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Based on record and interview, the facility failed to ensure 3 patient (Patient 15, Patient 28, and Patient 31) out of 32 patients had care plans developed for care which involved a medical diagnosis, physician orders and nursing interventions as part of a treatment plan when:

1. Patient 15 lacked a skin breakdown prevention care plan when he was at risk of skin breakdown due to debilitated state.

2. Patient 28 lacked a restraint care plan when he was placed in soft wrist restraints to prevent injury due to confusion.

3. Patient 31 lacked a diabetic care plan when diabetic nursing interventions were part of her treatment plan for diabetes.

Theses failures to ensure care plans were developed decreased the continuity and assurance that outcomes were accomplished to meet goals of treatment and had the potential to result in a delay in treatment.

Findings:

1. During an interview on 9/8/15 at 3:25 p.m., Licensed Staff J stated Patient 15 was very malnourished and "bony" in appearance. Licensed Staff J stated she began a care plan when Patient 15 developed skin breakdown due to skin shear to his bony spine. She stated that there should have been a prevention skin breakdown care plan if his Braden Scale (tool to determine skin breakdown potential) was lower than 18.

Patient 15's emergency room physician report dated 1/8/14, on 9/9/15 at 2 p.m.,
indicated Patient 15 had a kyphotic (curvature of spine) condition, reduced range of motion and small skin changes noted on the right hip consistent with stasis (reduced blood flow).

Nurses notes from 1/8/14, when patient 15 was admitted, indicated fragile, intact skin, limited mobility, on bed rest, inadequate nutrition with friction and shear as a potential problem. The Braden scale (scale for skin breakdown) score was 13 out of 23 (moderate risk), redness was noted on the 1/19/14 and abrasion, open wound to mid spine documented on 1/21/14.

Patient 15's care plans indicated that a care plan was not initiated for prevention of or skin breakdown until 1/21/14, after skin breakdown was noted.

The Pressure Ulcer and Wound Care assessment and management last revised on 1/15 indicated that interventions to prevent skin breakdown based on the Braden Scale for pressure ulcer risk indicated that a Braden scale # of 13-14 was moderate risk and interventions included turning, positioning pads, pressure reduction surface protection devices and managing moisture and friction and shear. The Policy indicated that all patients will be assessed for risk of skin breakdown (Braden scale) on admission and a care plan will be documented on those patients whose score was 18 or less.

2. Patient 28 had a physician's order dated 6/26/15, for soft wrist restraints for pulling out intravenous lines and tubes. The order form indicated that staff should update the care plan to reflect the use of restraints. Patient 28's care plans did not indicate there was a care plan for restraints. During an interview at this time, Administrative Staff I stated there was no care plan in the record when the restraints were initiated.

On 9/10/15, review of the policy and procedure for the use of restraints dated 3/14, indicated the use of restraints must be documented in the Patient's plan of care or treatment plan.

History and physical dated 7/15/15 indicated Patient 31 was admitted on 7/15/15 with cellulitis (bacterial infection of the inner layer of skin) and had a complex medical history which included diabetes mellitus and was on peritoneal (abdominal) dialysis at home.

Medication administration record dated 7/15/15 indicated patient was on Insulin NPH (Neutral Protamine Hagedorn- intermediate acting insulin) 10 units per SQ (subcutaneous tissue injection) two times a day. During an interview at this time, Administrative Staff I agreed that there was no care plan for diabetes in the record.

Physician telephone orders, dated 7/15/15, indicated blood sugar finger stick testing every AC (before meals) and HS (bedtime) with insulin sliding scale (insulin adjustment according to blood sugars) and Patient 31 was to use her own dialysis machine for dialysis.

Patient 31's nursing care plans dated 7/15/15, included skin integrity, wounds, physiological and psychological disturbances, knowledge deficit and risk for injury but did not include interventions for diabetic care.

During an interview on 9/11/15 at 10:20 a.m., Administrative Staff I stated that care plans were important for the continuity of care and were what staff should be focusing on. The nursing care plans should be "customized" for each patient.

