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Based on review of clinical records, hospital policies, hospital documentation, committee minutes and interviews with staff and vendors, the Condition of Participation for QAPI has not been met. The hospital failed to utilize data collected during multiple investigations of surgical/procedural errors to develop an ongoing safety program to ensure that recurrent surgical and/or procedural errors did not occur.

Please see A286

Based on review of the clinical record, hospital policy and interviews for nine of sixteen sampled patients who underwent a surgical and/or invasive procedure in which an adverse event/error occurred (Patients #6, #7, #8, #10, #11, #12, #18, #106, and #111), the hospital failed to utilize the data collected during multiple investigations of surgical/procedural errors to develop an ongoing safety program to ensure that recurrent surgical and/or procedural errors did not occur. The finding includes:


a. Patient #6 was admitted to the hospital on 11/3/14 and underwent a total abdominal hysterectomy for leiomyoma of the uterus. The instrument and sponge count was documented as correct. The patient's hospital course was uncomplicated and she was discharged to home on 11/5/14.
On 11/9/14 Patient #6 was admitted to the emergency room complaining of lower abdominal and back pain. Imaging revealed a large amount of stool and the patient was administered an enema with positive results. The patient was sent home on 11/9/14. Patient #6 was advised to take stool softeners and follow up with her gynecologist.
On 3/2/15 Patient #6 presented to the emergency room complaining of light vaginal bleeding for three weeks and abdominal cramping for two days. A speculum examination revealed a small piece of blue surgical sponge in the vaginal canal. A computed tomography (CT) scan of the abdomen was conducted without evidence of a foreign body.
Interview with MD #7 on 1/28/16 at 9:30 AM identified she was the surgeon conducting the operation and indicated she does not recall how the radiopaque tape became separated from the sponge. MD #7 identified her procedure was to hand off the sponge to the surgical technician however she does not check to see if the sponge and/or radiopaque tape is intact. Interview with RN #8 on 2/1/16 at 10:00 AM who was one of the nurses responsible for conducting the sponge and instrument count for the case indicated the sponge count did not include checking the blue radiopaque tape that was adhered to the surgical sponge. On 2/1/16 at 10:30 AM interview with Nursing Director #2 indicted subsequent to the event all blue radiopaque tape must be visualized for its integrity when a sponge count is conducted by hanging the blue tail outside of the sponge counter bag to ensure it is intact.
Interview with MD #10 on 1/28/16 at 11:50 AM identified she was the gynecologist called to the emergency department to evaluate Patient #6 and removed a torn piece of blue surgical tape from on operative sponge. MD #10 indicated she placed the surgical tape in a specimen cup that was to be sent to pathology for identification. MD #10 identified she did not place the order for the foreign body to be sent to pathology as she thought the emergency room practitioner would write the order. Interview with the Chairman of the Emergency Department on 2/1/16 at 11:30 AM identified it was the responsibility of the physician who removed the foreign body to direct the order for a pathological examination of the specimen and she did not.
Review of a Corrective Action Plan (CAP) with a completion date of 09/30/15 identified that, as part of the final sponge count, sponges will be placed in the sponge counter with the tails hanging outside of the bag and the blue tail will be inspected to ensure it is intact. The nurses and surgical technicians in the Main OR will be educated on the new count process. The hospital did not ensure that other areas of the hospital that utilized sponges with blue tails (radiopaque) were provided with the same education and/or a revised count process. Additionally, the hospital did not ensure that other areas of the hospital, including the ED, that may collect specimens for examination by pathology received education on specimen management and/or that all questionable retained foreign bodies throughout the hospital, will be saved and sent to pathology for examination.

b. Patient #7 identified that on 10/8/15, the patient successfully completed a vaginal delivery. Review of the documentation dated 10/8/15, identified that the initial and final count of sponges and sharps utilized during the delivery was correct. The patient was recovered and discharged on 10/10/15, only to return on 10/11/15 after she passed an object from the vagina that upon examination was identified as a 4x4 gauze sponge. During interview on 1/28/16 at approximately 2:00 PM, Nurse Manager #9 identified that a root cause analysis (RCA) completed by the hospital identified that the sponges, when counted at the vaginal delivery was between the physician and the nurse. In this case, the 4 by 4's were banded together and not separated individually, but fanned out, when counted, thus causing the possibility of an inaccurate count and not following the hospital policy.

Review of the hospital policy for Sponge, Sharp and Instrument Count directed that a sponge count is performed on all surgical procedures, including vaginal deliveries. This policy directed that the two persons counting must separate the sponges, so that each sponge is counted individually. During the procedure, each used sponge is counted and placed in a hanging sponge counter bag, which was not utilized at the time of this delivery.

The hospital's corrective action plan was to change the 4 by 4 sponge use to that of 18 by 18 lap sponges with a ring attached that will be placed in a sponge counter bag now located in every room once the sponge is used. The sponge counter bag had not been used during vaginal deliveries routinely, however was utilized now per hospital policy. The hospital continues to monitor 10 vaginal deliveries per month to ensure that the corrective actions are utilized.

The hospital failed to utilize the sponge counter bag in the delivery room, despite previous issues with retained sponges in other areas of the hospital including the main OR.

c. Patient #8 underwent an off-pump coronary artery bypass graft on 8/4/2014. Review of the intraoperative record dated 8/4/14, identified that an initial and a final sponge, sharps and instrument count was completed, however, the record was lacking documentation that a count was completed prior to the closing of the chest cavity. Additionally, the surgeon's operative report failed to reflect that he was notified that a lap sponge was missing. The documentation reflected that a chest x-ray was completed when the final count was incorrect without evidence that anything was retained in the patient's chest. Despite daily chest x-rays, the missing lap sponge wasn't located until 8/6/14 at 6:37 when an unidentified rectangular density was located overlying the right hilium and the patient was returned to surgery for removal of the lap sponge.
During interview on 2/1/16 at approximately 2:00 PM, MD #21 stated he was not told of the sponge discrepancy until the patient's chest was being wired shut. He stated he could not risk reopening the chest secondary to bleeding issues and that he requested a chest x-ray. MD #21 stated that the sponge could not be identified during x-ray because the radiopaque tail of the tapered sponge was rolled up inside the sponge which had been utilized to angle the heart for access during surgery. MD #21 stated that from that time on, an announcement is made to the team when such a rolled sponge is utilized to alert the team. The surgeon stated that he did not participate in the root-cause analysis secondary to being in surgery.

