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The hospital failed to meet the Condition of Participation for surgical services when it failed to ensure that surgical care and services achieved the highest acceptable standards of practice by failing to ensure the following:

Surgical "Count Bags" (Bags with transparent pockets used to visualize individual surgical sponges used during surgical procedures) were used according to facility policy and procedure during all surgical procedures for locating and accounting of all surgical sponges used during the surgical procedures of patients at Hospital 1, 2, 3 and 4. This deficient practice resulted in a retained sponge left in Patient 1's subcutaneous tissue (under the skin), at Hospital 1 and required a second surgical procedure to remove the retained sponge. This failure had the potential at Hospitals 1, 2, 3 and 4 of retaining surgical sponges in all patients requiring surgical procedures.

The cumulative effect of this deficient practice resulted in Patient 1 requiring a second surgical procedure to remove the retained sponge at Hospital 1, and had the potential to affect the health and safety of patients requiring surgical interventions at Hospital 1, 2, 3, and 4.

Based on interview and record review, the facility failed to ensure to follow its policy and procedure for the final sponge counts (counting soft cloths used during surgery), for all sponges used and accounted for during surgical procedures performed in the operating rooms at Hospital 1, 2, 3 and 4. (Hospital 1 had 3 other hospitals with Operating Rooms under its license). These deficient practices resulted in the unintended retention of a surgical sponge in Patient 1, at Hospital 1, which resulted in infection, pain, subsequent surgery (2nd surgery), prolonged recovery, increased risk of organ rejection and had the potential for retained surgical sponges at Hospitals 1, 2, 3 and 4 for all surgical patients seeking intervention.

Findings:

An interview was confirmed on August 3, 2016, at 10:00 AM, with the Quality and Patient Safety Specialist (QPSS), she stated that a surgical sponge was left inside of Patient 1 during a kidney transplant surgery on May 31, 2016 at Hospital 1. The surgery was performed by a Transplant Surgeon (Surgeon 1), and by an Assistant Surgeon (Surgeon 2), along with the transplant surgical team. QPSS stated that a subsequent surgery was performed on June 13, 2016 to remove a retained surgical sponge from Patient 1 (13 days after Patient 1 had kidney transplant surgery.)

A review on August 3, 2016, of the Surgical Count Record (a document confirming surgical sponge, needles/sharps and instrument counts are correct), dated May 31, 2016, performed in Hospital 1's operating room, revealed documentation that the final sponge count was "correct" (all sponges were present and accounted for) The sponge count was verified by the Circulating Nurse (RN 1), and the Surgical Tech (ST 1) and electronically signed May 31, 2016 at 4:55 PM.

A review on August 3, 2016, of the Transplant Clinic notes dated June 13, 2016 at 11:29 AM, revealed that Patient 1 was seen in the Outpatient Transplant Clinic on June 13, 2016 complaining of pain over the incision site (where the cut was made on the skin for the kidney operation). Documentation indicated purulent drainage (white oozing substance) was noted coming from the incision site. Patient 1 was assessed by a Nurse Practitioner (NP 1) and a CT scan (computerized tomography, a diagnostic test) was ordered to be completed upon admission to the hospital. Further intervention plans were discussed with Surgeon 2 regarding Patient 1's current condition of complaints of pain over the incision site and purulent drainage. A discussion pursued regarding how to proceed and resolve Patient 1's symptoms as presented.

On August 3, 2016, a review of the face sheet (the first page of a chart indicating patient demographics) at Hospital 1 dated June 13, 2016 at 5:04 PM (the same day as the clinic visit) revealed "Admission Type: Urgent...Admitting diagnosis; Wound infection, Postoperative wound infection, Wound infection following procedure, ex lap (exploratory laparotomy, (a method of abdominal exploration, a diagnostic tool that allows physicians to examine the abdominal organs). Procedure: EXPLORATORY LAPAROTOMY".

