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Based on observation, interview, and record review, the facility failed to ensure surgical services were provided in accordance with accepted standards of practice when:

1. Instruments opened in the operating room (OR), but not used during the surgical case, were not considered contaminated and were not cleaned and decontaminated;

2. Two instrument sets, used during surgical cases, were sprayed with a pre-cleaning agent, brushed with a worn and discolored brush, and not decontaminated prior to packaging for sterilization;

3. One set of instruments, used to debride (remove dead, damaged, or infected tissue) an infected wound, were not brushed during the cleaning and decontamination process;

4. The decontamination room and the scope reprocessing room were not terminally cleaned;

5. Surgical Technician (ST) 1 opened the instruments and supplies for a surgical procedure with the OR door open to the hallway;

6. The autoclave (sterilizer) in the scope reprocessing room was not maintained to prevent buildup of calcium and discoloration of the autoclave pipe and surrounding floor, and to prevent steam from entering the room through a grate in the floor;

7. Endoscopes and colonoscopes (used for visualizing the esophagus, stomach, and colon) were stored in a cabinet in the OR hallway, not properly functioning or covered;

8. The surgery department was reprocessing disposable instruments for use in the emergency department;

9. Multiple surgical instruments had tape on them that was becoming loose and creating a flap for bio burden and other substances to adhere to; and,

10. One registered nurse (CN) who was not qualified to perform the duties of a circulating nurse in the OR, was placed on call as a circulating nurse (Refer to A944).

The cumulative effect of these systemic problems resulted in a retained surgical sponge, an increased risk of surgical site infections, and the inability to ensure surgical services were being provided in a safe and effective manner.

Findings:

1. During a tour of the OR on April 17, 2018, at 2:45 p.m., two instrument trays, each with multiple instruments in them, were observed on a shelf in the instrument decontamination room.

During an interview with ST 1 on April 17, 2018, at 5 p.m., ST 1 stated one of the trays was a, "minor tray," and was used earlier in the day to repair a hernia. ST 1 stated the other tray was a, "D&C tray," (for gynecological procedures) and was used earlier in the day to remove a vaginal polyp (growth).

ST 1 stated at the end of the surgical cases, he separated the used instruments from the unused instruments, only decontaminated the instruments that had been used, then placed the decontaminated instruments back into the tray with the unused instruments. ST 1 stated he did not do any cleaning or decontamination of the unused instruments.

During an interview with the Chief Nursing Officer (CNO) on April 18, 2018, at 1:10 p.m., the CNO stated the surgery department staff should be following Association of periOperative Registered Nurses (AORN) guidelines.

According to the AORN Guidelines for Cleaning and Care of Surgical Instruments,

Recommendation III.c:

All instruments opened onto the sterile field in the operating room or procedure room should be cleaned and decontaminated whether or not they have been used. Scrubbed persons may touch and contaminate instruments without being aware of it. Instruments that were used may come in contact with unused items. Airborne microorganisms may come in contact with instruments that have not been used. Contamination of unused instruments on the sterile field can occur without the occurrence being noticed.

2. During a tour of the OR on April 17, 2018, at 2:45 p.m., a two compartment sink was observed in the instrument decontamination room. Each compartment of the sink contained surgical instruments and a small sized round metal basin, with a residual amount of suds in each basin. The instruments did not have suds on them. The instruments on the right side included one clamp and one laryngoscope blade (used for inserting an airway during anesthesia), both with a blood colored substance on them.

On April 17, 2018, at 4 p.m., ST 1 was observed processing the instruments. ST 1 used a white brush with worn, discolored (yellowish) bristles to brush the instruments under running water. He did not submerge the instruments in water. He did not use any chemical or detergent during the cleaning/decontamination of the instruments.

In a concurrent interview, ST 1 stated the brush he used on the instruments had been in use, "for awhile," and they did not decontaminate the brush on a regular basis. ST 1 stated he sprayed the instruments with a pre-cleaning agent at the end of the cases (each side of the sink had instruments from a different case), then put the instruments in the sink until he could clean/decontaminate them at the end of the day. ST 1 stated both sets of instruments were, "slightly used," and they did not have, "that much blood," on them, so he did not use any detergent or any chemical for cleaning/decontamination. ST 1 stated the pre-cleaning agent was, "cheaper," than enzymatic detergent, so if there was only a little bit of blood on the instruments, he just used the pre-cleaning spray and did not use enzymatic detergent.