Review of the hospital policy for Sponge, Sharp and Instrument Count directs that the scrub and circulator audibly and visibly count all items as the surgeon closes an organ within a body cavity and the circulating nurse announces out loud to the surgeon the results of the count.

During interview on 2/1/16 at 9:30 AM, Nurse Manager #4 stated that the OR team identified that "of course we counted, we just didn't document it." The Manager stated that re-education of staff occurred in 2014 and that yearly re-education of counting competency occurs. Additionally, staff were re-educated regarding next steps to take when an x-ray is negative for the missing item.

Review of the CAP with completion date of 02/15/15 identified that the staff, in the Main OR would be re-educated regarding the count policy including performance of counts per policy, timing of count prior to insertion of chest wires, proper separation of surgical sponges and tapes using surgical hanging count bags, and documentation of all counts performed in the electronic record. The hospital did not ensure that staff in other surgical areas at risk for retained sponges were re-educated.

d. Patient #10 was admitted to the hospital on 7/24/15 with acute pyelonephritis. On 7/25/15, Patient #10 had a central line inserted by Resident #5. Patient #10 tolerated the procedure well and was subsequently discharged on 8/3/15. On 8/11/15, Patient #10 returned to the Emergency Department with nausea and vomiting, low blood pressure and hematemesis. Review of the chest x-ray dated 8/11/15 identified that Patient #10 had a retained guide wire. Patient #10 was taken to interventional radiology where the guidewire was removed without difficulty. Interview with Resident #5 (Pulmonary Fellow) on 2/1/16 identified that he/she just started his/her fellowship and was not familiar with the checklist utilized at the hospital. Resident #5 indicated that he/she was alone during the insertion except for the time out prior to insertion and did not realize he/she did not remove the guidewire. Interview with RN #15 on 2/1/16 identified that he/she had gathered the equipment for the resident and was present for the time out portion of the procedure, however, he/she had to take care of another patient so he/she left the room and did not witness the insertion of the central line by Resident #5. In addition, interview with Resident #5 and RN #15 both indicated that there was a problem with the brown port of the central line and was taped off to not use.

Review of hospital policy (central line insertion checklist) identified that the procedure required to check the guidewire was removed and all lines were inspected and intact with central line orders inputted by provider.

Review of the CAP with completion date of 01/31/16 identified, in part, that focused education would be provided to the first and second year Pulmonary Fellows and Internal Medicine Residents regarding use of central line kits, insertion check lists, and use of the central line access device (CVAD) order post central line insertion, additionally all new RNs hired for the MICU would have focused training on related topics. The hospital did not ensure that education was provided in other areas of the hospital at risk for retained guidewires secondary to central line insertion.

e. Patient #11 was admitted to the hospital on 8/15/14 for anterior cervical discectomy and fusion at C4-C5 and exploration of the fusion at C5-C6 and C6-C7 levels. Review of the clinical record identified that universal protocol was followed and an 18-gauge needle was placed in the anterior aspect of the c-spine and an intraoperative radiograph was obtained to confirm location. The first cross table lateral film was obtained and identified that the needle was marked in the C2 location. The needle was moved and another cross table lateral film was obtained which showed the needle was at the level of C4-C5. The procedure then continued with dissection through a very large amount of thickened anterior cervical soft tissue and over a large amount of bony osteophyes and deformed vertebral body. Once completed an interbody graft and anterior plate were placed and the incision was closed. An x-ray revealed that the level that had been done was the C3-C4 level, which was not part of the original plan. MD #15 indicated that Patient #11 was reopened and the C4-C5 level was completed in accordance with the pre-operative plan and indicated that the C3-C4 level needed to be repaired anyway.
Review of hospital policy identified that for spinal procedures, special intraoperative imaging techniques must be used for locating and marking the exact vertebral level and images must be available, visible, correct and properly labeled. Interview with the Chief of Surgery on 1/27/16 indicated that the surgeon needed to ensure the needle used to locate the proper level is lodged in the bone and confirmed by x-ray and the needle has not been dislodged. If dislodged, the surgeon needs to re-insert the needle and confirm location with an x-ray.

f. Patient #12 was admitted to the hospital on 2/2/15 for a pterygium excision and amniotic graft of the right eye. During the surgery, sponges were allowed to sit on the eye surface for five minutes. Patient #12 was discharged home and to follow up with the physician on an outpatient basis. On 4/10/15 (2 months later), Patient #12 had developed pain in the right eye and was started on topical antibiotics. On 4/14/15, Patient #12 was admitted to the hospital and diagnosed with orbital cellulitis and was treated with intravenous antibiotics. Patient was discharged on 4/21/15 and went to short term rehabilitation. Patient #12 continued to have issues with the right eye and a recommendation was made to have a second right eye surgery. On 6/15/15, Patient #12 was admitted to the hospital for lens removal and replacement. During surgery, a 4 x 4 mm foreign body with two eyelashes behind it was removed from the conjunctiva of the right eye.
Review of the intraoperative report dated 2/2/15 failed to identify that sponges were accounted for. Review of hospital policy identified that a sponge count is performed on all surgical procedures. Interview with MD #17 identified that the sponges utilized were cut into small pieces and all were accounted for after the procedure. Interview with Nursing Director #2 on 1/27/16 at 11:30 AM identified that sponges were counted but not documented and pieces of sponges that were cut were not counted for.