On August 3, 2016, a review of the form titled, "Brief Op-Note Form", dated June 13, 2016 (second operation 13 days from the original surgery when the sponge count was deemed correct, but in reality was not, and a sponge was retained) as written by Surgeon 2 documented, "Pre-Operative Diagnosis: SP (Status post/after) kidney transplant with wound drainage and CT showing possible surgical sponge with inflammation for surgical exploration. Post-Operative Diagnosis "SP Exploration of surgical wound from renal (kidney) transplant incision, removal of surgical sponge, irrigation of wound...Findings: Surgical sponge covered with pus (A generally viscous, yellowish-white fluid formed in infected tissue) in the subcutaneous (under the skin) tissue."

An interview was confirmed on August 3, 2016, at 10:15 AM, regarding an interview that took place with the Executive Director of Operating Room (EDOR-1) when he was asked if the surgical team used count bags (small clear plastic pockets hung on a rack for visualizing individual sponges used for accounting for all sponges used during a surgical procedure) for counting during or after surgical procedures, he advised they are available for surgery staff to use, but they were not required for use all the time.

An interview was confirmed on August 3, 2016, at 10:10 AM, with the Director of the Operating Room (DOR) she advised count bags were available for surgical staff to use, but was not sure if the policy required staff to use them at all times. She later stated she reviewed the policy and procedure and stated counting bags are required. The DOR stated most surgical staff members used the count bags. (Implying some surgical staff do not during surgical procedures).

An interview was confirmed on August 3, 2016 at 10:15 AM, with RN 1 when he stated about four minutes before the final closure of the skin, the final count was deemed correct by both the scrub tech and himself. RN 1 stated "I'm assuming the surgeon must have tucked a surgical sponge up under the skin after the count was completed and I did not see it." RN 1 stated the final sponge count is always done during skin closure and not after. RN 1 stated, the final sponge count is done during skin closure because there is very little risk of an instrument, sharp or sponge being left under the skin.

An interview was confirmed on August 3, 2016, at 10:20 AM, regarding Scrub Tech (ST 1), who was present at the time of Patient 1's initial transplant surgery and who conducted the final sponge count with RN 1, she advised the final sponge count was correct during the closure of the skin after the kidney transplant; and that the surgeon must have tucked the surgical sponge under the skin and it wasn't noticed. She stated, The final count is always completed during the skin closure. She then stated, the skin is being closed, there is very little risk of an instrument, sharp or sponge being left under the skin and all surgeons are aware of this practice.

During the same interview with RN 1 and ST 1, when asked if the count bag was used during Patient 1's surgery, RN 1 and ST 1 stated yes, but not all surgical sponges were placed in the bag pockets. RN 1 and ST 1 advised some of the used surgical sponges were in the kick bucket (a bucket on the floor to place bloody or fluid filled sponges in) and some on top of the abdomen (stomach) used for cleaning the patient after surgery. The circulating nurse usually takes the soiled sponges from the kick bucket then places them in the counter bag, but sometimes they are counted while still in the kick bucket.

An interview was confirmed on August 3, 2016, regarding the retained sponge with Surgeon 1, he stated the sponge was left under the Patient 1's subcutaneous tissue (under the skin) during surgery on May 31, 2016, and removed on June 13, 2016. He also stated he could not remember placing a sponge in the subcutaneous tissue; it had been a couple of months since the surgery. Surgeon 1 advised after the final count was completed, he continued to use surgical sponges during skin closure, not all sponges were placed in the count bag, and a few sponges were left on the field (either on the back table or on top of the patient) for cleaning. He also stated that he thought there was always an additional count after the skin closure to ensure the count was correct.


During a review of the clinical record on August 3, 2016, for Patient 1, dated June 13, 2016 through June 18, 2016, (five days post second surgery to remove the surgical retained sponge, at Hospital 1, it indicated that Patient 1 received multiple doses of pain medications both oral (by mouth) and IV (intravenous - given through the vein for faster relief from pain) for mild, moderate and sever pain between June 14, 2016 and June 18, 2016. The medical record indicated Patient 1 was discharged home on June 18, 2016 with a wound vacuum (a device to create suction in the wound to help with removal of blood and fluids which aids with healing), and home health care (a nurse to care for the patient at home).