The facility care plan on line guidelines, (Lippincott source) for Care Plan Preparation, revised 4/3/15, indicated a care plan directed the patient's nursing care for admission to discharge. The care plan should be written for each patient preferably within 24 hours of admission and usually started by the patient's primary care nurse who admitted the patient.

Based on interview and record review, the facility failed to delineate clearly and implement an effective system for obtaining physician signatures on telephone orders. This failure had the potential to result in inappropriate treatment or care activities when telephone orders were not authenticated by a physician.

Findings:

Review of the medical record on 9/10/15 for Patient 2 revealed telephone orders dated 9/5/15 at 0655 (6:55 a.m.), 1400 (2 p.m.), and 2220 (10:20 p.m.). Telephone orders are given by the physician via telephone to authorized staff and must be authenticated with the physician's signature at a future time. None of the orders were signed by a physician.

Review of the medical record on 9/10/15 for Patient 26 revealed telephone orders dated 6/8/15 at 1000 (10 a.m.), 6/8/15 at 1348 (1:48 p.m.), 6/9/15 at 1725 (5:25 p.m.), 6/10/15 at 1130 (11:30 a.m.), 6/10/15 at 1248 (12:48 p.m.), 6/10/15 at 1350 (1:50 p.m)., 6/11/15 at 0005 (12:05 a.m.), and 6/11/15 1300 (1 p.m.). None of the orders were signed by a physician.

Review of the medical record on 9/10/15 for Patient 30 revealed telephone orders dated 7/12/15 at 0655 (6:55 a.m.) and 7/13/15 at 1315 (1:15 p.m.). Neither order was signed by a physician.

Review of the medical record on 9/10/15 for Patient 31 revealed a telephone order dated 7/15/15 at 2130 (9:30 p.m.). The order was not signed by a physician.

During an interview on 9/10/15 at 10 a.m., Licensed Staff B stated telephone orders are flagged by the unit secretary with a small yellow tab for the primary physician or another physician assuming care of the patient to sign. Licensed Staff B stated unsigned telephone orders which are identified by medical records staff in a chart audit after the patient is discharged are faxed to the physician for a signature. Licensed Staff B confirmed the above orders did not have the required physicians' signatures.

During an interview and concurrent record review on 9/10/15 at 10:35 a.m., Pharmacy K stated the pharmacy did not have a way to obtain electronic signatures on the above-listed telephone orders. Pharmacist K stated, "These have to be signed manually."

During an interview and concurrent record review on 9/10/15 at 11:45 a.m., Staff C stated telephone orders needing a signature are flagged electronically by the medical records department and sent to the physician's queue for an electronic signature. Staff C stated the electronic signature is evident on the computer screen and on printed copies of the telephone order after it is completed. Staff C confirmed the above-listed telephone orders lacked the required physician signature.

Review of facility policy titled "Clinical Documentation in the Patient Medical Record," reviewed/revised July 2014, revealed "When a handwritten order by MD or telephone order by RN or other authorized ancillary staff is present in the chart, it is the responsibility of the RN to note the order. This is completed by:... [Item] 5. Telephone order must be signed by the MD within 48 hours."

Review of facility policy titled "Verbal and Telephone Order Policy," reviewed/revised November 2014, revealed "All verbal and electronic orders issued and recorded on a paper record must be cosigned, dated and timed within 30 days."

