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Based on observation, interview and record review, the facility failed to meet the Condition of Participation for Nursing Services, by failing to:

1. Ensure Registered Nurse 4 (RN 4) documented the packing (a special type of dressing placed inside a wound to help it heal) material type and quantity of the purposely retained lap pad during the initial surgery, for one of thirty (30) sampled patients (Patient 1). (Refer to A 0398)

2. Ensure Registered Nurse 3 (RN 3) prepared intravenous medication in a clean designated medication preparation area not adjacent to potential sources of contamination for one of thirty (30) sampled patients (Patient 1). (Refer to A 0405)

The cumulative effect of these systemic problems resulted in the facility's inability to provide quality health care in a safe environment.

Based on interview and record review, the facility failed to ensure Registered Nurse 4 (RN 4) documented the packing (a special type of dressing placed inside a wound to help it heal) material type and quantity of the purposely retained lap pad (a packing material left inside the abdominal cavity of Patient 1 with the intention of removing the lap pad at a later time) during the initial surgery, for one of thirty (30) sampled patients (Patient 1).

This deficient practice led to a lap pad (laparotomy pad, usually cotton pad place to soak up fluid during surgery), which was unaccounted for, being retained in Patient 1's abdomen after the surgery was completed leading to possible infection and the need for additional surgery to remove the material (lap pad).


Findings:

A review of Patient 1's history and physical (H&P), dated 5/24/2022, indicated that Patient 1 was admitted to the facility on 5/24/2022 due to a motor vehicle collision.

A review of Patient 1's "Operation Report," dated 5/24/22, at 2:12 P.M., indicated that Patient 1 had an exploratory laparotomy (surgery to open up the belly area [abdomen]) for trauma (injury resulting from a motor vehicle collision) (Surgery #1).

A review of Patient 1's "Operation Report," dated 5/24/22, at 11:49 P.M., indicated that Patient 1 had undergone a "Reopening of recent laparotomy" and "bedside pericardial window (procedure done on the sac around the heart)." (Surgery #2)

A review of the document, titled "Operative Report," dated 5/27/2022, indicated Patient 1 had an abdominal closure performed by Surgeon 2 (MD 2) (Surgery #3). The Operative Report did not indicate that the intentionally retained lap pad inside patient 1's abdominal cavity, on 5/24/2022, was removed during this surgery (Surgery #3).

A review of the document titled "X-Ray Abdomen 1 View, X-Ray Chest 1 View, dated 5/27/2022, at 5:10 P.M., indicated that there was a left sided chest tube (a surgical drain that is inserted through the chest wall to remove air, fluid, or blood) and packing material or lap pad in the left upper quadrant of Patient 1. The final impression given by this report (radiology test) was that there was no evidence of unintended retention of surgical instrument in the abdomen.

A review of the document, titled "Operative Report," (Surgery #4) dated 6/3/2022, indicated Patient 1 underwent an abdominal closure (a surgical procedure to close the patient's skin using a suture material [a thread used to close wounds] following a surgical incision [cut]) on 5/27/2022. According to the Operative Report, Patient 1 had two procedures before this surgery on 6/3/2022, which was related to a motor vehicle accident. The previous surgeries (Surgery #1 and Surgery #2) done on 5/24/2022) required that the surgical sites at the abdomen and chest be left open. The Operative Report also indicated the removal of a lap pad which was not removed during a previous surgery on 5/27/2022.

During an interview on 11/08/2022, at 3:00 P.M., with Surgeon 1 (MD 1), MD 1 stated he (MD 1) intentionally left a QuikClot and a lap pad in Patient 1's abdomen during an exploratory laparotomy (a surgical procedure to open the belly area) on 5/24/2022 during Surgery #1.

During an interview on 11/14/2022, at 10:15 A.M., with Registered Nurse 2 (RN 2), RN 2 stated the operating room (OR) nurses are responsible for documenting the type and quantity of materials packed in the patient and when it (packing material such as a lap pad) was removed and documented on the packing flowsheet (a place to record and track a sequence of events).