ST 1 stated the facility did not have a washer to put the instruments through, so they had to, "hand wash," all of the instruments.

The Medline Foam First Surgical Instrument Pre-Clean instructions for use (IFU) were reviewed on April 18, 2018. The IFUs indicated the following:

a. The spray was to be used for pre-treating soiled instruments immediately after surgical procedures, prior to further cleaning and sterilization;

b. The spray was used to, "quickly start," the cleaning process; and,

c. The proper procedure was to spray the foam on, then allow the instruments to soak in the foam, "until ready for further cleaning."

During an interview with the Chief Nursing Officer (CNO) on April 18, 2018, at 1:10 p.m., the CNO stated the surgery department staff should be following Association of periOperative Registered Nurses (AORN) guidelines. She stated ST 1 was never told to use only pre-cleaning spray on surgical instruments.

According to the AORN Guidelines for Cleaning and Care of Surgical Instruments;

Recommendation III:

Instruments should be cleaned and decontaminated as soon as possible after use;

Recommendation IX.a.3:

Instruments should be submerged while cleaning in a solution of water and detergent intended for cleaning surgical instruments; and,

Recommendation VIII.d.2:

Brushes used to clean instruments should be either designed for single use and discarded after each use or be reusable and decontaminated at least daily or more frequently as needed.

3. On April 17, 2018, at 4:05 p.m., ST 1 was observed cleaning/decontaminating a (different) set of surgical instruments (just used to debride a wound). ST 1 filled the right hand side of the sink to a pre-marked red line, then added a package of an enzymatic pre-soak to the water. ST 1 soaked the instruments for 20 minutes, then added a package of enzymatic detergent and soaked the instruments for another 20 minutes.

At 4:45 p.m., ST 1 drained the enzymatic treated water from the sink. ST 1 then rinsed the instruments with running water and placed them in the instrument container to dry. ST 1 did not brush any of the instruments that were used to debride the wound.

During an interview with the Chief Nursing Officer (CNO) on April 18, 2018, at 1:10 p.m., the CNO stated the surgery department staff should be following Association of periOperative Registered Nurses (AORN) guidelines.

According to the AORN Guidelines for Cleaning and Care of Surgical Instruments;

Recommendation VIII.d.1:

Tissue and debris can become lodged in crevices, lumens, and other areas of instruments. Use of a brush intended for these difficult-to-clean areas assists in effectively removing organic material and debris.

4. On April 17, 2018, at 4:20 p.m., The housekeeper was observed cleaning the walls in OR 1. During a concurrent interview, the housekeeper stated they terminally cleaned both ORs at the end of each day. The housekeeper stated they did not terminally clean any other areas in the surgery department, including the two areas where instruments and scopes were decontaminated or the sterile processing department.

During an interview with the Chief Nursing Officer (CNO) on April 18, 2018, at 1:10 p.m., the CNO stated the surgery department staff should be following Association of periOperative Registered Nurses (AORN) guidelines.

According to the AORN Guidelines for Cleaning and Care of Surgical Instruments;

Recommendation IV:

Perioperative areas should be terminally cleaned;

Recommendation IV.a:

Terminal cleaning and disinfection of perioperative areas, including sterile processing areas, should be performed daily when the areas are being used; and,

Recommendation IV.a.1:

For terminal cleaning in semi-restricted and restricted areas (eg, operating or procedure rooms, sterile processing areas, corridors, storage areas), a multidisciplinary team should determine the frequency and extent of cleaning required when areas are not occupied (eg, unused rooms, weekends).

5. On April 17, 2018, at 2:30 p.m., ST 1 was observed in OR 1 opening instruments and supplies to be used for the next (sterile) surgical procedure. The door to OR 1 was in the open position while he opened the case. The nurse anesthetist was observed entering the room from the surgery hallway, and did not close the door when she entered.

In a concurrent interview, ST 1 stated they were waiting for the patient to arrive to bring them into the room.