Based on observation, interview, record review, and document review, the facility failed to provide surgical services in a well organized manner in accordance with acceptable standards of practice when:

1. Staff did not follow policies and procedures to ensure a sponge was not left in a surgical patient after surgery. This resulted in a foreign body left in Patient 14 which could have resulted in infections and adverse health conditions. Patient 14 had to have another surgery to remove the retained sponge that put Patient 14 at risk for bleeding, infection, and breathing problems. (Refer A951)

2. Staff did not follow policies and procedures to prevent immediate use sterilization for elective case instruments, which could lead to inadequate infection control measures to ensure adequate sterilization of instruments. (Refer 951)

3. Staff did not contain instruments and solutions used in surgical cases so cross contamination would not occur from a restricted to semi restricted areas upon transport. (Refer 951)

4. Staff did not maintain the restricted area for surgical cases when they moved the red surgical line used for the restricted area into a semi restricted area so they could transport contaminated instruments that were not contained to prevent cross contamination in to the decontamination area. (Refer 951)


The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the health and safety of patients who required surgical services in a safe and effective manner.

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

1. Ensure Staff followed policies and procedures to ensure a sponge was not left in a surgical patient after surgery. This resulted in a foreign body left in Patient 14 which could have resulted in infections and adverse health conditions. Patient 14 had to have another surgery to remove the retained sponge that put Patient 14 at risk for bleeding, infection, and breathing problems. (Refer A951)


2. Ensure staff followed policies and procedures to prevent the use of immediate use sterilization for elective case instruments, which could lead to inadequate control measures to ensure adequate sterilization of instruments.

3. Ensure staff contained instruments and solutions used on surgical cases so cross contamination did not occur in clean restricted or semi restricted areas upon transport.

4. Ensure staff maintain the restricted area for surgical cases when they moved the red surgical line for used for the restricted area into a semi restricted area so they could transport contaminated instruments that were not contained to prevent cross contamination in to the decontamination area. (Refer 951)


Findings:

1. The Department received a phone call from the facility Chief Quality Officer that a sponge was left in during a surgery performed on 5/21/15, and the sponge was removed during another surgery performed to remove the sponge.

During an observation on 9/8/15 at 11:20 a.m., of a laparoscopic cholecystectomy (gallbladder removal using a scope and small incisions), staff used gauze that had a radiopaque markings ( X-ray detectable). Staff counted the sponges before the start of the procedure and marked the amounts on a board on the wall in the Operating Room.

During an interview on 9/8/15 at 11:30 p.m., Staff A (operating room technician) stated, during the case on 5/21/15, there was a lot of bleeding and the physician must have grabbed things. Staff A stated she did not see the sponge put in the patient. Staff A stated, staff did not count at the end of the case. Staff A stated that the doctor wanted to close fast and did not finish the whole case, because the patient was so sick. Staff A stated that she thought about counting at the end, but the Registered Nurse who was circulating (nurse who supplies equipment and supplies to the sterile field during the case) was running around getting things for the doctors. Staff A stated that staff are supposed to count at the beginning, before closing each cavity, and when they close skin.

During an interview on 9/8/15 at 11:50 p.m., Licensed Staff D who circulated on the case, stated that he found out about the retained sponge when he got a phone call the next day. Licensed Staff D stated that he relieved a nurse who started the case. Licensed Staff D stated he went in and out of the operating room for things. Licensed Staff D stated (Patient 14) did not tolerate the procedure and they were in a rush to get the patient to recovery room. Licensed Staff D stated the surgeon did not communicate to the operating room staff that he put a sponge in the patient and Licensed Staff D was focused on helping anesthesia. Licensed Staff D stated that normally the last count is done before the dressing is placed on the patient. Licensed Staff D stated that the urgency of the case resulted in the error and stated "We completely failed the patient as a team". Licensed Staff D stated the count was "Pre Charted" (documentation before the event), that it was done and correct, which was a false chart entry and Licensed Staff D was not sure if he or the previous nurse entered the information.