During an interview conducted on August 3, 2016 at 9:55 PM, with Registered Nurse (RN 1), at Hospital 2, she stated nurses try to place all sponges in the counter bag (a plastic bag with pockets to hold individual sponges for visualization), however, the practice of placing sponges in the counter bag has only recently been enforced over the past few months.

During an interview conducted on August 3, 2016 at 10:10 AM, with Registered Nurse (RN 2), at Hospital 2, she stated some sponges were left on the abdomen for cleaning and are not placed in the counter bag 100% of the time, although they should be. She also stated the hospital had only recently enforced using the counter bag on all surgeries, not just the open case surgeries (when a body cavity is open).

During an interview conducted on August 3, 2016 at 10:25 AM, with Registered Nurse (RN 3) at Hospital 2, she stated the practice of using the counter bag has only been in practice for a few months to a year, not that long.

Hospital 2 failed to follow its policy and procedure in using "Count Bags" in the final counting process of surgical sponges during surgical procedures. This failure had the potential for surgical patients in retaining surgical sponges during surgery at Hospital 2.

The facility policy and procedure entitled, "Sponge, Sharp and Instrument count", dated January 2015 as "Reviewed", and indicated, "1. Sponges shall be counted on all surgical procedures in the operating room; exceptions: eye, cystoscopy (a procedure that allows the doctor to examine the lining of a bladder and the tube that carries urine out of the body) and other transurethral (the tube that carries urine out of your body) procedures when performed as the single procedure for the patient...The sponge count shall be final when all the sponges are in individual pockets of the count bag and verified by circulating nurse and scrub person... Refer to Mosby's (clinical standards for nursing) for counting procedure."

Mosby's Clinical Skills, entitled, "Sponge Counts", Copyright 2006-2016, indicated, "Follow a standardized counting procedure; retained sponges can still occur even when the scrub person and circulating nurse have correct counts... Count the sponges placed in the sponge counter (bag) throughout the surgical procedure."


During an interview conducted on August 3, 2016 at 11:18 AM, with Registered Nurse (RN 4), at Hospital 3, she stated the counter bags were used only for big cases using more than ten sponges. RN 4 stated the final count for smaller cases was done by placing individual sponges on the back table for visualization and counting. The final count could include sponges still in use by the surgeon.


During an interview conducted on August 3, 2016 at 11:40 AM, with the Director of Operating Room (DOR) at Hospital 3, she stated the use of counter bags had been left up to the discretion of the circulating nurses.

During an interview conducted on August 3, 2016 at 11:45 AM, with the Executive Director of Nursing Services, (EDNS) at Hospital 3, she stated the nurses had been instructed that the counter bags were not needed for minimally invasive surgeries, and placing the sponges on the back table had been the practice. The EDNS stated Hospital 3 only had two hangers for the counter bags (a device to hang the counter bag on for counting); therefore counter bags were not available for use in each Operating Room.

Hospital 3 failed to follow its policy and procedure in using "Count Bags" in the final counting process of surgical sponges during surgical procedures. This failure had the potential for surgical patients retaining surgical sponges during surgery Hospital 3.

The facility policy and procedure entitled, "Sponge, Sharp and Instrument count", dated January 2015 as "Reviewed", and indicated, "1. Sponges shall be counted on all surgical procedures in the operating room; exceptions: eye, cystoscopy (a procedure that allows the doctor to examine the lining of a bladder and the tube that carries urine out of the body) and other transurethral (the tube that carries urine out of your body) procedures when performed as the single procedure for the patient...The sponge count shall be final when all the sponges are in individual pockets of the count bag and verified by circulating nurse and scrub person... Refer to Mosby's (clinical standards for nursing) for counting procedure."