Review of the CAP identified that the staff were re-educated regarding the surgical sponge count policy and to utilize time-out/safety stop if a count is incorrect.


g. Patient #18 was admitted to the hospital on 12/3/15 for incision and drainage of the right transmetatarsal amputation site wound by MD #12. The immediate operative report by Resident #1 dated 12/3/15 noted, in part, that the white foam from the KLC Wound V.A.C. was packed in the wound. A progress note dated 12/6/15 by Resident #3 identified that the wound V.A.C. was to be changed today, stable granular wound without signs of infection, and continue wound V.A.C. Although nursing narratives dated 12/10/15 indicated that the MD changed the patient's wound VAC, a physician's assessment of wound on 12/10/15 was not documented. Patient #18 was discharged to home on 12/10/15 with the wound VAC in place.
Podiatry office notes by MD #12 dated 1/5/16 identified a retained approximate 4.0 centimeter (cm) by 2.0 cm piece of white VAC foam. Interview with MD #12 on 1/29/16 at 11:40 AM indicated that he/she informed Resident #1 of the need to change Patient #18's dressing on 12/6/15 and the need to remove the white foam. Interview with Resident #1 on 1/28/16 at 1:34 PM noted that patient information was communicated from Podiatry Resident to Podiatry Resident via a verbal report (hand- off). He/she further indicated that he/she informed Resident #2 and Resident #4 regarding the required dressing change for 12/6/15 and the need to remove the white foam. Interview with Resident #2 on 1/29/16 at 11:50 AM noted that he/she did not recall being informed of the presence of the white foam and/or the need to remove it, and therefore did not report this to the Resident who would administer the 12/6/15 dressing change (Resident #3). Interview with the Chief of Podiatry on 1/29/16 at 1:20 PM identified that he/she visualized Patient #18's right foot wound after Resident #3 removed the initial dressing on 12/6/15 and did not see the white foam in the wound at that time. Interview with Resident #4 on 2/1/16 at 8:50 AM noted that he/she did not recall the patient report given by Resident #1 regarding the patient's dressing change. Although the point of error for the unanticipated retained packing could not be identified, the facility submitted a corrective action plan on 1/29/16 to include a standardized hand- off tool to be utilized by Podiatry Residents, education for required dressing change documentation, and monitoring. The facility was found compliant with the plan as submitted. The facility medical staff bylaws identified that the management and coordination of each patient's care, treatment and services in the Hospital is the responsibility and privilege of a responsible Physician in the appropriate Section of the Department with appropriate privileges. The Hospital Resident Training Program Agreement identified that the Chairman of the Department in which the Resident is pursuing training is responsible for the supervision, instruction and training of the Resident.

Review of the Corrective Action Plan (CAP) with completion date of 05/15/2016 identified that the retained piece of foam was related to placement and changing of a wound vacuum in the Adult Surgical Unit by Podiatry Residents and did not address management of the wound vacuum and component foam sponges throughout the hospital by healthcare providers that are responsible for changing the sponges and/or removing and/or replacing the wound vacuum.


h. Patient #106 was admitted to the hospital on 05/04/16 for a total hip arthroplasty for a pre-operative diagnosis of degenerative joint disease. Consent was signed on 04/29/16. An operative report dated 05/04/16 at 6:29 PM by, surgeon, MD #30 identified that anesthesia included Enhanced Recovery After Surgery (ERAS) protocol combined spinal epidural including periarticular injection. Following operative preparation, MD #30 determined the sizes of the four required components of the prosthetic devices that included a size 52 millimeter (mm) acetabular shell, a 36 mm femoral head, a 36 mm polyethylene neutral liner and a 7.5 mm offset femoral stem. The devices were placed. The hip was reduced, found to be stable and closed in layers. The patient was then taken to recovery in stable condition, having tolerated the procedure well. Needle and sponge counts were correct and post-operative x-ray showed anatomic reconstruction of the hip.

A second operative note dated 05/04/16 identified the operative procedure of left hip femoral head revision for a preoperative diagnoses of femoral head revision for incorrect size. Indications for the procedure identified that at the conclusion of an additional case after Patient #106's left total hip arthroplasty, it was noted that the inventory of prosthetic hip components was incorrect, in that a femoral head did not match the remaining polyethylene neutral liner. MD #30 discussed the issue with Patient #106 obtained surgical consent, and brought the patient back to the OR as the next procedure. The hip was found to have a 32 mm femoral head instead of the requested 36 mm head. The 32 mm head was removed and replaced with the 36 mm head. The hip was reduced, irrigated, and the wound was closed in layers. The patient was eventually transported to recovery in stable condition having tolerated the procedure well.
Review of a discharge Summary dated 05/06/16 identified, in part, that Patient #106 began physical therapy on post-operative day #0, received pain medication, anticoagulation, and antibiotics and was discharged home on post operative day #2 without complications.

Interview with Vendor Representative (Rep) #2 on 05/18/16 at 1:30 PM identified that the responsibility of the vendor rep included selecting the correct size of each of the four prosthetic hip components as specified by the surgeon following measurement during the procedure. The surgeon announces each measurement which the circulating nurse should document. The vendor rep retrieves the requested component and verifies the size as recorded on the box label. The boxes are then brought into the OR and re-verified with the nurse and the surgeon prior to the box being opened and the prosthetic device being placed on the sterile field. Once placed on the field without benefit of the box, the device size cannot be verified. Vendor Rep #1 who provided the components for Patient #106's initial surgery was not available for interview.

Interview with MD #30 on 05/18/16 at 2:00 PM identified that there were a lot of variables with this incident and someone was inattentive. Initially, the vendor rep called out the measurement of 36 mm for the femoral head component, when, in fact, the box contained a 32 mm femoral head.

Interview with PA #4 on 05/17/16 identified that he/she was involved holding the retractors and did not hear the surgeon, circulating nurse or surgical tech verifying the prosthetic components, however, there were a number of distractions in the OR that day including a student surgical tech.

Interview with the circulating nurse, RN #28, on 05/17/16 at 2:10 PM identified that he/she was unaware of the final determination of the component size and, at no time, did he/she participate in a visual or audible verification. Once the boxes were opened and the prosthetic devices were removed and placed on the sterile field, RN #28 retrieved the product labels, scanned the bar codes, and placed the labels on a progress note form. Review of the progress note form dated and signed by RN #28 on 05/04/16 at 10:30 AM identified that the femoral head component measured 32 mm in diameter and the polyethylene neutral liner measured 36 mm. RN #28 identified that he/she did not read and verify the labels and was unaware of the mismatch at the time.