During an interview on 9/8/15 at 12:35 p.m., Physician E (Patient 14's surgeon) stated, during the procedure, Patient 14 became acidotic (increased acid in blood) with increased CO2 (carbon dioxide ) indicating respiratory distress when breathing is compromised. Physician E stated that Patient 14 had increased bleeding and he put a sponge in the abdomen to absorb the blood. Physician E stated Patient 14 was getting sicker, was septic (systemic Infection) had heart irregularities. Physician E stated that he did not pay attention to the count. Physician E stated that he was paying attention to Patient 14's oxygen saturation (amount of oxygen in the blood), heart rate and blood pressure. Physician E stated that the patient went to ICU (Intensive Care Unit) after recovery. Physician E stated that it was recognized that there was a sponge in the patient, the next day, when the radiologist did a CT scan (computerized Tomography-computerized X-ray image procedure) to drain the the gallbladder. The radiologist saw it and reported it to Administrative Staff F and Physician E was informed. Physician E stated that he put the sponge in the patient but the circulating nurse was out of the room. Physician E stated that he always documented about the count on his operation record notes.


Physician E's operative record dated 5/21/15, indicated that Patient 14 was elderly and came through the emergency room with abdominal pain due to acute cholecystitis or inflammation of the gallbladder. Patient 14 also had acute kidney failure and atrial fibrillation, was scheduled for a laparoscopic versus open cholecystectomy. During the surgery, it was noted that the gallbladder was inflamed and there were adhesions between the large and small bowel or intestines. Due to the inflammation and risk of bowel injury, Physician E did not feel it was appropriate to continue. The operation report indicated at the end of the case, the sponge, needle and instrument counts were correct.

The CT scan performed on on 5/22/15 indicated that a tube was placed in the gallbladder for drainage and during the procedure, it was noted that there was an intra abdominal metallic density like a wire looped upon itself in the epigastric (upper abdominal) region.

The operative record dated 5/23/15 indicated Patient 14 returned to surgery and was noted to have a retained a marked radiopaque sponge overlying the omentum (membrane tissue covering the intestines) and mid abdomen. The sponge and the gallbladder were removed during the procedure.

During an interview on 9/9/15 at 3:05 p.m., Administrative Staff F stated that staff should not leave sponges in the abdomen as infection, pain, discomfort and adhesions can develop and sometimes the foreign body was not found until years later.

On 9/10/15, review of the policy for counts, sponges, sharps and instruments, last reviewed 8/13 indicated that sponges should be counted before the case starts, prior to closure of the cavity, before wound closure and at skin closure at the end of the case.

During an interview on 9/10/15 at 2:50 p.m., Administrative Staff F stated that a new universal protocol check system was started to ensure sponge counts were verified during the case, which was part of their corrective action plan for quality improvement. The Surgical Safety checklist used as part of the new universal protocol indicated the circulating nurse confirmed with the team, before the wound was closed, that instrument, sponge and needle counts were correct. Administrative Staff F stated he did not start the audits or monitoring of the new universal check system yet. Administrative Staff F then provided an audit form that he stated he was going to use. The audit tool for the universal check system was titled "Surgical Safety Checklist Audit Tool" undated and did not include verification that counts were done at appropriate time or what was done if counts were incorrect. During an interview at this time, Administrative Staff F stated that the audit form was missing the count procedure information and that should be added. Review of the Corrective action Plan indicated that real time observation audits would be done to monitor compliance with the new processes.

The Corrective Action Plan undated, indicated for Inadequate sponge count documentation and lack of understanding of documentation requirements, a quality improvement plan should be implemented with required tracking.

2. An observation on 9/9/15 at 8:55 a.m., of the sterilizer for immediate use, in the substerile room (room between operating rooms), indicated the sterilizer had a load that it was sterilizing. The sterilizer panel indicated that the temperature was set at 270 degrees Fahrenheit with a 4 minute sterilization and a 1 minute dry time. During an interview at this time, Administrative Staff F stated, staff were autoclaving the eye surgery instruments as they had 4 cases today and only two eye sets. The first set was being processed for the third case. Administrative Staff F stated it was identified by their accreditation agency as a problem. The sterilizer should be used for emergency use only.

The Facility policy titled sterilization, last reviewed 8/13 indicated under "Flash Sterilization" or immediate use sterilization that flash sterilization should be used for emergency sterilization of clean unwrapped instruments and porous items only.