During a concurrent interview and record review on 11/14/2022, at 10:23 A.M., with OR Nurse Manager (NM 1), Patient 1's packing flowsheet was reviewed. The packing flowsheet, dated 5/24/2022, did not indicate a purposely retained lap pad inside Patient 1's abdominal cavity. NM 1 stated RN 4 should have also included the retention of the lap pad in the documentation.

A record review of Patient 1's packing flowsheet record from the dates from 5/24/2022 to 5/27/2022 did not indicate the packing material (lap pad) was removed from Patient 1's abdomen cavity.

A review of Patient 1's "Operation Report, dated 6/3/2022, at 4:00 A.M., indicated Surgeon 2 (MD 2) found a lap pad inside Patient 1's abdominal cavity. The lap pad was removed during Surgery #4 on 6/3/2022 and was sent to pathology (to study the cause of a disease or injury) and swabbed for culture (a test to find an infection).

A review of the document titled "X-ray of the Abdomen 1 View (collected 6/4/2022)," indicated that the left upper quadrant lap pad had been removed after surgery (Surgery #4) on 6/3/2022.

A review of the facility's policy and procedure (P&P) titled, "Counts: Sponges, Sharps, Instruments and Special Items Policy," dated 2/5/2020, indicated sponges intentionally used as packing and the patient leaves the operating room with this packing in place, the type and quantity of sponges(s) retained must be documented. The purpose of the P&P is to provide a consistent approach for prevention of retained surgical items for all surgical procedures.

Based on observation, interview, and record review, the facility failed to ensure Registered Nurse 3 (RN 3) prepared an intravenous (administered through the vein) medication in a designated clean area before administering it to one of thirty (30) sampled patients (Patient 2).

This deficient practice has the potential to cause contamination of the medication and transmission of infection to the patient (Patient 2).

Findings:

During a medication administration observation on 11/8/2022, at 1:37 P.M., RN 3 had retrieved a vial of Dilaudid (opioid pain medication) from the medication room in the PACU (Post Anesthesia Care Unit, designated area of the hospital where patients are monitored and cared for in the event that they have ill effects after surgery). The medication was in a single use vial and needed to be drawn up from the vial with a needle; the medication was then drawn through the needle into a syringe and given to the patient (Patient 2) intravenously (through a needle or tube, IV, inserted into a vein). At this time, RN 3, proceeded to draw the IV medicine at the bedside of Patient 2, next to the patient's head, where there can be potential sources of contamination. RN 3 then infused the medication into the IV of Patient 2.

During an interview on 11/8/2022, at 1:55 P.M., with the Director of Licensure and Regulation (DLR), DLR stated the facility uses the bedside table inside the patient's room as the medication preparation site for IV medications; she (DLR) further said that there were no countertops or areas within the medication rooms in which to prepare IV medications, and that there was no direct policy that references to preparing IV medication in the medication room.

A review of the facility's document, titled "Medication Administration and Documentation Procedure: Medication Management (effective date 07/29/2022) - Medication Administration, Injectables," indicated that single dose vials are to be discarded after single patient use. This procedure indicated that the vial septum (rubber stopper through which the medication can be drawn by a needle) should be cleansed with isopropyl alcohol before the needle enters the vial; this should be performed every time the needle enters the septum. The document indicated that IV administration systems should be maintained according to established nursing standards. Further review of the document did not reveal in what location intravenous medications were to be drawn or prepared from vials.

A review of the Centers for Disease Control and Prevention (CDC) document "Medication Preparation Questions," indicated Medications should be drawn up in a designated clean medication preparation area not adjacent to potential sources of contamination. In addition, any item that could have come in contact with blood or body fluids, such as soiled equipment used in a procedure, should not be in the medication preparation area. Examples of contaminated items that should not be near the medication preparation area include used equipment such as syringes, needles, IV tubing, blood collection tubes, or needle holders. There should be ready access to necessary supplies (such as alcohol-based hand rub, needles and syringes in their sterile packaging, and alcohol wipes) in the medication preparation area to ensure that staff can adhere to aseptic technique (a method or set of practices used to prevent contamination with microorganisms such as bacteria).

