by the surgical team that the surgical count was off with one (1) lap pad being unaccounted for. Surgeon #1 stated once he was informed the lap pad was missing he looked inside the surgical site and felt in the area, but did not locate the lap pad. He stated he continued with his closing procedure while the surgical team continued to look for the lap pad. Surgeon #4 stated while he was closing the site, radiology was consulted and an x-ray was obtained. When asked if he had completed the closing procedure when the x-ray results were received, he stated, "Yes, but I never broke the surgical field knowing I might have to go back in." Surgeon #4 then verified the laparotomy pad was seen on the x-ray, and he had to re-open the wound and retrieve the lap pad. Surgeon #4 informed surveyor that at his previous work site, he had been able to go ahead with closing the patient while waiting for x-ray results as long as he didn't break the surgical field. He then stated, he now knows not to completely close the surgical field until x-ray results are obtained.

In a telephone interview with Scrub Tech #5 on 11/3/2020 at 11:20 AM the Scrub Tech stated she was only in the OR to relieve Scrub Tech #4 for a lunch break. Scrub Tech #5 stated that while she was in the operating room, the surgeon placed two (2) laparotomy pads underneath Patient #4's heart in order to hold it in place while he was working on it and, "The laps were still inside the patient when I left the room." Scrub Tech #5 said she returned to the operating room later to help with the closing count, but stated the closing count had already been done and the count was off by one (1) laparotomy pad. Scrub Tech #5 stated, "X-ray was on the way when I got in there and the surgeon was finishing closing the patient." The Scrub Tech verified the lap pad was visible on x-ray and the surgeon had to re-open the patient's chest to retrieve it and, "After he [Surgeon #4] closed the patient, we did another count and everything was correct." Scrub Tech #5 was asked what measures the hospital had put in place to prevent future occurrences and the Scrub Tech stated, "Our supervisors have told us to step away from the table and not give the surgeons any supplies needed to close until the count is correct."

In a telephone interview with RN #5 on 11/4/2020 at 8:56 AM the RN stated she was one (1) of two (2) circulating nurses in the operating room during the surgery, and RN #6 completed the closing and final counts of the surgical items. RN #5 stated, the laparotomy pad count was incorrect and the entire surgical team was informed, radiology was contacted, and everyone began looking for the pad. The RN said she notified the Board Runner and RN Clinical Director informing them about the incorrect laparotomy pad count and then stated, "When x-ray arrived, the wound was already closed, but the x-ray was taken and the lap pad was seen on the x-ray. The radiologist did call back and confirm that with us. The surgeon had to reopen the patient and retrieve it..." When asked why the surgeon didn't stop closing the wound when he was notified the lap pad count was incorrect the RN stated, "I really don't know why he kept closing, but I found out it wasn't in our policy for him to stop closing...I think they are changing the policy now..."

In an interview with Scrub Tech #4 on 11/5/2020 at 10:14 AM the Scrub Tech verified Surgeon #4 was informed that a laparotomy pad was missing; however the surgeon continued to close the patient's incision without waiting for x-ray results. The Scrub Tech stated the laparotomy pad was seen on x-ray inside the p