Interview with surgical tech #2 identified that he/she was distracted by the presence of the surgical tech student and, although he/she verified the acetabular shell, the polyethylene neutral liner, and the femoral stem with MD #30 prior to opening the boxes, he/she did not verify the femoral head as it had already been removed from the box and placed on the sterile field.

The hospital lacked a written policy, procedure, and/or protocol for ensuring that the appropriate prosthetic device is inserted during a surgical procedure and/or that the roles of each member of the surgical team, including the vendor representative related are delineated in a written policy.

Review of the hospital's adverse event documentation identified that a time-out was instituted for surgical implants to verify correct size. A root cause analysis was initiated but had not yet concluded.



i. Patient #111 was admitted to the medical/surgical unit on 05/15/16 with diagnoses of closed fracture of the distal left femur, acute renal failure (ARF), developing bacteremia, and acute kidney injury (AKI). Past medical history included asthma, restrictive lung disease, hypertension, diabetes mellitus, coronary artery disease, four events of right sided ischemic stroke complicated by hemorrhagic conversion with spastic left hemiplegia. The patient was wheelchair bound.
A physician's order dated and signed by MD #32 on 05/17/2016 at 5:04 PM directed insertion of a Central Venous Access Device (CVAD) for central access for blood draws and infusions. Review of Central Line insertion procedure signed, dated, and performed by MD #32 on 05/17/2016 at 4:30 PM and authorized by the attending physician, MD #39, identified that a time out was initiated prior to the procedure that included verification of patient name, medical record number, date of birth and identification band. The procedure was confirmed and consent was obtained. Radiographic imaging (ultrasound) was utilized. Hand hygiene was performed and sterile technique was utilized. Local anesthetic was administered and a seven French, double lumen catheter was placed in the right bacilic vein with ultrasound guidance, successfully, with one attempt. Post-procedure the line was sutured and a dressing applied. Assessment identified blood return through all ports and free fluid flow. The patient tolerated the procedure well with no immediate complications. MD #32 commented that a right basilica mid line was inserted under ultrasound guidance. Documentation failed to identify removal of guidewires following successful insertion of the right mid line catheter and/or verification of placement.

On 05/17/16 at 8:07 PM, attending, MD #39 reviewed internal medicine resident, MD #40's assessment of Patient #111 and ordered an abdominal CT scan to rule out intraabdominal sources of pain.

On 05/17/16 at 11:00 PM, Resident, MD #41, identified concern that Patient #111 was exhibiting symptoms of opioid induced ileus and the abdominal CT scan was performed. Abdominal CT scan results dated 05/18/2016 identified a metallic guide wire/line extending from the right atrium to IVC bifurcation with the tip probably terminating into lumbar venous tributaries. Recommendation included to follow-up with a chest x-ray. Chest x-ray results dated 05/18/16 identified the presence of a metallic guidewire extending from the right axilla, projecting over the right atrium and IVC that corresponds with the metallic wire seen on the CT of the abdomen. A right midline catheter with its tip overlying the axilla was also visualized.

Further review of the clinical record identified that on 05/18/16, the decision was made to place the patient on nothing by mouth, and for aspirin, Plavix, and subcutaneous heparin to be held in preparation for a procedure to retire the guidewire and placement of a central line. The central line was placed at 7:25 AM with placement verified by x-ray. The retained guidewire was removed in interventional radiology, emergently, on 05/18/2016 at 11:17 AM. Vascular surgery was required for the cutdown to finish retrieval of the guidewire.

The patient was transferred to the Medical Intensive Care Unit.

Interview with MD #32 on 05/19/16 at 11:00 AM identified that Patient #111 required emergent placement of a central venous access device on 05/17/16 at 4:30 PM due to ongoing blood loss and need for IV fluids. MD #32, a second year resident, had been certified by the hospital to conduct central line insertions as well as having practiced as interventional radiologist in another country. MD #32 identified that he/she obtained a double lumen mid line catheter set (contained 2 guidewires) from the hospitalist and utilized a first year resident (not certified in central line insertion), MD #40 for assistance. A floor nurse was in attendance for the first time out, but returned to the floor before the procedure was complete. MD #40 held the patient's hands as MD #32 conducted the procedure. There was an initial gush of blood upon catheter insertion that made it difficult to determine which lumen contained the guide wire. Upon completion of the procedure MD #32 verified that the catheter was in the lumen of the vessel and removed one guidewire. He/she did not verify that the second guide wire was removed and/or that it was visible via ultrasound. MD #32 identified that a central line check list was utilized in the medical ICU but was not available for placement of a midline on a medical/surgical unit.

The hospital lacked a policy and procedure for insertion of a mid-line catheter.
Review of a Central Line Insertion Checklist, identified, in part, that during the intra-procedural period the guide wire (s) is to be removed, visually observed and verbally confirmed (dated 10/01/2015).

Review of the hospital's adverse event documentation identified that until further review of this case and completion of the RCA, medicine residents will not place mid-line catheters. A root cause analysis is currently being conducted and a corrective action plan are pending. The hospital is in the process of developing a checklist for mid-line catheter insertion including policy/procedure.
A review of the Professional and Quality Council Committee Meeting minutes and interviews with the Vice President of Performance Management, Director of Risk, Director of Performance Improvement, Performance Management Coordinator and the Director of Surgical Services occurred on 05/10/16. It was identified that all adverse events undergo a full review, corrective measures are instituted for each event in the location that it occurred, and they were discussed monthly at the quality council. However, the hospital (through the quality council) did not utilize the data collected during multiple, in depth investigations to develop an ongoing, hospital wide safety program in an effort to reduce future, related, occurrences of retained foreign bodies and/or surgical errors as a quality/performance measure.
A review of the hospital's 2016 Performance Improvement plan for quality and safety improvement identifies sustained efforts to remain a high reliability organization and address areas of "enterprise-wide" risk in patient safety and quality. Review of the Professional and Quality Council meeting minutes dated 1/21/16 identified a performance improvement plan for the hospital to sustain efforts to remain a high reliability organization which included assessing safety culture and address "enterprise-wide" risk in patient safety.