Based on interview and record review, the facility failed to meet the Condition of Participation for Surgical Services, when:

1. Documentation of the packing (a special type of dressing placed inside a wound to help it heal) material type and quantity of the purposely retained lap pad during the initial surgery, for one of thirty (30) sampled patients (Patient 1) was not done. (Refer to A 0951)

2. Radiologist 4 (MD 4) did not discuss imaging results with Surgeon 2 (MD 2) and Surgeon 5 (MD 5) for one of thirty (30) sampled patients (Patient 1). (Refer to A 0951)

The cumulative effect of these systemic problems identified resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the facility failed to ensure:

1. Documentation of the packing (a special type of dressing placed inside a wound to help it heal) material type and quantity of the purposely retained lap pad during the initial surgery, for one of thirty (30) sampled patients (Patient 1) was done. RN 4 failed to document the type and quantity of retained items for packing.

2. Communication between medical staff and documentation and tracking of the presence of intentional packing QuikClot and Lap pad for One of thirty (30) Sampled Patients (Patient 1). The intentionally retained lap pad by MD 1 was not communicated properly to MD 2 who was closing the abdominal cavity with the intentionally retained lap pad left inside Patient 1's abdominal cavity and was unaccounted for.

These deficient practices resulted in a fourth surgical procedure (Surgery #4) to remove a retained surgical item (lap pad) from Patient 1's abdominal cavity subjecting Patient 1 to potential bleeding, infection and even death.

On November 14, 2022, at 3:15 P.M., an Immediate Jeopardy (IJ, non-compliance that makes serious injury, harm, impairment, or death likely to occur to one or more recipients if the non-compliance is not corrected) situation was identified and called in the prese nce of the Regulatory Executive Director (RED), Senior VP Operations (SVPO), Chief Medical Officer (CMO), Chief Nursing Executive (CNE), and Chief Operating Officer (COO).

The facility failed to ensure the following:

1. RN 4 documented the type and quantity of retained items for "packing (a special type of dressing placed inside a wound to help it heal)."

2. The intentionally retained lap pad by MD 1 was not communicated properly to MD 2 who was closing the abdominal cavity with the intentionally retained lap pad left inside Patient 1's abdominal cavity and was unaccounted for.

During a review of Patient 1's medical record indicated a total of 4 surgeries were conducted on Patient 1 during Patient 1's hospital stay. Surgery #1 on 5/24/2022 was an exploratory laparotomy (surgery to open up the belly area [abdomen]. This surgery was done to find the cause of problems (such as belly pain or bleeding) subsequent to a Motor Vehicle Accident (MVA) and the abdomen was left open by Surgeon 1. Surgery #2 was conducted later that evening on 5/24/2022 for an emergent sternotomy (a procedure that allows the physician to reach the heart or nearby organs and blood vessels through a cut in the skin) for suspected tamponade (a serious condition that occurs when extra fluid or blood builds up in the space between the heart and the sac around the heart) and the chest left open by Surgeon 2. The Surgery #3 was done on 5/27/2022 for sternal (a vertical bone that forms the anterior portion of the chest wall) and abdominal closure.

Due to Patient 1's fever and suspected foreign body, a mediastinal exploration and washout (re-opening of a surgical incision [cut] in the patient's chest and wash out clot,or drain accumulated fluids) was performed (Surgery #4) on 6/3/2022. For surgery one (Surgery #1), the documentation indicated that MD 1 intentionally left a QuikClot (material used to control bleeding) and a laparotomy pad (lap pad-white cloth used to soak up fluid and control bleeding during surgery) inside Patient 1's abdomen that would not be removed until closure of the abdomen on 5/27/2022 (Surgery #3). A chest x-ray on 5/27/2022 (Surgery #3) indicated that there was a remaining packing material or lap pad in the left upper quadrant of patient 1's abdomen. Patient 1 subsequently developed a fever. CT (Computerized Tomography-a diagnostic procedure using x-ray to visualize parts of the body and diagnose a disease or injury) scan of the chest/abdomen/pelvis was taken on 6/3/2022, which showed stable packing material (lap pad) within the left upper quadrant of Patient 1's abdomen. There was a successful removal of the lap pad on 6/3/2022 (Surgery #4).