During an interview with the Chief Nursing Officer (CNO) on April 18, 2018, at 1:10 p.m., the CNO stated the surgery department staff should be following Association of periOperative Registered Nurses (AORN) guidelines.

According to the AORN Guidelines for a Safe Environment of Care:

Recommendation IV.j:

Doors to the operating room should be kept closed except during the entry and exit of patients and personnel, when opening is required for a procedure related reason. When the doors are left open, the heating/ventilation/air conditioning (HVAC) system is unable to maintain critical environmental control parameters. Leaving the door open can disrupt pressurization. The ventilation system in the OR is designed to administer air pressure that is greater than the pressure in the semi-restricted (hallway) area.

6. During a tour of the surgery department on April 17, 2018, at 2:35 p.m., an autoclave (sterilizer for surgical instruments) was observed in an alcove that joined the surgery hallway to the recovery room. A square shaped grate was observed in the floor between the autoclave and a blanket warmer, and a continuous audible hissing sound was heard coming from the area. The floor grate was a rusty color, and the floor had brown discoloration around the grate. The pipes coming from the autoclave had a bluish green discoloration approximately halfway up the pipes, with a crusted white substance covering the bottom quarter of the pipes. A continuous flow of steam was observed coming from the grate into the alcove.

During a tour of the surgery department on April 18, 2018, at 10:55 a.m., the alcove with the autoclave continued to have a hissing sound, with a continuous flow of steam still coming from the grate in the floor.

During an interview with ST 1 on April 18, 2018, at 11:05 a.m., ST 1 stated he did not know why steam was coming from the grate in the floor. ST 1 stated that was out of his, "realm."

During an interview with the Chief Nursing Officer (CNO) on April 18, 2018, at 1:10 p.m., the CNO stated the surgery department staff should be following Association of periOperative Registered Nurses (AORN) guidelines.

During a tour of the surgery department with the Infection Control Coordinator (ICC), the CNO, and the Assistant Manager of Plant Operations (AM) on April 18, 2018, at 1:30 p.m., the AM stated the grate in the floor was a steam trap. He stated he did not know if the autoclave was supposed to release steam continuously like it was doing, or if it should release steam intermittently. The AM stated he did not know if it was functioning properly, so he would call the company and have them come out and check the autoclave. The AM stated the white buildup on the autoclave pipes was calcium deposits, and there was rust on the grate in the floor. The AM stated, "It needs to be cleaned up."

According to the AORN Guidelines for Environmental Cleaning;

Recommendation II:

The patient should be provided with a clean, safe environment.

7. During a tour of the surgery department on April 17, 2018, at 3 p.m., a scope storage cabinet was observed in the surgery hallway with six scopes (endoscopes and colonoscopes) hanging in it. A rectangular box with vents was observed in the upper right hand corner, inside the cabinet. There was no air flowing from the vents. The cabinet had a roll down door that was in the open position. The cabinet was covered with a rectangular cover made of nylon on the top, back, and sides, and plastic in the front. A zipper was located on each side of the cover, extending from the top to the bottom of the cover. The top corners of the cover were not lined up with the top corners of the cabinet, resulting in an incorrect fit. The side zippers were not zipped, and the scopes were exposed to the traffic of staff and patients going into and out of the department.

During an interview with the Chief Nursing Officer (CNO) on April 18, 2018, at 1:10 p.m., the CNO stated the surgery department staff should be following Association of periOperative Registered Nurses (AORN) guidelines.

During an interview with ST 2 on April 18, 2018, at 1:45 p.m., ST 2 stated the vent in the cabinet, "has been broken for a long time."

According to the AORN Guidelines for Processing Flexible Endoscopes;

Recommendation IX:

Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage;

Recommendation IX.b.1:

Flexible endoscopes should be stored in a drying cabinet. Drying cabinets include a drying system that circulates HEPA-filtered air through the cabinet while filtered air under pressure is forced through the endoscope channels; and,

Recommendation IX.b.2:

If a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscope.

8. During a tour of the surgery department on April 17, 2018, at 2:45 p.m., multiple pairs of scissors and pickups (surgical instrument used to hold skin and tissue during a procedure) were observed on a shelf in the decontamination room.