Based on review of clinical records, hospital policies, hospital documentation, committee minutes and interviews with staff and vendors, the Condition of Participation for Surgical Services has not been met. The hospital failed to ensure that responses to surgical/procedural errors were organized and that those responses were instituted hospital-wide to decrease and/or to ensure that recurrent surgical and/or procedural errors did not occur.


Please see A951

Based on review of the clinical record, hospital policy and interviews for nine of sixteen sampled patients who underwent a surgical and/or invasive procedure (Patients #6, #7, #8, #10, #11, #12, #18, #106, and #112), the hospital failed to ensure that recurrent surgical and/or procedural errors did not occur including failure to ensure that a surgical sponge was checked for integrity prior to the completion of surgery and/or surgical sponge counts were conducted according to hospital policy and/or laterality was correct, and/or that the guidewire was removed after a central line insertion and/or that packing was not retained and/or that dressing change documentation was complete and/or that a foreign body was sent to pathology for identification and/or that a prosthetic device was of the proper size resulting in the need for further invasive procedures. The findings includes:

a. Patient #6 was admitted to the hospital on 11/3/14 and underwent a total abdominal hysterectomy for leiomyoma of the uterus. The instrument and sponge count was documented as correct. The patient's hospital course was uncomplicated and she was discharged to home on 11/5/14.
On 11/9/14 Patient #6 was admitted to the emergency room complaining of lower abdominal and back pain. Imaging revealed a large amount of stool and the patient was administered an enema with positive results. The patient was sent home on 11/9/14. Patient #6 was advised to take stool softeners and follow up with her gynecologist.
On 3/2/15 Patient #6 presented to the emergency room complaining of light vaginal bleeding for three weeks and abdominal cramping for two days. A speculum examination revealed a small piece of blue surgical sponge in the vaginal canal. A computed tomography (CT) scan of the abdomen was conducted without evidence of a foreign body.
Interview with MD #7 on 1/28/16 at 9:30 AM identified she was the surgeon conducting the operation and indicated she does not recall how the radiopaque tape became separated from the sponge. MD #7 identified her procedure was to hand off the sponge to the surgical technician however she does not check to see if the sponge and/or radiopaque tape is intact. Interview with RN #8 on 2/1/16 at 10:00 AM who was one of the nurses responsible for conducting the sponge and instrument count for the case indicated the sponge count did not include checking the blue radiopaque tape that was adhered to the surgical sponge. On 2/1/16 at 10:30 AM interview with Nursing Director #2 indicted subsequent to the event all blue radiopaque tape must be visualized for its integrity when a sponge count is conducted by hanging the blue tail outside of the sponge counter bag to ensure it is intact.
Interview with MD #10 on 1/28/16 at 11:50 AM identified she was the gynecologist called to the emergency department to evaluate Patient #6 and removed a torn piece of blue surgical tape from on operative sponge. MD #10 indicated she placed the surgical tape in a specimen cup that was to be sent to pathology for identification. MD #10 identified she did not place the order for the foreign body to be sent to pathology as she thought the emergency room practitioner would write the order. Interview with the Chairman of the Emergency Department on 2/1/16 at 11:30 AM identified it was the responsibility of the physician who removed the foreign body to direct the order for a pathological examination of the specimen and she did not.
Review of a Corrective Action Plan (CAP) with a completion date of 09/30/15 identified that, as part of the final sponge count, sponges will be placed in the sponge counter with the tails hanging outside of the bag and the blue tail will be inspected to ensure it is intact. The nurses and surgical technicians in the Main OR will be educated on the new count process. The hospital did not ensure that other areas of the hospital that utilized sponges with blue tails (radiopaque) were provided with the same education and/or a revised count process. Additionally, the hospital did not ensure that other areas of the hospital, including the ED, that may collect specimens for examination by pathology received education on specimen management and/or that all questionable retained foreign bodies throughout the hospital, will be saved and sent to pathology for examination.

b. Patient #7 successfully completed a vaginal delivery on 10/8/15. Review of the documentation dated 10/8/15, identified that the initial and final count of sponges and sharps utilized during the delivery was correct. The patient was recovered and discharged on 10/10/15, only to return on 10/11/15 after she passed an object from the vagina that upon examination was identified as a 4x4 gauze sponge. During interview on 1/28/16 at approximately 2:00 PM, Nurse Manager #9 identified that a root cause analysis (RCA) completed by the hospital identified that the sponges, when counted at the vaginal delivery was between the physician and the nurse. In this case, the 4 by 4's were banded together and not separated individually, but fanned out, when counted, thus causing the possibility of an inaccurate count and not following the hospital policy.

Review of the hospital policy for Sponge, Sharp and Instrument Count directed that a sponge count is performed on all surgical procedures, including vaginal deliveries. This policy directed that the two persons counting must separate the sponges, so that each sponge is counted individually. During the procedure, each used sponge is counted and placed in a hanging sponge counter bag, which was not utilized at the time of this delivery.

The hospital's corrective action was to change the 4 by 4 sponge use to that of 18 by18 lap sponges with a ring attached that will be placed in a sponge counter bag now located in every room once the sponge is used. The sponge counter bag had not been used during vaginal deliveries routinely, however was utilized now per hospital policy. The hospital continues to monitor 10 vaginal deliveries per month to ensure that the corrective actions are utilized.

The hospital failed to utilize the sponge counter bag in the delivery room, despite previous issues with retained sponges in other areas of the hospital including the main OR.

c. Patient #8 underwent an off-pump coronary artery bypass graft on 8/4/2014. Review of the intraoperative record dated 8/4/14, identified that an initial and a final sponge, sharps and instrument count was completed, however, the record was lacking documentation that a count was completed prior to the closing of the chest cavity. Additionally, the surgeon's operative report failed to reflect that he was notified that a lap sponge was missing. The documentation reflected that a chest x-ray was completed when the final count was incorrect without evidence that anything was retained in the patient's chest. Despite daily chest x-rays, the missing lap sponge wasn't located until 8/6/14 at 6:37 when an unidentified rectangular density was located overlying the right hilium and the patient was returned to surgery for removal of the lap sponge.
During interview on 2/1/16 at approximately 2:00 PM, MD #21 stated he was not told of the sponge discrepancy until the patient's chest was being wired shut. He stated he could not risk reopening the chest secondary to bleeding issues and that he requested a chest x-ray. MD #21 stated that the sponge could not be identified during x-ray because the radiopaque tail of the tapered sponge was rolled up inside the sponge which had been utilized to angle the heart for access during surgery. MD #21 stated that from that time on, an announcement is made to the team when such a rolled sponge is utilized to alert the team. The surgeon stated that he did not participate in the root-cause analysis secondary to being in surgery.