On November 15, 2022, at 4:00 P.M., the Immediate Jeopardy was removed after verifying an acceptable IJ removal plan. The IJ removal plan included re-education for all operative nursing staff regarding documentation of the packing type and quantity used during surgery including a re-education among the nursing staff and surgeons about the process to review presence of packing material.

Findings:

1. A review of Patient 1's history and physical (H&P), dated 5/24/2022, indicated that Patient 1 was admitted to the facility on 5/24/2022 due to a motor vehicle collision.

A review of Patient 1's "Operation Report," dated 5/24/22, at 2:12 P.M., indicated that Patient 1 had an exploratory laparotomy (surgery to open up the belly area [abdomen]) for trauma (injury resulting from a motor vehicle collision) (Surgery #1).

A review of Patient 1's "Operation Report," dated 5/24/22, at 11:49 P.M., indicated that Patient 1 had undergone a "Reopening of recent laparotomy" and "bedside pericardial window (procedure done on the sac around the heart)." (Surgery #2)

During an interview on 11/08/2022, at 3:00 P.M., with Surgeon 1 (MD 1), MD 1 stated he (MD 1) intentionally left a QuikClot and a lap pad in Patient 1's abdomen during an exploratory laparotomy (a surgical procedure to open up the belly area) on 5/24/2022.

During an interview on 11/14/2022, at 10:15 AM, with Registered Nurse 2 (RN 2), RN 2 stated the operating room (OR) nurses would document the type and quantity of materials packed in the patient and when it was removed on the packing flowsheet (a place to record and track a sequence of events). These documentations were not done during Surgery #1 for Patient 1.

During a concurrent interview and record review on 11/14/2022, at 10:23 A.M., with OR Nurse Manager (NM 1), Patient 1's packing flowsheet was reviewed. The packing flowsheet, dated 5/24/2022, did not indicate a purposely retained lap pad inside Patient 1's abdominal cavity. NM 1 stated RN 4 should have also included the retention of the lap pad in the documentation.

During an interview 11/10/2022, at 3:00 P.M., with Surgeon 2 (MD 2), MD 2 stated the risk for leaving surgical material inside Patient 1 could potentially lead to an infection.

A review of Patient 1's Computerized Tomography (CT- a scan of the body used to identify disease, injury, and items inside the body) report dated 6/3/2022 indicated a lap pad within Patient 1's left upper abdomen.

A review of Patient 1's packing flowsheet record, from 05/24/2022 to 5/27/2022, did not indicate the packing material (lap pad) was removed from Patient 1's abdomen.

A review of Patient 1's "Operation Report, dated 6/3/2022, at 4:00 A.M., indicated Surgeon 2 (MD 2) found a lap pad inside Patient 1's abdominal cavity. The lap pad was removed during Surgery #4 on 6/3/2022 and was sent to pathology (to study the cause of a disease or injury) and swabbed for culture (a test to find an infection).

A review of the facility's policy and procedure (P&P) titled, "Counts: Sponges, Sharps, Instruments and Special Items Policy," dated 2/5/2020, indicated sponges intentionally used as packing and the patient leaves the operating room with this packing in place, the type and quantity of sponges(s) retained must be documented. The purpose of the P&P is to provide a consistent approach for prevention of retained surgical items for all surgical procedures.


2. During an interview with Surgeon 1 (MD 1) on 11/9/2022, at 3:30 P.M., MD 1 said that during the Abdominal Surgery of Patient 1, on 5/24/2022, MD 1 intentionally left a QikClot and a laparotomy pad (lap pad) inside Patient 1's abdomen-Left Upper Quadrant (LUQ).