During an interview with ST 1 on April 17, 2018, at 5:10 p.m., ST 1 stated the instruments were sent from the emergency department for reprocessing, and sent back to them sterile in peel packs. ST 1 stated the instruments were supposed to be disposable, but they resterilized them and reused them. ST 1 stated he did not know whether the facility had literature from the manufacturer or any other organization indicating resterilizing the disposable instruments was a safe practice.

During an interview with the Chief Nursing Officer (CNO) on April 18, 2018, at 1:10 p.m., the CNO stated the surgery department staff should be following Association of periOperative Registered Nurses (AORN) guidelines. The CNO stated she did not know they were resterilizing disposable surgical instruments, and they should not be.

According to the AORN Guidelines for Cleaning and Care of Surgical Instruments;

Recommendation II:

Devices labeled as single-use should not be reprocessed unless the Food and Drug Administration (FDA) guidelines for reprocessing of single-use devices can be met. The requirements include registering as a reprocessing firm and listing all products that are reprocessed, submitting reports of associated adverse events to the FDA, tracking devices that (in the event of failure) could have serious outcomes, correcting or removing from the market unsafe devices, and meeting manufacturing and labeling requirements.

9. On April 18, 2018, at 11:15 a.m., ST 1 was observed assembling a minor tray (of surgical instruments). Multiple instruments in the tray (including clamps, scissors, and a retractor) were observed with surgical marking tape wrapped around a part of the instrument, with the edges lifted and curling off, creating a flap effect. In a concurrent interview, ST 1 stated he was aware of the tape lifting, but they did not have time to remove the tape from the instruments.

According to the Association for the Advancement of Medical Instrumentation (AAMI), Instruments should be carefully inspected for flaws, damage, debris, detergent residue, and completeness, then dried. Instrument tape and plastic dipping material, when used properly, are ways to identify specific instruments. These types of marking products wear out over time. As soon as the tape begins to peel or chip, it must be cleaned off and replaced. Staff should check the tape each time the instrument is processed, and tape changes should be documented.

Based on interview and record review, the facility failed, to ensure a registered nurse qualified in performing the duties of a circulating nurse in the operating room (OR), was on call for Patient 1's emergency surgical procedure, in accordance with their policy and procedure and recommended standards of practice. This failure resulted in no audible first count of the surgical sponges, sharps, or instruments, which resulted in one surgical sponge remaining in Patient 1, necessitating an additional surgical procedure to remove the retained sponge.

Findings:

A review of Patient 1's record was conducted. Patient 1 presented to the facility's emergency department, on March 24, 2018, at 6:28 a.m., with complaints of abdominal pain, nausea, vomiting, diarrhea, and general weakness.

On March 24, 2018, at 6:48 p.m., Patient 1 had an esophagogastroduodenoscopy conducted by the Surgeon (MD) 1, to evaluate the source of the abdominal pain, (EGD-a test to examine the lining of the esophagus, stomach, and the first part of the small intestine).

The record review indicated, during the EGD Patient 1 required an emergency laparotomy, (a surgical procedure involving an incision through the abdominal wall to gain access into the abdominal cavity) due to a bleeding duodenal ulcer (an ulcer that develops in the first part of the small intestine).

Further record review indicated Patient's post operative course was complicated by ongoing drainage from a Jackson-Pratt (JP) drain (for collecting bodily fluids draining from surgical sites). Due to this drainage a CAT scan (a type of x-ray), was taken which revealed a retained surgical item. A second surgery was completed on April 4, 2018, to remove what was found to be a surgical sponge and determine the cause of the ongoing drainage from the surgical site.

After the second surgery drainage from the JP drain continued and due to this drainage Patient 1 was subsequently transferred on April 8, 2018, to a higher level of care where an interventional gastroenterologist could intervene as needed (a specialist in doing endoscopies, a procedure that involves the use of a flexible scope).

An interview was conducted on April 18, 2018, at 9:20 a.m., with MD 1. MD 1 stated during (Patient 1's) EGD, when a biopsy was taken, blood began, "pouring out." At that time Patient 1 was moved from operating room (OR) two, to OR one as the patient's blood pressure was falling. MD 1 further stated an immediate laparotomy was performed due to a bleeding duodenal ulcer. The patient was transfused with four units of blood. A JP drain was placed. MD 1 stated he thought about doing an X-ray when the patient was stable after the surgery but did not order an X-ray.