Review of the hospital policy for Sponge, Sharp and Instrument Count directs that the scrub and circulator audibly and visibly count all items as the surgeon closes an organ within a body cavity and the circulating nurse announces out loud to the surgeon the results of the count.

During interview on 2/1/16 at 9:30 AM, Nurse Manager #4 stated that the OR team identified that "of course we counted, we just didn't document it." The Manager stated that re-education of staff occurred in 2014 and that yearly re-education of counting competency occurs. Additionally, staff were re-educated regarding next steps to take when an x-ray is negative for the missing item.

Review of the CAP with completion date of 02/15/15 identified that the staff, in the Main OR would be re-educated regarding the count policy including performance of counts per policy, timing of count prior to insertion of chest wires, proper separation of surgical sponges and tapes using surgical hanging count bags, and documentation of all counts performed in the electronic record. The hospital did not ensure that staff in other surgical areas at risk for retained sponges were re-educated.

d. Patient #10 was admitted to the hospital on 7/24/15 with acute pyelonephritis. On 7/25/15, Patient #10 had a central line inserted by Resident #5. Patient #10 tolerated the procedure well and was subsequently discharged on 8/3/15. On 8/11/15, Patient #10 returned to the Emergency Department with nausea and vomiting, low blood pressure and hematemesis. Review of the chest x-ray dated 8/11/15 identified that Patient #10 had a retained guide wire. Patient #10 was taken to interventional radiology where the guidewire was removed without difficulty. Interview with Resident #5 (Pulmonary Fellow) on 2/1/16 identified that he/she just started his/her fellowship and was not familiar with the checklist utilized at the hospital. Resident #5 indicated that he/she was alone during the insertion except for the time out prior to insertion and did not realize he/she did not remove the guidewire. Interview with RN #15 on 2/1/16 identified that he/she had gathered the equipment for the resident and was present for the time out portion of the procedure, however, he/she had to take care of another patient so he/she left the room and did not witness the insertion of the central line by Resident #5. In addition, interview with Resident #5 and RN #15 both indicated that there was a problem with the brown port of the central line and was taped off to not use.

Review of hospital policy (central line insertion checklist) identified that the procedure required to check the guidewire was removed and all lines were inspected and intact with central line orders inputted by provider.

Review of the CAP with completion date of 01/31/16 identified, in part, that focused education would be provided to the first and second year Pulmonary Fellows and Internal Medicine Residents regarding use of central line kits, insertion check lists, and use of the central line access device (CVAD) order post central line insertion, additionally all new RNs hired for the MICU would have focused training on related topics. The hospital did not ensure that education was provided in other areas of the hospital at risk for retained guidewires secondary to central line insertion.

e. Patient #11 was admitted to the hospital on 8/15/14 for anterior cervical discectomy and fusion at C4-C5 and exploration of the fusion at C5-C6 and C6-C7 levels. Review of the clinical record identified that universal protocol was followed and an 18-gauge needle was placed in the anterior aspect of the c-spine and an intraoperative radiograph was obtained to confirm location. The first cross table lateral film was obtained and identified that the needle was marked in the C2 location. The needle was moved and another cross table lateral film was obtained which showed the needle was at the level of C4-C5. The procedure then continued with dissection through a very large amount of thickened anterior cervical soft tissue and over a large amount of bony osteophyes and deformed vertebral body. Once completed an interbody graft and anterior plate were placed and the incision was closed. An x-ray revealed that the level that had been done was the C3-C4 level, which was not part of the original plan. MD #15 indicated that Patient #11 was reopened and the C4-C5 level was completed in accordance with the pre-operative plan and indicated that the C3-C4 level needed to be repaired anyway. Review of hospital policy identified that for spinal procedures, special intraoperative imaging techniques must be used for locating and marking the exact vertebral level and images must be available, visible, correct and properly labeled. Interview with the Chief of Surgery on 1/27/16 indicated that the surgeon needed to ensure the needle used to locate the proper level is lodged in the bone and confirmed by x-ray and the needle has not been dislodged. If dislodged, the surgeon needs to re-insert the needle and confirm location with an x-ray.

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f. Patient #12 was admitted to the hospital on 2/2/15 for a pterygium excision and amniotic graft of the right eye. During the surgery, sponges were allowed to sit on the eye surface for five minutes. Patient #12 was discharged home and to follow up with the physician on an outpatient basis. On 4/10/15 (2 months later), Patient #12 had developed pain in the right eye and was started on topical antibiotics. On 4/14/15, Patient #12 was admitted to the hospital and diagnosed with orbital cellulitis and was treated with intravenous antibiotics. Patient was discharged on 4/21/15 and went to short term rehabilitation. Patient #12 continued to have issues with the right eye and a recommendation was made to have a second right eye surgery. On 6/15/15, Patient #12 was admitted to the hospital for lens removal and replacement. During surgery, a 4 x 4 mm foreign body with two eyelashes behind it was removed from the conjunctiva of the right eye.
Review of the intraoperative report dated 2/2/15 failed to identify that sponges were accounted for. Review of hospital policy identified that a sponge count is performed on all surgical procedures. Interview with MD #17 identified that the sponges utilized were cut into small pieces and all were accounted for after the procedure. Interview with Nursing Director #2 on 1/27/16 at 11:30 AM identified that sponges were counted but not documented and pieces of sponges that were cut were not counted for.