A Review of MD 1's Medical Record Note titled "Operative Report," dated 5/24/2022, under Operative Procedure section of the Operative Report, indicated MD 1 discussed X-ray findings with radiology. However, the MD 1 Note did not specify which radiologist he [MD 1] spoke with. The Operative Report further indicated that MD 1 intentionally left a "QuikClot lap pad" in Patient 1's abdominal cavity. Additional review of the Operative Report's section titled: "DRAINS/TUBES/LAPS," also indicated "One (1) QuikClot lap pad in the left upper quadrant."

During a concurrent interview and record review on 11/9/2022, at 3 P.M., with Radiologist 3 (MD3), Patient 1's Chest and Abdomen X-ray report (taken on 5/24/2022) was reviewed. The X-ray report indicated the presence of a lap pad in Patient 1's abdominal cavity (LUQ). MD 3 stated the X-ray finding was communicated to Surgeon 1 (MD 1) in the operating room on 5/24/2022.

During a concurrent interview and record review on 11/10/2022, at 3:00 P.M., with Surgeon 2 (MD 2), Patient 1's X-ray report, dated 5/27/22, and MD 2's Operative Report, dated 5/27/2022, were reviewed. MD 2's Operative Report indicated MD 2 performed Patient 1's Abdominal closure surgery on 5/27/22 (Surgery #3). MD 2 stated he (MD 2) was not notified about an intentionally retained lap pad in Patient1's abdominal cavity in the LUQ (lap pad was intentionally left in place by MD 1 on 5/24/2022 during Surgery #1).

A review of Patient 1's Chest X-ray and Abdominal X-ray report (Radiology Report), dated 5/27/2022, which was completed by Radiologist 2 (MD 4), indicated presence of "stable packing material or lap pad in LUQ." The Radiology Report also indicated that MD 4 reviewed and discussed the Abdominal X-ray results with RN 1 on 5/27/2022 at 5:53 P.M. There was no documentation to indicate if Operating Room Nurse (RN 1-who received the X-ray report from MD 4) relayed the reported presence of the retained lap pad in Patient 1's abdominal cavity to MD 2 who performed the abdominal closure on 5/27/2022 (Surgery #3).

A review of Patient 1's Acute Care Surgery Daily Trauma Team Notes, with dates from 5/24/2022 to 5/27/2022, did not indicate presence and plan for the intentionally left lap pad in Patient 1's abdominal cavity (LUQ) (intentionally left by MD 1 on 5/24/2022). The Trauma Team Notes also indicated that Patient 1 developed a fever on 6/3/2022. Further review of the Trauma Team Daily Notes indicated that, on 6/3/2022, a CT of Abdomen indicated "Stable packing material lap pad within the left upper quadrant." Consequently, On 6/3/2022, Patient 1 had an operation for removal of retained lap pad in Patient 1's abdominal cavity, which was not removed on 5/27/2022 during the abdominal closure (Surgery #3).

A review of Patient 1's Computerized Tomography (CT- a scan of the body used to identify disease, injury, and items inside the body) of Abdomen Report, dated 6/3/2022, indicated that the clinical indication for the CT abdomen done on 6/3/2022 was for "fever of unknown origin."

A review of the facility's Policy and Procedure (P&P), titled "Reporting of Imaging Studies and Procedures: Critical Tests, Emergent and Unexpected/Significant Abnormalities," dated 5/13/2001, indicated Critical tests and emergent results is communicated by phone or other verbal communication to responsible Healthcare provider, and if unable to reach the Physician, these results will be communicated to the floor nurse.

A review of the facility's Policy and Procedure (P&P), titled "Counts: sponges, sharps, instruments, and Special Items Policy: Clinical manual/General Clinical," dated 2/5/2020, indicated, 1. the Intentionally used packing type and quantity should be documented in the intraoperative record. 2. There should be RN to RN hand off reports of the intentional retained packing and, 3. If Patient returns to the OR the removal must be documented and verified by X-ray.