Survey and Certification 14-44 indicated "Surgical instruments must ordinarily be sterilized using terminal sterilization cycles within rigid sterilization containers, wrappers, or primary packaging designed to maintain the instruments' sterility and which allow the devices to be stored for later use ("terminal sterilization"). "Flash Sterilization" is a term that was traditionally used to describe steam sterilization cycles where medical instruments and devices" are generally not packaged in preparation for sterilization;
are subjected to an abbreviated steam exposure time and no or minimal drying time; and are used promptly (i.e. without being stored)...Practices associated with the outmoded term "flash: sterilization have been implicated in surgical site infections and are considered to pose an increased risk of complication because of potential barriers to thorough completion of all necessary reprocessing steps."


The "Immediate Use Steam Sterilization" (IUSS) policy, effective 9/13, indicated immediate use sterilization should be kept to a minimum and only used in selected clinical situations such as when there is insufficient time to process in full cycle designed for wrapped instruments and in a controlled manner. IUSS should not be used as a substitute for insufficient surgical inventory.




3. During an observation on 9/9/15 at 3:30 p.m., Orthopaedic (bone) instruments that had just been used on a case were brought out of the operating room. They were on a table with a table cover and drape over the instruments. Staff G brought the table past 4 sterile wrapped instrument trays on a uncovered table in the hallway. Staff G then brought the table into the decontamination room and removed the drape to show bloody drill handles and bloody instruments in a basin. There was solution in the basin which Staff G stated was 1 liter (1000 cc) of sterile water. Staff G stated she used the drapes from the table, that were open on the procedure to cover the instruments during transport.

On 9/11/15, review of the Sanitation in the Operating Room Policy, dated 8/13 indicated every surgical procedure was considered contaminated and standard precautions were followed. Gowns, gloves and drapes were to be removed and placed in the proper receptacles prior to leaving the operating room.

On 9/11/15, review of the AST (Association of Surgical Technologists) Standards, dated 4/16/09, provided by the facility, for decontamination of surgical instruments, indicated contaminated instruments should be contained during transport from the point of use to the decontamination area. Contaminated instruments should be handled as little as possible at the point of use and should be immediately contained and transported to the decontamination area. Types of recommended containers include closed bins with lids, rigid sterilization container systems and impermeable bags.





4. During an observation on 9/9/15 at 8:25 p.m., of the soiled utility area, Administrative Staff F explained the instruments were transported covered into the decontamination area. The facility did not have covered containers or carts because the design of the facility was a problem, and there was a backup of instruments. Administrative Staff F explained that they moved the red line for restricted area back, so they could have the dirty decontamination area within the red line and felt that then, they could transport the dirty instruments without a cart or enclosed container.

During an interview on 9/9/15 at 8:30 a.m., Staff L (instrument cleaning staff) stated that instruments come out to be cleaned from the case, on the table covered with drapes from the case, Staff L stated the carts were expensive and the facility didn't have a place to store them.

During an interview on 9/9/15 at 9:55 a.m., Administrative Staff H stated that they moved the red line so they could bring instruments into the decontamination room without a cart. Administrative Staff H stated she thought the location of the red line or restricted area was down the hall near the hallway of the operating room before. The bathroom was not in the restricted area before.

The "New Surgery Department: Restricted Vs Semi Restricted" schematic design provided to the Department for licensing of the new operating room in 2013, indicated that the restricted area marked with red line was inside the double doors to the hallway of the operating room suites. The bathroom and decontamination area was in a semi restricted area.

The facility's policy and procedure titled, "Traffic Control in the Operating Room" indicated "C. Restricted Zone: this area includes the operating rooms, sub-sterile areas where unwrapped supplies are sterilized, the scrub room and the clean center core. Personnel must wear scrub attire, cap shoe covers, and mask. Restricted areas shall be marked with restricted access signs on doors and the floor clearly marked with a red line for the unrestricted zone...Traffic in restricted zones shall be limited to properly attired personnel involving the care of the patient. B. Semi-restricted Zone: This includes the operating room control center, offices in the vicinity, clean storage areas, and inner corridors off operating rooms.
Personnel must wear scrub attire including cap and shoe covers."