MD 1 further stated the JP drain continued to drain post operatively and he thought there may be a leak in the patient's intestine. MD 1 stated he ordered a CAT scan, for Patient 1 and subsequently received a phone call from the radiologist who told MD 1 Patient 1 may have a pelvic abscess due to a foreign body. MD 1 stated a follow up X-ray confirmed a potential retained sponge.

MD 1 further stated he decided to proceed with a second surgery on April 4, 2018, to repair a potential leak in the patient's intestine and remove the retained sponge.

During a tour of the recovery room on April 17, 2018, at 3:45 p.m., an interview was conducted with the Registered Nurse, (CN), who was assisting as the circulating nurse during Patient 1's emergency laparotomy. The CN stated she usually worked in both the pre and post operative (op) areas, and was training to assist as a circulating nurse.

When asked about staffing and on call duties, the CN stated normally there were two registered nurses (RN's), one in pre and post op, and the other RN to do circulating duties during surgery. The CN further stated after hours there was only one RN on call who would circulate and recover the patient. The CN stated they recently had an emergency when she was on call and she circulated but realized she was not trained well enough to circulate and was now scared to take call.

A subsequent interview was conducted with the CN, on April 18, 2018, at 8:30 a.m. The CN stated, she was asked to cross train as a circulating nurse in the OR and she agreed to do so. The CN stated she had one or two days of learning how to circulate, when the OR manager went on vacation.

The CN stated she went into surgical cases when she had time, but it was difficult for the OR staff to instruct her during a busy case. The CN stated she bought a book about working in the OR so she could read it and try to learn. The CN stated she was never taught what to do during an emergency in the OR. The CN stated the problem was when she was placed on call she didn't feel prepared for emergencies as she had never circulated for an entire surgical case.

The CN further stated she was on call on March 24, 2018, and was called to come in to assist with an EGD involving (Patient 1). The CN stated, "MD 1 noticed a huge ulcer in the patient's duodenum and the ulcer started bleeding so fast, it was an emergency, (Patient 1) was pale, turning white, he was intubated, I wasn't paying attention to the (Surgical Tech), I was running around. I don't know a lot about instruments. I looked at the tray table and I did a silent count, I didn't interrupt anyone, I should have been more verbal. With (Patient 1) there were no audible first counts."

The CN stated, "The usual process is when the surgical technician opens the surgical case, an audible count is done and I write the sponge, needle and suture count on the white board. The instrument count would be written on a paper document."

An interview was conducted on April 19, 2018, at 1:10 p.m., with the Chief Nursing Officer , who stated the facility should adhere to the standards of the Association of periOperative Registered Nurses, (AORN).

According to the current AORN Guideline Recommended Practices for Prevention of Retained Surgical Item;

Recommendation I.b.1:

The RN circulator should facilitate the count process by initiating the count, performing count procedures in concert with the perioperative team, documenting count reconciliation activities, and reporting any count discrepancy.

Recommendation I.c:

The scrub person and the RN circulator should perform standardized procedures when accounting for all surgical items opened or used during a procedure as required by the health care organization's policy.

A review of the facility policy and procedure, "Surgical Services, (Revised: 09/11)," was conducted. The policy indicated, "All patients, undergoing surgical procedures, shall remain free from the retention of sponges, sharps, miscellaneous surgical supplies and instruments.

The procedure indicated, "A complete sponge, sharp, and instrument count will be performed: Prior to the start of the procedure...Sponges, when counted, should be separated, counted audibly, and concurrently viewed by the scrub person and a circulating RN."

A review of the facility's Surgical Services policy and procedure, "Staff Education and Training (Revised 03/10)," was conducted. The policy indicated the facility would provide relevant educational instruction and training to the Surgical Services nursing personnel based on the assessment and evaluation of employee knowledge and skills in the departmental requirements.

A review of the facility policy, "Surgical Services Department Scope of Service, (Review Date 3/17)," was conducted. The policy indicated, "The provision of nursing care Surgery Department is organized to provide safe and effective care for patients, under the direction of qualified, competent, and sufficient registered nurses."