Review of the CAP identified that the staff were re-educated regarding the surgical sponge count policy and to utilize time-out/safety stop if a count is incorrect.


g. Patient #18 was admitted to the hospital on 12/3/15 for incision and drainage of the right transmetatarsal amputation site wound by MD #12. The immediate operative report by Resident #1 dated 12/3/15 noted, in part, that the white foam from the KLC Wound V.A.C. was packed in the wound. A progress note dated 12/6/15 by Resident #3 identified that the wound V.A.C. was to be changed today, stable granular wound without signs of infection, and continue wound V.A.C. Although nursing narratives dated 12/10/15 indicated that the MD changed the patient's wound VAC, a physician's assessment of wound on 12/10/15 was not documented. Patient #18 was discharged to home on 12/10/15 with the wound VAC in place.
Podiatry office notes by MD #12 dated 1/5/16 identified a retained approximate 4.0 centimeter (cm) by 2.0 cm piece of white VAC foam. Interview with MD #12 on 1/29/16 at 11:40 AM indicated that he/she informed Resident #1 of the need to change Patient #18's dressing on 12/6/15 and the need to remove the white foam. Interview with Resident #1 on 1/28/16 at 1:34 PM noted that patient information was communicated from Podiatry Resident to Podiatry Resident via a verbal report (hand- off). He/she further indicated that he/she informed Resident #2 and Resident #4 regarding the required dressing change for 12/6/15 and the need to remove the white foam. Interview with Resident #2 on 1/29/16 at 11:50 AM noted that he/she did not recall being informed of the presence of the white foam and/or the need to remove it, and therefore did not report this to the Resident who would administer the 12/6/15 dressing change (Resident #3). Interview with the Chief of Podiatry on 1/29/16 at 1:20 PM identified that he/she visualized Patient #18's right foot wound after Resident #3 removed the initial dressing on 12/6/15 and did not see the white foam in the wound at that time. Interview with Resident #4 on 2/1/16 at 8:50 AM noted that he/she did not recall the patient report given by Resident #1 regarding the patient's dressing change. Although the point of error for the unanticipated retained packing could not be identified, the facility submitted a corrective action plan on 1/29/16 to include a standardized hand- off tool to be utilized by Podiatry Residents, education for required dressing change documentation, and monitoring. The facility was found compliant with the plan as submitted. The facility medical staff bylaws identified that the management and coordination of each patient's care, treatment and services in the Hospital is the responsibility and privilege of a responsible Physician in the appropriate Section of the Department with appropriate privileges. The Hospital Resident Training Program Agreement identified that the Chairman of the Department in which the Resident is pursuing training is responsible for the supervision, instruction and training of the Resident.

Review of the Corrective Action Plan (CAP) with completion date of 05/15/2016 identified that the retained piece of foam was related to placement and changing of a wound vacuum in the Adult Surgical Unit by Podiatry Residents and did not address management of the wound vacuum and component foam sponges throughout the hospital by healthcare providers that are responsible for changing the sponges and/or removing and/or replacing the wound vacuum.


h. Patient #106 was admitted to the hospital on 05/04/16 for a total hip arthroplasty for a pre-operative diagnosis of degenerative joint disease. Consent was signed on 04/29/16. An operative report dated 05/04/16 at 6:29 PM by, surgeon, MD #30 identified that anesthesia included Enhanced Recovery After Surgery (ERAS) protocol combined spinal epidural including periarticular injection. Following operative preparation, MD #30 determined the sizes of the four required components of the prosthetic devices that included a size 52 millimeter (mm) acetabular shell, a 36 mm femoral head, a 36 mm polyethylene neutral liner and a 7.5 mm offset femoral stem. The devices were placed. The hip was reduced, found to be stable and closed in layers. The patient was then taken to recovery in stable condition, having tolerated the procedure well. Needle and sponge counts were correct and post-operative x-ray showed anatomic reconstruction of the hip.

A second operative note dated 05/04/16 identified the operative procedure of left hip femoral head revision for a preoperative diagnoses of femoral head revision for incorrect size. Indications for the procedure identified that at the conclusion of an additional case after Patient #106's left total hip arthroplasty, it was noted that the inventory of prosthetic hip components was incorrect, in that a femoral head did not match the remaining polyethylene neutral liner. MD #30 discussed the issue with Patient #106 obtained surgical consent, and brought the patient back to the OR as the next procedure. The hip was found to have a 32 mm femoral head instead of the requested 36 mm head. The 32 mm head was removed and replaced with the 36 mm head. The hip was reduced, irrigated, and the wound was closed in layers. The patient was eventually transported to recovery in stable condition having tolerated the procedure well.
Review of a discharge Summary dated 05/06/16 identified, in part, that Patient #106 began physical therapy on post-operative day #0, received pain medication, anticoagulation, and antibiotics and was discharged home on post operative day #2 without complications.

Interview with Vendor Representative (Rep) #2 on 05/18/16 at 1:30 PM identified that the responsibility of the vendor rep included selecting the correct size of each of the four prosthetic hip components as specified by the surgeon following measurement during the procedure. The surgeon announces each measurement which the circulating nurse should document. The vendor rep retrieves the requested component and verifies the size as recorded on the box label. The boxes are then brought into the OR and re-verified with the nurse and the surgeon prior to the box being opened and the prosthetic device being placed on the sterile field. Once placed on the field without benefit of the box, the device size cannot be verified. Vendor Rep #1 who provided the components for Patient #106's initial surgery was not available for interview.

Interview with MD #30 on 05/18/16 at 2:00 PM identified that there were a lot of variables with this incident and someone was inattentive. Initially, the vendor rep called out the measurement of 36 mm for the femoral head component, when, in fact, the box contained a 32 mm femoral head.

Interview with PA #4 on 05/17/16 identified that he/she was involved holding the retractors and did not hear the surgeon, circulating nurse or surgical tech verifying the prosthetic components, however, there were a number of distractions in the OR that day including a student surgical tech.