AORN 2014-Definitions related to Perioperative Environmental Cleaning define restricted and semi-restricted areas as follows:
"Restricted area": A designated space contained within the semi-restricted area and accessible only through a semi-restricted area. The restricted area includes the operating and other rooms in which surgical or other invasive procedures are performed. Personnel in the restricted areas should wear surgical attire and cover head and facial hair. Masks should be worn when the wearer is in the presence of open sterile supplies or persons who are completing or have completed a surgical hand scrub. Only authorized personnel and patients accompanied by authorized personnel should be admitted to this area. Semi-restricted area: The peripheral support areas of the surgical suite. The area may include storage areas for equipment and clean and sterile supplies; work areas for processing instruments; sterilization processing room(s); scrub sink areas; corridors leading from the unrestricted area to the restricted areas of the surgical suite; and the entrances to locker rooms, preoperative admission area, the PACU, and sterile processing. This area is entered directly from the unrestricted area past a nurse ' s station or from other areas. Personnel in the semi-restricted area should wear surgical attire and cover all head and facial hair. Access to the semi-restricted area should be limited to authorized personnel and patients accompanied by authorized personnel."

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

1. Ensure Staff followed policies and procedures to ensure a sponge was not left in a surgical patient after surgery. This resulted in a foreign body left in Patient 14 which could have resulted in infections and adverse health conditions. Patient 14 had to have another surgery to remove the retained sponge that put Patient 14 at risk for bleeding, infection, and breathing problems. (Refer A951)


2. Ensure staff followed policies and procedures to prevent the use of immediate use sterilization for elective case instruments, which could lead to inadequate control measures to ensure adequate sterilization of instruments.

3. Ensure staff contained instruments and solutions used on surgical cases so cross contamination did not occur in clean restricted or semi restricted areas upon transport.

4. Ensure staff maintain the restricted area for surgical cases when they moved the red surgical line for used for the restricted area into a semi restricted area so they could transport contaminated instruments that were not contained to prevent cross contamination in to the decontamination area. (Refer 951)


Findings:

1. The Department received a phone call from the facility Chief Quality Officer that a sponge was left in during a surgery performed on 5/21/15, and the sponge was removed during another surgery performed to remove the sponge.

During an observation on 9/8/15 at 11:20 a.m., of a laparoscopic cholecystectomy (gallbladder removal using a scope and small incisions), staff used gauze that had a radiopaque markings ( X-ray detectable). Staff counted the sponges before the start of the procedure and marked the amounts on a board on the wall in the Operating Room.

During an interview on 9/8/15 at 11:30 p.m., Staff A (operating room technician) stated, during the case on 5/21/15, there was a lot of bleeding and the physician must have grabbed things. Staff A stated she did not see the sponge put in the patient. Staff A stated, staff did not count at the end of the case. Staff A stated that the doctor wanted to close fast and did not finish the whole case, because the patient was so sick. Staff A stated that she thought about counting at the end, but the Registered Nurse who was circulating (nurse who supplies equipment and supplies to the sterile field during the case) was running around getting things for the doctors. Staff A stated that staff are supposed to count at the beginning, before closing each cavity, and when they close skin.

During an interview on 9/8/15 at 11:50 p.m., Licensed Staff D who circulated on the case, stated that he found out about the retained sponge when he got a phone call the next day. Licensed Staff D stated that he relieved a nurse who started the case. Licensed Staff D stated he went in and out of the operating room for things. Licensed Staff D stated (Patient 14) did not tolerate the procedure and they were in a rush to get the patient to recovery room. Licensed Staff D stated the surgeon did not communicate to the operating room staff that he put a sponge in the patient and Licensed Staff D was focused on helping anesthesia. Licensed Staff D stated that normally the last count is done before the dressing is placed on the patient. Licensed Staff D stated that the urgency of the case resulted in the error and stated "We completely failed the patient as a team". Licensed Staff D stated the count was "Pre Charted" (documentation before the event), that it was done and correct, which was a false chart entry and Licensed Staff D was not sure if he or the previous nurse entered the information.