Mosby's Clinical Skills, entitled, "Sponge Counts", Copyright 2006-2016, indicated, "Follow a standardized counting procedure; retained sponges can still occur even when the scrub person and circulating nurse have correct counts... Count the sponges placed in the sponge counter (bag) throughout the surgical procedure."


During an interview conducted on August 3, 2016 at 1:20 PM, with Registered Nurse (RN 5), at Hospital 4, she stated clean sponges (sponges on the back table for use, but not yet used) are not placed in the counter bag. She also stated during the final sponge count, some sponges could be on the back table, the abdomen and in the counter bag, some cases were very short, and had been told by managers the sponge counter was not needed.

During an interview conducted on August 3, 2016 at 1:45 PM, with Registered Nurse (RN 6), at Hospital 4, she stated if the surgical case was not an open case (an open cavity); she would not use a counter bag. She also stated for smaller cases the sponges could be laid out on the back table for visualization and counting. If more than ten sponges were used she would use the counter bag. RN 6 also stated prior to June 23, 2016 when all staff were re-educated on the policy to use the counter bag, the use of the counter bag was not enforced, and the sponges could be place on the back table for visualization and counting.

Hospital 4 failed to follow its policy and procedure in using "Count Bags" in the final counting process of surgical sponges during surgical procedures. This failure had the potential for surgical patients retaining surgical sponges during all surgeries at Hospital 4.

The facility policy and procedure entitled, "Sponge, Sharp and Instrument count", dated January 2015 as "Reviewed", and indicated, " 1. Sponges shall be counted on all surgical procedures in the operating room; exceptions: eye, cystoscopy (a procedure that allows the doctor to examine the lining of a bladder and the tube that carries urine out of the body) and other transurethral (the tube that carries urine out of your body) procedures when performed as the single procedure for the patient... The sponge count shall be final when all the sponges are in individual pockets of the count bag and verified by circulating nurse and scrub person... Refer to Mosby's (clinical standards for nursing) for counting procedure."

Mosby's Clinical Skills, entitled, "Sponge Counts", Copyright 2006-2016, indicated, "Follow a standardized counting procedure; retained sponges can still occur even when the scrub person and circulating nurse have correct counts... Count the sponges placed in the sponge counter (bag) throughout the surgical procedure.


During an interview conducted on August 3, 2016 at 3:00 PM, with the Executive Director of Operating Rooms (EDOR-2) at Hospital 1, she stated prior to the re-education conducted on June 23, 2016, that staff at all hospitals had been instructed if a lot of sponges where used, staff should use counter bags. Counter bag use was not suggested for any particular cases, but if using 10-15 or more sponges, the counter bag should be utilized. She stated that until education was conducted to remind staff of the policy, that counter bag use was not enforced.

The facility policy and procedure entitled, "Sponge, Sharp and Instrument count", dated January 2015 as "Reviewed", and indicated, " 1. Sponges shall be counted on all surgical procedures in the operating room; exceptions: eye, cystoscopy (a procedure that allows the doctor to examine the lining of a bladder and the tube that carries urine out of the body) and other transurethral (the tube that carries urine out of your body) procedures when performed as the single procedure for the patient... The sponge count shall be final when all the sponges are in individual pockets of the count bag and verified by circulating nurse and scrub person... Refer to Mosby's (clinical standards for nursing) for counting procedure."

Mosby's Clinical Skills, entitled, "Sponge Counts", Copyright 2006-2016, indicated, "Follow a standardized counting procedure; retained sponges can still occur even when the scrub person and circulating nurse have correct counts... Count the sponges placed in the sponge counter (bag) throughout the surgical procedure."

The facility (Hospital 1, 2, 3 and 4) did not follow their policy and procedures at all times when it failed to use count bags for the final sponge count at Hospital 1, for patient 1, and did not consistently follow its policy and procedure by not using count bags for surgical procedures for its final sponge counts at Hospital 1, 2, 3 and 4, which had the potential of surgical patients retaining surgical sponges during a surgical procedure.