Interview with the circulating nurse, RN #28, on 05/17/16 at 2:10 PM identified that he/she was unaware of the final determination of the component size and, at no time, did he/she participate in a visual or audible verification. Once the boxes were opened and the prosthetic devices were removed and placed on the sterile field, RN #28 retrieved the product labels, scanned the bar codes, and placed the labels on a progress note form. Review of the progress note form dated and signed by RN #28 on 05/04/16 at 10:30 AM identified that the femoral head component measured 32 mm in diameter and the polyethylene neutral liner measured 36 mm. RN #28 identified that he/she did not read and verify the labels and was unaware of the mismatch at the time.

Interview with surgical tech #2 identified that he/she was distracted by the presence of the surgical tech student and, although he/she verified the acetabular shell, the polyethylene neutral liner, and the femoral stem with MD #30 prior to opening the boxes, he/she did not verify the femoral head as it had already been removed from the box and placed on the sterile field.

The hospital lacked a written policy, procedure, and/or protocol for ensuring that the appropriate prosthetic device is inserted during a surgical procedure and/or that the roles of each member of the surgical team, including the vendor representative related are delineated in a written policy.

Review of the hospital's adverse event documentation identified that a time-out was instituted for surgical implants to verify correct size. A root cause analysis was initiated but had not yet concluded.


i. Patient #111 was admitted to the medical/surgical unit on 05/15/16 with diagnoses of closed fracture of the distal left femur, acute renal failure (ARF), developing bacteremia, and acute kidney injury (AKI). Past medical history included asthma, restrictive lung disease, hypertension, diabetes mellitus, coronary artery disease, four events of right sided ischemic stroke complicated by hemorrhagic conversion with spastic left hemiplegia. The patient was wheelchair bound.
A physician's order dated and signed by MD #32 on 05/17/2016 at 5:04 PM directed insertion of a Central Venous Access Device (CVAD) for central access for blood draws and infusions. Review of Central Line insertion procedure signed, dated, and performed by MD #32 on 05/17/2016 at 4:30 PM and authorized by the attending physician, MD #39, identified that a time out was initiated prior to the procedure that included verification of patient name, medical record number, date of birth and identification band. The procedure was confirmed and consent was obtained. Radiographic imaging (ultrasound) was utilized. Hand hygiene was performed and sterile technique was utilized. Local anesthetic was administered and a seven French, double lumen catheter was placed in the right bacilic vein with ultrasound guidance, successfully, with one attempt. Post-procedure the line was sutured and a dressing applied. Assessment identified blood return through all ports and free fluid flow. The patient tolerated the procedure well with no immediate complications. MD #32 commented that a right basilica mid line was inserted under ultrasound guidance. Documentation failed to identify removal of guidewires following successful insertion of the right mid line catheter and/or verification of placement.

On 05/17/16 at 8:07 PM, attending, MD #39 reviewed internal medicine resident, MD #40's assessment of Patient #111 and ordered an abdominal CT scan to rule out intraabdominal sources of pain.

On 05/17/16 at 11:00 PM, Resident, MD #41, identified concern that Patient #111 was exhibiting symptoms of opioid induced ileus and the abdominal CT scan was performed. Abdominal CT scan results dated 05/18/2016 identified a metallic guide wire/line extending from the right atrium to IVC bifurcation with the tip probably terminating into lumbar venous tributaries. Recommendation included to follow-up with a chest x-ray. Chest x-ray results dated 05/18/16 identified the presence of a metallic guidewire extending from the right axilla, projecting over the right atrium and IVC that corresponds with the metallic wire seen on the CT of the abdomen. A right midline catheter with its tip overlying the axilla was also visualized.

Further review of the clinical record identified that on 05/18/16, the decision was made to place the patient on nothing by mouth, and for aspirin, Plavix, and subcutaneous heparin to be held in preparation for a procedure to retire the guidewire and placement of a central line. The central line was placed at 7:25 AM with placement verified by x-ray. The retained guidewire was removed in interventional radiology, emergently, on 05/18/2016 at 11:17 AM. Vascular surgery was required for the cutdown to finish retrieval of the guidewire.

The patient was transferred to the Medical Intensive Care Unit.

Interview with MD #32 on 05/19/16 at 11:00 AM identified that Patient #111 required emergent placement of a central venous access device on 05/17/16 at 4:30 PM due to ongoing blood loss and need for IV fluids. MD #32, a second year resident, had been certified by the hospital to conduct central line insertions as well as having practiced as interventional radiologist in another country. MD #32 identified that he/she obtained a double lumen mid line catheter set (contained 2 guidewires) from the hospitalist and utilized a first year resident (not certified in central line insertion), MD #40 for assistance. A floor nurse was in attendance for the first time out, but returned to the floor before the procedure was complete. MD #40 held the patient's hands as MD #32 conducted the procedure. There was an initial gush of blood upon catheter insertion that made it difficult to determine which lumen contained the guide wire. Upon completion of the procedure MD #32 verified that the catheter was in the lumen of the vessel and removed one guidewire. He/she did not verify that the second guide wire was removed and/or that it was visible via ultrasound. MD #32 identified that a central line check list was utilized in the medical ICU but was not available for placement of a midline on a medical/surgical unit.

The hospital lacked a policy and procedure for insertion of a mid-line catheter.
Review of a Central Line Insertion Checklist, identified, in part, that during the intra-procedural period the guide wire (s) is to be removed, visually observed and verbally confirmed (dated 10/01/2015).

Review of the hospital's adverse event documentation identified that until further review of this case and completion of the RCA, medicine residents will not place mid-line catheters. A root cause analysis is currently being conducted and a corrective action plan are pending. The hospital is in the process of developing a checklist for mid-line catheter insertion including policy/procedure.
A review of the Professional and Quality Council Committee Meeting minutes and interviews with the Vice President of Performance Management, Director of Risk, Director of Performance Improvement, Performance Management Coordinator and the Director of Surgical Services occurred on 05/10/16. It was identified that all adverse events undergo a full review, corrective measures are instituted for each event in the location that it occurred, and they were discussed monthly at the quality council. However, the hospital (through the quality council) did not utilize the data collected during multiple, in depth investigations to develop an ongoing, hospital wide safety program in an effort to reduce future, related, occurrences of retained foreign bodies and/or surgical errors as a quality/performance measure.