During an interview on 9/8/15 at 12:35 p.m., Physician E (Patient 14's surgeon) stated, during the procedure, Patient 14 became acidotic (increased acid in blood) with increased CO2 (carbon dioxide ) indicating respiratory distress when breathing is compromised. Physician E stated that Patient 14 had increased bleeding and he put a sponge in the abdomen to absorb the blood. Physician E stated Patient 14 was getting sicker, was septic (systemic Infection) had heart irregularities. Physician E stated that he did not pay attention to the count. Physician E stated that he was paying attention to Patient 14's oxygen saturation (amount of oxygen in the blood), heart rate and blood pressure. Physician E stated that the patient went to ICU (Intensive Care Unit) after recovery. Physician E stated that it was recognized that there was a sponge in the patient, the next day, when the radiologist did a CT scan (computerized Tomography-computerized X-ray image procedure) to drain the the gallbladder. The radiologist saw it and reported it to Administrative Staff F and Physician E was informed. Physician E stated that he put the sponge in the patient but the circulating nurse was out of the room. Physician E stated that he always documented about the count on his operation record notes.


Physician E's operative record dated 5/21/15, indicated that Patient 14 was elderly and came through the emergency room with abdominal pain due to acute cholecystitis or inflammation of the gallbladder. Patient 14 also had acute kidney failure and atrial fibrillation, was scheduled for a laparoscopic versus open cholecystectomy. During the surgery, it was noted that the gallbladder was inflamed and there were adhesions between the large and small bowel or intestines. Due to the inflammation and risk of bowel injury, Physician E did not feel it was appropriate to continue. The operation report indicated at the end of the case, the sponge, needle and instrument counts were correct.

The CT scan performed on on 5/22/15 indicated that a tube was placed in the gallbladder for drainage and during the procedure, it was noted that there was an intra abdominal metallic density like a wire looped upon itself in the epigastric (upper abdominal) region.

The operative record dated 5/23/15 indicated Patient 14 returned to surgery and was noted to have a retained a marked radiopaque sponge overlying the omentum (membrane tissue covering the intestines) and mid abdomen. The sponge and the gallbladder were removed during the procedure.

During an interview on 9/9/15 at 3:05 p.m., Administrative Staff F stated that staff should not leave sponges in the abdomen as infection, pain, discomfort and adhesions can develop and sometimes the foreign body was not found until years later.

On 9/10/15, review of the policy for counts, sponges, sharps and instruments, last reviewed 8/13 indicated that sponges should be counted before the case starts, prior to closure of the cavity, before wound closure and at skin closure at the end of the case.

During an interview on 9/10/15 at 2:50 p.m., Administrative Staff F stated that a new universal protocol check system was started to ensure sponge counts were verified during the case, which was part of their corrective action plan for quality improvement. The Surgical Safety checklist used as part of the new universal protocol indicated the circulating nurse confirmed with the team, before the wound was closed, that instrument, sponge and needle counts were correct. Administrative Staff F stated he did not start the audits or monitoring of the new universal check system yet. Administrative Staff F then provided an audit form that he stated he was going to use. The audit tool for the universal check system was titled "Surgical Safety Checklist Audit Tool" undated and did not include verification that counts were done at appropriate time or what was done if counts were incorrect. During an interview at this time, Administrative Staff F stated that the audit form was missing the count procedure information and that should be added. Review of the Corrective action Plan indicated that real time observation audits would be done to monitor compliance with the new processes.

The Corrective Action Plan undated, indicated for Inadequate sponge count documentation and lack of understanding of documentation requirements, a quality improvement plan should be implemented with required tracking.

2. An observation on 9/9/15 at 8:55 a.m., of the sterilizer for